Before the

**DEPARTMENT OF HEALTH AND HUMAN SERVICES**

**FOOD AND DRUG ADMINISTRATION**

**Rockville, MD**

**)**

**In re: Request for Comment on First ) Docket No. 02N-0209**

**Amendment Issues )**

**)**

**)**

**)**

# COMMENTS OF

**JULIAN M. WHITAKER, M.D.; DURK PEARSON AND SANDY SHAW; PURE
ENCAPSULATIONS, INC.; WELLNESS LIFESTYLES, INC.; SUAREZ CORPORATION
INDUSTRIES, INC.; LIFE ENHANCEMENT PRODUCTS, [INC.; AND LIFE EXTENSION
FOUNDATION]{.underline}**

## Jonathan W. Emord;

Claudia A. Lewis-Eng;

Andrea G. Ferrenz;

Jonathan R. Goodman,

Legal Counsel

**Emord & Associates, P.C.**

## 1050 Seventeenth Street, N.W.

## Suite 600

Washington, D.C. 20036

**•**

## 5282 Lyngate Court

Burke, VA 22015

## Phone: 202-466-6937 • Fax: 202-466-6938

<jemord@emord.com>

Table of Contents

Introduction 3

I. Overview 8

II\. The Courts' Application of First Amendment Precedent to FDA Speech

Suppression 15

III\. FDA Censorship Rationales Are Anachronistic and Illegal in Light
of Current

First Amendment Precedent 36

IV\. First Amendment Limits on FDA Speech Regulation 42

A.  Scientific or Commercial Speech? 43

B.  The Principal Purpose of FDA Speech Regulation Is to Suppress
    Content,

> Not to Regulate Underlying Economic Activity, as such Exacting
> Scrutiny
>
> Must Be Applied 45

V. FDA Regulations, Guidances, Policies, and Practices that Violate the
First

Amendment 51

A.  FDA's Health and Structure/Function Claim Regulations Violate the
    First Amendment 52

    1.  FDA's Suppression of Health Claims for Dietary Supplements
        Violates the First Amendment 52

    2.  FDA's Suppression of Health Claims for Foods Violates the First
        Amendment 64

B. FDA's Suppression of Structure/Function Claims Due to the Presence of
Alleged

"Implied" Disease Claims Violates the First Amendment 70

1\. Dietary Supplements 71

2\. Foods 76

3\. FDA's Lack of a Provision for a Health Claim; Structure/Function
Claim

Regime for Animal Foods and Supplements Violates the First

Amendment 76

C. FDA's Nutrient Content Claim Regulations Violate the First Amendment
79

D. FDA's Authoritative Statements Review Violates the First Amendment 84

E. FDA's Drug and Device Claim Regulations Violate the First Amendment
92

1\. FDA's Suppression of Off-Label Use Claims Violates the First

Amendment 96

2\. FDA's Restrictions on Manufacturer Distribution of Scientific
Literature

on Off-Label Uses Violates the First Amendment 100

3.  FDA's Suppression of Medical Device Off-Label Use Claims Violates
    the

> First Amendment 107
>
> 4\. FDA's Restrictions on Industry-Sponsored Educational Activities
> Violate
>
> the First Amendment 108
>
> 5\. FDA's Restrictions on Direct to Consumer Drug Advertising Violate
> the
>
> First Amendment 116
>
> 6\. FDA's Suppression of Extralabel Use Claims for Animal Drugs
> Violate
>
> the First Amendment 127

F. FDA's Suppression of Secondary Therapeutic Claims for Cosmetics
Violates the

First Amendment 129

G. FDA's Suppression of Secondary Cosmetic Claims for Drugs Violates the
First

Amendment 134

H. FDA's Enforcement Practices Violate the First Amendment 135

VI\. Proposed Revisions to Regulations, Guidances, Policies, and
Practices 138

A. Health Claims (Foods and Dietary Supplements) 139

B. Structure/Function Claims (Dietary Supplements) 144

C. Structure/Function Claims (Foods) 145

D. Health Claims for Animal Foods and Animal Supplements 146

E. Structure/Function Claims for Animal Foods and Animal Dietary
Supplements 147

F. Nutrient Content Claims (Foods and Dietary Supplements) 147

G. Authoritative Statements for Foods and Dietary Supplements 147

H. Off-Label and Extralabel Use Claims for Human and Animal Drugs and
Medical

Devices 148

I. Industry-Sponsored Educational Activities 150

J. Direct to Consumer Advertising 151

K. Secondary Therapeutic Claims for Cosmetics 151

L. Secondary Cosmetic Claims for Drugs 152

M. FDA Injunction Practices 152

VII\. Proposed First Amendment Guidance for FDA Speech Regulators 153

VIII\. Conclusion 157

**Table of Authorities**

+--------------------------------------------------------+-------------+
| **Constitutional Provisions**                          |             |
+--------------------------------------------------------+-------------+
| U.S. [Const]{.smallcaps}. amend.                       | *passim*    |
| I......                                                |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| U.S. [Const.]{.smallcaps} art. VI,                     | 67          |
| cl.2...                                                |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
|                                                        |             |
+--------------------------------------------------------+-------------+
| **Cases**                                              |             |
+--------------------------------------------------------+-------------+
| *Supreme Court*                                        |             |
+--------------------------------------------------------+-------------+
| [44 Liquormart v. Rhode Island]{.underline}, 517 U.S.  | *passim*    |
| 484 (1996)..................\...\...                   |             |
+--------------------------------------------------------+-------------+
| [Abrams v. United States]{.underline}, 250 U.S. 616    | 11          |
| (1919)...............................                  |             |
+--------------------------------------------------------+-------------+
| [Arkansas Writers' Project, Inc. v.                    | 124         |
| Ragland]{.underline}, 481 U.S. 221 (1987).........     |             |
+--------------------------------------------------------+-------------+
| [Bates v. State Bar of Arizona]{.underline}, 433 U.S.  | 39, 41      |
| 350 (1977).........................                    |             |
+--------------------------------------------------------+-------------+
| [Bolger v. Youngs Drug Prods. Corp.]{.underline}, 463  | 19, 39, 43, |
| U.S. 60 (1983)...............\...                      | 47, 57, 58  |
+--------------------------------------------------------+-------------+
| [Brown v. Hartlage]{.underline}, 456 U.S. 45           | 45, 98      |
| (1982).......................................          |             |
+--------------------------------------------------------+-------------+
| [Butler v. Michigan]{.underline}, 352 U.S. 380         | 39, 58      |
| (1957)......................................           |             |
+--------------------------------------------------------+-------------+
| [Carey v. Population Services Int'l]{.underline}, 431  | 44          |
| U.S. 678 (1977)....................                    |             |
+--------------------------------------------------------+-------------+
| [Central Hudson Gas & Elec. Corp. v. Public Serv.      | *passim*    |
| Comm'n of N.Y.]{.underline}, 447 U.S. 557              |             |
| (1980)........                                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Chapman v. Houston Welfare Rights                     | 20          |
| Organization]{.underline}, 441 U.S. 600                |             |
| (1979)........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Consolidated Edison Co. v. Public Service             | 43          |
| Comm'n]{.underline}, 447 U.S. 530 (1980)               |             |
| .........................                              |             |
| ..................................................\... |             |
+--------------------------------------------------------+-------------+
| [Edenfield v. Fane]{.underline}, 507 U.S. 761          | *passim*    |
| (1993).......................................          |             |
+--------------------------------------------------------+-------------+
| [Elrod v. Burns]{.underline}, 427 U.S. 347             | 13          |
| (1976)..........................................       |             |
+--------------------------------------------------------+-------------+
| [Ibanez v. Florida Dep't of Bus. & Professional        | *passim*    |
| Regulation, Bd. of Accountancy]{.underline}, 512 U.S.  |             |
| 136                                                    |             |
| (1994)..........................................\...   |             |
+--------------------------------------------------------+-------------+
| [In re RMJ]{.underline}, 455 U.S. 191                  | 9, 47       |
| (1982)................................................ |             |
+--------------------------------------------------------+-------------+
| [Keyishian v. Board of Regents]{.underline}, 385 U.S.  | 43          |
| 589 (1967).....................\...                    |             |
+--------------------------------------------------------+-------------+
| [Lakewood v. Plain Dealer Publishing Co.,]{.underline} | 13          |
| 486 U.S. 750 (1988)..........                          |             |
+--------------------------------------------------------+-------------+
| [Linmark Associates, Inc. v. Willingboro]{.underline}, | 38, 40, 44  |
| 431 U.S. 85 (1977).............                        |             |
+--------------------------------------------------------+-------------+
| [Marbury v. Madison]{.underline}, 5 U.S. 137           | 66          |
| (1803)....................................\...         |             |
+--------------------------------------------------------+-------------+
| [Miami Herald Pub. Co. v. Tornillo]{.underline}, 418   | 56          |
| U.S. 241 (1974)..................                      |             |
+--------------------------------------------------------+-------------+
| [Minneapolis Star & Tribune Co. v. Minnesota Comm'r of | 123, 131    |
| Revenue]{.underline}, 460 U.S. 575                     |             |
| (1983)........                                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Meyer v. Grant]{.underline}, 486 U.S. 414             | 124         |
| (1988).......................................\...      |             |
+--------------------------------------------------------+-------------+
| [New York Times v. Sullivan]{.underline}, 367 U.S. 254 | 11, 43      |
| (1964).........................                        |             |
+--------------------------------------------------------+-------------+
| [Peel v. Attorney Registration and Disciplinary        | 19, 20, 41, |
| Comm'n]{.underline}, 496 U.S. 91                       | 47, 48      |
| (1990)........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Pittson Coal v. Sebben]{.underline}, 488 U.S. 105     | 14          |
| (1988)..............................\...               |             |
+--------------------------------------------------------+-------------+
| [Posadas de Puerto Rico Assocs. V. Tourism             | 81          |
| Co.]{.underline}, 478 U.S. 328                         |             |
| (1996)........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Republican Party of Minnesota v. White et             | 45, 97      |
| al.]{.underline}, 2002 U.S. LEXIS 4883 (June 27,       |             |
| 2002).............                                     |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Riley v. National Federation of the                   | 13, 32, 124 |
| Blind]{.underline}, 784 U.S. 781 (1988)...........     |             |
+--------------------------------------------------------+-------------+
| [Rubin v. Coors Brewing Co.]{.underline}, 514 U.S. 476 | 44, 46, 49, |
| (1995) .........................                       | 50          |
+--------------------------------------------------------+-------------+
| [Secretary of State of Maryland v. Joseph H. Munson    | 124         |
| Co.]{.underline}, 467 U.S. 947                         |             |
| (1984)........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Shapero v. Kentucky Bar Association]{.underline}, 486 | 41, 48      |
| U.S. 466 (1988)...............                         |             |
+--------------------------------------------------------+-------------+
| [Simon & Schuster, Inc. v. New York Crime Victims      | 45          |
| Board]{.underline}, 502 U.S. 105                       |             |
| (1991)...................                              |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Stafford v. Briggs]{.underline}, 444 U.S. 527 (1980)  | 14          |
| ....................................                   |             |
+--------------------------------------------------------+-------------+
| [Thompson v. Western States Med. Ctr.,]{.underline}    | *passim*    |
| 122 S. Ct. 1497 (2002)...........                      |             |
+--------------------------------------------------------+-------------+
| [U.S. v. Batchelder]{.underline}, 442 U.S. 114         | 67, 97      |
| (1979)......................................           |             |
+--------------------------------------------------------+-------------+
| [United States v. United Foods, Inc.]{.underline}, 533 | 32          |
| U.S. 405 (2001)..................                      |             |
+--------------------------------------------------------+-------------+
| [Virginia State Board of Pharmacy et. al. v. Virginia  | 32, 38, 40, |
| Citizen's Consumer Council, Inc., et.                  | 56, 57      |
| al.]{.underline}, 425 U.S. 748                         |             |
| (1976).....................\...                        |             |
+--------------------------------------------------------+-------------+
| [West Virginia Board of Education v.                   | 56          |
| Barnette]{.underline}, 319 U.S. 624                    |             |
| (1943)........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Whitney v. California]{.underline}, 274 U.S. 357      | 39          |
| (1927).................................                |             |
+--------------------------------------------------------+-------------+
| [Zauderer v. Office of Disciplinary Counsel of the     | 44, 48, 50, |
| Supreme Court of Ohio]{.underline}. 471 U.S. 626       | 55          |
| (1985)                                                 |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
|                                                        |             |
+--------------------------------------------------------+-------------+
| *Federal Courts*                                       |             |
+--------------------------------------------------------+-------------+
| [Board of Trustees of Leland Stanford Junior           | 43          |
| University v. Sullivan]{.underline}, 773 F. Supp. 472, |             |
| (D.D.C.                                                |             |
| 1991).........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Borgner v. Brooks]{.underline}, 284 F.3d 1204 (11^th^ | 48          |
| Cir. 2002)..........................                   |             |
+--------------------------------------------------------+-------------+
| [Brownsburg Area Patrons Affecting Change v.           | 13          |
| Baldwin]{.underline}, 137 F.3d 503 (7^th^ Cir.         |             |
| 1998)...............                                   |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Crawford v. Lungren]{.underline}, 96 F.3d 380 (9^th^  | 45, 97, 123 |
| Cir. 1996)...........................                  |             |
+--------------------------------------------------------+-------------+
| [Estee Lauder, Inc., v. United States Food and Drug    | 130         |
| Administration]{.underline}, 727 F. Supp. 1 (D.D.C.    |             |
| 1989)                                                  |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Horton v. Department of Justice]{.underline}, 926     | 14          |
| F.2d 1215 (D.C. Cir. 1991)......\...                   |             |
+--------------------------------------------------------+-------------+
| [Iowa Right to Life Comm, Inc. v.                      | 13          |
| Williams]{.underline}, 187 F.3d 963 (8^th^ Cir         |             |
| 1999).........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Jackson v. City of Columbus]{.underline}, 194 F.3d    | 13          |
| 737 (6^th^ Cir. 1999)................                  |             |
+--------------------------------------------------------+-------------+
| [Joe Conte Toyota, Inc. v. Louisiana Motor Vehicle     | 47          |
| Commission, et.al.]{.underline}, 24 F.3d 754 (5^th^    |             |
| Cir.                                                   |             |
| 1994)                                                  |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [National Association for the Advancement of Colored   | 56          |
| People v. Jones]{.underline}, 131 F.3d 1317 (9^th^     |             |
| Cir.                                                   |             |
| 19                                                     |             |
| 97)................................................... |             |
+--------------------------------------------------------+-------------+
| [New York Magazine v. Metropolitan Transportation      | 13          |
| Authority,]{.underline} 136 F. 3d 123 (2^nd^ Cir.      |             |
| 1998).......                                           |             |
| ..................................................\... |             |
+--------------------------------------------------------+-------------+
| [Nutrilab v. Schweiker]{.underline}, 713 F.2d 335 (7th | 76, 130,    |
| Cir. 1983).....................\...                    | 145         |
+--------------------------------------------------------+-------------+
| [Pearson v. Shalala]{.underline}, 164 F.3d 650 (D.C.   | *passim*    |
| Cir. 1999)........................\...                 |             |
+--------------------------------------------------------+-------------+
| [Pearson v. Shalala]{.underline}, 172 F.3d 72 (D.C.    | 12, 16, 98  |
| Cir.                                                   |             |
| 1999).........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Pearson v. Shalala]{.underline}, 130 F. Supp. 2d 105  | *passim*    |
| (D.D.C. 2001)....................                      |             |
+--------------------------------------------------------+-------------+
| [Pearson v. Thompson]{.underline}, 141 F. Supp. 2d 105 | *passim*    |
| (D.D.C. 2001) ...............                          |             |
+--------------------------------------------------------+-------------+
| [United States v. An Article..."Sudden                 | 130         |
| Change,"]{.underline} 409 F.2d 734 (2d Cir.            |             |
| 1969).........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [United States v. Articles of Drug \*\*\*Rucker        | 103         |
| Pharmaceutical Co.]{.underline}, 625 F.2d 665 (5^th^   |             |
| Cir.                                                   |             |
| 1980)....                                              |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [United States v. Diapulse Corp.]{.underline}, 748     | 136         |
| F.2d 56 (2d Cir. 1984)............\...                 |             |
+--------------------------------------------------------+-------------+
| [Warner-Lambert Co. v. FTC]{.underline}, 562 F.2d 749  | 55          |
| (D.C. Cir. 1977)..............                         |             |
+--------------------------------------------------------+-------------+
| [Washington Free Community v. Wilson]{.underline}, 426 | 13          |
| F.2d 1213 (D.C. Cir.                                   |             |
| 1969).........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Washington Legal Foundation v. Friedman]{.underline}, | 29, 41      |
| 13 F. Supp. 2d 51 (D.D.C. 1998)                        |             |
| ........................                               |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Washington Legal Foundation v. Henney]{.underline},   | 12, 30, 98  |
| 56 F. Supp. 2d 81 (D.D.C.                              |             |
| 1999).........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Washington Legal Foundation v. Henney]{.underline},   | 28          |
| 128 F. Supp. 2d 11 (D.D.C.                             |             |
| 2000)...........................                       |             |
| ................................................\..... |             |
+--------------------------------------------------------+-------------+
| [Washington Legal Foundation v. Henney]{.underline},   | *passim*    |
| 202 F.3d 331 (D.C. Cir.                                |             |
| 2000).........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Washington Legal Foundation v. Kessler]{.underline},  | 29          |
| 880 F. Supp. 26                                        |             |
|                                                        |             |
| (D.C. 1995)..                                          |             |
| ...............                                        |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Whitaker et. al. v. Shalala]{.underline}, Civil       | 59          |
| Action No. 99-3247 (D.D.C. 1999).....                  |             |
+--------------------------------------------------------+-------------+
|                                                        |             |
+--------------------------------------------------------+-------------+
| **Statutes, Regulations, & Guidance Documents**        |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. §                                            | 100, 107    |
| 99.1............                                       |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. §                                            | 108, 148,   |
| 99.101.........                                        | 149         |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. §                                            | 149         |
| 99.201.........                                        |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. §                                            | *passim*    |
| 101.14.........                                        |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. §                                            | 79, 80      |
| 101.54........                                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. §                                            | 79          |
| 101.56.........                                        |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. §                                            | 79          |
| 101.60.......                                          |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. §                                            | 79          |
| 101.62.........                                        |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. §                                            | 80          |
| 101.69.........                                        |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. §                                            | 70, 72,     |
| 101.93.........                                        | 144, 146    |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. §                                            | *passim*    |
| 202.1...........                                       |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. § 530.2 (2002)                               | 127         |
| .....................................................  |             |
+--------------------------------------------------------+-------------+
| 21 C.F.R. § 530.4 (2002)                               | 127, 150    |
| .....................................................  |             |
+--------------------------------------------------------+-------------+
| 59 Fed. Reg. 395 (January 4,                           | 21, 59, 63  |
| 1994)............................................      |             |
+--------------------------------------------------------+-------------+
| 61 Fed. Reg. 17,706 (April 22,                         | 77          |
| 1996).......................................\...       |             |
+--------------------------------------------------------+-------------+
| 61 Fed. Reg. 52,800 (October 8,                        | 92          |
| 1996)........................................          |             |
+--------------------------------------------------------+-------------+
| 62 Fed. Reg. 64,093 (December 3,                       | 92, 108     |
| 1997)....................................              |             |
+--------------------------------------------------------+-------------+
| 64 Fed. Reg. 3,250 (January 21,                        | 148         |
| 1999).......................................           |             |
+--------------------------------------------------------+-------------+
| 64 Fed. Reg. 48,841 (September 8,                      | 23          |
| 1999)....................................              |             |
+--------------------------------------------------------+-------------+
| 64 Fed. Reg. 67,289 (December 1,                       | 22          |
| 1999)....................................              |             |
+--------------------------------------------------------+-------------+
| 65 Fed. Reg. 1,000 (January 6,                         | 73, 145     |
| 2000).........................................         |             |
+--------------------------------------------------------+-------------+
| 65 Fed. Reg. 14,219 (March 16,                         | 23, 59      |
| 2000)........................................          |             |
+--------------------------------------------------------+-------------+
| 65 Fed. Reg. 14,286 (March 16,                         | 92, 94, 103 |
| 2000).......................................           |             |
+--------------------------------------------------------+-------------+
| 65 Fed. Reg. 58,917 (October 3,                        | 21, 23      |
| 2000)........................................          |             |
+--------------------------------------------------------+-------------+
| 65 Fed. Reg. 59,855 (October 6,                        | 17, 23      |
| 2000)........................................          |             |
+--------------------------------------------------------+-------------+
| 67 Fed. Reg. 34,942 (May 16,                           | 9           |
| 2002)..........................................        |             |
+--------------------------------------------------------+-------------+
| 5 U.S.C. §                                             | 12, 154     |
| 3331..........                                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 U.S.C. § 301 et. seq.                               | 70          |
| (                                                      |             |
| 1994)................................................. |             |
+--------------------------------------------------------+-------------+
| 21 U.S.C. §                                            | *passim*    |
| 321...........                                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 U.S.C. §                                            | 92, 94, 103 |
| 331...........                                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 U.S.C. §                                            | *passim*    |
| 343.............                                       |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 U.S.C. §                                            | 94          |
| 351.............                                       |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 U.S.C. §                                            | 94, 103,    |
| 352.............                                       | 116, 118    |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 U.S.C. §                                            | 59, 94, 95  |
| 355.............                                       |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 21 U.S.C. § 360aaa                                     | 101, 102,   |
| (2002)                                                 | 103, 104    |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| 28 U.S.C. §                                            | 13          |
| 1361.............                                      |             |
| ..................................................\... |             |
+--------------------------------------------------------+-------------+
| [FDA's Regulation of Pet Food]{.underline}, Food and   | 77          |
| Drug Administration, Center for Veterinary Medicine,   |             |
| www.fda.gov/cvm/index/consumer/petfoodflier.html (last |             |
| visited August 19,                                     |             |
| 2002)...........                                       |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Guidance for Industry: Consumer-Directed Broadcast    | 118, 122    |
| Advertisements]{.underline} (August                    |             |
| 1999)................                                  |             |
| ..................................................\... |             |
+--------------------------------------------------------+-------------+
| [Guidance for Industry: Notification of a Health Claim | 86, 147     |
| or Nutrient Content Claim Based on an Authoritative    |             |
| Statement of a Scientific Body]{.underline} (June 11,  |             |
| 1998)......                                            |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Guidance for Industry; Significant Scientific         | 59, 64      |
| Agreement in the Review of Health Claims For           |             |
| Conventional Foods and Dietary                         |             |
| Supplements]{.underline}, Food and Drug                |             |
| Administration, Center for Food Safety and Applied     |             |
| Nutrition, December 22,                                |             |
| 1999.................................................. |             |
+--------------------------------------------------------+-------------+
| Labeling of Dietary Supplements                        | 63, 85      |
| <http://www.cfsan.fda.gov/~dms/ds-labl.html> (last     |             |
| visited                                                |             |
| 8/21/02)\...\...\...\...\...\...\...\...\.             |             |
| ..\...\...\...\...\...\...\...\...\...\...\...\...\... |             |
+--------------------------------------------------------+-------------+
| [What are FDA requirements regarding nutrient content  | 79          |
| claims?]{.underline} Excerpted from [Requirements of   |             |
| Laws and Regulations Enforced by the U.S. Food and     |             |
| Drug Administration]{.underline}                       |             |
| (1997)..............................                   |             |
+--------------------------------------------------------+-------------+
|                                                        |             |
+--------------------------------------------------------+-------------+
| **Miscellaneous**                                      |             |
+--------------------------------------------------------+-------------+
| Balaji, K., [Generics: the Opportunity                 | 93          |
| Beckons]{.underline} (July 2001)                       |             |
| [http:///www.inpharm.com/intelligenc                   |             |
| e/frost010701.html]()\...\...\...\...\...\...\...\.... |             |
+--------------------------------------------------------+-------------+
| Bryan A. Liang & Kurt M. Hartman, [It's Only Skin      | 130, 134    |
| Deep: FDA Regulation of Skin Care Cosmetic             |             |
| Claims]{.underline}, 8 [Cornell J. L. & Pub.           |             |
| Pol'y]{.smallcaps} 249                                 |             |
| (1999)...........                                      |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| Cynthia Susan Clegg, [Press Censorship in Jacobian     | 5           |
| England]{.smallcaps}                                   |             |
| (2001)........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| Edmund Polubinski, III, [Closing the Channels of       | 95          |
| Communication: A First Amendment Analysis of the FDA's |             |
| Policy on Manufacturer Promotion of Off-Label          |             |
| Use]{.underline}, 83 [Va. L. Rev]{.smallcaps}. 991,    |             |
| 998 (1997)............                                 |             |
+--------------------------------------------------------+-------------+
| Fran Kritz, [FDA Seeks to Add Drugs' New Uses to       | 95          |
| Labels]{.underline}, Wash. Post, Mar. 29, 1994, Health |             |
| Section, at                                            |             |
| 11..........................................           |             |
+--------------------------------------------------------+-------------+
| [H. Conf. R.]{.smallcaps} 105-399 at                   | 88          |
| 98...........................................          |             |
+--------------------------------------------------------+-------------+
| <http://www.fda.gov/cber/gdlns/consumad.htm> (last     | 119         |
| visited                                                |             |
|                                                        |             |
| 8/19/02)......................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| <http://www.fda.gov/cder/ddmac/dtctitle.htm> (last     | 117         |
| visited                                                |             |
| 5/22/02)\...\...\...\...\...\...\.                     |             |
| ..\...\...\...\...\...\...\...\...\...\...\...\...\... |             |
| \...\...\...\...\...\...\...\...\...\...\...\...\..... |             |
+--------------------------------------------------------+-------------+
| http://                                                | 117         |
| [www.fda.gov/cder/ddmac/DTCPANEL3.                     |             |
| HTM](http://www.fda.gov/cder/ddmac/DTCPANEL3.HTM)(last |             |
| visited                                                |             |
| 5/22/02)......................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| J. Mill, [On Liberty]{.smallcaps} 52 (S. Beer & O.     | 11          |
| Hardison, Jr., eds.                                    |             |
| 1947).........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| JA Henderson Jr. & A.D. Twerski, [Drug Designs are     | 93          |
| Different]{.underline}, 111 [Yale L.J.]{.smallcaps}    |             |
| 151                                                    |             |
| (2001)......                                           |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| James M. Beck & Elizabeth D. Azari, [FDA, Off-Label    | 95          |
| Use and Informed Consent: Debunking Myths and          |             |
| Misconceptions]{.underline}, 53 [Food & Drug           |             |
| L.J.]{.smallcaps} 71                                   |             |
| (1998)........                                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| Letter from Melinda K. Plaisier of FDA to the          | 65, 66      |
| Honorable David M. McIntosh of the U.S. House of       |             |
| Representatives (May 16, 2000)..........               |             |
+--------------------------------------------------------+-------------+
| M. Hughes, [John Milton Complete Poems and Major       | 11          |
| Prose]{.smallcaps} 746                                 |             |
| (1957)........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| Melinda Ledden Sidak, [Dietary Supplements and         | 62          |
| Commercial Speech]{.underline}, 48 [Food & Drug L.J.   |             |
| 441                                                    |             |
| (1993).....                                            |             |
| .........................................]{.smallcaps} |             |
+--------------------------------------------------------+-------------+
| Pines, W., [A History and Perspective on               | 117         |
| Direct-to-Consumer Promotion]{.underline}, 54 [Food    |             |
| Drug L.J.]{.smallcaps} 489                             |             |
| (1999)..................................               |             |
+--------------------------------------------------------+-------------+
| [S. Rep. No.]{.smallcaps} 103-410 at 7                 | 34, 62, 86  |
| (                                                      |             |
| 1994).............................................\... |             |
+--------------------------------------------------------+-------------+
| U.S. Food and Drug Administration, Center for Food     | 129         |
| Safety and Applied Nutrition, Office of Cosmetics and  |             |
| Colors, [Is it a Cosmetic, a Drug, or Both? (or is it  |             |
| Soap?)]{.underline} (last modified July 8, 2002)       |             |
| (http://www.cfsan.fda.gov/\~dms/cos-218.htm            |             |
| l)\...\...\...\...\...\...\...\...\...\...\...\...\... |             |
+--------------------------------------------------------+-------------+
| V. Henry, [Problems with Pharmaceutical Regulations in | 93          |
| the United States]{.underline}, 14 [J. Leg.            |             |
| Med.]{.smallcaps} 617                                  |             |
| (1993)..........................................\...   |             |
+--------------------------------------------------------+-------------+
| Ward, S., [WLF and the Two-Click Rule: The First       | 95, 106     |
| Amendment Inequity of the Food and Drug                |             |
| Administration's Regulation of Off-Label Drug Use      |             |
| Information on the Internet]{.underline}, 56 [Food &   |             |
| Drug L.J.]{.smallcaps} 41                              |             |
| (2001)........................                         |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+
| [Webster's New Universal Unabridged                    | 67          |
| Dictionary]{.smallcaps}, 139 (Barnes & Noble Books     |             |
| 1996).....                                             |             |
| ...................................................... |             |
+--------------------------------------------------------+-------------+

  ---------------------------------------------------------------------------- -------------
  Wilke, M., [Ad Fever Sweeps Health Care Industry]{.underline}, Advertising   117
  Age 1 (Jan. 13                                                               
  1997).....................................................................   

                                                                               
  ---------------------------------------------------------------------------- -------------

Before the

**DEPARTMENT OF HEALTH AND HUMAN SERVICES**

**FOOD AND DRUG ADMINISTRATION**

**Rockville, MD**

**)**

**In re: Request for Comment on First ) Docket No. 02N-0209**

**Amendment Issues )**

**)**

**)**

**)**

# COMMENTS OF

**JULIAN M. WHITAKER, M.D.; DURK PEARSON AND SANDY SHAW; PURE
ENCAPSULATIONS, INC.; WELLNESS LIFESTYLES, INC.; SUAREZ CORPORATION;
LIFE ENHANCEMENT PRODUCTS, INC.; AND LIFE [EXTENSION
FOUNDATION]{.underline}**

Julian M. Whitaker, M.D.; Durk Pearson and Sandy Shaw; Pure
Encapsulations, Inc. Wellness Lifestyles, Inc.; Suarez Corporation
Industries, Inc.; Life Enchancement Products, Inc.; and the Life
Extension Foundation[^1] (hereinafter "Joint Commenters") hereby submit
comments in response to FDA's request for evaluation of First Amendment
issues arising from agency speech regulation. These comments explain in
detail (1) the limitations the First Amendment places on FDA speech
regulation; (2) the First Amendment violations caused by current FDA
speech regulation; and (3) the immediate steps FDA must take to end
those violations. The comments are divided into nine parts. Part I is an
overview of First Amendment limits on, and free speech implications of,
FDA speech regulation. Part II presents the federal courts' relevant
First Amendment jurisprudence governing FDA speech regulation. Part III
explains why FDA rationales for speech suppression are out of sync with
(and are illegal in light of) the

Supreme Court's apposite First Amendment decisions. Part IV explains the
limits that First Amendment precedent places upon FDA speech regulation.
Part V explains which

FDA regulations, guidances, policies, and practices affecting speech
violate the First Amendment. Part VI presents draft regulations to
correct the First Amendment violations and ensure future compliance.
Part VII presents a draft First Amendment guidance for FDA speech
regulators to help ensure future First Amendment compliance. Part VIII
is a summary conclusion and call for immediate relief.

INTRODUCTION

The Joint Commenters have evaluated FDA speech regulation of food,
dietary supplement, drug, medical device, and cosmetic labels and
labeling under the applicable First Amendment standards. That evaluation
reveals in every area of FDA speech regulation that this agency
suppresses far more speech than necessary to achieve its legitimate
interests in protecting public health and eliminating fraud. The
critical point is not that FDA regulation fails to suppress speech that
is inherently misleading; to be sure it does block some speech of that
kind. Rather, the critical point is that FDA's chosen means is not
narrowly tailored to effect that end and, instead, draws within its
proscriptive grasp much speech that is protected by the First Amendment.
Indeed, most, if not all, of the accurate information suppressed by
FDA's chosen means would, if allowed to enter the market, perform the
salutary function of aiding consumers in achieving better health and
longevity and in identifying fraud and, thus, neutralizing fraud's
effect. The Joint Commenters' goal is, thus, to reform FDA speech
regulation so that it favors disclosure over suppression in all but
those extremely rare instances in which the speech before the agency is
not backed by credible evidence and, further, is specifically
contradicted by the weight of credible evidence. In all circumstances
where evidence supporting regulated speech is inconclusive, the First
Amendment precedent requires that it be disclosed and compels FDA to
rely on accurate, succinct, and reasonable disclaimers and warning
statements as less speech restrictive alternatives to outright
suppression.

The Joint Commenters have found, at every turn, obvious, less speech
restrictive alternatives to the current regime, ones that depend upon a
change in the operative rule within the agency from suppression to
disclosure. There thus exists a dire need for reform to attain First
Amendment compliance. Nothing short of the measures the Joint Commenters
recommend here can ensure that compliance.

FDA now has the dubious distinction of being that agency within the
federal government that suppresses more protected speech than any other.
Through a complex labyrinth of content controls that rely variously on
blanket speech bans or costly regulatory hurdles (too costly for all but
a very few), FDA effectively deprives consumers of information: (1) on
the actual and potential effects of foods and dietary supplements on
disease; (2) on accurate nutrient content claims not officially
approved; (3) on all structure/function claims that can be construed to
"imply" a disease claim; (4) on off-label uses of FDA-approved drugs and
medical devices; (5) on known secondary therapeutic effects of
cosmetics; and (6) on known secondary cosmetic effects of FDA-approved
drugs.

The quantity of health information FDA locks out of the market is
staggering. The role of FDA in censoring such an enormous amount of
information is reminiscent of censorship in Sixteenth and Seventeenth
Century England when, before its abolition in 1641, the Courts of Star
Chamber succeeded in ridding that country of many political and
religious tracts deemed heretical to orthodoxies of the Crown and the
Church.[^2] Given the United States' historic commitment to free and
open idea and information markets and its trust in those markets as the
best means to ferret out falsehood and parry it with truth, FDA stands
as a stark anomaly---an anachronistic throw-back to a time when a small
number of patricians with authority to govern could deny the public
access to speech thought capable of causing acceptance of doctrines
antithetical to their own.

Like the Star Chamber Courts, the FDA daily censors speech with little
reasoned decisionmaking (i.e., without regard to the First Amendment
restraints on its action), in a largely arbitrary and capricious manner
(i.e., without regard to the limits of logic or the decisions of the
federal courts condemning its action), and in service to paternalistic
notions of the public good never proven with empirical evidence and
rejected as grounds for speech suppression by our Supreme Court and,
fundamentally, by those who fought from 1787 to 1793 to make the First
Amendment a part of the United States Constitution.

Without question FDA speech regulation has long locked out of idea and
information markets an enormous quantity of truthful
information---information invaluable to consumers in their quest for
better health and greater longevity. In some instances, the information
kept from the public creates inconvenience (falling hardest on the poor,
the disabled, and the bed-ridden), forcing consumers to expend more time
and money in the search for information relevant to a purchase. In other
instances, such as in the case of FDA's ill-fated multi-year ban on a
folic acid-neural tube defect risk reduction health claim; the folic
acid, vitamin B6, and vitamin B12 vascular disease risk reduction health
claim; and the omega-3 fish oil heart disease risk reduction health
claim, the information kept from the public contributes directly to
losses (sometimes horrific) in human life and health.[^3]

In every case, if FDA acts---as the Joint Commenters here recommend---to
remove unconstitutional barriers to protected expression, health markets
will undergo a dramatic transformation, improving the health of the
citizenry and of the economy. With the unconstitutional barriers gone,
health markets will experience a mass infusion of new information on
means to improve health and reduce or eliminate disease, concomitantly
improving consumers\' ability to pursue their own self interest;
increasing competition in food, dietary supplement, drug, medical
device, and cosmetic markets; pushing manufacturers to improve the
quality and health benefits of the products they sell; and checking the
excesses of fraud by allowing good counsels now censored to enter the
market and ferret out bad ones consistent with the marketplace of ideas
First Amendment principle.

At the risk of being immodest, the Joint Commenters here perform a major
public service (indeed, one they regard as a duty in defense of
constitutional liberty). They serve the agency with a comprehensive
report on its First Amendment violations. They also serve the agency
with a correction for each violation identified. In particular, they
supply the agency with precise changes, via new draft regulations, to
alter existing law in ways that will achieve full First Amendment
compliance.

On notice of the many First Amendment violations present and of
precisely how to stop them, FDA now has no excuse for failing to take
corrective action promptly. FDA should not (to be sure, it cannot
lawfully) delay in acting to achieve full First Amendment compliance.
Our Supreme Court has held government to a high standard when put on
notice of First Amendment violations. Delay of any kind is the bane of
the First Amendment, and our federal courts have repeatedly shown that
they will force the hand of a lethargic bureaucrat to ensure that First
Amendment violations are brought to an abrupt end.

In this proceeding, FDA has the extraordinary opportunity to start anew,
to commence a new era of respect for civil liberties, to become---for
the first time---an agency that advances the core values of the First
Amendment rather than one that acts in utter disregard of them. While in
the first instance the decision of when and how to act will remain the
agency's, in the long run corrections for the agency's failings will be
dictated by the federal judiciary. How FDA responds to the comments it
receives will in large measure determine whether the public, regulatees,
and the courts can place confidence in FDA to abide by the Supreme law
of the First Amendment or whether they must seek redress from the
federal courts to stop the unconstitutional exercise of agency power and
thereby compel FDA to abide by the Supreme law.

**PART I: OVERVIEW**

**I.**

**[OVERVIEW]{.underline}**

In the Federal Register notice, "Request for Comment on First Amendment
Issues," 67 Fed. Reg. 34,942 (May 16, 2002), the agency writes of a need
"to ensure that its regulations, guidances, policies, and practices
*continue* to comply with the governing First Amendment case law"
(emphasis added). The sentence implies that FDA's regulations,
guidances, policies, and practices currently comply with the First
Amendment and, presumably, need only be adjusted in some minor way to
maintain compliance. Close inspection reveals, however, that FDA food,
dietary supplement, drug, medical device, and cosmetic speech
regulations do not comply with the First Amendment and are in need of
substantive reform to achieve compliance.

As explained herein, FDA speech regulation is an anomaly because it
often relies on advance censorship (blanket speech bans) or cost
prohibitive regulatory hurdles to prevent speech it disfavors from
reaching the market. FDA's reliance on those forms of speech suppression
is grossly out of step with applicable First Amendment jurisprudence in
no small measure because our Supreme Court has repeatedly interpreted
that amendment to require less restrictive alternatives to speech
suppression, to require disclosure of more information, not less, and to
prefer disclaimers and warning statements, not censorship, as a
correction for potentially misleading speech. [See
generally]{.underline}, [44 Liquormart v. Rhode Island]{.underline}, 517
U.S. 484 (1996); [Ibanez v. Florida Dep't of Bus. & Professional
Regulation, Bd. of Accountancy]{.underline}, 512 U.S. 136 (1994); [In re
RMJ]{.underline}, 455 U.S. 191 (1982).

FDA suppression of truthful claims for dietary supplements, foods,
drugs, medical devices, and cosmetics violates the First Amendment and
stifles innovation, progress, and debate in idea and information
markets. It promotes lack of awareness about health and disease,
increases the likelihood of mistake in the effectuation of consumer
demand, promotes misallocation of resources by consumers and by
companies impaired in their ability to communicate truthfully with
consumers, and reduces consumers' ability to discern fraud in the
market. In short, FDA's decades-long regime of censorship not only
violates the First Amendment, it also harms the health and the finances
of regulated product producers and consumers alike.[^4] Reversal of that
suppression will cause the agency to comply with the First Amendment,
but it will also aid consumers as never before by giving them far
greater access to scientific information on actual and potential
benefits from the extraordinary number and kinds of products regulated
by this agency. It will educate consumers at the point of sale to a much
greater extent, facilitating freedom of informed choice as never before
and enabling consumers (based on the new science freed from FDA
suppression and freed from the chilling effect that suppression
generates) to discern much more readily the existence of fraudulent
claims. Fraudulent claims now go largely unchallenged in the market
because much of the private scientific speech that could be used to
disabuse the public concerning that fraud is itself suppressed by the
FDA (and so it is, for example, that true nutrient-disease claims are
blocked from entering the market to rebut false ones appearing
unlawfully there).[^5]

The FDA's historic presumption that consumers cannot be trusted either
to comprehend or put to good use scientific information not only is
contrary to the opposite presumption that undergirds our First
Amendment, but it is also the enemy of innovation, the search for truth,
the arrest of disease, and freedom of informed choice. That arrogant
presumption has no doubt deprived us of innovations in medical science
that could have come from just one ingenious member of the lay public
exercising her mind on a vexing public health issue revealed through
open exchange in the market. FDA must either accept the challenge to
bring its archaic regulatory structure in line with the Supreme Court's
First Amendment presumption favoring disclosure over suppression or
relegate yet another generation of Americans to cope with dysfunctional
idea and information markets where the actual and potential benefits of
FDA regulated substances remain locked out of commerce by force of law
(law that while unconstitutional continues to be enforced by this
agency).

On no fewer than five occasions, federal courts have held
unconstitutional FDA speech suppression. [See]{.underline} [Pearson v.
Shalala]{.underline}, 164 F.3d 650 (D.C. Cir. 1999), [rehearing
denied]{.underline}, 172 F.3d 72 (D.C. 1999) (hereinafter
"[Pearson]{.underline} I"); [Washington Legal Foundation v.
Henney]{.underline}, 56 F. Supp. 2d 81 (D.C. 1999), [rev'd and
remanded,]{.underline} 202 F.3d 331 (2000); [Pearson v.
Shalala]{.underline}, 130 F. Supp. 2d 105 (D.C. 2001) (hereinafter
"[Pearson]{.underline} II"); [Pearson v. Thompson]{.underline}, 141 F.
Supp. 2d 105 (D.C. 2001) (hereinafter "[Pearson]{.underline} III");
[Thompson v. Western States Med. Ctr.]{.underline}, 122 S. Ct. 1497
(2002). The foregoing decisions are based on broad First Amendment
principles that apply in all instances where government restricts
commercial speech; those principles are decidedly not bound to the
peculiar facts of each case and apply to all FDA speech regulation.
Applied to FDA speech regulation, the teachings of those cases dictate
the need for certain fundamental reforms to put an end to the First
Amendment violations present. Those reforms are a constitutional
necessity of great immediacy, not matters for the exercise of FDA
discretion at some indefinite future date.

Our constitutional law plainly requires the utmost alacrity to achieve
First Amendment compliance by all in government, including the executive
and quasi judicial agents of the FDA (who are sworn to support and
defend the Constitution of the United States and to execute well and
faithfully the duties of their offices ([See]{.underline} 5 U.S.C. §
3331)). It is settled First Amendment law that "\[t\]he loss of First
Amendment freedoms, for even minimal periods of time, unquestionably
constitutes irreparable injury," [Elrod v. Burns]{.underline}, 427 U.S.
347, 373 (1976); [see also]{.underline} [Jackson v. City of
Columbus]{.underline}, 194 F.3d 737, 747 (6^th^ Cir. 1999); [Iowa Right
to Life Comm., Inc. v. Williams]{.underline}, 187 F.3d 963, 969 (8^th^
Cir. 1999); [Brownsburg Area Patrons Affecting Change v.
Baldwin]{.underline}, 137 F.3d 503, 507 (7^th^ Cir. 1998); [New York
Magazine v. Metropolitan Transportation Authority]{.underline}, 136 F.3d
123, 127 (2^nd^ Cir. 1998); [Lakewood v. Plain Dealer Publishing
Co.]{.underline}, 486 U.S. 750, 758 (1988) (noting that "opportunities
for speech," if suppressed, "are irretrievably lost"); [Washington Free
Community v. Wilson]{.underline}, 426 F.2d 1213, 1218 (D.C. Cir. 1969)

("Speakers . . . cannot be made to wait for years before being able to
speak with a measure of security"); [Riley v. National Federation of the
Blind]{.underline}, 784 U.S. 781, 793-94 (1988); [Pearson v.
Shalala]{.underline}, 130 F. Supp. 2d at 119 (D.C. 2001) (applying
[Elrod]{.underline} and progeny in the health claims context); [Pearson
v. Thompson]{.underline}, 141 Supp.2d 105, 108, 112 (D.C. 2001)
(faulting FDA's motion for reconsideration of a Court order as further
evidence of FDA's "reluctance to fully comply with Pearson I" and
finding that "FDA has again refused to accept the reality and finality
of \[[Pearson I]{.underline}\]").[^6]

The decisions in [Pearson]{.underline} I, [Pearson]{.underline} II, and
[Pearson]{.underline} III make clear that continued failure by the FDA
to comply with First Amendment limits on agency power (by favoring
disclosure over suppression as the operative rule) tempts fate under 28
U.S.C. § 1361 (by which the United States District Court retains
original jurisdiction "to compel an officer or employee of the United
States or any agency thereof to perform a duty owed to the plaintiff").
[See]{.underline} [Pittson Coal v. Sebben]{.underline}, 488 U.S. 105,
122 (1988); [Horton v. Department of Justice]{.underline}, 926 F.2d 1215
(D.C. Cir. 1991); [Stafford v. Briggs]{.underline}, 444 U.S. 527 (1980).
If the agency does not enact the required reforms without delay, it runs
the real risk of not only losing the respect of the federal judiciary
but also of losing to the federal courts effective jurisdiction and
control over claims for regulated products. As guardians of the
Constitution, the federal courts must protect private parties against
FDA censorship; duty bound to fulfill the courts' mandates, this agency
has no lawful choice but to end its speech suppressive practices without
delay. If the agency proves itself unwilling to perform that task in
case after case due to either gross negligence or contumacious refusal,
the Courts will (indeed, must) assume greater and greater control over
the claims machinery at the agency.

Consider carefully the extensive precedent holding FDA speech
suppression unconstitutional. The teachings in that precedent are
profound, making fundamental changes in the way in which the agency
evaluates its regulatees' speech imperative. It would be a serious
mistake for the FDA to take a crabbed view of that precedent. The plain
implications are far reaching for the agency. The precedent stands
against FDA speech suppression regardless of whether the act of
suppression arises in the context of dietary supplements, foods, drugs,
medical devices, or cosmetics. These comments explain the impact of that
precedent in each area of FDA regulation.

**PART II: THE COURTS' APPLICATION OF FIRST AMENDMENT PRECEDENT TO FDA
SPEECH SUPPRESSION**

**II.**

**THE COURTS' APPLICATION OF FIRST AMENDMENT PRECEDENT**

**TO FDA SPEECH SUPPRESSION**

While the considerable number and variety of commercial speech decisions
from the Supreme Court, not to mention the lower federal courts, would
be enough to guide us without reference to those specifically applied to
FDA speech regulation, it is of course best to focus our attention on
those decisions that have passed directly on FDA speech regulation to
discern in particular how the First Amendment applies to FDA speech
suppression. We now turn to each of those decisions and the lessons they
provide.

***The Court of Appeals Decision in Pearson v. Shalala.*** In
[Pearson]{.underline} I, the United States Court of Appeals for the D.C.
Circuit held (in a 3-0 decision) FDA's practice of refusing to authorize
health claims with corrective disclaimers a violation of the First
Amendment. [See id.]{.underline} at 655. The FDA petitioned for
rehearing of the decision but was rebuffed by the entire D.C. Circuit in
an 11-0 decision issued April 2, 1999. [Pearson v. Shalala,]{.underline}
172 F.3d 72 (D.C. 1999). The Department of Justice requested Supreme
Court review, but the Solicitor General declined to pursue the matter
further, thus making [Pearson]{.underline} I final and binding upon this
agency.

The [Pearson]{.underline} Court rejected FDA's justifications for
outright suppression of health claims in lieu of allowing them with
corrective disclaimers. FDA unsuccessfully argued (1) that health claims
lacking "significant scientific agreement" are *inherently* misleading
by that fact alone and can be suppressed outright and (2) that even if
the claims are only *potentially* misleading, FDA was not legally
obligated to allow them with disclaimers. [Pearson]{.underline} I, 164
F.3d at 655. Concerning FDA's first argument, the Court of Appeals
wrote:

> As best we understand the government, its first argument runs along
> the following lines: that health claims lacking "significant
> scientific agreement" are inherently misleading because they have such
> an awesome impact on consumers as to make it virtually impossible for
> them to exercise any judgment *at the point of sale*. It would be as
> if the consumers were asked to buy something while hypnotized, and
> therefore they are bound to be misled. We think this contention is
> almost frivolous. . . . We reject it.

[Id.]{.underline} at 655.

Concerning FDA's second argument, the Court of Appeals wrote:

> The government insists that it is never obliged to utilize the
> disclaimer approach, because the commercial speech doctrine does not
> embody a preference for disclosure over outright suppression. Our
> understanding of the doctrine is otherwise. . . . \[T\]he \[Supreme\]
> Court has . . . repeatedly point\[ed\] to disclaimers as
> constitutionally preferable to outright suppression.
>
> It is clear . . . that when government chooses a policy of suppression
> over disclosure---at least where there is no showing that disclosure
> would not suffice to cure misleadingness---government disregards a
> "far less restrictive" means \[under the fourth prong of the [Central
> Hudson]{.underline} test\].

[Id.]{.underline} at 657-658.

The Court of Appeals explained (and the agency has since accepted,
[see]{.underline} [Food Labeling; Health Claims and Label Statements for
Dietary Supplements; Update to Strategy for Implementation of Pearson
Court Decision]{.underline}, 65 Fed. Reg. 59,855 (October 6, 2000)) that
regardless how FDA defines "significant scientific agreement,"
regulatees may not be barred from making health claims that do not
satisfy that standard, so long as the claims are truthful or can be
rendered so through the addition of reasonable disclaimers. That in no
small measure accounted for the Court's decision to "invert the normal
order \[of review\] to discuss first appellants' most powerful
constitutional claim." [Id.]{.underline} at 654. The Court of Appeals
wrote:

> Normally we would discuss the nonconstitutional argument first,
> particularly because we believe it has merit. We invert the normal
> order here to discuss \[the claim\] that the government has violated
> the First Amendment by declining to employ a less draconian
> method---the use of disclaimers---to serve the government's interests,
> because the requested remedy stands apart from appellants' request
> under the APA that the FDA flesh out its standards. That is to say,
> even if "significant scientific agreement" were given a more concrete
> meaning, appellants might be entitled to make health claims that do
> not meet that standard---with proper disclaimers.

[Id.]{.underline}

The four claims there in issue were supported by scientific evidence,
but the FDA thought the evidence concerning the underlying
nutrient-disease relationships inconclusive.[^7] The Court of Appeals
observed: "The problem with these claims, according to the FDA, was not
a dearth of supporting evidence; rather, the agency concluded that the
evidence was inconclusive for one reason or another and thus failed to
give rise to 'significant scientific agreement.'" [Id.]{.underline} at
653. But the inconclusiveness of the evidence served as no sound
justification for suppressing the claims. Indeed, our Court of Appeals
found inconclusiveness an appropriate basis for inclusion of a
disclaimer to that effect. [Id.]{.underline} at 658. Moreover, the Court
told the agency that if it feared the public would perceive the claims
as FDA authorized, that too could be rectified through use of a
disclaimer, to wit: "The FDA does not approve this claim."
[Id]{.underline}. at 659. The Court even found the presence of adverse
effects from use of dietary supplements rectifiable not through outright
claim suppression but, again, through use of a disclaimer, writing:
"\[T\]he government's interest in preventing the use of labels that are
true but do not mention adverse effects would seem to be satisfied---at
least ordinarily---by inclusion of a prominent disclaimer setting forth
those adverse effects." [Id.]{.underline}

The Court evaluated FDA's suppression of the four health claims under
the Supreme Court's commercial speech standard, explaining that the
burden of proof lay with the agency to justify each act of speech
suppression. [See id]{.underline}. Thus, the Court taught us that FDA is
not unlike other agencies of the federal government; it may not suppress
speech without first satisfying a heavy burden of proof under the First
Amendment, a burden that FDA may not shift to its regulatees but must
always bear alone as the party seeking speech restriction or
suppression. [See]{.underline} [In re R.M.J.]{.underline}, 455 U.S. at
203; [Peel v. Attorney Registration and Disciplinary
Comm'n]{.underline}, 496 U.S. 91, 109 (1990); [Edenfield v.
Fane]{.underline}, 507 U.S. 761, 770 (1993) ([quoting]{.underline}
[Bolger v. Youngs Drug Prods. Corp.]{.underline}, 463 U.S. 60, 71, n.20
(1983)).

In suppressing the four health claims, FDA failed to satisfy the "direct
advancement" and "means-ends fit" prongs of the [Central
Hudson]{.underline} commercial speech standard. Considering the
government's health and safety goal, the FDA's direct advancement
showing fell far short of the mark:

> The government simply asserts its "common sense judgment" that the
> health of consumers is advanced *directly* by barring any health
> claims not approved by the FDA. Because it is not claimed that the
> product is harmful, the government's underlying---if
> unarticulated---premise must be that consumers have a limited amount
> of either attention or dollars that could be devoted to pursuing
> health through nutrition, and therefore products that are not
> indisputably health enhancing should be discouraged as threatening to
> crowd out more worthy expenditures. We are rather dubious that this
> simplistic view of human nature or market behavior is sound, but, in
> any event, it surely cannot be said that this notion---which the
> government does not even dare openly to set forth---is a *direct*
> pursuit of consumer health; it would seem a rather indirect route, to
> say the least.

[Pearson]{.underline} I, 164 F. 3d at 656. The Court did find the
government's fraud goal directly advanced by suppression but found
suppression to fail [Central Hudson]{.underline}'s fourth prong. In
particular, the Court held use of disclaimers to correct potential
misleadingness an obvious, less speech restrictive alternative to
outright suppression and one in accord with the constitutional
preference, repeatedly expressed in the Supreme Court's commercial
speech jurisprudence, that disclosure is the preferred remedy.
[Id.]{.underline} at 658 ([citing 44 Liquormart v. Rhode
Island]{.underline}, 507 U.S. 484, 509 (1996)); [see also]{.underline},
[In re R.M.J.]{.underline}, 455 U.S. at 203 (1982);
[Ibanez]{.underline}, 512 U.S. at 144 (1994); [Peel v. Attorney
Registration and Disciplinary Comm'n of Illinois]{.underline}, 496 U.S.
91, 99-111 (1990).

Significantly, the [Pearson]{.underline} I Court compelled FDA to adhere
to the First Amendment separate and apart from the statutory health
claim review required for dietary supplements.[^8] In effect the Court
has established a second (and, due to its constitutionally required
status, superior) claim review to that prescribed by statute. This
second constitutional claim review must be undertaken if FDA elects not
to *authorize* a claim; pursuant to it FDA must favor disclosure of
*unauthorized* claims over their suppression in all instances where use
of disclaimers can render potentially misleading messages not so and can
thereby serve as a less speech restrictive alternative to censorship. To
be sure, as the [Pearson]{.underline} I Court explained, this
constitutional review will result in allowance of claims with
disclaimers that fail to satisfy the agency's "significant scientific
agreement" review. That allowance, however, is precisely the means by
which FDA can (and therefore must) avoid a conflict between statutory
construction of 21 U.S.C. § 343(r)(5)(d) and the First Amendment (see
the section below on food health claims).

> ***FDA's Response to Pearson I.*** Although [Pearson]{.underline} I
> was decided January

15, 1999, the FDA sadly (indeed, contumaciously) did not act on the
decision with anything approaching alacrity. At the time of the Court of
Appeals' decision, each of the four [Pearson]{.underline} I health
claims had been unconstitutionally suppressed by the FDA for five years,
since 1994 ([See]{.underline} 59 Fed. Reg. 395 (January 4, 1994)). FDA
did not complete its reevaluation of the four [Pearson]{.underline}
health claims for another 2 years past the [Pearson]{.underline} I
decision date. FDA did not revoke the four rules held unconstitutional
in [Pearson]{.underline} I until 18 months after the decision issued
(and even then ruled that the substantive prohibitions of those rules
would remain in effect, 65 Fed. Reg. 58,917, 58,918 (Oct. 3, 2000))---an
unreasonable delay according to the United States District Court for the
District of Columbia: "\[T\]here is no question that the agency has
acted with less than reasonable speed in this case; for example, it
waited for more than 18 months before revoking rules declared
unconstitutional by our Court of Appeals." [Pearson]{.underline} II 130
F. Supp. 2d at 120.

When FDA finally revisited the four claims, (1) it once again refused to
allow ".8 mg of folic acid in a dietary supplement is more effective in
reducing the risk of neural tube defects than a lower amount in foods in
common form" (hereinafter "Folic Acid Claim") to appear on supplement
labels and in labeling (a decision Judge Gladys Kessler of the United
States District Court for the District of Columbia declared
unconstitutional under the First Amendment and enjoined in
[Pearson]{.underline} II) (from the time that folic acid claim was first
sought to the time the Court ordered it to be allowed spanned 7
years[^9]); (2) FDA again refused to allow any claim that antioxidant
vitamins may reduce the risk of certain kinds of cancer (a decision now
on appeal in Case Number 01CV01539 before the United States District
Court for the District of Columbia (Judge Gladys Kessler presiding)
(from the time that claim was first sought to the present spans 8
years); (3) FDA again refused to allow any claim associating fiber with
reduction in the risk of colorectal cancer (a decision not appealed);
and (4) FDA finally allowed the claim sought for omega-3 fatty acids and
heart disease with the very disclaimer plaintiffs said they would have
accepted in 1994 (the agency doing so on February 8, 2002) (from the
time the claim was first sought to the present spanned 7 years).[^10]

FDA did not address implementation of the [Pearson]{.underline} I
decision until December 1, 1999, eleven months after
[Pearson]{.underline} I was decided and 8 months after the
[Pearson]{.underline} remand order formally issued from the United
States District Court for the District of Columbia (April 20, 1999 cited
in [Pearson]{.underline} II, 130 F. Supp. 2d at 110). In that
implementation notice, "Food Labeling: Health Claims and Label
Statements for Dietary Supplements; Strategy for Implementation of
Pearson Court Decision," 64 Fed. Reg. 67,289 (December 1, 1999)
(hereinafter "Pearson Implementation Notice"), FDA did not agree to any
specific deadline for ultimate action on the constitutional and
administrative mandates before it. Rather than immediately re-evaluate
the rejected claims in light of the decision and the then extant
administrative record, FDA commenced new rulemakings on each claim
(soliciting a new round of scientific submissions), lengthening the time
for action considerably. [See id.]{.underline} at 67,290. FDA requested
public comments on each of the remanded claims. [See]{.underline} 64
Fed. Reg. 48,841 (September 8, 1999). FDA held a public meeting on
implementation of the decision, "to solicit input on changes to FDA's
general health claim regulations for dietary supplements . . ," pursuant
to 65 Fed. Reg. 14,219 (March 16, 2000), and FDA planned, but never
commenced, a rulemaking to reconsider the general health claims
regulations for dietary supplements in light of the
[Pearson]{.underline} I decision. 64 Fed. Reg. at 67290. The choice of
these lengthy, indefinite procedures in the face of a certain
constitutional order holding the regulations unconstitutional plainly
appeared to be administrative "gamesmanship" calculated for delay.

FDA did not revoke the four rules held unconstitutional by the Court of
Appeals in [Pearson]{.underline} I until October 3, 2000, fully eighteen
months after that decision. As explained above, the revocation notice
had no substantive effect because the underlying claims were still
disallowed in the revocation order. [See]{.underline} 65 Fed. Reg.
58,917, 59,918 (Oct. 3, 2000).

On October 6, 2000, FDA published a notice stating that it had modified
"its approach to processing new health claim petitions for dietary
supplements" on an interim basis. 65 Fed. Reg. 59,855, 59,856 (October
6, 2000). "Rather than denying all petitions that do not meet the
significant scientific agreement standard pending completion of the
general rulemaking" (what it had stated it would do in the Pearson
Implementation Notice), FDA would "exercise enforcement discretion in
the appropriate circumstances," such as when, among other things, "the
scientific evidence in support of \[a\] claim outweighs the scientific
evidence against the claim, the claim is appropriately qualified, and
all statements in the claim are consistent with the weight of the
scientific evidence . . ." [Id]{.underline}.[^11]

Despite the decisions holding FDA speech suppression unconstitutional,
the FDA has to date failed to eliminate in toto those regulations,
guidances, policies, and practices that violate the First Amendment's
free speech guarantee and, to the extent necessary, replace them with
regulations, guidances, policies, and practices that comply with the
First Amendment.

***The United States District Court Decisions Compelling Adherence to
Pearson I.*** The United States District Court for the District of
Columbia (Judge Gladys Kessler) ruled on February 2, 2001, that FDA
violated the First Amendment and the plain meaning of
[Pearson]{.underline} I when it chose to maintain suppression of the
Folic Acid Claim following the Court of Appeals' remand order. The
District Court granted the plaintiffs' motion for summary judgment,
finding that the FDA had violated the First Amendment in refusing to
approve the plaintiffs' Folic Acid Claim, with or without disclaimers,
and ordering that the case be immediately remanded to the FDA "for the
purpose of drafting one or more short, succinct, and accurate
alternative disclaimers, which may be chosen by the plaintiffs to
accompany their Folic Acid Claim." [Pearson]{.underline} III, 141 F.
Supp. 2d 105, 107 (2001) [citing Pearson]{.underline} II, 130 F. Supp.
2d. at 121. That decision provides important teachings for FDA on its
constitutional duties under [Pearson]{.underline} I. There is no
evidence that FDA has heeded those teachings beyond complying with the
Court's injunction order (and that, as the District Court observed, the
agency did very reluctantly).

At the time of the decision of [Pearson]{.underline} II, Judge Kessler
found no evidence of substantive compliance with the
[Pearson]{.underline} I disclosure and disclaimer requirements. Indeed,
she wrote:

> \[T\]he agency appears to have at best, misunderstood, and at worst,
> deliberately ignored, highly relevant portions of the Court of Appeals
> Opinion.

[Pearson]{.underline} II at 112.

> In sum, the FDA has simply failed to adequately consider the teachings
> of Pearson: that the agency must shoulder a very heavy burden if it
> seeks to totally ban a particular health claim. With respect to the
> two disclaimers which the Pearson Court suggested might cure all
> potential misleadingness, the FDA did not consider one of them at all,
> and summarily rejected the other in a single sentence. Nor did the FDA
> "demonstrate with empirical evidence that disclaimers similar to the
> ones" suggested by the Court of Appeals would "bewilder consumers and
> fail to correct for deceptiveness." . . . . Indeed, the FDA did not
> consider any other disclaimers, except for "The FDA has not evaluated
> this claim," a disclaimer no one has suggested and which is obviously
> inaccurate.
>
> [Id.]{.underline} at 118.
>
> \[T\]he Court concludes that the FDA did not undertake the necessary
> analysis required by Pearson, especially as evidenced by its failure
> to consider clarifying disclaimers that could cure the alleged
> misleading nature of the Folic Acid Claim.
>
> [Id.]{.underline} at 119.
>
> \[T\]he Court concludes that the FDA acted unconstitutionally, and
> particularly in violation of the Court of Appeals decision in Pearson
> v. Shalala, in suppressing Plaintiffs' Claim rather than proposing a
> clarifying disclaimer to accompany the Claim.
>
> [Id.]{.underline} at 114.

The Court explained that, to the date of the decision, the "FDA has
continually refused to authorize the disclaimers suggested by the Court
of Appeals---or any disclaimer, for that matter," [Id.]{.underline}, and
the Court found "as a matter of law, that Plaintiffs' Folic Acid Claim
is not 'inherently misleading,' and the FDA therefore erred in not
drafting disclaimers to accompany the Claim." [Id.]{.underline} The
Court found "even a cursory examination of the scientific literature on
which the FDA relied in its Folic Acid Decision" to "demonstrate\[\]
that the FDA's conclusion . . . was arbitrary, capricious and otherwise
in violation of law." [Id.]{.underline} at 115.

Once again, a federal court determined that FDA could not require near
conclusive proof as a condition precedent for allowing a scientific
claim but had to allow the claim to be made, even if inconclusive,
resorting to disclaimers to make the inconclusiveness clear to the
consumer. Judge Kessler explained:

> \[A\]s the Pearson opinion strongly suggests, the FDA may not ban the
> Folic Acid Claim simply because the scientific literature is
> inconclusive about whether synthetic folic acid is superior to
> naturally occurring food folate. . . . The question which must be
> answered under Pearson is whether there is any "credible evidence"
> that synthetic folic acid is superior to naturally occurring food
> folate. See id. (observing that "it appears that credible evidence did
> support" the Folic Acid Claim). There clearly is such evidence, as the
> FDA itself acknowledged . . . In short, even if the FDA's criticism of
> the sub-claim is valid, this criticism does not make the Claim
> inherently misleading; rather, it suggests the need for a well-drafted
> disclaimer, which the FDA has steadfastly thus far refused to even
> consider.

[Id.]{.underline} at 118.

Moreover, Judge Kessler made clear that the absence of significant
affirmative evidence in support of a particular health claim did not
translate into negative evidence against the claim. The mere absence of
affirmative evidence was simply not enough to justify claim suppression.
The FDA would have to prove evidence against the claim outweighed
evidence for it in order to justify suppression. [See]{.underline}
[Pearson]{.underline} II, 130 F. Supp. 2d at 115. The difference is a
critical one, underscoring the fact that disclosure of information has
become the operative legal rule, a rule that has been consistently
ignored by this agency in every one of its health claims reviews, since
[Pearson]{.underline} I was decided.

Judge Kessler emphasized that claim suppression was forbidden absent a
"showing" that alleged misleadingness was incurable through a
disclaimer:

> The Pearson Court clearly ruled that the FDA may not prohibit a health
> claim unless it first makes a "showing" that the claim's alleged
> "misleadingness" could not be cured through the use of a disclaimer or
> other types of disclosure.

[Id.]{.underline} at 118.

The FDA unsuccessfully sought reconsideration of Judge Kessler's order
on the Folic Acid Claim. Judge Kessler's decision on reconsideration
provides the agency additional, important instruction on the need for
strict and immediate adherence to the First Amendment mandate of the
Court of Appeals in [Pearson]{.underline} I. Her Honor wrote:

> \[I\]t must be remembered that the Court's Opinion in Pearson II
> concluded that Defendants failed to comply with Pearson I, in which
> the Court of Appeals

(1) considered the precise Folic Acid Claim at issue here and rejected

> Defendants' previous argument that the claim was inherently
> misleading;

(2) suggested two disclaimers for Defendants to examine, one of which

> Defendants ignored and the other of which Defendants summarily
> dismissed as inadequate;

(3) indicated that Defendants must "demonstrate with empirical evidence
    that

> disclaimers similar to the \[two it\] suggested . . . would bewilder
> consumers and fail to correct for deceptiveness," which Defendants
> have yet to do; and

(4) established a very heavy burden which Defendants must satisfy if
    they wish to

> totally suppress a particular health claim.
>
> Given Defendants continuing failure to comply with these and other
> essential aspects of Pearson II, the Court must deny Defendants'
> motion for reconsideration.

[Id.]{.underline} at 111.

The Court again faulted FDA for not abiding by the Court of Appeals'
mandate:

> In moving for reconsideration, Defendants again seem to ignore the
> thrust of Pearson I. While that decision might leave certain specific
> issues to be fleshed out in the course of future litigation, the
> philosophy underlying Pearson I is perfectly clear: that the First
> Amendment analysis in [Central Hudson Gas & Elec. Corp. v. Public
> Serv. Comm'n of N.Y.]{.underline}, 447 U.S. 557, 65 L.Ed.2d 341, 100
> S.Ct. 2343 (1980), applies in this case, and that if a health claim is
> not inherently misleading, the balance tilts in favor of disclaimers
> rather than suppression. In its motion for reconsideration, the FDA
> has again refused to accept the reality and finality of that
> conclusion by the Court of Appeals.

[Id.]{.underline} at 112.

***The Importance of the Washington Legal Foundation Decision.*** In
[Washington Legal Foundation v. Henney]{.underline}, 202 F.3d 331 (D.C.
Cir. 2000), the United States Court of Appeals for the D.C. Circuit
vacated the decision of the United States District Court for the
District of Columbia that the FDA Modernization Act and agency Guidance
provisions restricting drug and medical device manufacturers'
dissemination of off-label use information violated the First Amendment.
[Id.]{.underline} at 337. It did so because on appeal the government
took the position that it understood the provisions of FDAMA and the
guidance documents not to create enforceable restrictions on speech but
to create a safe harbor that, if followed, would cause certain forms of
conduct not to be questioned as misbranding by the agency.
[Id]{.underline}. at 335. [See also]{.underline} [Washington Legal
Foundation v. Henney]{.underline}, 128 F. Supp. 2d 11, 13 (D.C. 2000).
The Court of Appeals therefore concluded that an actual case or
controversy, and thus standing, did not exist and vacated the
constitutional decision of the court below. In so doing, the Court did
"not criticize the reasoning or conclusions of the district court" and
did not "reach the merits of the district court's First Amendment
holdings . . ." [Id]{.underline}. at 337.

It is thus the case that the underlying decision of the District Court,
while no longer law, is instructive on how the district court may
resolve future cases involving FDA restriction on the use of off-label
information. In the two decisions of import below, the United States
District Court held (1) the FDA's Guidance documents and (2) the FDAMA
provisions concerning manufacturer distribution of enduring materials on
off label uses violated the First Amendment. In particular, FDA's then
extant guidance documents limited distribution by manufacturers to
doctors of "enduring materials" (medical journals, articles, textbooks,
and the like) containing "off-label" use information. The guidance
documents also limited manufacturer support of scientific and
educational activities, including medical symposia, wherein off-label
use information would be discussed or demonstrated. [See]{.underline}
[Washington Legal Foundation v. Kessler]{.underline}, 880 F. Supp. 26,
28 (D.C. 1995). The Court held that FDA's restrictions violated the
fourth prong of [Central Hudson]{.underline} because they were more
extensive than necessary to serve the state's interests. In particular,
the Court rejected the argument "that any and all scientific claims
about the safety, effectiveness, contraindications, side effects, and
the like regarding prescription drugs are presumptively untruthful or
misleading until the FDA has had the opportunity to evaluate them,"
explaining that through this argument "FDA exaggerates its overall place
in the universe." [Washington Legal Foundation v. Friedman]{.underline},
13 F. Supp. 2d 51, 67 (D.D.C. 1998). The Court held the restrictions
invalid under the fourth prong of [Central Hudson]{.underline}, finding
them more extensive than necessary to further the government's interest:

> The court finds that the restrictions in the Guidance Documents are
> considerably more extensive than necessary to further the substantial
> government interest in encouraging manufacturers to get new uses
> on-label. This determination is based in large part upon the fact that
> there exist less-burdensome alternatives to this restriction on
> commercial speech . . . The most obvious alternative is full,
> complete, and unambiguous disclosure by the manufacturer . . . Full
> disclosure not only addresses all of the concerns advanced by the FDA,
> but addresses them more effectively. It is less restrictive on speech,
> while at the same time deals more precisely with the concerns of the
> FDA and Congress.

[Id.]{.underline} at 73. In assessing FDAMA's off-label use provisions,
the Court additionally reasoned the FDAMA requirement that a
supplemental new drug application be filed for the off-label use to
"amount to a kind of constitutional blackmail---comply with the statute
or sacrifice your First Amendment rights." 56 F. Supp. 2d at 87. Again
the restriction was found in excess of that reasonably necessary and,
thus, unconstitutional under the First Amendment. [See id.]{.underline}

***The Supreme Court's Decision in Thompson v. Western States Medical
Center.*** In [Thompson v. Western States Medical Center]{.underline},
122 S.Ct. 1497 (2002), the Supreme Court held the advertising and
promotion provisions of FDA Modernization Act Section 503A
unconstitutional restrictions on commercial speech. [See
id]{.underline}. at 1500. Under that Section, pharmacies, licensed
pharmacists, and licensed physicians were prohibited from advertising or
promoting the compounding of any particular drug, class of drug, or type
of drug. That same entity and those same individuals were permitted to
advertise and promote the existence of compounding services. [See
id]{.underline}. The Court found the prohibition failed the final prong
of the [Central Hudson]{.underline} test because the Government could
have achieved its objectives in a manner that did not restrict speech,
reciting several non-speech related means to achieve the Government's
ends. [See id]{.underline}. at 1508. The Court stated without
equivocation that under the final prong of [Central Hudson]{.underline}
if Government can pursue a non-speech related means to achieve a
regulatory end, it must (choosing speech suppression in such cases is
not an option): "In previous cases addressing \[the\] final prong of the
[Central Hudson]{.underline} test, we have made clear that if the
Government could achieve its interests in a manner that does not
restrict speech, or that restricts less speech, the Government must do
so." [Id]{.underline}. at 1506.

The Court faulted the government for making speech restriction a first
resort: "If the First Amendment means anything, it means that regulating
speech must be a last---not first---resort. Yet here it seems to have
been the first strategy the Government thought to try."
[Id]{.underline}. at 1507. Although the Government did not argue that
the advertisements in question were misleading, had they done so the
Court made clear that it would not have accepted outright suppression as
a constitutional option; rather the less speech restrictive alternative
of a warning statement would have to be used: "Even if the Government
did argue that it had an interest in preventing misleading
advertisements, this interest could be satisfied by the far less
restrictive alternative of requiring each compounded drug to be labeled
with a warning that the drug had not undergone FDA testing and that its
risks were unknown." [Id]{.underline}. at 1508. Thus,
[Thompson]{.underline} reinforces the heavy constitutional onus in favor
of disclosure over suppression and in favor of disclaimers as less
speech restrictive alternatives to outright suppression.

***Reforming the Agency's Mindset (the Need to Adopt and Inculcate First
Amendment Doctrine).*** To comply with the requirements of First
Amendment precedent, FDA must accept and implement the paramount First
Amendment preference for disclosure over suppression in every area of
agency speech regulation. To do so consistently and faithfully requires
a basic change in regulatory mindset. Agency staff must come to
appreciate that private speech carries with it a
[constitutional]{.underline} presumption that it is protected from
government suppression. Delicate tools must be applied. Rather than
censor all speech containing potentially misleading connotations,
regulators at this agency must be careful to correct the potential to
mislead with more speech and allow the entire lot to reach the consumer,
trusting the consumer to perceive his or her own best interest, and to
make the ultimate choice on how best to satisfy that interest. So long
as agency staff hinder, restrict, or burden truthful information and so
long as potentially misleading speech is not allowed with corrective
disclaimers, there will be no end to First Amendment violations and no
end to constitutional challenges.

Our Supreme Court has made clear that regulators who presume to know
better than consumers what is in the best interest of consumers and who
restrict information on that basis cannot overcome the very high burden
of proof that the First Amendment places upon them. The First Amendment
stands squarely against state-compelled speech orthodoxies.
[See]{.underline} [United States v. United Foods, Inc.]{.underline}, 533
U.S. 405, 410 (2001); [Riley v. Nat'l Fed'n of Blind, Inc.]{.underline},
487 U.S. 781, 796-797 (1988). The First Amendment stands for the
proposition that consumers can pursue their own best interests if well
enough informed and that consumer error is best corrected through more
speech, not less. [See]{.underline} [Virginia State Board of
Pharmacy]{.underline}, 425 U.S. at 770. FDA must make disclosure the
rule and suppression the very rare exception (allowable only in
instances where the claim in issue is inherently misleading, i.e., where
no reasonable disclaimer, warning statement, or disclosure can suffice
to cure the misleadingness).

FDA must transform itself from a communication barrier to a
communication facilitator. If given access to all manner of truthful
health information concerning health care products, Americans will be in
a far better position to exercise informed choice and will be less
likely to fall prey to fraud. That, at least, is a basic, irreducible
teaching of our First Amendment precedent. [See]{.underline} [Virginia
State Board of Pharmacy]{.underline}, 425 U.S. at 770 ("It is precisely
this kind of choice, between the dangers of suppressing information, and
the dangers of its misuse if it is freely available, that the First
Amendment makes for us.").

Because FDA's speech bans and speech regulatory hurdles prevent
responsible regulatees from communicating truthfully many health
benefits or regulated substances, those bans and hurdles lock out of the
marker all manner of accurate representations about actual and potential
disease prevention, mitigation and cure benefits of regulated products.
Consequently, consumers at the point of sale frequently guess about the
potential effectiveness of regulated products.

Into the information void have stepped charlatans, operating virtually
unchecked by the government because regulatory resources are
insufficient to identify and stop all purveyors of fraud. As a practical
matter, even if FDA had an unlimited enforcement budget it could not
hope to stop all fraud in regulated markets. FDA depends on voluntary
compliance with its rules. Punishments after the fact will always be
necessary yet will never be sufficient to save every consumer from those
who use deception to pray upon the gullible. Yet among would be victims
of fraud are many, if not all, who would never fall pray were they given
more complete information on the actual and potential benefits of the
regulated products in question. It is thus the case that the information
void created by FDA suppression of truthful speech actually exacerbates
the power of fraud in the market by affording it no free speech
corrective. Those who lack a substantive basis upon which to question
the validity of a fraudulent claim are obviously at much higher risk of
being duped than those afforded accurate information at the point of
sale. The net effect, then, of FDA's policy of favoring suppression over
disclosure is to leave far more consumers at risk of harm than would
otherwise be.

The FDA must find a better way. That better way involves allowing the
free flow of accurate health information to reach the market where it
can educate consumers, arming them with greater knowledge. It is
presently the case that consumers awash in false information lack that
volume of true counsel that only a more open information market can
provide. Consequently, consumers-deprived of the truth at the point of
sale-unknowingly rely on falsehoods that would otherwise be rebuffed in
a free and open exchange. A free and open exchange of truthful
information leads to a more sophisticated consumer and, consequently, a
diminution in profits from fraudulent activity, thus reducing the
incentive for fraud and, ultimately, the amount of fraud in the market.
In the end a reduction in fraud will enable the government more
effectively and economically to fulfill its law enforcement duties.

If the FDA at once implements a policy across the board favoring
disclosure of accurate health information instead of its suppression,
false counsels will confront true ones en masse, consumers will benefit
from the receipt of more accurate information, the evolution of science
on substances commonly ingested will accelerate, and in the end
consumers will exercise more informed choice with greater resulting
health benefits than they do now. That market transformation could
greatly increase the health of the public and decrease reliance on
public coffers and private insurance for maladies that could in certain
circumstances be avoided through greater public awareness.[^12]

FDA will continue to violate the First Amendment until it comes to
accept that the several federal judicial decisions which have held FDA
speech suppression a First Amendment violation are final and binding
limits on its power and that failure to abide by those limits in every
area of FDA speech regulation is unlawful. The FDA cannot reasonably
expect its regulatees to respect the limits FDA places on their freedom
to act when the FDA violates the limits the Constitution places on FDA's
exercise of power.

It would behoove the agency (1) to recognize, frankly, its
unconstitutional legacy of suppression; (2) to repudiate that legacy;
and (3) to demand that its scientific and legal staff accept and follow
the precepts of the First Amendment whenever they evaluate regulatees'
speech. It is this kind of clean break from the past that FDA
desperately needs to put itself on a constitutional footing.

**PART III: FDA CENSORSHIP RATIONALES ARE ANACHRONISTIC AND ILLEGAL IN
LIGHT OF CURRENT FIRST AMENDMENT PRECEDENT**

III. **FDA CENSORSHIP RATIONALES ARE ANACHRONISTIC AND ILLEGAL IN LIGHT
     OF CURRENT FIRST AMENDMENT PRECEDENT**

FDA cannot hope to comply with the First Amendment until it finally
divorces itself from anachronistic (and now illegal) grounds for
censorship to which it has been wedded for the past seven decades. FDA's
censorship justifications may be summarized as follows:

(1) accurate health information is in itself harmful and may lead
    individuals to act

against their own best interests;[^13]

(2) consumers cannot be trusted to evaluate accurate health information
    because

they lack the sophistication necessary to do so;[^14] and

(3) censorship of health information better serves consumers than
    disclosure of

that information (with disclaimers, as necessary to eliminate potential
misleadingness)[^15].

Each of those notions so much a part of regulatory thinking at FDA (and
so much a part of that history of government speech suppression the
First Amendment was intended to eliminate) has been rejected by our
Court of Appeals and by our Supreme Court. The high Court has made clear
that those notions have no legal legitimacy, no proper place in any
department or agency of the United States government. [See Thompson v.
Western States Medical Center]{.underline}, 122 S. Ct. at 1507-1508; [44
Liquormart]{.underline}, 517 U.S. at 504. Each of those repressive
notions contradicts fundamental constitutional precepts that have been a
part of our First Amendment jurisprudence since 1793, precepts the Court
expects all in government to adopt, to respect, to inculcate, and to
follow consistently and faithfully.

**[Our Supreme Court has rejected as an illegitimate basis for
commercial speech suppression the notion that accurate commercial speech
is in itself harmful or may induce individuals to act in ways the
government thinks not in their own best interest]{.underline}**.
[See]{.underline} [Thompson v. Western States Medical
Center,]{.underline} 122 S. Ct. at 1507-1508; [44
Liquormart]{.underline}, 517 U.S. at 503; [Linmark Associates, Inc. v.
Willingboro]{.underline}, 431 U.S. 85, 96 (1977); [Central
Hudson]{.underline}, 447 U.S. at 576 (Blackmun, J. concurring). In
[Thompson v. Western States Medical Center]{.underline}, 122 S. Ct. at
1508, the Supreme Court reiterated: "There is, of course, an alternative
to this highly paternalistic approach. That alternative is to assume
that...information is not in itself harmful, that people will perceive
their own best interests if only they are well enough informed, and that
the best means to that end is to open the channels of communication
rather than to close them," citing [Virginia Bd. of Pharmacy v. Virginia
Citizens Consumer Council, Inc.]{.underline}, 425 U.S. 748, 770 (1976);
[see also]{.underline} [Thompson]{.underline}, 122 S.Ct. at 1507 ("We
have previously rejected the notion that the Government has an interest
in preventing the dissemination of truthful commercial information in
order to prevent members of the public from making bad decisions with
the information."); [44 Liquormart, Inc. v. Rhode Island]{.underline},
517 U.S. at 503 ("Bans against truthful, nonmisleading commercial speech
. . . usually rest solely on the offensive assumption that the public
will respond 'irrationally' to the truth. The First Amendment directs us
to be especially skeptical of regulations that seek to keep people in
the dark for what the government perceives to be their own good");
[Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n]{.underline},
447 U.S. 557, 572 (1980) (Brennan J., concurring) ("no differences
between commercial speech and other protected speech justify suppression
of commercial speech in order to influence public conduct through
manipulation of the availability of information"); [Central Hudson Gas &
Elec. Corp.]{.underline}, 447 U.S. at 576 (Blackmun J., concurring) ("If
the First Amendment guarantee means anything, it means that, absent
clear and present danger, government has no power to restrict expression
because of the effect its message is likely to have on the public"); and
[Whitney v. California]{.underline}, 274 U.S. 357, 377 (1927) ("If there
be time to expose through discussion the falsehood and fallacies, to
avert the evil by the processes of education, the remedy to be applied
is more speech, not enforced silence. Only an emergency can justify
repression.").

**[Our Supreme Court has rejected as an illegitimate basis for
commercial speech suppression the notion that accurate commercial speech
may be too complex for consumers to understand]{.underline}**. In
[Thompson v. Western States Medical Center]{.underline}, 122 S. Ct. at
1503, the Court reiterated: ". . . the general rule is that the speaker
and the audience, not the government, assess the value of \[\]
information . . ," citing [Edenfield v. Fane]{.underline}, 507 U.S. 761,
767 (1993). [See also]{.underline} [Bates v. State Bar of
Arizona]{.underline}, 433 U.S. 350, 374-375 (1977) (". . . the argument
assumes that the public is not sophisticated enough to realize the
limitations of advertising, and that the public is better kept in
ignorance than trusted with correct but incomplete information. We
suspect the argument rests on an underestimation of the public. In any
event, we view as dubious any justification that is based on the
benefits of public ignorance."); [Bolger v. Youngs Drug Products
Corp.]{.underline}, 463 U.S. 60, 74 (1983) ("the level of discourse in
reaching a mailbox simply cannot be limited to that which would be
suitable for a sandbox"); [Butler v. Michigan]{.underline}, 352 U.S.
380, 383 (1957) (the government may not "reduce the adult population . .
. to reading only what is fit for children").

**[Our Supreme Court has rejected as an illegitimate basis for
commercial speech suppression the notion that censorship of information
better serves consumers than disclosure of information]{.underline}**.
In [Thompson v. Western States Medical Center]{.underline}, 122 S. Ct.
at 1507, the Supreme Court reiterated: "We have . . . rejected the
notion that the Government has an interest in preventing the
dissemination of truthful commercial information in order to prevent
members of the public from making bad decisions with the
information\[,\]" citing [44 Liquormart, Inc. v. Rhode
Island]{.underline}, 517 U.S. 173, 503 (1999). Indeed, in [44
Liquormart, Inc.]{.underline}, 517 U.S. at 503-504, the Court wrote at
length to reject paternalistic regulation of commercial speech:

Precisely because bans against truthful, nonmisleading commercial speech
rarely

> seek to protect consumers from either deception or overreaching, they
> usually rest solely on the offensive assumption that the public will
> respond "irrationally" to the truth. [Linmark]{.underline}, 431 U.S.
> at 96. The First Amendment directs us to be especially skeptical of
> regulations that seek to keep people in the dark for what the
> government perceives to be their own good. That teaching applies
> equally to state attempts to deprive consumers of accurate information
> about their chosen products:
>
> The commercial marketplace, like other spheres of our social and
> cultural life, provides a forum where ideas and information flourish.
> Some of the ideas and information are vital, some of slight worth. But
> the general rule is that the speaker and the audience, not the
> government, assess the value of the information presented. Thus, even
> a communication that does no more than propose a commercial
> transaction is entitled to the coverage of the First Amendment.
> [See]{.underline} [Virginia State Bd. of Pharmacy]{.underline} . . .
> [Edenfield v. Fane,]{.underline} 507 U.S. 761, 767 (1993).

[See also]{.underline} [Virginia Bd. of Pharmacy]{.underline}, 425 U.S.
at 765 ("So long as we preserve a predominantly free enterprise economy,
the allocation of our resources in large measure will be made through
numerous private economic decisions. It is a matter of public interest
that those decisions, in the aggregate, be intelligent and well
informed. To this end, the free flow of commercial information is
indispensable"); [Central Hudson Gas & Electric Corp. v. Public Serv.
Comm'n]{.underline}, 447 U.S. 557, 562 (1980) ("Even when advertising
only an incomplete version of the relevant facts, the First Amendment
presumes that some accurate information is better than no information at
all."); [Pearson v. Shalala]{.underline}, 164 F.3d 650, 657 (1999)
("'the preferred remedy is more disclosure, rather than less,'" citing
[Bates v. State Bar of Arizona]{.underline}, 433 U.S. 350, 376 (1977)),
explaining that "the Court has reaffirmed \[the\] principle \[of
disclosure over suppression\], repeatedly pointing to disclaimers as
constitutionally preferable to outright suppression," citing [Peel v.
Attorney Registration and Disciplinary Comm'n of Illinois]{.underline},
496 U.S. 91, 110 (1990); [In re R.M.J.,]{.underline} 455 U.S. 191, 206
n.20 (1982); [Shapero v. Kentucky Bar Association]{.underline}, 486 U.S.
466, 478 (1988)), and rejecting "the government's position that there is
no general First Amendment preference for disclosure over suppression,"
[Pearson]{.underline}, 164 F.3d at 658); [see also]{.underline} [Central
Hudson Gas & Electric Corp.]{.underline}, 447 U.S. at 567 ("\[e\]ven in
monopoly markets, the suppression of advertising reduces the information
available for consumer decisions and thereby defeats the purpose of the
First Amendment"); [Washington Legal Foundation v.
Friedman]{.underline}, 13 F. Supp. 2d 51, 70, 73 (D.C. 1998) ("\[T\]he
Supreme Court has repeatedly rejected governmental attempts to equate
less information with better decision-making . . ." ; "Full disclosure
not only addresses all of the concerns advanced by the FDA, but
addresses them more effectively. It is less restrictive on speech, while
at the same time deals more precisely with the concerns of the FDA and
Congress"; and "the Supreme Court \[prefers to combat\] potentially
problematic speech with more speech").

**PART IV: FIRST AMENDMENT LIMITS ON FDA SPEECH REGULATION**

**IV.**

**FIRST AMENDMENT LIMITS ON FDA SPEECH REGULATION**

A.  **SCIENTIFIC OR COMMERCIAL SPEECH?**

The speech FDA regulates on labels and in labeling of foods, dietary
supplements, drugs, medical devices, and cosmetics (and in drug
advertising) is in fact *scientific* albeit FDA has long treated it as
entirely commercial. It concerns either directly or indirectly the
physiological effect of the regulated product upon the body. Scientific
and academic speech are fully protected under the First Amendment. [See,
e.g.]{.underline}, [Keyishian v. Board of Regents]{.underline}, 385 U.S.
589, 603 (1967); [Board of Trustees of Leland Stanford Junior University
v. Sullivan]{.underline}, 773 F. Supp. 472, 474 (D.D.C. 1991) (". . .
\[T\]he First Amendment protects scientific expression and debate just
as it protects political and artistic expression."). While some of the
speech is economically motivated, a substantial amount is in no sense
motivated by any economic impetus greater than the one that led four
protestors to solicit contributions through an ad in the New York Times
([See]{.underline} [New York Times v. Sullivan]{.underline}, 376 U.S.
254 (1964)(applying strict judicial scrutiny)). In any event, the
economic motivations of the speakers are not in and of themselves
acceptable bases upon which to categorize the speech as commercial.
[See]{.underline} [Bolger v., Youngs Drug Products Corp]{.underline}.,
463 U.S. 60, 67 (1983). Moreover, the speech on labels and in labeling
is not "related solely to the economic interests of the speaker."
[Consolidated Edison Co. v. Public Service Comm'n]{.underline}, 447 U.S.
530, 561-62 (1980). The speech concerns how the products in issue affect
consumer health and welfare and thus concerns the health interests of
consumers. The speech does not propose a commercial transaction. It does
not make an offer to sell, yet even if it did that too would not "in and
of itself dictate the constitutional analysis that should apply . . ."
[44 Liquormart]{.underline}, 517 U.S. at 501; [see also]{.underline}
[Rubin v. Coors Brewing Co.]{.underline}, 514 U.S. at 491-494 (Stevens,
J., concurring in judgment). The speech is not particularly durable or
hardy because acts of FDA suppression have led responsible parties to
avoid for years use of the same or similar speech on labels and in
labeling, classic evidence of a chilling effect. [See]{.underline}
[Zauderer v. Office of Disciplinary Counsel of the Supreme Court of
Ohio]{.underline}. 471 U.S. 626, 651 (1985) (where the Supreme Court
recognizes the risk of a chilling effect in a commercial speech
context).

Moreover, FDA speech regulations strike at the heart of the information
communicated, not at the underlying commercial transaction. It is the
very aim of the regulations to prohibit certain kinds of scientific
information from reaching consumers predicated on a paternalistic and
speculative fear that receipt of such information by consumers will lead
them invariably to make unsound economic and health choices, choices FDA
*presumes* not in their best interest.[^16] The Supreme Court has made
clear that regulations of that kind are far more suspect under the First
Amendment than other forms of commercial speech regulation: ". . .\[A\]s
we explained in [Linmark]{.underline}, the State retains less regulatory
authority when its commercial speech restrictions strike at 'the
substance of the information communicated' rather than the 'commercial
aspect of \[it\]---with offerors communicating offers to offerees.'
[Linmark Associates, Inc. v. Willingboro]{.underline}, 431 U.S. 85, 96
(1977); [Carey v. Population Services Int'l]{.underline}, 431 U.S. at
701, n.28." [44 Liquormart]{.underline}, 517 U.S., at 499. The Court has
"serious First Amendment concerns about "blanket advertising
prohibitions that do not protect consumers from commercial harms."
[Id.]{.underline} at 500. It has held such regulations "particularly
dangerous" in recognition of the grave "dangers that attend governmental
attempts to single out certain messages for suppression."
[Id.]{.underline} at 501-502.

At the outset, therefore, the Joint Commenters challenge the view long
held by FDA that scientific speech communicated on labels, in labeling
and in drug advertising is entitled to less than full First Amendment
protection. The FDA should require that its regulators establish as a
condition precedent to any restriction on the content of scientific
speech that the regulation as applied satisfies the requirements of
strict scrutiny: "Under the strict-scrutiny test, \[the government has\]
the burden to prove that the \[restriction on speech\] is (1) narrowly
tailored, to serve (2) a compelling state interest." [Republican Party
of Minnesota v. White et al.]{.underline}, 2002 U.S. LEXIS 4883 at \*17
(June 27, 2002). The regulatory restriction is narrowly tailored only if
it does not "unnecessarily circumscribe protected expression."
[Id.]{.underline}, [citing]{.underline} [Brown v. Hartlage]{.underline},
456 U.S. 45, 54 (1982). A regulation that is content based is
presumptively unconstitutional under strict scrutiny. [See]{.underline}
[Crawford v. Lungren]{.underline}, 96 F.3d 380, 384 (9^th^ Cir. 1996)
([citing]{.underline} [Simon & Schuster, Inc. v. New York Crime Victims
Board]{.underline}, 502 U.S. 105, 118 (1991). In that regard, FDA must
prove that its regulatory objective is compelling, that its regulation
is content neutral, that its chosen means are narrowly tailored to serve
the compelling interest, and that its chosen means do not "circumscribe
protected expression." [See, e.g.,]{.underline} [Brown v.
Hartlage]{.underline}, 456 U.S. 45, 54 (1982).

B.  **THE PRINCIPAL PURPOSE OF FDA SPEECH REGULATION IS TO SUPPRESS
    CONTENT, NOT TO REGULATE UNDERLYING ECONOMIC ACTIVITY, AS SUCH
    EXACTING SCRUTINY MUST BE APPLIED**

Assuming arguendo that this agency deems the speech in issue
commercial,[^17] FDA's speech regulation avowedly and unabashedly aims
at suppressing specific scientific content to prevent consumers from
being influenced in ways FDA presumes not in their best interest. The
principal purpose of FDA labeling law is to control content reaching
consumers, not regulate the saleability of lawful dietary supplements,
foods, drugs, medical devices, and cosmetics. As explained above, our
Supreme Court has demanded that government agents who engage in this
kind of speech regulation face particularly exacting scrutiny, requiring
under the direct advancement prong of the commercial speech test proof
that harms recited be *real*, that chosen means *directly* advance
chosen ends, and that chosen means alleviate alleged harms to a
*material* degree. [See]{.underline} [Edenfield v. Fane]{.underline},
507 U.S. 761, 767 (1993); [Rubin v. Coors Brewing Co]{.underline}., 514
U.S. 476, 487 (1995).[^18]

Under the commercial speech standard, the burden of proof lies squarely
with the agency. [See]{.underline} [Western States Medical
Center]{.underline}, 122 S. Ct.. at 1507 ("\[i\]t is well established
that 'the party seeking to uphold a restriction on commercial speech
carries the burden of justifying it," [Ibanez v. Florida Dep't of
Business and Prof'l Reg.]{.underline}, 512 U.S. 136, 143 (1994),
[citing]{.underline} [Edenfield v. Fane]{.underline}, 507 U.S. at 770
(quoting [Bolger v. Youngs Drug Products Corp]{.underline}., 463 U.S.
60, 71, n.20 (1983)).

In [Western States Medical Center,]{.underline} 122 S. Ct. at 1503, the
Supreme Court recently reiterated the standard that must be satisfied
before commercial speech may be restricted.

> Under \[the commercial speech\] test we ask as a threshold matter
> whether the commercial speech concerns unlawful activity or is
> misleading. If so, then the speech is not protected by the First
> Amendment. If the speech concerns lawful activity and is not
> misleading, however, we next ask "whether the asserted governmental
> interest is substantial." *Id.*, at 566. If it is, then we "determine
> whether the regulation directly advances the governmental interest
> asserted," and, finally, "whether it is not more extensive than is
> necessary to serve that interest." *Ibid*. Each of these latter three
> inquiries must be answered in the affirmative for the regulation to be
> found constitutional.

***[Does the Speech Mislead or Concern Unlawful
Activity?]{.underline}*** The speech in issue concerns ingredients in or
functional aspects of lawfully sold products. Since [In re
RMJ]{.underline}, the Supreme Court has consistently drawn a distinction
between speech that is *misleading* (by which the Court means inherently
misleading) and speech which is at worst only *potentially misleading*
(by which the Court means speech that can be rendered nonmisleading
through the addition of a reasonable disclaimer, warning statement, or
other information). [See]{.underline} [In Re R.M.J.]{.underline}, 455
U.S. 191, 203 (1982); [See also]{.underline} [Ibanez v. Florida Dep't of
Bus. And Prof'l Regulation]{.underline}, 512 U.S. 136, 144-46 (1994);
[Peel v. Attorney Registration and Disciplinary Comm'n]{.underline}, 496
U.S. 91, 99-111 (1990). If the former, government may suppress the
speech outright. [See]{.underline} [Joe Conte Toyota, Inc. v. Louisiana
Motor Vehicle Commission, et.al.]{.underline}, 24 F.3d 754 (5^th^ Cir.
1994); [Pearson]{.underline} I, 164 F.3d at 655. If the latter, it is
protected under the First Amendment. The Government cannot suppress
potentially misleading speech but, if it chooses to regulate that
speech, the Court will allow it to require reasonable disclaimers or
warning statements as less speech restrictive alternatives to
suppression. [See]{.underline} [Peel]{.underline}, 496 U.S. at 100; [In
Re R.M.J.]{.underline}, 455 U.S. at 207; [Shapero v. Kentucky Bar
Association]{.underline}, 486 U.S. at 479; [Pearson]{.underline} I, 164
F.3d at 655. A reasonable disclaimer is, *inter alia*, one that is
succinct and accurate and does not engender a chilling effect on others
willingness to communicate the same message. [See]{.underline}
[Zauderer]{.underline}, 471 U.S. at 651; [see also]{.underline} [Borgner
v. Brooks]{.underline}, 284 F.3d 1204 (11^th^ Cir. 2002).

***[Is the Government Interest Substantial?]{.underline}*** The federal
courts have not questioned

the substantiality of the FDA's interest in protecting public health or
in eliminating fraud. [See Pearson]{.underline} I, 164 F.3d at 656. In
each area of speech regulation, FDA has variously articulated its
interest as protection of public health or elimination of fraud or both.
[Id.]{.underline} It would therefore appear that so long as those two
objectives drive its regulatory mission, the courts will find FDA's
interest substantial.

***[Does the Regulation Directly Advance the Governmental Interest
Asserted?]{.underline}***

As explained above, FDA speech regulation involves bans on the
communication of specific scientific information precisely because the
agency objects on paternalistic grounds to the content communicated. In
other words, FDA speech regulation is by definition content based,
endeavoring to prevent consumers from receiving a message FDA believes
may influence them to act in ways the FDA thinks not in their best
interest. Under such circumstances, the interest advancement prong of
the [Central Hudson]{.underline} test has been applied with exactitude,
requiring not merely proof that the regulation will advance the state's
interest but *that it will do so "to a material degree."* In [44
Liquormart]{.underline}, 517 U.S. at 505, the Court explained:

> In evaluating the ban's effectiveness in advancing the State's
> interest, we note that a commercial speech regulation "may not be
> sustained if it provides only ineffective or remote support for the
> government's purpose. \[[Central Hudson]{.underline}, 447 U.S.\] at
> 564. For that reason, the State bears the burden of showing not merely
> that its regulation will advance its interest, but also that it will
> do so "to a material degree." [Edenfield]{.underline}, 507 U.S. at
> 771; [see also]{.underline} [Rubin v. Coors Brewing Co.]{.underline},
> 514 U.S. at 486-488. The need for the State to make such a showing is
> particularly great given the drastic nature of its chosen means---the
> wholesale suppression of truthful, nonmisleading information.
> Accordingly, we must determine whether the State has shown that \[its
> regulation\] will *significantly* reduce \[the alleged harm\].

When suppression of content, not regulation of the underlying commercial
transaction, is the aim of the government action, that action will not
be found to have advanced the government's interest in the absence of
significant empirical evidence. Speculation or conjecture about the
potential of the regulation to advance the government's interest is
wholly inadequate ("\[s\]uch speculation certainly does not suffice when
the State takes aim at accurate commercial information for paternalistic
ends," [44 Liquormart]{.underline}, 517 U.S., at 507)). "\[W\]ithout any
findings of fact, or . . . evidentiary support," the Court will not
agree that content-based suppression of commercial speech "significantly
advance\[s\] the State's interest. . ." [See]{.underline} [44
Liquormart]{.underline}, 517 U.S. at 505.

The Court also expects the advancement to be "direct." In that regard, a
regulation will not be sustained if it "provides only ineffective or
remote support for the government's purpose." [Ibanez]{.underline}, 512
U.S. at 143 (1994); [Central Hudson]{.underline}, 447 U.S. at 564.
Moreover, a regulation will not be sustained if its restriction is in
excess of that needed to advance the government's interest, i.e., the
regulation must be in "reasonable proportion to the interests served."
[Ibanez]{.underline}, 512 U.S. at 143; [Edenfield v. Fane]{.underline},
507 U.S. at 767 (1993); [In re R.M.J.]{.underline}, 455 U.S. at 203.

Finally, the Court expects the government to "demonstrate that the harms
it recites are real and that its restriction will in fact alleviate them
to a material degree." [Ibanez]{.underline}, 512 U.S. at 143.
"Unsupported assertions" of harm will not suffice because the "free flow
of commercial information is valuable enough to justify imposing on
would-be regulators the costs of distinguishing the truthful from the
false, the helpful from the misleading, and the harmless from the
harmful." [Id.]{.underline}, [citing]{.underline}
[Zauderer]{.underline}, 471 U.S. at 646; [see also]{.underline}
[Edenfield]{.underline}, 507 U.S. at 770, 771.

***[Is the Regulation More Extensive Than Necessary to Serve the
Interest?]{.underline}*** In [Western States Medical
Center]{.underline}, 122 S. Ct. at 1506, the Court explained that it has
"in previous cases addressing this final prong of the [Central
Hudson]{.underline} test, . . . made clear that if the Government could
achieve its interests in a manner that does not restrict speech, or that
restricts less speech, the Government must do so." In [Rubin v.
Coors]{.underline}, 514 U.S. at 490-91, and again in [Western States
Medical Center]{.underline}, 122 S. Ct. at 1506-7, the Court evaluated
all feasible less speech restrictive alternatives to the means chosen
and condemned speech restrictions in both cases because they were by
comparison more extensive restrictions on speech. The Court reminds
regulators that "\[i\]f the First Amendment means anything, it means
that regulating speech must be a last---not first---resort."
[Id.]{.underline} at 1507.

**PART V: FDA REGULATIONS, GUIDANCES, POLICIES, AND PRACTICES THAT
VIOLATE THE FIRST AMENDMENT**

**V.**

> **FDA REGULATIONS, GUIDANCES, POLICIES, AND PRACTICES THAT VIOLATE THE
> FIRST AMENDMENT**

Applying strict scrutiny-or, what we might term, heightened intermediate
scrutiny (for content-based restrictions on commercial speech)-yields
the same result in each area analyzed below. FDA speech regulations are
archaic, predating the Supreme Court's current First Amendment tests for
the speech in issue. They are not narrowly tailored and, thus, there are
obvious less speech restrictive alternatives for each. As a consequence,
FDA's speech regulations violate the First Amendment. The agency has yet
to accept its obligations under the First Amendment and to modify its
internal culture, policies, and regulations to comply with it.

A.  **FDA'S HEALTH AND STRUCTURE/FUNCTION CLAIM REGULATIONS VIOLATE THE
    FIRST AMENDMENT**

> **1. FDA's Suppression of Health Claims for Dietary Supplements
> Violates the First Amendment**

FDA regulation of dietary supplement health claims[^19] violates the
First Amendment in five ways. (1) FDA has failed to implement at all,
let alone do so consistently, the constitutional preference for
disclosure over suppression in its evaluation of dietary supplement
health claims, choosing not to undertake the First Amendment analysis
prescribed in [Pearson]{.underline} I, II, and III. (2) FDA has chosen
to suppress claims despite credible evidence in support of them rather
than rely on disclaimers explaining the inconclusiveness of the science
as a less speech restrictive alternative. (3) FDA has failed to rely on
concise and accurate disclaimers and ones calculated to avoid a chilling
effect on use of the claims by others. (4) FDA has failed to assess the
truthfulness of the health claim itself and, instead, has focused on the
extent to which the underlying nutrient-disease relationship has been
proven to a near conclusive degree. (5) FDA has recently chosen to
restrict the definition of health claim to preclude grant of claims
concerning the effect of nutrients on existing diseases.[^20]

In no instance of dietary supplement health claim review has the FDA
fully and faithfully followed the First Amendment criteria prescribed in
[Pearson]{.underline} I, II, and III. To satisfy the First Amendment
standard:

\(1\) FDA must clearly distinguish its review under the First Amendment
from its "significant scientific agreement" review pursuant to 21 U.S.C.
§ 343(r)(5)(d). "Significant scientific agreement" review concerns
instances where FDA "authorizes" a claim. It is an official endorsement
by the agency. [Pearson]{.underline} I explained to FDA that its inquiry
concerning claims does not end when it determines not to "authorize"
(i.e., officially endorse) a claim. Rather, FDA must proceed to assess
whether the claim it has found not backed by "significant scientific
agreement" must nevertheless be allowed in order to satisfy the
strictures on government imposed by the First Amendment. Thus, under
[Pearson]{.underline} I FDA must rely on a bifurcated system of review.
FDA must proceed simultaneously on dual tracks to avoid unlawful
suppression. Quite obviously the Court of Appeals contemplates allowance
under the First Amendment of claims the FDA determines it cannot (or
will not) "authorize" under significant scientific agreement when
disclaimers suffice to cure misleadingness. In this latter circumstance,
all claims backed by credible evidence must be allowed (including claims
backed by inconclusive evidence). [See]{.underline}
[Pearson]{.underline} I, 164 F.3d at 659. For a claim not "authorized,"
FDA must determine whether the claim must nevertheless still be allowed
because its suppression would violate the higher law of the First
Amendment. In that regard, the agency's focus must be on the actual
claim, its actual wording, and not---as in the case of its present
"significant scientific agreement" review---on the nutrient-disease
relationship.

(2) For a claim not "authorized," FDA must determine whether it is
    "inherently

misleading." As the [Pearson]{.underline} I court made clear, a claim
said by the agency to lack "significant scientific agreement" is not
ipso jure inherently misleading. Under the First Amendment, it is not
enough for FDA to find evidence in support of the claim inconclusive.
[Pearson]{.underline} I instructs the agency that inconclusiveness is
grounds for use of a disclaimer, not claim suppression. Under
[Pearson]{.underline} I, inconclusive science renders a claim, at worst,
only "potentially misleading," constitutionally requiring resort to a
disclaimer as a less speech restrictive alternative to claim
suppression. [Pearson]{.underline} II warns FDA not to interpret the
absence of scientific evidence for a claim to be the same as the
presence of scientific evidence against a claim. Only in the latter
context when the scientific evidence against the claim outweighs the
evidence for it (i.e., as [Pearson]{.underline} II instructs when there
is [no]{.underline} credible evidence to support a claim
[and]{.underline} the weight of credible evidence is
[against]{.underline} it) can the FDA declare the claim incurable by
disclaimer and suppress it outright.

\(3\) FDA must allow each "potentially misleading" claim to be made,
relying on a disclaimer as a less speech restrictive alternative to
claim suppression. All claims not inherently misleading are, by default,
potentially misleading. The First Amendment prohibits suppression of
potentially misleading claims. [See]{.underline} [In re
R.M.J.,]{.underline} 455 U.S. at 203 ("States may not place an absolute
prohibition on certain types of potentially misleading information...if
the information also may be presented in a way that is not deceptive.").

\(4\) FDA must draft accurate, succinct, and reasonable disclaimers for
potentially

misleading claims. To pass muster under the First Amendment, disclaimers
must be reasonable. [See id.]{.underline} at 203 ("Restrictions
on...advertising may be no broader than reasonably necessary to prevent
the deception."). In that regard they must be succinct and accurate.
[See]{.underline} [Pearson]{.underline} II, 130 F. Supp. 2d. at 112.
They should be grammatically correct and worded in plain English (or the
language otherwise used on the label). To be reasonable, they must not
engender a chilling effect, i.e., they must not dissuade others from
using the claim. [See]{.underline} [Zauderer]{.underline}, 471 U.S. at
651; [see also, e.g.]{.underline}, [Warner-Lambert Co. v.
FTC]{.underline}, 562 F.2d 749, 770 (D.C. Cir. 1977).

The constitutional presumption in favor of disclosure over suppression
and the high burden of proof against government restriction on speech
combine to make allowance of health claims with disclaimers the
operative rule (and, conversely, claim suppression the rare exception).
In present practice, FDA has it backwards, one look at its health claim
decisions since [Pearson]{.underline} I reveals suppression to be the
operative rule with allowance of health claims with disclaimers the rare
exception, frequently achieved only with judicial intervention.
Moreover, FDA's few recommended disclaimers are often long and
confusing, making unlikely use of the claim accompanied by them.

The requirement that disclaimers be accurate, succinct, and reasonable
is also one that must be undertaken with a deferential regard for
protecting the speech of the regulatee from restriction to the maximum
extent possible. It must be remembered that the First Amendment protects
the right of a private speaker to convey his or her own message, not
transform that speaker into the oracle of a government orthodoxy.
[See]{.underline} [West Virginia Board of Education v.
Barnette]{.underline}, 319 U.S. 624, 642 (1943) (\"If there is any fixed
star in our constitutional constellation, it is that no official, high
or petty, can prescribe what shall be orthodox in politics, nationalism,
religion, or other matters of opinion or force citizens to confess by
word or act their faith therein.\"). Moreover, speakers' rights may not
be circumscribed based on listeners' preferences, interests, or needs.
[See]{.underline} [National Association for the Advancement of Colored
People v. Jones]{.underline}, 131 F.3d 1317, 1322 (9^th^ Cir. 1997)
("While both the speaker and the listener have the right to assert First
Amendment rights, no precedent exists that the listener's rights are
greater than those of the speaker."). The Supreme Court has rejected the
notion that listeners have an independent First Amendment right to edit
speech to suit their interests or needs. Thus it is that the Court
struck down a Florida right of reply statute as an abridgement of the
speaker's First Amendment rights. [See]{.underline} [Miami Herald Pub.
Co. v. Tornillo]{.underline}, 418 U.S. 241 (1974).

Applying this First Amendment principle in the health claim context
yields recognition of the fact that FDA may neither prohibit scientific
speech in health claims nor "dumb down" that speech upon either an
assumption, or proof, that consumers do not comprehend the claim. FDA
cannot justify restriction or suppression of a truthful or a potentially
misleading claim on the argument that some or all in the target audience
fail to comprehend the speaker's message. The Supreme Court has held the
complexity of speech no justification for suppressing that speech.
[See]{.underline} [Virginia State Board of Pharmacy et. al. v. Virginia
Citizen's Consumer Council, Inc., et. al.,]{.underline} 425 U.S. 748
(1976). The FDA cannot dumb down content by force of law because it
believes consumers too unsophisticated to comprehend the content.
[See]{.underline} [Bolger v. Youngs Drug Products Corp.,]{.underline}
463 U.S. 60, 74 (1983) (Speech cannot be abridged solely on the level of
understanding of the listener, as "the level of discourse in reaching a
mailbox simply cannot be limited to that which would be suitable for a
sandbox.").

This then leads invariably to the conclusion that FDA must conduct a
plain English (or the language otherwise used on the label) and grammar
evaluation of each claim and each disclaimer. If the claim is
grammatical and in plain English (or the language otherwise used on the
label) it cannot be deemed inherently misleading simply because some (or
all) in the audience fail to understand it. Likewise, the disclaimers
the FDA drafts must also be grammatical and in plain English (or the
language otherwise used on the label). A disclaimer cannot be rejected
and the claim deemed incurable simply because the audience fails to
understand a grammatically correct disclaimer. The evolution of
scientific understanding among consumers is a function of competition in
the idea and information markets, a claim and a disclaimer are but
single contributions to the overall market. The solution lies in more
speech, not less. The solution lies in greater education. The Supreme
Court has repeatedly explained that the First Amendment requires
government to place its trust in truthful free speech markets as
self-regulating mechanisms on the theory that in a free and open
encounter good counsels win out over bad ones and truth comes to the
fore but only if consumers are well enough informed. The Court refuses
to condone restrictions on speech that attempt to reduce all discourse
to the most basic level. [See]{.underline} [Bolger]{.underline}, 463
U.S. at 74; [Butler v. Michigan]{.underline}, 352 U.S. 380, 383 (1957)
(the government may not "reduce the adult population...to reading only
what is fit for children.").

In that regard, if FDA finds that consumer survey or other such evidence
reveals a lack of public understanding of a claim or disclaimer that is
otherwise grammatical and in plain English (or the language otherwise
used on the label), its proper resort -- consistent with the
constitutional presumption in favor of disclosure over suppression -- is
to propound more speech on the subject. FDA cannot justify suppression
of claims on the argument that the message, despite its plain English
(or the language otherwise used on the label) and grammatical content,
is beyond the intellectual grasp of the average consumer. FDA could use
its extensive public and media outreach powers to educate consumers to
the relevant facts, to publish memoranda for the public on the subjects,
to direct media to experts on the subjects, and to post relevant
information on the web---all in an effort to improve public awareness
and understanding. In no instance involving potentially misleading
speech may FDA rely on suppression as an alternative to disclosure of
information predicated on the theory that consumers lack the
sophistication necessary to comprehend the message. The agency's remedy
under the First Amendment is more speech.

In addition, in its action on a health claim for association of saw
palmetto with a reduction in the symptomology of mild benign prostatic
hypertrophe (BPH), FDA declared that claims that associate a nutrient
with an effect on an existing disease would not be evaluated as dietary
supplement health claims but could only be made if the underlying
substance were approved as a new drug pursuant to the new drug approval
process in 21 U.S.C. § 355. [See]{.underline} 65 Fed. Reg. 14,219
(2000). The agency thereby assured suppression of the claim by placing a
cost prohibitive regulatory obstacle (new drug approval) between
truthful speech and public access to it. Those actions violate the First
Amendment. [See]{.underline} Complaint Seeking Review of Administrative
Agency Action, Declaratory Judgment and Injunctive Relief at 11,
[Whitaker et. al. v. Shalala]{.underline}, Civil Action No. 99-3247
(D.C. 1999); [See also]{.underline}, Plaintiffs' Memorandum of Points
and Authorities at 15, [Whitaker et. al. v. Shalala]{.underline}, Civil
Action No. 99-3247 (D.C. 1999). FDA's denial of the health claims at
issue has the effect of suppressing the health claim indefinitely.
[Id.]{.underline}

In evaluating health claims for dietary supplements, FDA must fulfill
two essential legal duties and must do so simultaneously. In response to
the statutory directive in 21 U.S.C. § 343(r)(5)(D), FDA has promulgated
a procedure for the evaluation of dietary supplement health claims that
entails application of the same approach that 21 U.S.C. § 343(r)(3)(B)
requires for evaluation of food health claims. [See]{.underline} 59 Fed.
Reg. 395 (January 4, 1994). Accordingly, before FDA *authorizes* a
health claim for a dietary supplement, FDA must determine if there is
significant scientific agreement that the *claim* is supported by
scientific evidence under a defined standard. FDA has promulgated a
Guidance document on evaluation of dietary supplement and food health
claims which is at odds with its extant final rules on dietary
supplement health claims. [Compare]{.underline} [Guidance for Industry;
Significant Scientific Agreement in the Review of Health Claims For
Conventional Foods and Dietary Supplements]{.underline}, Food and Drug
Administration, Center for Food Safety and Applied Nutrition, December
22, 1999 [with]{.underline} 21 C.F.R. § 101.14(c). In particular, in its
Guidance, FDA demands proof of scientific support not for the *claim*
presented by the regulatee but for the *relationship* between the
substance and disease referenced in the claim. Moreover, FDA has never
articulated what level of proof short of near conclusive scientific
evidence of a substance-disease relationship will suffice to establish
"significant scientific agreement." In that regard, FDA remains in
violation of [Pearson]{.underline} I because it has not made it possible
for regulatees to discern with anything approaching reasonable certainty
what level, degree, quality, or quantity of scientific evidence FDA
requires for approval of a health claim. In [Pearson]{.underline} I, the
United States Court of Appeals held that failure, and FDA's refusal to
define "significant scientific agreement" comprehensibly, arbitrary and
capricious decisionmaking. The Court explained to the agency that
"\[t\]o refuse to define the criteria it is applying is equivalent to
simply saying no without explanation," 164 F.3d 650, 660, and ordered
the agency to make it "possible for the regulated class to perceive the
principles which are guiding agency action" by either "explain\[ing\]
what it means by significant scientific agreement or, at minimum, what
it does not mean." 164 F.3d at 661. Although in December 1999, the FDA
released a guidance on "significant scientific agreement," that guidance
did not inform regulatees of how FDA would treat claims of a nutrient's
potential effect upon disease backed by credible but inconclusive
scientific evidence.[^21]

In practice, since the issuance of the guidance, FDA has effectively
demanded near conclusive proof that a nutrient [will]{.underline} halt
or reverse a disease end-point before it will find "significant
scientific agreement" of a claim that a nutrient may reduce the risk of
a disease, thereby ignoring or minimizing the significance of evidence
that a nutrient [may]{.underline} reduce the risk of the disease. [See,
e.g.]{.underline}, Response to Health Claim Petition Regarding Dietary
Supplements of Vitamin E and Reduced Risk of Heart Disease from FDA to
Jonathan Emord, Docket No. 99P-4375 (January 11, 2000), Dietary
Supplement Claim for Saw Palmetto Extract and Benign Prostatic
Hyperplasia: Denied from FDA to Jonathan Emord (May 26, 2000), Letter
Regarding Dietary Supplement Health Claim for Fiber with Respect to
Colorectal Cancer from FDA to Jonathan Emord, Docket No. 91N-0098
(October 10, 2000), Letter Regarding Dietary Supplement Health Claim for
Folic Acid With Respect to Neural Tube Defects from FDA to Jonathan
Emord[,]{.underline} Docket No. 91N-100H (October 10, 2000), Letter
Regarding Dietary Supplement Health Claim for Omega-3 Fatty Acids and
Coronary Heart Disease from FDA to Jonathan Emord, Docket No. 91N-0103
(October 31, 2000), Letter Regarding Dietary Supplement Health Claim for
Folic Acid, Vitamin B~6~, and Vitamin B~12~ and Vascular Disease from
FDA to Jonathan Emord, Docket No. 99P-3029 (November 28, 2000), Letter
Regarding Dietary Supplement Health Claim for Vitamin E and Heart
Disease from FDA to Jonathan Emord, Docket No. 99P-4375 (February 9,
2001), Letter Responding to Request Regarding Dietary Supplement Health
Claim for Folic Acid, Vitamin B~6~ Vitamin B~12~, and Vascular Disease
from FDA to Jonathan Emord, Docket No. 99P-3029 (February 9, 2001),
Letter Regarding a Health Claim for Folic Acid and Neural Tube Defects
from FDA to Jonathan Emord, Docket No. 91N-100H (April 3, 2001), Letter
Regarding Dietary Supplement Health Claim for Antioxidant Vitamins and
Certain Cancers from FDA to Jonathan Emord, Docket No. 91N-0101 (May 4,
2001), Letter Responding to a Request to Reconsider the Qualified Claim
for a Dietary Supplement Health Claim for Omega-3 Fatty Acids and
Coronary Heart Disease from FDA to Jonathan Emord, Docket No. 91N-0103
(February 8, 2002). The approach taken conflicts with the statutory
definition of "significant scientific agreement." That definition
permits claims that are less than universally accepted and focuses on
"significant agreement," not conclusive proof, that "the *claim* \[not
the underlying nutrient-disease relationship\] is supported by such
evidence." [S. Rep. No. 103-410,]{.smallcaps} at 23 (1994). Thus, under
"significant scientific agreement," accurate claims of a potential
relationship are just as appropriate for authorization as the extremely
rare claims of a conclusive relationship. [See]{.underline} Melinda
Ledden Sidak, [Dietary Supplements and Commercial Speech]{.underline},
48 [Food & Drug L.J. 441 (1993).]{.smallcaps}

The point becomes somewhat academic in light of [Pearson]{.underline} I,
however. The [Pearson]{.underline} Court made clear, and the progeny of
[Pearson]{.underline} have reiterated exhaustively, that satisfaction of
FDA's "significant scientific agreement" standard cannot be requisite to
allowance of a claim if that claim is either truthful and nonmisleading
or potentially misleading and rectifiable through addition of a
disclaimer. The Court of Appeals explained that inconclusive claims must
be allowed with disclaimers to that effect. [See]{.underline}
[Pearson]{.underline} I, 163 F.3d at 658-59. Judge Kessler has explained
that no claim backed by credible evidence (not contradicted by the
weight of credible evidence against it) can be suppressed on grounds of
the insufficiency of the evidence. The agency's proper resort (indeed
its required least speech restrictive alternative under the First
Amendment) is to require an accurate, succinct, and reasonable
disclaimer.

In addition, FDA currently does not allow health claims based on
"authoritative statements" to be made on the labels of dietary
supplements. [See]{.underline},
http://www.cfsan.fda.gov/\~dms/ds-labl.html (last visited August 28,
2002) (FDA states "Congress did not include dietary supplements in the
provisions for health claims based on authoritative statements.
Consequently, this method of oversight for health claims cannot be used
for dietary supplements at this time"). "Authoritative statements," as
discussed [infra]{.underline}, are statements made by a scientific body
of the United States Government with official responsibility for public
health protection human nutrition research that identify a relationship
between a nutrient and a disease or health-related condition.
[See]{.underline} 21 U.S.C. § 343(r)(2)(G). While such statements are
allowed to be used for food labels, FDA does not permit their use on
dietary supplement labels. That distinction is arbitrary and capricious,
since the FDA has long understood food provisions of the Act to include
dietary supplements and has promulgated its own regulations which treat
both foods and dietary supplements identically concerning use of health
claims in labeling. [See]{.underline} Final Rule, [Food Labeling;
General Requirements for Health Claims for Dietary
Supplements]{.underline}, 59 Fed. Reg. 395 (January 4, 1994) (FDA amends
its food labeling regulations to make dietary supplements of vitamins,
minerals, herbs, or other similar nutritional substances (dietary
supplements) subject to the same general requirements that apply to all
other types of food concerning use of health claims that characterize
the relationship of a substance to a disease or health-related condition
and the content of petitions for obtaining authorization for such health
claims).

Thus, manufacturers of dietary supplements should be entitled to put
health claims based on authoritative statements on their labels and in
their labeling. To deny manufacturers the right to communicate truthful
information regarding authoritative statements is a content-based
restriction on speech that will not withstand constitutional scrutiny.

2.  FDA's SUPPRESSION OF HEALTH CLAIMS FOR FOODS VIOLATES THE FIRST
    AMENDMENT

### Under 21 U.S.C. § 343(r)(3)(B), in order to make a health claim on a conventional 

food the FDA must determine based on the totality of publicly available
scientific evidence (including evidence from well-designed studies
conducted in a manner consistent with generally recognized scientific
procedures and principles) that there is significant scientific
agreement among experts qualified by scientific training and experience
to evaluate such claims that the claim is supported by such evidence.
[See id.]{.underline} at (r)(3)(B). That "significant scientific
agreement" requirement is the same one that the FDA chose to apply to
health claims for dietary supplements, albeit the statutory provisions
applicable to dietary supplements would allow FDA to choose another
standard and procedure. [See]{.underline} 21 U.S.C. § 343(r)(5)(D); 21
C.F.R. § 101.14(c).

FDA's guidance document on significant scientific agreement applies to
health claims for dietary supplements and conventional foods alike.
[Guidance for Industry: Significant Scientific Agreement in the Review
of Health Claims for Conventional Foods and Dietary
Supplements]{.underline}, FDA, CFSAN (Dec. 22, 1999) (hereinafter
"Significant Scientific Agreement Guidance"). As discussed above with
dietary supplements, in its Guidance FDA demands proof of scientific
support for the [relationship]{.underline} between the substance and the
disease referenced in the claim, not for the [claim]{.underline}
presented; it is thus at odds with the statute. [See id]{.underline}.
FDA has thus improperly shifted its focus from the language and meaning
of the claim to an assessment of the strength of the underlying
nutrient-disease association without any inquiry into the actual meaning
of claim language. The effect is to obscure entirely the significance of
claim language which can convey that the association is less than
conclusive, possible or probable but not established, or otherwise
indicative but not determinative. The agency's narrow focus on the
association is contrary to the command of the statute which compels a
focus on the claim itself. Through that erroneous focus, FDA demands of
even tentatively worded claims near conclusive proof of causality
between the nutrient and an ultimate measurable disease end-point, thus
effectively demanding that a claim worded in this form (X may reduce the
risk of Disease Y) be proven as if it were worded in this form (X
prevents Disease Y).

FDA has failed to state what level of proof, short of near conclusive
scientific evidence of a substance-disease relationship, will suffice to
establish "significant scientific agreement." [See id.]{.underline} The
Significant Scientific Agreement Guidance fails to address how FDA will
treat claims of a potential food-disease relationship backed by
credible, but inconclusive, scientific evidence. [See id.]{.underline}

FDA has taken the position that the holding in [Pearson I]{.underline}
ordering FDA to abide by the constitutional preference for disclosure
over suppression does not apply to health claims for conventional foods.
[See]{.underline} Letter from Melinda K. Plaisier of FDA to the
Honorable David M. McIntosh of the U.S. House of Representatives (May
16, 2000). Yet the [Pearson I]{.underline} court's First Amendment
holding rests on precedent and principles that apply in every instance
of government suppression of commercial speech, not just in the dietary
supplement context.

FDA apparently bases its decision to deny foods the benefit of First
Amendment protection called for in [Pearson]{.underline} I and its
progeny on the weak reed that 21 U.S.C. § 343(r)(3)(B) provides that it
shall promulgate regulations authorizing health claims for foods only if
the FDA determines that significant scientific agreement exists to
support the claim (or, as FDA has it, erroneously, the nutrient-disease
relationship). [See]{.underline} Letter from Melinda K. Plaisier of FDA
to the Honorable David M. McIntosh of the U.S. House of Representatives
(May 16, 2000). Were we to presume, as FDA does, that the statute
prescribed significant scientific agreement as the only means for claim
allowance, that would posit a direct conflict between the statute and
the First Amendment, begging invalidation of the statute. In such a
circumstance there could be but one outcome: the statute could neither
be enforced by FDA nor allowed to stand by a Court of law because the
First Amendment is Supreme law.[^22] To be sure, FDA's interpretation of
section 343(r)(3)(B) to deem itself statutorily bound to deny food
health claims First Amendment protection is an incomplete (and
thoroughly erroneous) legal analysis. Because the First Amendment is the
supreme law, FDA cannot reach any conclusion without proceeding to the
second half of the analysis, concluding that the First Amendment trumps
the statute. The First Amendment and the Supremacy Clause compel that
result. [See]{.underline} U.S.[Const.]{.smallcaps} art. VI, cl.2; [see
also]{.underline} fn. 11.

The federal courts require FDA to construe its statutory authority to
avoid a constitutional conflict if at all possible. [See
e.g.,]{.underline} [U.S. v. Batchelder]{.underline}, 442 U.S. 114, 122
(1979). Fortunately, here, that is not only possible, the way has been
paved for the agency in [Pearson]{.underline} I. Section 343(r)(3)(B)
refers to FDA claim "authorization." To authorize is "to give authority
or official power to," according to Webster's. [Webster's New Universal
Unabridged Dictionary]{.underline}, 139 (Barnes & Noble Books 1996).
Claim authorization thus involves FDA giving sanction to (or, in other
words, officially endorsing) a particular claim. It is thus the case
that any who seek such official endorsement must meet the requirements
of the Act; but, as [Pearson]{.underline} I teaches, that is not the end
of the inquiry, because even *unauthorized* claims may have to be
allowed by FDA to comply with the First Amendment. Even if FDA finds
that under 21 U.S.C. § 343(r)(3)(B), it cannot *authorize* a food health
claim, it may nevertheless have to *allow* it to be made without its
authorization, relying on disclaimers as less speech restrictive
alternatives. Applying [Pearson]{.underline} I, every food health claim
that is, at worst, only potentially misleading must be allowed by the
agency (i.e., the agency must assure the party concerned that it will
not take any action against it for using the claim). In that context,
FDA may require that the claim carry with it the disclaimer that "FDA
does not approve this claim," as so recommended in [Pearson]{.underline}
I, and it may require such additional accurate, succinct, and reasonable
disclaimer as it believes necessary to avoid misleadingness. But FDA may
not, without violating the First Amendment on grounds substantively
indistinguishable from those held unconstitutional in
[Pearson]{.underline} I, impose a ban on every food health claim that it
finds not backed by significant scientific agreement. It may not
interpret its statutory authority in that way because the alternative
interpretation explained here fully comports with the statute and the
First Amendment, avoiding an otherwise unavoidable conflict between the
two.

We now turn to apply the relevant First Amendment standards to FDA's
refusal to rely on disclaimers as a less speech restrictive alternative
in the food health claim context. We start with strict scrutiny. FDA's
interests in protecting public health and eliminating fraud are
compelling. However, its insistence on near conclusive proof of a
nutrient-disease relationship before allowing *any* claim to be made
about the association ensures suppression of truthful speech and of
potentially misleading speech, both of which are protected from
censorship by the First Amendment. [See]{.underline}
[Pearson]{.underline} I. The consequences that flow from that censorship
are profound. A necessary preoccupation of every human on earth
(indispensable to life), food (and knowledge concerning its potential
disease risk reduction, mitigation, treatment, and curative effects) is
invaluable to all. Rather than facilitate disclosure of all truthful
food-disease claims to consumers, the FDA has chosen to suppress all but
a very narrow subset of those claims, i.e., those proven true to a near
conclusive degree. That mass suppression of all claims except those
proven to a near conclusive degree, in lieu of allowing inconclusive
claims with reasonable disclaimers, is not narrowly tailored to serve
FDA's interests in protecting public health and eliminating fraud. To
demand that speech be proven to a near conclusive degree before it may
be communicated to the public ensures that an extraordinary quantity of
credible scientific information, indeed the vast majority of scientific
evidence, will never reach the public at the point of sale. Denying
consumers the opportunity to incorporate credible science into their
decisions, FDA functions in precisely that kind of paternalistic way
that our Supreme Court has condemned as antithetical to the core meaning
of our First Amendment.

At a time when nutrition science is still very much in its infancy,
denying consumers accurate information on the *potential* of foods to
affect disease not only interferes with the First Amendment right to
receive a truthful message but also reduces the quantum of useful
information available to guide consumers in exercising informed choice.
FDA can, and constitutionally must, rely on means less speech
suppressive than outright censorship. The aforementioned blanket
suppression of food health claims circumscribes protected expression and
thereby violates the First Amendment.

The result is the same under the heightened intermediate scrutiny of the
commercial speech test. The communication of food health claims in
labeling is neither unlawful activity nor misleading speech. As
explained above, the FDA's interest in protecting public health and
eliminating fraud are substantial. However, the means chosen (blanket
suppression of all claims not approved under FDA's "significant
scientific agreement" review) does not directly and materially advance
FDA's interest because it locks out of consumer markets an enormous
number of claims that are truthful and nonmisleading or, at worst,
potentially misleading and, thus, protected by the First Amendment. It
thereby increases the likelihood that consumers not educated of the
actual potential for foods and food ingredients to affect disease will
be misled or defrauded by false claims now proceeding largely unchecked
in consumer markets.

The FDA's blanket suppression of all but those claims proven to a near
conclusive degree deprives consumers of that great bulk of credible
science on the potential for foods to affect disease. It effectively
removes from consumers information they need to distinguish the known
health benefits of one food over another in the daily quest to achieve
better health through nutrition. Rather than directly and materially
advance FDA's interest in public health and elimination of fraud, FDA's
censorship produces the opposite effect: It covers consumers in a shroud
of ignorance, handicapping them in their ability to pursue informed
self-interest in the food marketplace. As [Pearson]{.underline} I and
its progeny make clear, the far less speech restrictive alternative of
allowing claims backed by credible evidence and relying on reasonable
disclaimers to qualify those claims complies with the First Amendment
presumption favoring disclosure over suppression yet alerts consumers to
the lack of conclusiveness in the science concerning the claims.
Reliance on that less speech restrictive alternative is constitutionally
required, as explained in [Pearson]{.underline} I and its progeny. FDA
must therefore apply the [Pearson I]{.underline} disclaimer approach
fully and faithfully to all food health claims.

## **B. FDA's SupPresSion of structure/function claims DUE TO THE PRESENCE OF ALLEGED "implied" disease claims violates the first amendment**

Although by statute, Dietary Supplement Health and Education Act of
1994, 21 U.S.C. § 301 et. seq. (1994), FDA is required to permit without
advance approval statements concerning the effect of a dietary
supplement on a body structure or function without reference to a
disease, FDA prohibits such statements if it finds that they "imply" a
disease treatment. By regulation, 21 C.F.R. § 101.93, FDA allows certain
structure/function claims for foods, but prohibits them if it finds that
they "imply" a disease treatment. In each case, where the proponent of
the claim does not wish to market the product as a drug, the FDA's
decision to suppress the claim based on a potential implication of
disease treatment violates the First Amendment. The obvious, less speech
restrictive alternative of a disclaimer is both a necessary and
sufficient way to eliminate the disease treatment connotation. Thus, if
nutrient X reduces blood pressure levels, a claim to that effect should
be allowed. The FDA's proper resort is not to deny consumers that
information on the supposition that they will regard the product as an
appropriate treatment for hypertension. Rather, FDA's proper resort is
to require use of a disclaimer to eliminate the disease treatment
connotation. Here, for example, a disclaimer could be required that
reads: "This product is not an FDA-approved treatment for high blood
pressure. If you have high blood pressure, see a doctor for a diagnosis
and appropriate medical treatment."[^23]

**1. Dietary Supplements**

Those who sell dietary supplements are entitled to make statements on
supplement labels and in supplement labeling that describe the role of a
nutrient or dietary ingredient in the structure or function of the body
or that characterize the documented mechanism by which a nutrient or
dietary ingredient acts to maintain such structure or function.
[See]{.underline} 21 C.F.R. § 101.93(f) (2002). If, however, the
labeling bears what the FDA determines to be an "implied" disease claim,
the product will be treated as a drug and required to be the subject of
a new drug approval grant before the claim may be made. [See
id.]{.underline} Disease claims are those that describe damage to an
organ, part, structure, or system of the body such that it does not
function properly (e.g., cardiovascular disease), or a state of health
leading to such dysfunctioning (e.g., hypertension). [See]{.underline}
21 C.F.R. § 101.93(g).

Companies that wish to make structure/function claims must notify the
Office of Nutritional Products, Labeling and Dietary Supplements, Center
for Food Safety and Applied Nutrition within 30 days of first marketing
the product. [See]{.underline} 21 U.S.C. § 343(r); 21 C.F.R. § 101.93.
That notice must contain, [inter alia]{.underline}, the
structure/function claims being used and a certification that the
manufacturer has adequate substantiation that the claims are truthful
and non-misleading. Upon receipt of that notice, FDA may send a
"courtesy letter" to the manufacturer advising that a particular claim
is one the manufacturer may not make absent new drug approval. FDA may
regulate products as drugs if they make explicit disease claims on their
labels (e.g. "This product cures cancer") or what FDA considers implied
claims (e.g. "This product lowers cholesterol levels").

In FDA's Final Rule regarding structure/function claims, the following
were among those identified as examples of implied drug claims
prohibited absent new drug approval: "Promotes low blood pressure";
"Improves joint mobility and reduces joint inflammation and pain";
"Promotes cholesterol clearance"; "Relief of heartburn"; "Maintain
normal bone density in post-menopausal women"; "Alcohol intoxication;"
"Severe depression associated with menstrual cycle;" "Helps individuals
using antibiotics to maintain normal intestinal flora;" "Dietary support
during the cold and flu season;" "Helps to reduce difficulty falling
asleep;" "Builds virility and sexual potency;" "Helps maintain normal
urine flow in men over 50 years old." [See]{.underline} [Regulations on
Statements Made for Dietary Supplements Concerning the Effect of the
Product on the Structure or Function of the Body; Final
Rule]{.underline}, 65 Fed. Reg. 1,000 (January 6, 2000).

To allow such claims to be made, FDA would have the party in question
shoulder a financial burden of between \$300,000 (for an abbreviated new
drug application) and over \$200 million (for a new drug application).
[See]{.underline} Brief for Petitioners in [Thompson v. Western States
Medical Ctr. et al.]{.underline}, Case No. 01-344 at 26 (Dec. 31, 2001).
At a minimum, FDA would have the party in question shoulder the tens of
thousands of dollars required to pursue a health claim petition to final
disposition. In any event, the effect of this regulatory policy is to
suppress an enormous amount of truthful and nonmisleading scientific
information without regard to the adverse effect that suppression has on
speech rights or on the public health. There exists an obvious less
speech restrictive alternative under the teachings of
[Pearson]{.underline} I: a disclaimer eliminating the drug claim
implication. In every instance where a structure/function claim may be
interpreted to imply disease treatment, that implication may be
expressly disclaimed, leaving only the structure/function claim
implication. Doing so preserves the speech in question and achieves
FDA's aim in a less speech restrictive manner without violating the
First Amendment.

FDA should thus change its "courtesy letter" policy and practice to
distinguish, in the first instance, express from implied drug claims.
For the latter, FDA should afford the regulatee in writing the
opportunity to avoid the disease treatment connotation through use of an
appropriate disclaimer. For example, claim "Dietary Supplement X may
lower LDL cholesterol levels," could be disclaimed as follows: "This
product is not FDA-approved for treating high cholesterol. If you have
high cholesterol, see a doctor for a diagnosis and appropriate medical
treatment."

Let us now turn to assess FDA's blanket ban on structure/function claims
that it presumes imply disease treatment under the First Amendment
standards, starting with strict scrutiny and proceeding to heightened
intermediate scrutiny. Under strict scrutiny, FDA has a compelling
interest in protecting public health and eliminating fraud. However, its
ban on structure/function claims that it presumes imply disease
treatment is an unconstitutional content-based restriction on speech,
not tailored to avoid suppression of protected speech. Under FDA's
current regulatory regime, if a product marketed as a dietary supplement
contains truthful claims that are supported by scientific evidence, and
the FDA determines that such claims are implied disease claims, then the
agency will require the regulatee to invest considerable time and
extraordinary expense to obtain new drug approval before making those
claims. Such a restriction holds true even if the regulatee wants only
to tell consumers a structure/function effect and an appropriate
disclaimer is included. This restriction amounts to an extraordinary
(indeed, largely insurmountable) burden on speech, one that only a small
number of companies (none in the dietary supplement industry) can afford
to overcome.[^24] The effective prohibition of truthful claims is not
narrowly tailored to serve the FDA's interest and does not provide for
any comparable alternatives to communicate truthful and lawful speech.
FDA's regulations regarding implied disease claims thus violate the
First Amendment.

Under the heightened intermediate scrutiny test for commercial speech,
the claims restriction also fails to pass muster. Communication of a
truthful structure/function claim is neither an illegal activity nor
misleading speech. As mentioned [supra]{.underline}, FDA has a
substantial interest in protecting public health and eliminating fraud.
However, FDA's chosen means, a blanket prohibition on structure/function
claims that imply disease treatment, does not directly and materially
advance FDA's interests. In fact, it is harmful to consumers because it
prevents important information from reaching consumers and thus impedes
their ability to exercise informed choice in the search for good
health.[^25] In a comment to FDA concerning its structure/function claim
restrictions, a former Surgeon General argued wisely that supplements
should be permitted to make implied health claims about such concerns as
lowering cholesterol, since "our citizens deserve the opportunity to
know when safe and effective dietary supplements are available to lower
cholesterol." 65 Fed. Reg. at 1019.

The current regulations are also far more extensive than necessary. If a
dietary supplement manufacturer wishes to make truthful statements
regarding the effect of a dietary supplement on a body structure or
function, FDA cannot justify imposing on that party a cost-prohibitive
condition on the right to speak, either through a new drug application
or a health claim petition. Instead, the far less speech restrictive
alternative of a reasonable disclaimer is constitutionally required, as
explained above.

## **Foods**

### By law, 21 U.S.C. § 321(g)(1)(C), FDA allows food manufacturers and 

distributors to make structure/function claims for foods so long as they
do no more than describe the taste, aroma, or nutritive value of the
food. [See also]{.underline} [Nutrilab v. Schweiker]{.underline}, 713
F.2d 335 (7th Cir. 1983). As with dietary supplements, FDA strictly
prohibits foods from carrying structure/function claims on food product
labels or in food product labeling if it construes those claims to
"imply" disease treatment. For the very same reasons given for reliance
on disclaimers in the dietary supplement context, so too here, FDA is
required by the First Amendment to rely on disclaimers to disabuse
consumers of the disease treatment connotation because that remedy
provides an obvious, less speech restrictive alternative to the present
regime of censorship. Manufacturers and distributors have a right to
inform consumers, and reciprocally, consumers have a right to receive,
truthful information about the effect of a food or nutrient on a sign or
symptom of a disease. That structure/function effect is one that this
agency need not suppress to dissuade consumers from using the food or
nutrient as an alternative to a FDA-approved drug for the treatment of
the ailment in question. Because the matter is one that, at root,
depends upon use of censorship to affect public opinion, it strikes at
the very heart of the First Amendment and cannot survive constitutional
review. The less restrictive alternative of a disclaimer is, thus, a
constitutional imperative.

## **FDA'S LACK OF A PROVISION FOR A HEALTH CLAIM; STRUCTURE/FUNCTION CLAIM REGIME FOR ANIMAL FOODS AND SUPPLEMENTS VIOLATES THE FIRST AMENDMENT**

FDA has interpreted DSHEA not to apply to animal products.
[Inapplicability of the Dietary Supplement Health and Education Act to
Animal Products]{.underline}, 61 Fed. Reg. 17,706 (April 22, 1996). For
animal products, structure/function claims can only be made in limited
circumstances where the product concerned is a food (defined as
something that provides "nutrition, taste, or aroma") and the effect is
a result of those properties. [FDA's Regulation of Pet
Food]{.underline}, Food and Drug Administration, Center for Veterinary
Medicine, www.fda.gov/cvm/index/consumer/petfoodflier.html (last visited
August 19, 2002). If, however, a substance affects the structure or
function of the body apart from its nutritive value, it will be
considered a drug. [See id.]{.underline} Thus, if a manufacturer wishes
to make truthful and non-misleading structure/function claims regarding
a pet dietary supplement, it will be prohibited from doing so unless it
undergoes a costly pre-market animal drug approval. Likewise, if a pet
food or supplement reduces or eliminates disease, that claim may not be
made without costly pre-market animal drug approval. Those prohibitions
on speech plainly violate the First Amendment because the human model
includes obvious, less speech restrictive alternatives (procedures for
the allowance of health claims and structure/function claims) and there
is no sound justification for denying scientific speech concerning pet
foods and supplements equal treatment.

We now turn to evaluate the First Amendment significance of FDA's
failure to accord pet foods and supplements equal treatment under the
extant health and structure/function claims review process. As discussed
[supra]{.underline}, FDA's interest in protecting public health (and,
here, pet health) and eliminating fraud are compelling. In order to
satisfy strict scrutiny, however, a prohibition on speech must be
content-neutral and narrowly tailored to serve a compelling government
interest. Prohibiting structure/function and health claims for animal
dietary supplements without drug pre-market approval is a content-based
restriction on speech. By imposing a general prohibition on
structure/function and health claims for pet foods and supplements
(absent the costly new drug approval), FDA effectively bans an enormous
quantity of truthful and non-misleading statements regarding foods and
supplements. In order to communicate truthful information, a company
must invest a great deal of time and money to get new drug approval,
amounting to an extraordinary, often prohibitive burden on speech. Such
a burden is an unconstitutional condition under the First Amendment
because obvious, less speech restrictive alternatives exist, namely the
very system (preferably rid of constitutional defects, as recommended
herein) now employed to permit structure/function claims for human foods
and dietary supplements and to authorize or allow health claims for
those same products.

Even under the heightened intermediate scrutiny afforded commercial
speech, FDA's failure to apply its health claims review and
structure/function claim regime to pet foods and supplements violates
the First Amendment. Communication of health and structure/function
claims is not unlawful activity or misleading speech. While FDA has a
compelling interest in protecting the public, a complete prohibition on
structure/function claims for pet foods and dietary supplements absent
pre-market drug approval does not directly and materially advance FDA's
interests. Without distinguishing true claims from false ones and,
instead, suppressing the entire lot, FDA ensures that true health
information (useful to consumers in their search for well-being and
health enhancement for their companion animals) is locked out of the
market. Thus, rather than directly and materially advance FDA's public
health interest, the blanket ban impedes the ability of consumers to
improve the health and well-being of their pets.

Moreover, as stated in the human dietary supplement and food context,
actions that bar honest corporate actors from telling the truth about
the effects of pet dietary supplements on animal health exacerbate the
harm done by fraud in the market: False claims go unrebutted by true
information, may predominate in the market, and may win out in the minds
of consumers. Finally, there are obvious, less speech restrictive
alternatives to FDA's blanket ban on structure/function and health
claims for pet foods and dietary supplements. FDA can permit such claims
relying on the very same procedures it now employs to permit
structure/function claims for human foods and supplements and to
authorize and allow health claims for those same products.

## **FDA'S NUTRIENT Content Claim regulations violate the first amendment**

Nutrient content claims expressly or implicitly describe the amount of a
nutrient in a food. [See]{.underline} 21 U.S.C. § 343(r)(1)(B); 21
C.F.R. § 101.13. They are prohibited altogether unless FDA has adopted
regulations to define them. [See]{.underline} 21 U.S.C. § 343(r)(1)(B);
see also FDA/CFSAN [What are FDA requirements regarding nutrient content
claims?]{.underline} Excerpted from [Requirements of Laws and
Regulations Enforced by the U.S. Food and Drug
Administration]{.underline} (1997). Nutrient content claims that FDA has
defined include the terms "good source," "high," "more," "high potency,"
and "light or lite."[^26] [See]{.underline} 21 C.F.R. §§ 101.54; 101.56.
It has also defined claims concerning the calorie, sodium, fat, fatty
acid and cholesterol content of foods. 21 C.F.R. §§ 101.60 - 101.62. The
requirements for each claim depend on the relative amounts of specific
ingredients or, in the case of general terms, ingredients for which
daily values have been established. [See e.g., id.]{.underline} at
101.54(b). To use a nutrient content claim that FDA has not previously
approved and published in the Federal Register, a manufacturer must
submit a petition for approval. [See]{.underline} 21 C.F.R. § 101.69.

Through its nutrient content claim regulations, FDA severely restricts
manufacturers' right to use descriptive words and phrases to help
consumers identify and compare nutrient content on labels and in
labeling. FDA will not permit any private use of descriptive claims of
nutrient content on labels or in labeling without the government first
defining each such descriptive claim\--that despite use of words in
common parlance that have acquired commonly understood meanings.

Descriptive claims of nutrient content are valuable speech forms. They
afford a shorthand means for food and dietary supplement companies to
alert consumers to atypical characteristics of their products on product
labels (where space is scarce). Thus, when a company lists on its food
or dietary supplement label "High in Antioxidant Vitamin C" it endeavors
to inform the consumer that unlike other products that contain vitamin
C, its product likely contains more. [See]{.underline} 21 C.F.R. §
101.54(g). If the typical Vitamin C containing dietary supplement has
double or triple the RDI of, say, antioxidant Vitamin C, then the claim
"High in Antioxidant Vitamin C" would appear appropriate only on foods
or supplements containing substantially more Vitamin C than that which
is typical in comparable foods or supplements, respectively. In every
case the market will dictate (subject to change effected by evolution in
consumer tastes and preferences) what constitutes typicality and what
constitutes a departure from typicality. The definition in the market
will always be evolutionary and dynamic. It is thus the case that static
regulatory definitions, even if an accurate depiction of popular
understanding at any single time, lock the market into an anachronistic
world view that disallows the kind of flexibility robust competition
requires. Moreover, it tends to mislead consumers whose understanding is
based on the dynamic common vernacular not on a largely arbitrary and
entirely static regulatory definition, one that is frequently
understandable only by attorneys who specialize in FDA labeling law.

The First Amendment burden of proof lies strongly against government
intrusion into the idea and information marketplace to control the
meaning of words in commerce. Government is not at liberty under our
First Amendment to structure information markets by choosing what
particular words will mean in commerce. FDA cannot lightly trench upon
the freedom to choose descriptive words without first overcoming its
high First Amendment burden of proof. Thus far FDA, on the one hand, has
ascribed meaning to a precious few nutrient content claims and has
disallowed all others without the slightest regard the suppression
effects of its blanket ban or for its First Amendment duties to avoid
such censorship.

Indeed, in none of the nutrient content claim proceedings has FDA
evaluated its actions under the strictures of apposite First Amendment
precedent. Were it to do so, as explained below, it would find that the
Ninth Circuit [Lundgren]{.underline} decision (which had been relied
upon for a similar restriction on the use of descriptive terms under
California law) has been rejected by our Court of Appeals in
[Pearson]{.underline} I based in no small measure on the Supreme Court's
rejection in [44 Liquormart]{.underline} of the reasoning from [Posadas
de Puerto Rico Assocs. v. Tourism Co.]{.underline}, 478 U.S. 328 (1986)
which [Lundgren]{.underline} is based. [See]{.underline}
[Pearson]{.underline} I at 657-58.

Finally, and most importantly, FDA's concerns about preventing perceived
risks of consumer misperception arising from nutrient content claims can
be easily and fully addressed without imposition of a broad regime of
labeling censorship. If a party wishes to use a nutrient content claim,
files a petition to allow the use, and FDA deems the use, *based on
empirical evidence*, inherently misleading, FDA may suppress it
outright. For example, if the claim "high in antioxidant vitamin C" were
to be placed on the label of a product that did not contain vitamin C or
that contained vitamin C in amounts lower than the RDI, FDA could
reasonably disallow the misleading use. For all others, if FDA finds
potential misleadingness, it may constitutionally resort to the less
speech restrictive alternative of a disclaimer for use with the nutrient
content claim. For example, a party making the claim "High in
Antioxidant Vitamin C" could be required to place an asterisk after the
claim which corresponds to another on the same or an immediately
adjacent panel, next to which could appear a defining and clarifying
statement, e.g.: "Product contains \_\_\_\_ mg, \_\_\_\_% of the RDI for
Vitamin C, an antioxidant." The First Amendment requires reliance on
this sort of less speech restrictive alternative.

In short, FDA's present nutrient content claim rules and policies call
for blanket bans on all nutrient content claims not the subject of an
official orthodoxy (a government definition promulgated through a
regulation). That mass suppression of speech violates the First
Amendment. It must therefore be revised without delay to permit use of
disclaimers as less speech restrictive alternatives to government
mandated definitions and to the otherwise operative blanket claim ban.

We now turn to evaluate the current nutrient content claim regime under
strict scrutiny. FDA's interests in protecting public health and
eliminating fraud are compelling. Its nutrient content claim prohibition
is, however, a content-based restriction on speech. FDA aims precisely
to prohibit on every food and dietary supplement label any descriptive
claim of nutrient content in a product unless FDA has first defined the
claim. FDA's chosen means has no rational relationship to its interests
in protecting public health or eliminating fraud. FDA has no proof that
nutrient content claims are [per se]{.underline} misleading to
consumers. They only mislead in an irreparable way when they are
inherently misleading. Imposition of a blanket ban is, thus, a grossly
overbroad regulatory construct. It suppresses the vast majority of
truthful and nonmisleading uses of nutrient content claims in a
misguided attempt to rid the market of inherently misleading ones. The
means chosen is thus not narrowly tailored to rid the market of the
inherently misleading claims. The means chosen thus circumscribes much
protected expression. FDA's nutrient content claim regulations violate
the First Amendment because they circumscribe much protected expression
in the face of an obvious, less speechrestrictive alternative: accurate,
succinct, and reasonable disclaimers.

Even under heightened intermediate scrutiny, FDA's nutrient content
claims regulations violate the First Amendment. Communication using
descriptive nutrient content claims is neither unlawful activity nor
misleading speech. As stated above, FDA has an undoubted substantial
interest in protecting public health and eliminating fraud. FDA's chosen
means, however, do not directly and materially advance its interests. To
the contrary, by imposing a blanket ban on the communication of all as
yet legally undefined nutrient content claims and by barring use of
nutrient content claims that are the subject of regulatory definition if
used outside of the definitional context, FDA ensures that an
extraordinary number of informative nutrient content claims remain
locked out of the information market and that private parties propound a
state orthodoxy on the meaning of otherwise commonly understood terms.
By censoring speech in this way, FDA not only fails to advance its
interest directly and materially but it also denies consumers precisely
that kind of succinct and informative information at the point of sale
that can aid them in making informed choices on what to consume.
Consequently, the speech prohibition inhibits informed decisionmaking
and increases the likelihood that consumers will be misled or defrauded.
Finally, the regulation is far more extensive than necessary to serve
FDA's legitimate interest in protecting public health and eliminating
fraud. In lieu of the blanket ban and state orthodoxy approach now in
use, FDA can simply require parties to petition for a specific planned
use of nutrient content claim and then allow use of a disclaimer in
association with such claim (i.e., if FDA does not authorize it),
providing consumers with the definitive content information upon which
the claim is based. FDA can continue to prohibit inherently misleading
nutrient content claims but it need not prohibit (and, indeed, cannot
constitutionally prohibit) potentially misleading ones.

## **FDA'S AUTHORITATIVE STATEMENTS REVIEW VIOLATES THE FIRST AMENDMENT**

The Food and Drug Administration Modernization Act of 1997 (FDAMA)
created two provisions that permit food distributors and manufacturers
to make nutrient content claims[^27] or health claims[^28] when such
claims are based on current, published, authoritative statements from
certain federal scientific bodies or from the National Academy of
Sciences (NAS). [See]{.underline} FDAMA Sections 303 and 304 amending
FDCA Sections 403(r)(3) and 403(r)(2)(21 U.S.C. § 343(r)(3) and (2)). In
1999 FDA published a proposed rule to extend these same provisions to
dietary supplements. [See]{.underline} 64 F.R. 3,250 (Jan. 21, 1999).
FDA has failed to take any further action on that proposed rule and
presently disallows use of authoritative statement claims on dietary
supplement labels and in supplement labeling. [See]{.underline} FDA,
"Labeling of Dietary Supplements"
<http://www.cfsan.fda.gov/~dms/ds-labl.html> (last visited 8/21/02).

The statutory requirements for using an authoritative statement are
essentially identical for nutrient content claims and health claims.
[See]{.underline} 21 U.S.C. § 343(r)(2)(G) and (3)(C). The submission
for approval shall be authorized if the following requirements are met:

(i) a scientific body of the United States Government with official
    responsibility for public health protection or research directly
    relating to human nutrition (such as the National Institutes of
    Health or the Centers for Disease Control and Prevention) or the
    National Academy of Sciences or any of its subdivisions has
    published an authoritative statement, which is currently in effect,
    \[which identifies the nutrient level or is about the relationship
    between a nutrient and a disease or health-related condition\] to
    which the claim refers;

(ii) at least 120 days before the food bearing the claim is first
     introduced into commerce the applicant submits to the Secretary of
     HHS (1) a notice of the exact words of the claim and a concise
     description of the basis relied upon for determining that the
     requirements of part (i) above are satisfied; (2) a copy of the
     authoritative statement relied upon, and (3) a balanced
     representation of the scientific literature relating to the
     nutrient level to which the claim refers;

(iii) The claim and the food on which it appears are in compliance with
      clauses (A) and (B), and are otherwise in compliance with
      paragraph (a) and section 201(n); and

(iv) The claim is stated in a manner so that the claim is an accurate
     representation of the authoritative statement and it enables the
     public to comprehend the information provided in the claim and to
     understand the relative significance of such information in the
     context of a total daily diet.

[See id.]{.underline} FDAMA also states that a statement shall be
regarded as authoritative in subclause (i) only if the statement is
published by a scientific body of the federal government and shall not
include a statement of an employee of the scientific body made in the
individual capacity of the employee. [See id.]{.underline}

In addition to the above statutory requirements, and despite the fact
that Congress intended this process to be an alternative to, not a
subset of, "significant scientific agreement" review pursuant to 21
U.S.C. § 343(r)(3)(B); ([See also]{.underline} [S. Rep. No.
103-410,]{.smallcaps} at 23 (1994)), FDA has required proof of
"significant scientific agreement" in this process as a condition
precedent to allowing authoritative statement claims. [See]{.underline}
[Guidance for Industry: Notification of a Health Claim or Nutrient
Content Claim Based on an Authoritative Statement of a Scientific
Body]{.underline} (June 11, 1998) (hereinafter "Authoritative Statement
Guidance"). It has thus violated congressional intent and rendered the
section, in the end, a substantive redundancy of "significant scientific
agreement" review.

In the Authoritative Statement Guidance FDA states that "FDAMA provides
that FDA may issue a regulation under section 403(r)(3)(B)(i) of the Act
to prohibit or modify a claim." [Id.]{.underline} Section
403(r)(3)(B)(i) states,

The Secretary shall promulgate regulations authorizing claims of the
type described in subparagraph (1)(B) only if the Secretary determines,
based on the totality of publicly available scientific evidence
(including evidence from well-designed studies conducted in a manner
which is consistent with generally recognized scientific procedures and
principles), that there is significant agreement, among experts
qualified by scientific training and experience to evaluate such claims,
that the claim is supported by such evidence.

21 U.S.C. § 343(r)(3)(B)(i). However, when Congress created the
authoritative statement approval process it specifically excepted it
from the significant scientific agreement requirement:

Notwithstanding the provisions of clauses (A)(I) and (B)\[where B is the
above significant scientific agreement section\], a \[health claim\]
which is not authorized by the Secretary in a regulation promulgated in
accordance with (B) shall be authorized and may be made with respect to
a food if \[it meets the authoritative statement requirements listed
above\].

21 U.S.C. § 343(r)(3)(C).

In the Authoritative Statement Guidance FDA states that it believes from
the legislative history that authoritative statements should reflect a
consensus within the identified scientific body if published by a
subdivision of a federal scientific body[^29] and be based on a
deliberative review by the scientific body of the scientific evidence.
[See id.]{.underline} Those two provisions exceed FDAMA's statutory
requirements, which define an authoritative statement as being (1) about
the relationship between a nutrient and a disease or a health-related
condition for a health claim or identifies the nutrient level to which
the claim refers for a nutrient content claim; (2) published by the
scientific body; (3) currently in effect; and (4) not including a
statement of an employee of the scientific body made in the individual
capacity of the employee. [See id.]{.underline} Because it was the very
purpose of the statute to reduce the burden imposed by "significant
scientific agreement" review and provide an alternative to it, FDA's
insistence on satisfaction of weighty conditions precedent beyond those
in the statute violate congressional intent.

Violating clear statutory directives, FDA states that it intends to
evaluate authoritative statement claims under the very system of review
for which the authoritative statement section was to serve as an
alternative, namely "significant scientific agreement" review. That
flouts the will of Congress. The agency also states that it does not
believe the significant scientific agreement standard would allow a
claim based on findings characterized as preliminary results, statements
that indicate research is inconclusive, or statements that are intended
to guide further research. [See id.]{.underline} That not only flouts
the will of Congress, it also violates the First Amendment by banning
inconclusive claims rather than allowing them with reasonable
disclaimers.. [Pearson]{.underline} I stands plainly against such a
blanket ban approach and would compel reliance on the less speech
restrictive remedy of a reasonable disclaimer.

The legislative history plainly limits the scientific agreement review
standard for use only when FDA has already approved and rendered
effective a health claim through rulemaking under Section 403(r)(3)(B)
and finds that the authoritative statement proffered under Section 303
concerns the same diet/disease relationship it has authorized pursuant
to Section 403(r)(3)(B). [See]{.underline} [S. Rep. No.]{.smallcaps}
105-43, at 51 (1997).

The Conference Report on FDAMA makes clear that Congress intended to
achieve two objectives with Section 303: (1) expedited processing of
claims within its purview and (2) communication of more scientifically
sound nutrition information than had heretofore been permitted under
FDA's "significant scientific agreement" review pursuant to 21 U.S.C. §
343(r)(3)(B). The Conference Report reads, in pertinent part:

The conference agreement makes streamlined procedures available for the
Secretary to permit more scientifically sound nutrition information to
be provided to consumers.

[H. Conf. R]{.smallcaps}. 105-399 at 98.

Moreover, the Senate Report states in pertinent part:

The amendments this legislation makes to section 403(3) of the Federal
Food Drug and Cosmetic Act would prevent a recurrence of the kind of
problem presented by the folic acid/neural tube defect claim. While the
legislation makes no change to the existing standards governing the
health claims approval process, it establishes an alternative procedure
by which health claims supported by an authoritative statement of an
appropriate scientific body of the U.S. Government are authorized.

S. R., [supra]{.underline}.

By prohibiting use of any authoritative statement except that which FDA
finds backed by "significant scientific agreement" and, in the process,
disallowing any authoritative statement except that which FDA finds
proven to a near conclusive degree, FDA ensures that interpretation of
21 U.S.C. § 343(r)(3)(C) will be construed in a manner that is
substantively identical to the review scheme held unconstitutional in
[Pearson]{.underline} I. Under [Pearson]{.underline} I, FDA may not
constitutionally suppress any health claim supported by credible
scientific evidence if a disclaimer can be used to eliminate potential
misleadingness. In the case of authoritative statements published by
other government agencies, there can be no question but that FDA's
interest in conveying the lack of conclusiveness of science supporting
such statements can be accommodated fully through use of a disclaimer.
Thus, FDA may not constitutionally deny a petitioner the right to make a
claim based on authoritative statements of other government agencies if
its interest in protecting public health and eliminating fraud can be
achieved through resort to a disclaimer in lieu of outright suppression.
Because the matter in issue is one of First Amendment import and, as
explained above, delay is the bane of First Amendment jurisprudence, FDA
should immediately act on the pending proposed rule (FDAMA Joint
Comments, [supra]{.underline}) and authorize all claims previously
denied relying on disclaimers as a less speech restrictive alternative
to outright suppression.

We now turn to evaluate FDA's interpretation of the Authoritative
Statements provisions of FDAMA under strict scrutiny. FDA's objectives
of protecting public health and eliminating fraud are undoubtedly
compelling. Its suppression of all authoritative statements that lack
what FDA regards as "significant scientific agreement," however,
violates the First Amendment. It does so by ensuring that an enormous
quantity of truthful and nonmisleading information concerning the
potential of nutrients to affect disease contained in published
statements of government health agencies never reaches the American
consumer. The blanket suppression approach is not narrowly tailored to
serve a compelling interest but, instead, circumscribes protected
expression on credible, but less than conclusive, associations between
foods and dietary supplements and disease. Disclaimers are an obvious
less speech restrictive alternative required in [Pearson]{.underline} I
for circumstances virtually identical to those present here. FDA has no
lawful authority under the Constitution to refuse use of disclaimers as
a less speech restrictive alternative to claim suppression whether the
claim arises under the NLEA's health claims provisions or under FDAMA's
authoritative statement provisions. In each case, if FDA believes it
cannot "authorize" a statement under one or the other section, it must
still perform its constitutional duty and determine whether the
statement must nevertheless be "allowed," relying in the latter context
on use of succinct, accurate, and reasonable disclaimers as less speech
restrictive alternatives to outright suppression.

Even under the heightened intermediate scrutiny test applied to
commercial speech, FDA's interpretation of FDAMA's Authoritative
Statement provisions fails to pass muster. Communication of
authoritative statements on labels and in labeling is neither unlawful
activity nor misleading speech. Undoubtedly the FDA's interest in
protecting public health and eliminating fraud is substantial. Mass
suppression of claims that do not satisfy FDA's "significant scientific
agreement" review standard (i.e., that are not backed by near conclusive
proof) does not directly and materially advance FDA's interest, however.
Indeed, denying consumers at the point of sale the very same information
other federal health agencies publish elsewhere impairs consumers'
ability to exercise informed choice in the purchase of food and dietary
supplements. Moreover, the loss of such information increases, rather
than decreases, the vulnerability of consumers to acts of fraud because
they will be less well informed on the actual and potential health
benefits of foods and dietary supplements in the market and will,
therefore, be more apt to believe falsehoods about those foods and
supplements.[^30]

FDA has no empirical evidence to support the conclusion that public
health will be harmed or that consumers will be defrauded by reading
information published by their own Government reprinted at the point of
sale. Denying consumers at the point of sale the very same information
the Government publishes elsewhere is also far more extensive than
necessary to protect public health and eliminate fraud. To the extent
that information published by those other agencies is based on science
that is less than conclusive, the simple resort to a disclaimer alerting
consumers to that fact is a fully adequate, less speech restrictive
alternative. It satisfies the strong First Amendment presumption in
favor of disclosure over suppression while at the same time keeping
consumers apprised of the fact that evidence supporting a statement
published by a Government health agency may be less than conclusive. For
the foregoing reasons, FDA's current position on authoritative
statements and its application of that policy violate the First
Amendment.

C.  FDA'S DRUG AND DEVICE CLAIM REGULATIONS VIOLATE THE FIRST AMENDMENT

The Joint Commenters do not challenge the Food and Drug Administration's
statutory pre-market approval authority for new drugs to the extent that
those provisions are not construed in a manner that conflicts with the
First Amendment. Moreover, the Joint Commenters agree with FDA's
long-standing policy to avoid restriction of the independent
professional discretion of a physician in prescribing FDA approved drugs
for unapproved uses (so-called off-label uses). [See]{.underline} 21
U.S.C. §§ 331(a) and (d); 62 Fed. Reg. 64,093 (December 3, 1997); [see
also]{.underline} [Washington Legal Foundation v. Henney]{.underline},
202 F.3d 331, 333 (D.C. Cir. 2000) ("\[N\]either Congress nor the FDA
has attempted to regulate the off-label use of drugs by doctors or
consumers."). Consistent with the statute, once FDA has determined that
a drug is safe and efficacious for a particular use, its principal
post-market interest turns to issues of misbranding, adulteration, and
adverse reactions. FDA's off-label use policy is a rather clear
recognition that unapproved uses are an accepted and important part of
medical practice that FDA neither wishes, nor needs, to prohibit.
[See]{.underline} 61 Fed. Reg. 52,800, 52,801 (October 8, 1996); [see
also]{.underline} 65 Fed. Reg. 14,286, 14,287 (March 16, 2000).
Off-label uses have become commonplace (and indispensable) in several
areas of medical specialty and safe use pursuant to a physician's
prescription has become the rule, not the exception.

The critical First Amendment issue arises not in labeling review
attendant to the pre-market approval of a new drug but in labeling
review thereafter. The critical issue concerns whether FDA may
constitutionally prohibit those who make, sell, and distribute FDA
approved drugs from informing physicians and consumers of discoveries of
truthful off-label uses for those drugs. As explained in greater detail
below, the First Amendment prohibits FDA from suppressing the
dissemination of truthful information concerning off-label uses and
places the onus squarely on the FDA to establish inherent misleadingness
in every instance. While it would not offend the First Amendment for FDA
to require manufacturers to inform the agency of off-label use
information intended for labels or labeling and to permit FDA to impose,
where appropriate and with speed, required accurate, succinct, and
reasonable disclaimers to avoid potential misleadingness, it does offend
the First Amendment for FDA to require manufacturers to file new drug
applications (and incur the enormous costs, often hundreds of millions
of dollars) as a condition precedent to dissemination of that same
information. In short, FDA may not constitutionally impose the
extraordinary cost and burden of the new drug approval process[^31] upon
a drug manufacturer who desires not to change the approved substance it
markets but solely to inform physicians and consumers of truthful
information on new therapeutic uses for that substance. The new drug
approval process currently imposes a substantial (and oftentimes speech
prohibitive) tax on truthful speech in the presence of a far less speech
restrictive alternative. That alternative, required filing of
prospective new drug claims along with science supporting those claims
and required use of disclaimers to cure potential misleadingness, is a
necessary and sufficient regulatory response for drugs that have already
been approved as safe and efficacious for a particular use.

Currently FDA prohibits manufacturers from disseminating information on
off-label uses of FDA approved drugs[^32]: 1) on labels and in labeling;
2) in scientific literature disseminated to physicians, or to the
public; 3) in industry sponsored educational activities; 4) on their
internet websites; and 5) in direct-to-consumer advertising.

Off-label uses are unapproved uses of approved drugs. [See
e.g.]{.underline}, [WLF]{.underline} at 332. An off-label use is a "new
use" of an approved drug. [See e.g.,]{.underline} 65 Fed. Reg. 14,286
(March 16, 2000). Under FDA's current interpretation of the FDCA, it is
unlawful for a manufacturer[^33] to introduce a new use of an approved
drug into the market without advance agency approval. Doing so
constitutes the sale of an unapproved new drug and misbranding.
[See]{.underline} 21 U.S.C. §§ 331(a) and 352(f); 355(a)(b)(d) and (j).

We start our analysis in this section with a condition precedent: the
drugs in question must have been approved by FDA as safe and effective
for a particular use in humans (or in animals for veterinary drugs)
before they may be labeled and promoted for any other therapeutic use.
The drugs in question have thus undergone FDA's intense scrutiny in the
lengthy and onerous new drug approval process.[^34] [See]{.underline} 21
U.S.C. § 355(b). Through that process (and the testing and documentation
required by it) FDA has found the drug in question safe for its intended
use.

We also start with recognition of the fact that neither Congress nor the
FDA has restricted the ability of doctors to [prescribe]{.underline} and
consumers to [take]{.underline} FDA approved drugs for off-label,
unapproved uses. [See]{.underline} [WLF]{.underline}, at 333 (citation
omitted)(emphasis added). Thus, implicitly, FDA condones off-label
claims by physicians to patients and has determined there to be no
contrary statutory bar to exercise of its enforcement discretion to
permit that communication. [See id]{.underline}. Indeed, "it is
undisputed that the prescription of drugs for unapproved uses is
commonplace in modern medical practice and ubiquitous in certain
specialties." [Id.]{.underline} citing James M. Beck & Elizabeth D.
Azari, [FDA, Off-Label Use and Informed Consent: Debunking Myths and
Misconceptions]{.underline}, 53 Food & Drug L.J. 71, 80 (1998).

M. Roy Schwartz, the American Medical Association's Vice President for
Science and Education, estimated in 1994 that 40-60% of all drugs
prescribed are for off-label uses. [See]{.underline} Ward, S., [WLF and
the Two-Click Rule: The First Amendment Inequity of the Food and Drug
Administration's Regulation of Off-Label Drug Use Information on the
Internet]{.underline}, 56 Food & Drug L.J. 41, 45 (2001) citing Fran
Kritz, [FDA Seeks to Add Drugs' New Uses to Labels]{.underline}, Wash.
Post, Mar. 29, 2994, Health Section, at 11. The use of prescription
drugs for off-label purposes is highest among certain specialties. Over
30% of prescriptions for cancer patients are for off-label uses, 40% for
AIDS patients, 80% for children and 90% for patients with rare diseases
(those affecting 200,000 people or fewer in the United States). Ward,
supra at 45 citing Edmund Polubinski, III, [Closing the Channels of
Communication: A First Amendment Analysis of the FDA's Policy on
Manufacturer Promotion of Off-Label Use]{.underline}, 83 Va. L. Rev.
991, 998 (1997).

Compared to other interested parties manufacturers have the greatest
incentives to keep abreast of the current research on the uses of their
drugs, to monitor safety and efficacy, and to determine ways of
enhancing market share and sale potential. Manufacturers are in the best
position to provide healthcare practitioners and the public with
truthful information on the safety and efficacy of the off-label uses of
their drugs. Moreover, manufacturers are under FDA's jurisdiction so the
agency has the power to take enforcement action for any untruthful or
misleading statements. Of course were a manufacturer to promote an
off-label use that harmed patients, that manufacturer would incur
substantial products liability risks as well as long term reputation
damage capable of either destroying the company or, at a minimum,
reducing its profitability.

## **fda'S SUPPRESSION OF OFF-LABEL USE CLAIMS VIOLATES THE FIRST AMENDMENT**

Public health in no small measure depends on off-label prescription of
FDA approved drugs, as FDA has admitted and the United States District
Court for the District of Columbia has recognized. [See]{.underline}
[WLF]{.underline} [supra]{.underline}. Each barrier to the dissemination
of truthful off-label information thus not only offends the First
Amendment, as explained below, but also creates dysfunctional drug
markets to the detriment of physicians and, indeed, patients whose
speedy recovery or relief from pain may depend on the off-label use. It
stands to reason that an effective off-label use not communicated to a
patient in need or not communicated to that patient's physician creates
the very real risk that the patient's need will go unsatisfied or
inadequately satisfied. It is thus likely that physicians who, due to
FDA restraints, lack truthful off-label information may unwittingly
cause harm to patients by denying them an effective treatment
alternative. Likewise, patients who, due to FDA restraints, lack that
same information may fail to inquire competently of their physicians
about potentially effective off-label treatments.

We now turn to evaluate FDA's restrictions on off-label use under strict
scrutiny We also evaluate those restrictions under the heightened
intermediate scrutiny standard applied to commercial speech. The
restrictions fail under each standard. Under both First Amendment
standards, however, the result is the same: FDA's current interpretation
of the statute to equate off-label use information with misbranding and
the sale of an unapproved new drug causes the statute to violate the
First Amendment. As explained below, that interpretation is not required
by the plain wording of the statute and another interpretation is
possible wholly consistent with the First Amendment. In accordance with
the canons of statutory construction, which permit the striking of a
statute only if a constitutional interpretation is not possible[^35],
that other interpretation is the only one legally available to the
agency and should therefore become the operative rule of law.

Under strict scrutiny, FDA's interest must be compelling.
[See]{.underline} [Republican Party]{.underline}, supra, at \*17.
Protecting the public health and combating fraud are compelling
interests. Under strict scrutiny, FDA's prohibition on off-label use
information on drug labeling must be content-based. FDA's speech ban is
imposed on all labeling content concerning therapeutic effects not
previously approved by FDA for that drug. Accordingly, it is
content-based and presumptively unconstitutional. [See]{.underline}
[Crawford]{.underline}, 96 F3d. at 384.

Under strict scrutiny, the government is constrained to choose means
that are narrowly tailored to serve its interests. FDA's prohibition on
off-label use information in drug labeling is a blunderbuss approach. It
suppresses substantial quantities of truthful and nonmisleading speech
concerning the therapeutic effects of drugs. FDA has done nothing to
tailor its speech ban in a way that suppresses only false
representations. Rather, FDA's labeling ban censors *all* off-label
claims, the true and the false alike (a sledge hammer to kill a gnat).
In the absence of any tailoring to limit the speech ban to demonstrably
false claims, the ban cannot survive strict scrutiny. The Court has
routinely struck down such overbroad restrictions on protected speech.
[See]{.underline} [Pearson v. Shalala]{.underline}, 164 F.3d 650 (D.C.
Cir. 1999), rehearing denied, 172 F.3d 72 (D.C. 1999); [Washington Legal
Foundation v. Henney]{.underline}, 56 F. Supp. 2d 81 (D.C. 1999), rev'd
and remanded, 202 F.3d 331 (2000); [Pearson v. Shalala]{.underline}, 130
F. Supp. 2d 105 (D.C. 2001); [Pearson v. Thompson]{.underline}, 141 F.
Supp. 2d 105 (D.C. 2001); [Thompson v. Western States Med.
Ctr.,]{.underline} 122 S. Ct. 1497 (2002).

Under strict scrutiny, the government must ensure that its chosen means
are do not trench on or circumscribe protected expression. Here, the
chosen means aim at suppressing an entire category of speech (all
therapeutic claims not previously approved by FDA) and thus directly
censor true off-label claims. The suppressive effect is not incidental
but the very aim of the regulation. Accordingly, the prohibition is of a
kind held unconstitutional by the Supreme Court. [See]{.underline}
[Brown v. Hartlage]{.underline}, 456 U.S. 45 (1982).

Even under the heightened intermediate scrutiny standard applied to
commercial speech, the restriction fails to pass muster. The placement
of therapeutic claims on labels and in labeling is not illegal activity.
The placement of off-label use information in labeling is not inherently
misleading speech unless the content the manufacturer seeks to express
is itself inherently misleading, in which case, upon proper proof, the
Government may suppress it outright. Undoubtedly, the Government's
interest in protecting the public health and eliminating fraud are
substantial interests. The FDA has not established that there is any
harm associated with placing truthful off-label use information on
labels and in labeling. The FDA has not established that the wholesale
suppression of all off-label use information, the true and the false
alike, ***directly*** furthers its interest in protecting the public
health and safeguarding the public against fraud or that such a blanket
ban furthers that interest to a ***material*** degree. To the contrary,
depriving physicians, pharmacists, and patients of truthful off-label
use information in labeling would appear to increase risk to public
health by making it more likely either that drugs will not be made
available for off-label uses to patients in need of such uses or that
drugs when used for off-label purposes will be used improperly (in
incorrect dose amounts, for an insufficient duration, or in the
treatment of the wrong condition or symptom). Thus, the goal of
protecting the public health and eliminating fraud would be served
directly and materially not by suppressing all off-label use information
in labeling but by permitting truthful off-label use information in
labeling. Accordingly, the FDA's ban does not directly and materially
advance its interest.

The regulation cannot be in excess of that necessary to advance FDA's
interest. It must be in reasonable proportion to the interest served.
[See]{.underline} [Ibanez]{.underline}, 512 U.S. at 143. FDA's
prohibition on off-label uses on labels and in labeling is an absolute
prohibition that suppresses all off-label claims in labeling without
distinguishing the true from the false and without offering any
alternative to the extraordinarily burdensome and taxing new drug
approval process. The prohibition is imposed without regulators
distinguishing "the truthful from the false, the helpful from the
misleading, and the harmless from the harmful." [Ibanez]{.underline},
512 U.S. at 143 (citations omitted). The prohibition is therefore
disproportionate to (an far in excess of) that necessary to protect the
public from harm and fraud.

The FDA makes no effort to distinguish inherently misleading off-label
claims from those that are, at worst, only potentially misleading. Under
apposite First Amendment precedent, the FDA may not suppress truth with
falsehood but must evaluate the speech before it with care and favor
disclosure of truthful, and even potentially misleading, information
(corrected for misleadingness with disclaimers) over its suppression.

Just as FDA exercises enforcement discretion now to avoid prosecution of
physicians who explain off-label uses of FDA-approved drugs to patients,
so too it should exercise enforcement discretion to allow off-label use
claims that are truthful (or can be rendered so through use of accurate,
succinct, and reasonable disclaimers) to appear on approved drug labels,
in approved drug labeling, and in approved drug advertising. While FDA
can constitutionally require receipt and review of scientific evidence
supporting the safety and efficacy of the use, it cannot prohibit the
off-label use description unless it is inherently misleading. Otherwise,
it must allow it to appear relying on accurate, succinct, and reasonable
disclaimers to ensure that physicians and the public appreciate that the
use is not FDA-approved.

## **2. FDA's RESTRICTIONS ON MANUFACTURER DISTRIBUTION OF SCIENTIFIC LITERATURE ON OFF-LABEL USES VIOLATES THE FIRST AMENDMENT**[^36]

When a drug manufacturer wishes to disseminate scientific literature on
the safety, effectiveness, or benefit of a use that is not included in
the approved labeling for an approved drug and that literature is to be
disseminated to a healthcare practitioner, pharmacy benefit manager,
health insurance issuer, group health plan, or Federal or State
Government agency, the manufacturer must adhere to the stringent and
onerous conditions FDA has created for such dissemination.
[See]{.underline} 21 U.S.C. § 360aaa (2002)[^37].

First, the type of literature that a manufacturer may disseminate is
limited. It must be (1) about a drug that has been approved, licensed or
cleared for marketing by the FDA; (2) it must be in the form of either:
(i) an unabridged reprint or copy of an article, peer-reviewed by
experts qualified by scientific training or experience to evaluate the
safety or effectiveness of the drug involved, which was published in a
scientific or medical journal, which is about a clinical investigation
with respect to the drug, and would be considered to be scientifically
sound by such experts, or (ii) a reference publication (defined at 21
U.S.C. § 360aaa-1(b)), that includes information about a clinical
investigation with respect to a drug that would be considered to be
scientifically sound by experts qualified by scientific training or
experience to evaluate the safety or effectiveness of the drug,
[and]{.underline} such materials are not false or misleading and would
not pose a significant risk to the public health. [See]{.underline} 21
U.S.C. §§ 360aaa(b)(1) and (2). The information also may not be derived
from clinical research conducted by another manufacturer without that
manufacturer's permission. [Id.]{.underline} at (3).

In addition, 60 days before dissemination, the manufacturer must submit
to the Secretary: (1) a copy of the information to be disseminated and
(2) clinical trial information or summaries of reports regarding the
safety and effectiveness of the new use. [See]{.underline} 21 U.S.C. §
360aaa(b)(4)(a) & (b). The manufacturer must also submit either a
supplemental application for new use, a certification that it is in the
process of completing the planned studies necessary to submit a
supplemental application, or an application for an exemption for the
requirement of a supplemental application. [See]{.underline} 21 U.S.C. §
360aaa(b)(5) ([referencing]{.underline} 21 U.S.C. § 360aaa-3(a), (b),
and (c).

Finally, if all the above requirements are met, the manufacturer must
include along with the information a variety of "prominently displayed
statement\[s\]" that disclose: (i) that the information concerns a use
of a drug or device that has not been approved or cleared by FDA; (ii)
if applicable, that the information is being disseminated at the expense
of the manufacturer; (iii) if applicable, the name of any authors of the
information who are employees of, consultants to, or have received
compensation from, the manufacturer, or who have a significant financial
interest in the manufacturer; (iv) the official labeling for the drug or
device and all updates regarding the labeling; (v) if applicable, a
statement that there are products or treatments that have been approved
or cleared for the use that is the subject of the information being
disseminated; and (vi) the identification of any person that has
provided funding for the conduct of a study relating to the new use of a
drug or device for which such information is being disseminated.
[See]{.underline} 21 U.S.C. § 360aaa(b)(6)(A). In addition to those
various disclosure statements, the manufacturer must provide a
bibliography of other articles from a scientific reference publication
or medical journal that have been previously published about the use of
the drug covered by the dissemination. 21 U.S.C. § 360aaa(b)(6)(B).

In addition to the stringent requirements listed above, FDA may require
even more information before a manufacturer is allowed to disseminate
information free of risk of a misbranding charge of off-label use. If
the Secretary finds that the information already provided fails to
provide data or analysis that is "objective and balanced," the Secretary
may require dissemination of: 1) additional "objective and
scientifically sound information that pertains to the safety or
effectiveness of the use and is necessary to provide objective and
balance," or (2) an objective statement of the Secretary based on data
or significantly sound information that bears upon the safety and
effectiveness of the use. [See]{.underline} 21 U.S.C. § 360aaa(c)(1) and
(2).

FDA stated that Part 99 of the Code of Federal Regulations creates a
safe harbor and that it does not independently authorize the FDA to
prohibit or to sanction speech. 65 Fed. Reg. 14,286, 14,287(March 16,
2000) (Agency notice "Decision in [Washington Legal Foundation v.
Henney]{.underline}"). Section 21 U.S.C. § 331(z) specifically prohibits
"the dissemination of information in violation of section 360aaa."
[WLF]{.underline}, [supra]{.underline} at 335. However, FDA stated that
it would use the dissemination of information that is not in compliance
with section 360aaa as evidence in a misbranding or "intended use"
enforcement action. [Id.]{.underline} An approved drug that is marketed
for a new use becomes an unapproved new drug with respect to that use.
[See]{.underline} 65 Fed. Reg. at 14,286. That drug is also misbranded
under the FDCA because the labeling of such a drug would not include
adequate directions for use of the new use. [See id.]{.underline}
[citing]{.underline} 21 U.S.C. § 352(f); [United States v. Articles of
Drug \*\*\*Rucker Pharmaceutical Co.]{.underline}, 625 F.2d 665, 673
(5^th^ Cir. 1980). Thus, if a manufacturer does not comply with FDA's
restrictions on the dissemination of truthful scientific literature, the
manufacturer remains at risk of an enforcement action under the FDCA, in
which FDA will use the journal articles and reference texts disseminated
by the manufacturer as evidence that an approved product is intended for
an unapproved use (i.e., is misbranded). [See]{.underline} 65 Fed. Reg.
at 14287.[^38] That, of course, engenders a chilling effect on the
willingness of responsible drug manufacturers to disseminate off-label
use information.

All FDA conditions and restrictions on the dissemination of scientific
literature by drug manufacturers, beyond simply requiring that the
corroborative scientific evidence be filed with FDA and that the content
be truthful, impose an unconstitutional condition and restriction on the
right to speak. The restrictions and conditions set forth in 21 U.S.C. §
360aaa thus violate the First Amendment and are unconstitutional.
Because government agencies have no lawful power to enforce
unconstitutional statutes, FDA must cease enforcement of section
360aaa.[^39]

FDA may not constitutionally limit the right of drug manufacturers to
disseminate scientific literature unless it establishes in a particular
case that the information to be disseminated is inherently misleading.
The less speech restrictive alternative of requiring a succinct,
accurate, and reasonable disclaimer to state that the uses described in
the literature have not been approved by FDA as safe and efficacious
should suffice to serve all readers with adequate notice. The FDA does
not argue, nor has it proven, that physician prescribed off-label uses
are inherently dangerous. Indeed, the only plausible argument concerns
the possibility that a person might perceive an off-label use as
FDA-approved but that can be rectified by simple resort to a disclaimer,
one that alerts physicians and patients to the fact that the use is
FDA-unapproved.[^40]

We turn now to apply strict scrutiny to FDA's restrictions on
dissemination of off-label use literature. To satisfy strict scrutiny,
FDA's prohibition must be content neutral and narrowly tailored to serve
a compelling state interest. While FDA's interest in protecting the
public health and eliminating fraud are undoubtedly compelling, its ban
focuses on suppression of content because FDA believes consumers will
react to off-label use information in ways it regards as against their
best interests. The prohibition is thus content-based and, accordingly,
invalid under the strict scrutiny test. Even were the prohibition not
content-based, it is nevertheless not narrowly tailored because it
prohibits all truthful off-label use information along with that which
is inherently misleading. Moreover it is both underinclusive and
overinclusive. It is underinclusive to the extent that FDA allows
physicians to communicate off-label use information to patients and to
prescribe FDA approved drugs for off-label uses. It is overinclusive to
the extent that it prohibits all off-label use information, including
the truthful, in an effort to suppress that which is false and
misleading. Consequently, FDA's prohibition circumscribes protected
expression and, thus, cannot withstand the Supreme Court's strict
scrutiny test.

The restrictions also fail under the heightened intermediate scrutiny
test applied to commercial speech. Dissemination of scientific
literature on off-label uses is neither an unlawful activity nor
misleading speech. The FDA's interests in protecting public health and
eliminating fraud are substantial. Far from directly advancing FDA's
public health and anti-fraud interests, FDA's restrictions on the
dissemination of scientific literature concerning off-label uses of
approved drugs increases the likelihood that either potentially
beneficial off-label prescriptions will not be made to patients in need
or that errors will be made in prescription, in dosing and in delivery
of the drugs. Accordingly, restricting the right of manufacturers to
distribute scientific literature does not directly and materially
advance the government's interest in protecting the public from harm and
fraud. FDA's restrictions on the dissemination of scientific literature
on off-label uses are far more extensive than necessary to protect the
public from physical harm and fraud. FDA restricts the type of
scientific literature that can be disseminated, how it is disseminated,
and requires preapproval before dissemination. Long standing FDA policy
permits physician off-label prescriptions recognizing that off-label
prescriptions are essential, particularly in medical specialties like
pediatrics and oncology where very large numbers of physicians must rely
on off-label prescriptions to treat diseases and disease symptoms for
which approved drugs and drug indications are lacking. [See]{.underline}
[WLF]{.underline}, [supra]{.underline} at 333; Ward, [supra]{.underline}
at 45 (citations omitted). It serves the FDA's interests that physicians
who make such prescriptions and patients who must rely upon them be
well-informed so that the risk of denying a treatment option to a
patient in need or making an error in the provision of an off-label
prescription is minimized to the maximum extent possible. In that
regard, FDA can fulfill its dual public health and anti-fraud objectives
through the use of succinct, accurate, and reasonable disclaimers for
use in association with off-label scientific literature disseminated by
manufacturers to physicians and patients. FDA can require that each
piece of such literature be accompanied by a prominent disclaimer from
the manufacturer that alerts physicians and patients to the fact that
(1) the use described in the literature has not been evaluated by the
Food and Drug Administration and has not been proven safe or effective
to the satisfaction of FDA and (2) the physician should be cautious in
the application of the drug for the unapproved use and in observing
patient reactions to the drug for that use. Those disclaimers give the
physicians ample notice of the potential risks involved and of the need
for close supervision of patients prescribed FDA approved drugs for
off-label uses. At once the risk of harm is reduced and the potential
misleadingness eliminated.

> **3. FDA's SUPPRESSION OF MEDICAL DEVICE OFF-LABEL USE CLAIMS VIOLATES
> THE FIRST AMENDMENT**

As discussed [supra]{.underline} at note 20, all regulations pertaining
to the dissemination of information for off-label use for drugs also
apply to medical devices pursuant to 21 C.F.R. § 99.1 (2002).
Accordingly, the same constitutional arguments apply. A medical device
is defined at 21 U.S.C. § 321(h) (2002) as an instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or other
similar or related article, including any component, part, or accessory,
which is---

\(1\) recognized in the official National Formulary, or the United
States Pharmacopeia, or any supplement to them,\
(2) intended for use in the diagnosis of disease or other conditions, or
in the cure, mitigation, treatment, or prevention of disease, in man or
other animals, or\
(3) intended to affect the structure or any function of the body of man
or other animals, and which does not achieve its primary intended
purposes through chemical action within or on the body of man or other
animals and which is not dependent upon being metabolized for the
achievement of its primary intended purposes.

Thus, if a manufacturer of a medical device wanted to disseminate
truthful information regarding an off-label use for its product, it
would be unable to do so without complying with the onerous regulatory
restrictions set forth in 21 C.F. R. § 99.101. As discussed above, that
amounts to an unconstitutional burden on the manufacturer's right to
free speech. [See]{.underline} pages 73-81, [supra]{.underline}.

## **4. FDA'S restrictions on Industry-Sponsored Educational Activities violate the first amendment**

FDA scrutinizes the involvement of manufacturers in educational
activities for medical practitioners (such as Continuing Medical
Education (CME) classes for physicians) to discourage the discussion of
off-label uses of the manufacturers' drugs. FDA divides
industry-sponsored educational activities into two categories: 1)
activities (both programs and materials) performed by, or on behalf of,
the companies that market the products discussed; and 2) activities,
supported by companies, that are otherwise independent from the
promotional influence of the supporting company. [See]{.underline}
[Guidance for Industry: Industry-Supported Scientific and Educational
Activities]{.underline}, 62 Fed. Reg. 64,093, 64,094 (December 3, 1997)
(hereinafter "Educational Activities Guidance"). Indicia of a
manufacturer's influence over program content (or, conversely, the
absence of proof of independence under FDA's criteria) determines
whether FDA shall consider discussions of new uses at an educational
event to be evidence of the manufacturer's intent to have its product
used for that new use.

FDA has a guidance document containing twelve factors that the FDA will
consider in determining whether a program is independent of a
manufacturer's influence. [See]{.underline} Educational Activities
Guidance. It is FDA's position that the "program and materials performed
and disseminated by companies are subject to the labeling and
advertising provisions of the FDCA." [Id.]{.underline} However, in the
Educational Activities Guidance FDA states that the constraints on
advertising and labeling when applied to scientific and educational
activities can restrict the freedom of participants to discuss their
data or express their views. [Id.]{.underline} The twelve factors FDA
uses to determine independence are:

1)  [Control of content and selection of presenters and
    moderators]{.underline}: FDA will examine whether the company had
    full control over the program or otherwise influenced the program's
    content. FDA will also consider whether the company suggests
    speakers who were or are actively involved in promoting the
    company's products or who have been the subject of complaints with
    regard to previous presentations regarded as misleading or biased.

2)  [Disclosures:]{.underline} FDA examines whether during the program
    the following are disclosed to the audience: (1) the company's
    funding of the program; (2) any significant relationship between the
    provider, presenters or moderators, and the supporting company;
    and (3) whether any unapproved uses of products will be discussed.

3)  [The focus of the program:]{.underline} FDA examines (1) whether the
    intent is to produce an independent and nonpromotional activity that
    is focused on educational content, free from commercial influence or
    bias; (2) whether the title accurately represents the presentation's
    scope; and (3) whether the central theme of the program is a single
    product of the company or a competing product (unless treatment
    options are so limited that discussion of alternative therapies is
    precluded).

4)  [Relationship between provider and supporting company:]{.underline}
    FDA examines whether there are legal, business, or other
    relationships between the company and provider that could place the
    company in a position to exert influence over the content of the
    program.

5)  [Provider involvement in sales or marketing:]{.underline} FDA
    examines whether an employee of the program provider, involved in
    designing or conducting scientific or educational activities, is
    also involved in advising or assisting the company with sales or
    marketing of products.

6)  [Provider's demonstrated failure to meet standards:]{.underline} FDA
    examines whether the program provider has a history of conducting
    programs that fail to meet standards of independence, balance,
    objectivity, or scientific rigor.

7)  [Multiple presentations:]{.underline} FDA considers whether there
    are multiple presentations of the same program.

8)  [Audience selection:]{.underline} FDA considers whether the program
    invitations are generated by the company's sales or marketing
    departments or are intended to reflect sales or marketing goals.

9)  [Opportunities for discussion:]{.underline} FDA examines whether
    there was an opportunity for discussion and questioning during the
    program.

10) [Dissemination:]{.underline} FDA examines whether information about
    the company's product presented in the program is further
    disseminated after the program, by or at the behest of the company,
    other than in unsolicited requests or through independent providers.

11) [Ancillary promotional activities:]{.underline} FDA examines whether
    there are promotional activities, such as presentations by sales
    representatives or promotional exhibits, taking place in the meeting
    room.

12) [Complaints:]{.underline} FDA examines whether any complaints have
    been raised by the program provider, presenters, or attendees
    regarding attempts by the company to influence content.

[Id.]{.underline} FDA does not consider those twelve factors to be
exhaustive and may consider other factors in a particular case. [See
id.]{.underline}

While the lower court in [WLF]{.underline} held that the Educational
Activities Guidance violated the First Amendment, enjoining FDA from
proscribing manufacturers from suggesting content to CME program
providers, FDA changed its position before the appellate court.
[See]{.underline} [WLF]{.underline}, [supra]{.underline}, at 334. At
oral argument FDA stated that the Educational Activities Guidance did
not independently authorize the FDA to prohibit or sanction speech. [See
id.]{.underline} at 335. FDA took the position that if a drug
manufacturer wishes to suggest content to a CME program provider in a
manner that runs afoul of all the guidance's twelve factors that, by
itself, is not a violation of the law. [See id.]{.underline} at 336.
However, as with the dissemination of literature not in compliance with
Part 99, FDA would use that promotional conduct as evidence in a
misbranding or intended use enforcement action. [See
id.]{.underline}[^41]

There may well be no better forum for the dissemination of scientific
information than an educational event. It is a forum that permits the
sharing of ideas, the debating of efficacy of procedures, and the
disseminating of information on new potential treatments. Industry
sponsorship of educational activities and the dissemination of
information at those events, whether through speakers, lead discussion
groups or distribution of materials, is entitled to full First Amendment
protection.[^42]

The highly subjective twelve-plus factor analysis the FDA employs to
assess whether industry sponsorship of educational activities
constitutes impermissible off-label promotion imposes an undue burden
and unconstitutional conditions on the right to speak, invites agency
abuse, cannot be applied without subjective bias, provides no sure
guidance to the industry, and, for those same reasons, discourages the
exchange of scientific information on off-label uses of FDA approved
drugs. Under the Guidance, would-be conference sponsors must expect to
be second-guessed in minute detail by an agency which holds the power to
charge and judge them simultaneously. Because FDA possesses
prosecutorial and certain quasi-judicial powers (e.g., suspension of
pre-market authority), the effect of the FDA's super-editorial function
is to dissuade presentation of content, including truthful off-label
content, that would otherwise be supported and presented at conferences.
It thereby retards the search for truth, discovery, and innovation in
medical science.

FDA purportedly aims to prevent the dissemination of false and
misleading content on the uses of drugs but its scrutiny extends far
beyond that limited focus. The agency assumes too much when it asserts
in advance of a presentation that the content to be communicated may be
impermissible (1) if the manufacturer exercised control over the
program's content; (2) if the manufacturer failed to disclose to the
audience its funding for the program or its relationship to a provider,
presenter, or moderator; (3) if the program content includes a
"commercial influence or bias" (whatever that may be); (4) if the
program provider and supporting company have legal, business, or other
relationships; (5) if an employee of the program provider was involved
in advising or assisting the supporting company with sales or marketing
of products; (6) if FDA thinks the program lacks balance, objectivity,
or scientific rigor; (7) if there are multiple presentations of the
program, if the program invitations are generated by company sales or
marketing departments, if there were opportunities for discussion during
the program, if information about a company product appeared in a
presentation, if there were presentations made by sales representatives,
or if any complaints were raised about company influence over program
content. None of those factors, taken alone or together, proves that
content communicated in an educational activity is false or misleading.
All of those factors could be present but if the message is truthful the
First Amendment bars FDA from acting against a company.

Thus, the Guidance factors create an environment of uncertainty that
discourages risk averse pharmaceutical company executives from
sponsoring education programs for physicians. It provides FDA with a
subtle, effective means to intimidate, coerce, and cajole corporate
sponsors away from these venues, effectively diminishing the amount of
funding provided and the extent of fora available for the exchange of
off-label use information, discussion, and debate.

That government exercise of de facto editorial supervision violates the
First Amendment. It is not narrowly tailored to serve a compelling state
interest and it is far more extensive than necessary to serve an
important interest. It thus fails both strict and heightened
intermediate scrutiny under the First Amendment scientific and
commercial speech standards.

Numerous less speech restrictive alternatives exist. For example, the
FDA may simply prohibit the communication of false and misleading
off-label use information on labels and in labeling. In individual
instances where the agency has proof that false representations have
been made, it may then proceed to take legal action against an
individual manufacturer. Short of that, it has no business in attempting
to influence who may speak or what may be said at an educational
activity. The current regime is a patent violation of the First
Amendment, whether assessed under noncommercial or commercial speech
standards.

We now turn to application of the strict scrutiny standard to FDA's [de
facto]{.underline} restrictions on industry sponsorship of educational
activities. Without question, FDA's interest in protecting the public
health and preventing fraud are compelling. However, its chosen means
endeavor to influence both who may speak and what may be said at
industry-sponsored educational activities. As such, they are
impermissibly content-based and cannot pass muster under the First
Amendment. FDA's chosen means of regulation, a blunderbuss policy that
alerts the industry that every facet of industry relationships will be
examined to determine whether misbranding charges will be brought,
effectively places FDA in the position of super-editor, wielding the
sword of enforcement above the heads of industry sponsors and program
providers. Those sponsors and providers must be sure that the speakers
who participate in a conference and the subjects chosen for discussion
will not suggest to FDA that any one of its twelve plus factors are
implicated. It is through this form of coercion that FDA endeavors to
affect decisions about who may speak and what may be said at educational
conferences. The means chosen are certainly not narrowly tailored to
serve the compelling interest in protecting the public health and
preventing fraud. They appear calculated to intimidate or dissuade
discussion of off-label uses, not targeted precisely at false and
misleading presentations. The entire content of the program could be
demonstrably truthful, yet if the factors are implicated, the FDA could
still bring misbranding charges against a manufacturer. It is therefore
the case that FDA's chosen means circumscribe protected expression,
subjecting to risk of prosecution (and, in some instances, actual
prosecution) those whose "crime" it is to have communicated a truthful
message about an off-label use of an FDA approved drug.

While FDA may succeed in diminishing excess hype, it has yet to prove
that any past educational activities have been dominated by falsehood
(or even infected with a little bit of falsehood). It has certainly not
proved that professionals who attend these conferences have been misled
and have acted on misrepresentations to the detriment of patients.
Rather, despite its burden of proof under the First Amendment, FDA bases
its interference in the idea and information market on nothing more than
academic supposition that those who sponsor educational activities
influence the content of presentations in ways that result in false and
misleading communications to conference attendees. That very weak
allegation of harm is a woefully inadequate basis upon which to support
a regime of censorship through editorial intimidation. Thus, under
strict scrutiny, FDA's Guidance fails.

In its place, FDA should simply serve notice that it will regard false
representations concerning off-label uses at educational conferences to
constitute misbranding and that it expects conference sponsors and
providers to inform attendees that off-label uses described in the
program have not been evaluated by the Food and Drug Administration and
have not been determined to be safe and effective by that agency. Those
notifications are both necessary and sufficient responses to FDA's
legitimate public health and anti-fraud interests.

Even under heightened intermediate scrutiny applied to commercial
speech, FDA's restriction on sponsorship activities does not pass
muster. Conferences at which off-label uses for FDA approved drugs are
discussed are neither engaged in unlawful activities nor (in the absence
of evidence) misleading speech. The FDA's public health and anti-fraud
interests are undoubtedly substantial. Under the Guidance, FDA
scrutinizes twelve-plus factors in an indirect effort to discern whether
misbranding is present. The regime calls for the agency to exercise
considerable discretionary oversight to determine whether corporate
influence as to who is selected to speak and as to what may be said
reveals wrongful misbranding (i.e., corporate promotion of off-label
uses in connection with the sale of an FDA approved drug). FDA's only
substantial interest in this context is to ferret out false and
misleading labeling claims. Yet, it imposes its multi-factoral scrutiny
over every company and provider, regardless of whether the off-label
content communicated is false and misleading. FDA's regime thus neither
directly nor materially advances its interests in promoting public
health and ferreting out fraud. Indeed, to the contrary, the
intimidation created by foreknowledge that FDA regulators will
second-guess private decisions concerning who may speak at the
conference and what may be said dissuades corporations and providers
from imparting to physicians in attendance important information on
truthful off-label uses. Accordingly, FDA's Guidance fails this prong of
the commercial speech test.

The Guidance effectively forces all drug companies who sponsor
educational activities, and all activity providers, to undergo the
super-editorial scrutiny of FDA regulators. Moreover, under threat of
misbranding charges, those same parties must avoid any apparent action
that implicates the twelve-plus factors, thereby affecting their
decisions of who may be permitted to speak and what may be said at the
conferences, regardless of whether the off-label use message intended to
be conveyed is truthful. The Guidance is, thus, far more extensive than
necessary to serve FDA's substantial interest in protecting public
health and stopping fraud. An obvious, less speech restrictive
alternative exists for the agency. FDA can serve notice to all corporate
sponsors that off-label use claims made at educational activities must
be truthful. In addition, FDA can require those sponsors to disclaim
such use presentations by advising attendees that off-label uses for the
drugs they sell described at the conference are not approved by the FDA
and that such uses have not been proven safe and effective through FDA's
new drug approval process.

## **5. FDA'S RESTRICTIONS ON Direct to Consumer Drug Advertising VIOLATE THE FIRST AMENDMENT**

FDA restricts the ability of manufacturers of prescription human and
animal drugs, including human biological products, to advertise directly
to consumers (so-called "direct to consumer advertising" or DTC).
[See]{.underline} 21 U.S.C. § 352(n); 21 C.F.R. Part 202.[^43]
Advertisements, whether in print, television or radio, are strictly
regulated both in content and required disclosures. [See
id.]{.underline}

DTC advertising has increased in recent years. In 1991 \$55,300,000 was
spent on DTC advertising, \$164,000,000 in 1993, \$340,000,000 in 1995,
\$600,000,000 in 1996, and almost \$1 billion in 1997. [See]{.underline}
Pines, W., [A History and Perspective on Direct-to-Consumer
Promotion]{.underline}, 54 Food Drug L.J. 489, 496 (1999)
[citing]{.underline} Wilke, M., [Ad Fever Sweeps Health Care
Industry]{.underline}, [Advertising Age]{.smallcaps} 1 (Jan. 13 1997)
(citations omitted). DTC advertising leads to lower prices for drugs due
to the competition it creates, and it increases the public's knowledge
of medicines, improving the knowledge base from which they may draw in
doctor-patient dialogues. [See]{.underline} FDA Public Hearing DTC
Promotion, Wednesday October 18, 1995, Statement of Dr. Paul Rubin,
Professor of Economics at Emory University;
[www.fda.gov/cder/ddmac/DTCPANEL3.HTM](http://www.fda.gov/cder/ddmac/DTCPANEL3.HTM)
(last visited May 22, 2002).

There have been a number of surveys on the effects of DTC advertising,
including ones conducted by FDA. [See]{.underline} Pines,
[supra]{.underline}, at 504-505; FDA, Office of Medical Policy,
[Attitudes and Behaviors Associated with Direct-to-Consumer (DTC)
Promotion of Prescription Drugs: Preliminary Survey
Results]{.underline}; <http://www.fda.gov/cder/ddmac/dtctitle.htm> (last
visited May 22, 2002) (hereinafter "FDA DTC Survey"). Early studies
indicated that consumers wanted more information about prescription
drugs and that advertising was an effective medium to convey risk and
benefit information. [See]{.underline} Pines, [supra]{.underline}, at
504-505.

In 1999 FDA conducted a survey finding that of the survey participants
that had seen a doctor in the last three months 51% stated that an
advertisement for a prescription drug caused them to look for more
information about the drug or about their health. FDA DTC Survey at
Question 13. Of that 51%, 81% sought information from their doctors.
[See id.]{.underline} at Question 14. Twelve percent of participants
specifically mentioned an advertisement or asked their doctor about a
prescription drug. [See id.]{.underline} at Question 28. Of that 12%,
50% of their doctors gave the prescription drug the person asked about,
while 90% of the doctors recommended a different prescription drug, an
over-the-counter drug, no drug, or that the person make a lifestyle or
behavior change.[^44] [See id.]{.underline} at Question 30. Finally, 86%
of survey participants said that advertisements for prescription drugs
helped make them aware of new drugs. [See id.]{.underline} at Question
35. That survey reveals that DTC advertising is an important source of
information on uses of drugs for consumers. It also reveals no basis for
concluding that DTC advertising interferes with the independent
decision-making of the prescribing doctor.

There are two main requirements imposed on DTC advertising. All the
advertisements must contain what FDA calls the "brief summary," and
broadcast advertisers must make "adequate provision" to supply consumers
with the product labeling. [See]{.underline} 21 C.F.R. § 202.1; FDA,
[Guidance for Industry: Consumer-Directed Broadcast
Advertisements]{.underline} (August 1999) at 1.[^45]

***Brief Summary.***[^46] All advertisements must contain information
concerning side effects, contraindications, and effectiveness.
[See]{.underline} 21 U.S.C. § 352(n). The information on effectiveness
must be a true statement of the effectiveness of the drug for the
purposes recommended or suggested in the advertisement.
[See]{.underline} 21 C.F.R. § 202.1(e)(3)(ii). The information for side
effects and contraindications must disclose each specific side effect
and contraindication under appropriate headings such as cautions,
special considerations, important notes, etc. [See id.]{.underline} at
(iii).[^47]

The advertisement must present approved labeling information on each
specific side effect and contraindication that relates to the uses and
drug dosage forms advertised.[^48] [See id.]{.underline} However, the
advertisement may recommend and suggest the drug only for those uses
contained in the labeling and:

(a) for which the drug is generally recognized as safe and effective
    among experts qualified by scientific training and experience to
    evaluate the safety and effectiveness of such drugs; or

(b) for which there exists substantial evidence of safety and
    effectiveness, consisting of adequate and well-controlled
    investigations, including clinical investigations by experts
    qualified by scientific training and experience to evaluate the
    safety and effectiveness of the drug involved, on the basis of which
    it can fairly and responsibly be concluded by such experts that the
    drug is safe and effective for such uses; or

(c) for which there exists substantial clinical experience on the basis
    of which it can fairly and responsibly be concluded by qualified
    experts that the drug is safe and effective for such uses; or

(d) for which safety is supported under any of the preceding clauses and
    effectiveness is supported under any other of such clauses.

[Id.]{.underline} at (e)(4)(ii).

The brief summary cannot recommend or suggest any use not approved by
FDA. [See id.]{.underline} at (e)(4)(i)(a). An advertisement does not
satisfy the requirement that it present a true statement of information
in the brief summary if the advertisement is false or misleading with
respect to side effects, contraindications, or effectiveness. The same
is true if the advertisement fails to present a fair balance between
information relating to side effects and contraindications. Likewise,
FDA finds information relating to effectiveness presented in greater
scope, depth, or detail than is required by section 502(n) of the FDCA
not fairly balanced. [Id.]{.underline} at (e)(5)(i-ii). Moreover, it
does not satisfy the true statement requirement if it fails to reveal
facts material in the light of its representations or material with
respect to consequences that may result from the use of the drug as
recommended or suggested in the advertisement. [Id.]{.underline} at
(iii).

FDA's regulation on DTC advertising specifies twenty instances in which
an advertisement is false, lacking in fair balance, or otherwise
misleading. [See id.]{.underline} at (e)(6)(i-xx). The list is not
intended to be exhaustive. FDA may use other grounds to find an
advertisement false, lacking in fair balance, or otherwise misleading.
[See id.]{.underline} The list includes drug comparison advertising
concerning safety or effectiveness; the selective referencing of
favorable scientific literature and failing to reference unfavorable
literature; the use of literature, quotes or references to convey a
false or misleading idea or to promote uses that are not approved; the
erroneous use of statistics; misrepresentation of dosage information; or
misrepresentation of treatments or side effects. [See
id.]{.underline}[^49]

FDA may require that a manufacturer seek preapproval before
disseminating an advertisement. [See]{.underline} 21 C.F.R. §
202.1(j)(1).[^50] Preapproval is required when (i) the sponsor or the
FDA has received information, not widely publicized, that the use of the
drug may cause fatalities or serious damage; (ii) the Commissioner
notified the sponsor that the information must be a part of the
advertisements for the drugs; and (iii) the sponsor has failed within a
reasonable time as specified in such notification to present to the FDA
a program, adequate in light of the nature of the information, for
assuring that such information will be publicized promptly and
adequately to the medical profession in subsequent advertisements. [See
id.]{.underline} Moreover, if the FDA Commissioner finds that the
manufacturer is not following the program presented to the FDA, the
sponsor may be required to obtain prior approval of all advertisements
for that particular drug. Dissemination of an advertisement not in
compliance with the prior approval requirement is deemed an act that
causes the drug to be misbranded under section 502(n) of the FDCA. [See
id.]{.underline} at (j)(3).

Any advertisement not in compliance with section 502(n) of the FDCA and
the applicable regulations thereunder causes stocks of the drug in
question (in possession of the person responsible for issuing the
advertisement and distributed by such person and still in the channels
of commerce) to be misbranded under section 502(n) of the FDCA. [See
id.]{.underline} at (k).

***Adequate Provision Requirement.*** Sponsors of broadcast
advertisements are required to present a brief summary or,
alternatively, make "adequate provision... for dissemination of the
approved or permitted package labeling in connection with the broadcast
presentation." 21 C.F.R. § 202.1(e)(1).

Broadcast advertisements for prescription drugs that are not false or
misleading in any respect, present a fair balance between information
about effectiveness and information about risk, include a thorough major
statement conveying all of the product's most important risk information
in consumer-friendly language, and communicate all information relevant
to the product's indication in consumer-friendly language must make
adequate provision to allow most of a potentially diverse audience to
have reasonably convenient access to the advertised product's approved
labeling. [See]{.underline} FDA, [Guidance for Industry:
Consumer-Directed Broadcast Advertisement]{.underline}, August 1999
(hereinafter "Adequate Provision Guidance").

The adequate provision requirement is satisfied by four actions: 1) a
toll-free number for consumers to call to receive the approved package
labeling via mail or via being read to them on the phone; 2) reference
to a mechanism to provide package labeling to consumers with restricted
access to sophisticated technology (alternatives include reference to
concurrent print advertisements and having a sufficient number of
brochures available in publicly-accessible locations); 3) reference to
an Internet site that provides access to the package insert; and 4)
disclosure that health care professionals may provide additional product
information. [See]{.underline} Adequate Provision Guidance.

The Direct to Consumer Drug Advertising regulations of the FDA violate
the First Amendment in the following respects. (1) The need to satisfy
the adequate provision requirement by supplying a toll-free number for
consumers to call to receive approved package labeling; by referencing a
print ad or publicly available brochures containing the package labeling
information; or by referencing an Internet site that contains the
package labeling information imposes an excessive, costly, and
unnecessary burden on the right to speak in violation of the First
Amendment. (2) The brief summary requirement for print advertisements is
also an excessive burden on the right to speak and simiarly violates the
First Amendment. (3) The prohibition on off-label use information in
direct to consumer advertising violates the First Amendment.

We now turn to evaluate the adequate provision requirement under strict
scrutiny. The FDA's interest in protecting the public health and
eliminating fraud are undoubtedly compelling, but the requirement that
companies wishing to engage in direct to consumer broadcast advertising
do so only upon providing consumers with package labeling reprinted in a
magazine, printed brochure available in public places, or reprinted via
a web site imposes an effective tax the payment of which is an
unconstitutional condition on the right to speak. In that respect it
violates the First Amendment. [See]{.underline} [Minneapolis Star &
Tribune Co. v. Minnesota Comm'n of Revenue]{.underline}, 460 U.S. 575,
582-583 (1983). Moreover, the restriction is not content neutral. It is
imposed selectively only upon those who wish to broadcast direct to
consumers truthful information concerning the effectiveness of
FDA-approved drugs. It is thus an unconstitutional content-based
restriction on speech. [See]{.underline} [Crawford]{.underline}, 96 F.3d
at 384.

Furthermore, the chosen means, imposition of a package labeling
publication requirement via print media or the web, is not narrowly
tailored to serve the FDA's interest in protecting the public health and
eliminating fraud. To the extent that the financial burden imposed makes
advertising less available to companies desiring to use it, it has the
effect of imposing an excessive, sometimes cost prohibitive, burden on
protected speech. [See]{.underline} [Meyer v. Grant]{.underline}, 486
U.S. 414 (1988) (financial or economic penalties of one sort or another
imposed upon constitutionally protected conduct have consistently been
held to by the Supreme Court to represent a direct burden); [Arkansas
Writers' Project, Inc. v. Ragland]{.underline}, 481 U.S. 221, 95 (1987);
[Riley v. National Federation of the Blind]{.underline}, 487 U.S. 781
(1988); [Secretary of State of Maryland v. Joseph H. Munson
Co.]{.underline}, 467 U.S. 947 (1984). In addition, the FDA has no proof
that republication outside the product package of the lengthy and
complex "brief summary" is even remotely effective in aiding consumers
to comprehend the prudence of taking a prescription medication or is
anything other than a costly redundancy of the actual package labeling.
It is also a fact of no minor significance that physicians serve as the
conduit through which prescription drugs reach consumers. There is no
basis to question the sufficiency of, nor the superior effectiveness of,
physician evaluation of patient need and risks following in-person
physical examinations. To be sure, such examinations are far more
appropriate in guiding patient choice than depending upon a patient's
lay interpretation of the scientific content contained in package
labeling. Physicians continue to serve as a necessary and sufficient
gatekeeper, protecting patients from unnecessary medication and ensuring
patients are not given substances that, in individual cases, may produce
serious adverse effects. Indeed, there is no sound evidence to establish
that republication of package labeling outside of the product package in
any way protects the public health better than the physician-patient
relationship which precedes drug prescription.[^51] There is also no
sound evidence to establish that republication of package labeling in
any way reduces patient susceptibility to fraud. Accordingly, FDA's
adequate provision requirement is not narrowly tailored to serve FDA's
compelling interest in protecting public health and eliminating fraud.

Even under heightened intermediate scrutiny, the adequate provision
requirement fails to pass muster. The broadcast of direct to consumer
advertising is neither unlawful activity nor (in the absence of
evidence) misleading speech. As stated above, FDA's interests in
protecting the public health and eliminating fraud are undoubtedly
substantial. The regulation does not, however, directly and materially
advance those interests. FDA has no empirical evidence that the
republication of package labeling does anything to improve consumer
awareness of the possible effects of prescription drugs beyond the
advice given patients by physicians who prescribe the drugs, pharmacists
who dispense the drugs, and the drug package labeling itself. There is
no evidence that republication of the package labeling in magazines, in
leaflets distributed in public places, or on the web materially advances
either the interest in public health or the interest in eliminating
fraud. The regulation is, in fact, far more extensive than necessary. It
does not apply solely to speech found misleading but, instead, to all
direct to consumer broadcast advertising. The operative alternative of
physician and pharmacist in-person guidance is an obvious less
burdensome and superior means because it takes into account the peculiar
physiology of the patient as well as the patient's relative acumen in
comprehending scientific information, interactivity impossible for
package labeling. For the foregoing reasons, the adequate provision
requirement fails to pass muster under the commercial speech test and
is, thus, an unconstitutional restriction on speech.

We now turn to evaluate the prohibition of off-label use information in
direct to consumer advertising under strict scrutiny. FDA has
undoubtedly compelling interests in protecting the public health and
eliminating fraud. FDA's blanket ban on inclusion of off-label use
information in direct to consumer broadcast advertising is an
unconstitutional content-based suppression of speech. In addition, FDA's
ban is not narrowly tailored to serve the agency's compelling interests.
A ban on all off-label use information in such advertising ensures
suppression of useful and, in some instances, indispensable information
on beneficial therapeutic effects other than those FDA approved.
Moreover, compelling a company to file a new drug application for an
existing drug to communicate truthful therapeutic information imposes an
extraordinary tax on the speech as a condition precedent, oftentimes
resulting in self-censorship as the only alternative. The effect is to
ensure suppression of much protected speech. Suppression of truthful
off-label use information disserves FDA's interest in protecting the
public health by depriving the public of information that may help those
in need to make inquiries of physicians about the propriety of off-label
uses in the treatment of their conditions. The physician continues to
serve as the exclusive conduit through which prescription drugs may be
obtained and, so, can disabuse patients who erroneously seek a drug by
informing the patient of the lack of appropriateness in a particular
case. That function is no different from the one routinely performed by
physicians in the counseling of patients on approved drug treatments. In
sum, the ban on off-label use information in direct to consumer
advertising circumscribes protected expression in violation of the First
Amendment.

Even under heightened intermediate scrutiny, the ban on off-label use
information in direct to consumer advertising fails to pass muster. As
stated above, direct to consumer broadcast advertising is neither
unlawful activity nor misleading speech. Undoubtedly FDA's interests in
protecting public health and eliminating fraud are substantial. The
chosen means, a blanket ban on off-label use information appearing in
direct to consumer advertising, does not, however, directly or
materially advance FDA's interests. Suppression of truthful and
nonmisleading off-label use information disserves FDA's interests by
depriving those in need of treatment information that in consultation
with their physicians could help achieve relief from disease or pain.
Moreover, the blanket ban is far more extensive than necessary to serve
the FDA's interests. The dual goals of protecting the public health and
eliminating fraud are served through the less speech restrictive
alternative of requiring a prominent disclaimer whenever off-label use
information is broadcast, to wit: "The described use has not been
evaluated by the Food and Drug Administration to determine its safety
and effectiveness. Consult with your physician to determine the
treatment appropriate for you." For the foregoing reasons, the ban on
off-label use information in direct to consumer advertising violates the
First Amendment.

> **6. FDA'S SUPPRESSION OF EXTRALABEL USE CLAIMS FOR ANIMAL DRUGS
> VIOLATE THE FIRST AMENDMENT**

As discussed [supra]{.underline}, off-label use of human drugs is
indispensable to the practice of medicine. The same holds true for
animal drugs in the practice of veterinary medicine. Extralabel uses for
animal drugs are permitted pursuant to the Animal Use Clarification Act
of 1994 (Pub. L. 103-396), and implemented through 21 C.F.R. § 530.2
(2002).

The FDA strictly prohibits the advertising and promotion of extralabel
uses for animal drugs. [See]{.underline} 21 C.F.R. § 530.4 (2002)
("Nothing in this part shall be construed as permitting the advertising
or promotion of extralabel uses in animals of approved new animal drugs
or approved human drugs."). That blanket ban on the dissemination of
truthful extralabel use information violates the First Amendment for the
same reasons stated in the human off-label use context.

We now turn to evaluate the ban on extralabel claims for animal drugs
under strict scrutiny. In order to satisfy the requirements of strict
scrutiny, FDA's prohibition must be content neutral and narrowly
tailored to serve a compelling interest. Undoubtedly FDA's interest in
protecting the public health (and, in this case, animal health) and in
eliminating fraud are compelling. However, a total ban on any
advertising or promotion claims regarding extralabel use of animal drugs
is a content-based restriction on speech. Assuming *arguendo* that the
prohibition is not content-based, it nevertheless lacks narrow tailoring
because it completely prohibits all truthful extralabel use information.
The regulation is thus an unconstitutional restriction on protected
speech, circumscribing much protected expression in violation of the
First Amendment.

Even under heightened intermediate scrutiny, FDA's blanket ban on
extralabel use information on labels, in labeling, and in advertising of
animal drugs violates the First Amendment. Communication of extralabel
uses for animal drugs is neither an illegal activity nor misleading
speech. As discussed, FDA has a substantial interest in protecting
public health and eliminating fraud. However, FDA's chosen means, a
blanket prohibition on any truthful information pertaining to extralabel
use of animal drugs, does not directly and materially advance FDA's
interests. To the contrary, such a prohibition adversely affects
veterinarians, consumers, and animals, since there is no information
regarding beneficial extralabel uses that are allowed to be
disseminated. Such a lack of truthful information does not directly and
materially advance FDA's interests.

In addition, there is an obvious, less speech restrictive alternative to
FDA's blanket ban. FDA may require companies to file extralabel claims
for approved animal drugs along with available science supporting the
claims before they are made. FDA could then promptly review the
materials, and unless the claim was inherently misleading, allow its use
on labels, in the labeling, and in advertising with an accurate,
succinct, and reasonable disclaimer, such as: "The described use has not
been evaluated by the Food and Drug Administration to determine its
safety and effectiveness. Consult with your veterinarian to determine
the treatment right for your pet." Currently, any type of information
regarding extralabel use is effectively banned. Instead of such a
sweeping prohibition, FDA should instead allow for reasonable
disclaimers in advertising and promotional materials.

D.  **FDA'S SUPPRESSION OF SECONDARY THERAPEUTIC CLAIMS FOR COSMETICS
    VIOLATES THE FIRST AMENDMENT**

The FDCA defines cosmetics as "articles intended to be rubbed, poured,
sprinkled, or sprayed on, introduced into, or otherwise applied to the
human body or any part thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance." 21 U.S.C. § 321(i) (2002).
Such products include skin moisturizers, perfumes, lipsticks, fingernail
polishes, eye and makeup preparations, shampoos, hair coloring,
toothpaste, and deodorant. [See, e.g.]{.underline} U.S. Food and Drug
Administration, Center for Food Safety and Applied Nutrition, Office of
Cosmetics and Colors, [Is it a Cosmetic, a Drug, or Both? (or is it
Soap?)]{.underline} (last modified July 8, 2002)
(http://www.cfsan.fda.gov/\~dms/cos-218.html).

A cosmetic may be deemed a drug by the agency depending on evidence of
its intended use. [See]{.underline} [Estee Lauder, Inc., v. United
States Food and Drug Administration]{.underline}, 727 F. Supp. 1 (D.C.
1989) ([citing]{.underline} [Nutrilab v. Schweiker]{.underline}, 713
F.2d 335 (7th Cir. 1983). A drug is defined by the FDCA, in pertinent
part, as articles "intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease..." 21 U.S.C. § 321(g)(1)(2002).
"Intended use" is a factor that may be determined from objective
evidence such as the product's current and past containers,
instructions, and advertisements. [See]{.underline} [Estee
Lauder]{.underline}, 727 F. Supp. at 4. Cosmetics that are also drugs
include fluoride toothpastes, deodorants that are also anti-perspirants,
and anti-dandruff shampoos. [See]{.underline}
http://www.cfsan.fda.gov/\~dms/cos-218.html, [supra]{.underline}.

If a cosmetic also qualifies as a drug based on its "intended use," the
product must comply with the stricter requirements applicable to drugs.
[See]{.underline} [Estee Lauder]{.underline}, 727 F. Supp. At 4
([citing]{.underline} [United States v. An Article..."Sudden
Change,"]{.underline} 409 F.2d 734, 739 (2d Cir. 1969). Thus, it is
subject to the costly drug pre-market approval process, including new
drug application procedures or investigational new drug application
procedures and drug labeling requirements. [See]{.underline} Article,
Bryan A. Liang & Kurt M. Hartman, [It's Only Skin Deep: FDA Regulation
of Skin Care Cosmetic Claims]{.underline}, 8 Cornell J. L. & Pub. Pol'y
249 (1999) ([citing]{.underline} 21 U.S.C. §§ 321-362 (1992)).

When a product has been first marketed as a cosmetic but is subsequently
found to have therapeutic or physiological effects, those secondary
effects, if communicated to the public, will transform the product into
an unapproved new drug. The transformation will take place by operation
of law even if the company manufacturing the product only wishes to
market it as a cosmetic but to do so truthfully by informing consumers
of the known secondary therapeutic effect. In short, to tell consumers
the whole truth, a cosmetic company must first file a new drug
application and pay the \$258,451 filing fee,[^52] go through the
lengthy and expensive drug approval process, and then, if approved, make
its cosmetic---previously available over-the-counter (OTC)---only by
prescription.

Such restrictions and forced market dislocations exceed in burdens on
speech those reasonably necessary to protect public health and eliminate
fraud. They thus violate the First Amendment rights of those who wish to
inform consumers of truthful secondary therapeutic effects from cosmetic
products. Moreover, they give cosmetic firms the impracticable choice
between suppressing the truthful therapeutic information in order to
continue marketing the cosmetic or making the claim after FDA approval
and then only upon restricting the product to prescription sales.

The requirement that companies marketing cosmetics must submit
themselves to the drug regulatory process as a condition precedent to
making truthful, secondary therapeutic effect claims for those products
violates the First Amendment. Forcing those companies to invest hundreds
of thousands, if not hundreds of millions, of dollars and months, if not
years, of time to obtain governmental approval in order to make a
truthful secondary claim impermissibly burdens protected speech. [See,
e.g.,]{.underline} [Minneapolis Star & Tribune Co. v. Minnesota
Commissioner of the Revenue]{.underline}, 460 U.S. 575, 582-583 (1983)
("A tax that burdens rights protected by the First Amendment cannot
stand unless the burden is necessary to achieve an overriding
governmental interest."). [See also]{.underline} [Central
Hudson]{.underline}, [supra]{.underline}; [see, e.g.,]{.underline} [44
Liquormart]{.underline}, 517 U.S. at 503 ("The First Amendment directs
us to be especially skeptical of regulations that seek to keep people in
the dark for what the government perceives to be their own good.");
[Central Hudson]{.underline}, 447 U.S. at 576 (Blackmun, J.,
concurring)("If the First Amendment guarantee means anything, it means
that, absent clear and present danger, government has no power to
restrict expression because of the effect its message is likely to have
on the public.").

We now turn to evaluate FDA's ban on secondary therapeutic effects under
strict scrutiny. FDA's interests in protecting public health and
eliminating fraud are no doubt compelling. However, its regulations
regarding cosmetic products and truthful claims of secondary therapeutic
effects are an unconstitutional content-based restriction on speech.
Under FDA's current regulatory scheme, a product properly sold as a
cosmetic is prohibited from making truthful secondary therapeutic claims
without first obtaining FDA pre-market approval for the sale of a new
drug. Thus, any truthful claim regarding a secondary therapeutic effect
of a cosmetic will in all but the most extraordinary cases be locked out
of the market to the great detriment of censored speakers and consumers
alike. In order to communicate truthful information, a cosmetics
manufacturer must invest considerable time and money to get new drug
approval, an extraordinary burden on speech, and must then market the
product by prescription only, an enormous market dislocation.

The effective prohibition of truthful claims is not narrowly tailored to
serve FDA's interests and does not provide equally effective
alternatives to communicate the lawful speech. FDA's effective ban on
secondary therapeutic effect claims for cosmetics thus violate the First
Amendment.

Even under the heightened intermediate scrutiny applied to commercial
speech, FDA's effective ban on secondary therapeutic claims for cosmetic
products violates the First Amendment. Communication of a secondary
therapeutic effect of a cosmetic product is neither illegal activity nor
misleading speech. As mentioned [supra]{.underline}, FDA has a
substantial interest in protecting public health and eliminating fraud.
However, FDA's chosen means, a blanket ban on secondary therapeutic
claims except upon pre-market drug approval does not directly and
materially advance FDA's interests. There is an obvious, less speech
restrictive alternative to the ban. Instead of a blanket ban (or, in the
case of pursuit of drug approval, prohibitory cost), FDA should require
cosmetic firms to file the prospective claim together with the
applicable science and should rely on the use of a disclaimer to
disabuse consumers of the possible misperception that the product is an
appropriate FDA-approved disease treatment. For example, assume Cosmetic
X contains an ingredient that has an antibacterial secondary effect
(killing, for example, propionibacterium acnes, bacteria that
contributes to simple acne). Following the submission of a proposed
claim and science concerning it, the cosmetic company could include on
labels and in labeling information concerning the fact that the product
contained an ingredient that had this antibacterial secondary effect.
The FDA could require use of an accompanying disclaimer, to wit: "This
product is not FDA approved as safe and effective for the treatment of
acne. If you have acne, see a doctor for diagnosis and appropriate
medical treatment."

In order to comply with the First Amendment, FDA must not unlawfully
burden commercial speech by actually or effectively prohibiting truthful
secondary therapeutic effect claims from appearing on cosmetic products,
labels and in cosmetic product labeling absent FDA drug approval. It may
not prohibit the claims outright, nor may it place an unduly burdensome
condition precedent on the company wishing to make the claims by forcing
the company to file and pursue at astronomical cost a new drug
application.

G. FDA'S SUPPRESSION OF SECONDARY COSMETIC CLAIMS FOR DRUGS VIOLATES THE
FIRST AMENDMENT

Drugs with secondary cosmetic effects can also suffer from this unduly
free speech insensitive and rigid regulatory construct. In 1995 Johnson
& Johnson marketed Retin-A which was used for the treatment of severe
acne. [See]{.underline} Liang & Hartmann, [It's Only Skin Deep: FDA
Regulation of Skin Care Cosmetics]{.underline} Claims, 8 [Cornell J. L.
& Pub. Pol'y]{.smallcaps} 249, 263 (1999). The product was later
discovered to have a secondary cosmetic effect of "reducing visible
lines in the skin." [Id.]{.underline} Johnson & Johnson then made
truthful claims regarding the efficacy of Retin-A for the secondary
cosmetic effect. Despite the truthfulness of those claims, FDA fined the
company five million dollars for promoting Retin-A for an "unapproved
use" and also fined the company an additional two and one-half million
dollars in restitution for government expenses. [Id.]{.underline} Thus,
although the claims made by Johnson & Johnson were truthful, FDA fined
the company for not undergoing the extensive drug approval process
before making a secondary cosmetic claim for the drug product.

We now turn to evaluate FDA's effective ban on secondary cosmetic effect
claims for FDA-approved drugs under strict scrutiny. As stated above,
FDA has a compelling interest in protecting the public health and
eliminating fraud. However, its regulations requiring an approved drug
to undergo new drug approval to make a truthful secondary cosmetic claim
is a content-based restriction on speech. FDA's restriction applies only
to those drug companies that discover secondary cosmetic benefits of
their products and wish to communicate those benefits in a truthful
manner. In that respect it violates the First Amendment. FDA's chosen
means has no rational relationship to its interests, nor are they
narrowly tailored to serve those interests. FDA's regulatory requirement
thus unconstitutionally circumscribes protected speech and thereby
violates the First Amendment.

Even under the heightened intermediate scrutiny applied to evaluate
commercial speech, FDA's effective ban on secondary cosmetic effect
claims for FDA-approved drugs violates the First Amendment.
Communication of a secondary cosmetic effect of a drug is neither an
unlawful activity nor misleading speech. While FDA's interest in
protecting public health may be compelling, its chosen means do not
directly and materially advance its interests. If a drug has already
undergone the regulatory approval process deeming it safe and effective,
and a beneficial secondary cosmetic effect is discovered, banning a
truthful claim about that secondary effect absent an additional drug
approval is an impermissible burden on protected speech. By prohibiting
such claims to be made, FDA does not further its interests, but rather
detrimentally affects consumers by denying them the right to be fully
informed about their drug purchases. In addition, the regulations are
far more extensive than necessary to serve FDA's substantial interests.
Forcing a company to undergo a second drug approval process in order to
inform consumers of a truthful secondary cosmetic effect is an
extraordinarily excessive and cost-prohibitive measure when less speech
restrictive means, such as a claim with appropriate disclaimers, are
available.

> **H. FDA'S ENFORCEMENT PRACTICES VIOLATE THE FIRST AMENDMENT**

Not only must all of FDA's regulations fully comply with the First
Amendment principles discussed [supra]{.underline}, but its enforcement
practices must also avoid running afoul of First Amendment rights.
Specifically, FDA must ensure that in judicial proceedings its requested
relief for alleged law violations is narrowly tailored to remedy
unlawful behavior without violating First Amendment rights.

FDA frequently seeks injunctive relief to stop law violations arising
from the content of product claims. [See, e.g.]{.underline} [United
States v. Diapulse Corp.]{.underline}, 748 F.2d 56 (2d Cir. 1984). The
injunctive relief sought often asks the Court to prohibit the sale of
substances entirely and all therapeutic claims. If the substance in
question is one that may properly be sold as a food, pursuant to 21
U.S.C. § 321(f); a dietary supplement, pursuant to 21 U.S.C. § 321(ff),
or as a cosmetic, pursuant to 21 U.S.C. § 321(i), FDA's request for a
blanket ban on the sale of the substances in question (because of
product claims) is overbroad, completely eliminating a forum for speech
when less speech restrictive, more tailored relief is entirely possible
(simply precluding sale of the substances as drugs). Likewise, a
requested injunction that blocks all disease prevention, treatment,
mitigation, and cure claims without FDA grant of new drug approval is
overbroad, denying a company the right to use FDA-approved (or allowed)
health claims if the substance in question is one that could be sold as
a food or a dietary supplement.

The obvious, less speech restrictive alternative of prohibiting sale of
the substance as an unapproved new drug is both necessary and sufficient
relief for the agency. FDA may enjoin the making of therapeutic claims
except insofar as the claims in question are FDA-approved health claims;
FDA-authorized or allowed health claims; FDA-authorized or allowed
authoritative statement claims; or FDA-authorized drug claims (pursuant
to grant of new drug approval). In short, FDA trenches upon First
Amendment rights when it uses injunctions to block the sale of
substances sold unlawfully as drugs when those same substances can be
lawfully sold as foods, dietary supplements, or cosmetics. FDA also
violates the First Amendment when it seeks injunctions that prohibit all
therapeutic claims, including the truthful and non-misleading, unless
the party in question receives new drug approval. Pursuit of drug
applications, by the Solicitor General's own estimate, cost between
\$300,000 and \$200 million, expenses that are prohibitive in all but
the rarest of circumstances. [See]{.underline} note 17,
[supra]{.underline}. The obvious, less speech restrictive alternative of
allowing sale of the substances as non-drugs and, where appropriate,
allowing health or authoritative statement claims should be included as
exceptions in injunctions for claim violations. FDA must rely on
sensitive and precise enforcement tools in all areas that involve
private speech to avoid trenching on protected speech rights.

**PART VI: PROPOSED REVISIONS TO REGULATIONS, GUIDANCES, POLICIES, AND
PRACTICES**

> **VI.**
>
> PROPOSED REVISION TO REGULATIONS, GUIDANCES, POLICIES, AND PRACTICES
>
> In this section the Joint Commenters recommend to the agency precise
> revisions to existing regulations, policies, guidances, and practices
> to eliminate First Amendment violations identified [infra]{.underline}
> and to ensure future compliance with the free speech guarantee.
> Revisions to the regulations listed below come in the form of, [inter
> alia]{.underline}, deletions (represented by strike-throughs) and
> recommended additions (represented by underlined words).

#### A. HEALTH CLAIMS (FOODS AND DIETARY SUPPLEMENTS)

> 21 C.F.R. 101.14

  § 101.14 Health claims: general requirements.\
\
    (a) Definitions. For purposes of this section, the following
definitions apply:\
\
(1) Health claim means any claim made on the label or in labeling of a
food, including a dietary supplement, that expressly or by implication,
including \"third party\" references, written statements (e.g., a brand
name including a term such as \"heart\"), symbols (e.g., a heart
symbol), or vignettes, characterizes the relationship of any substance
to a disease or health-related condition. Implied health claims include
those statements, symbols, vignettes, or other forms of communication
that suggest, within the context in which they are presented, that a
relationship exists between the presence or level of a substance in the
food and a disease or health-related condition.\
\
(2) Substance means a specific food or component of food, regardless of
whether the food is in conventional food form or a dietary supplement
that includes vitamins, minerals, herbs, or other similar nutritional
substances.\
\
(3) Nutritive value means a value in sustaining human existence by such
processes as promoting growth, replacing loss of essential nutrients, or
providing energy.\
\
(4) Disqualifying nutrient levels means the levels of total fat,
saturated fat, cholesterol, or sodium in a food above which the food
will be disqualified from making a health claim. These levels are 13.0
grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of
cholesterol, or 480 mg of sodium, per reference amount customarily
consumed, per label serving size, and, only for foods with reference
amounts customarily consumed of 30 g or less or 2 tablespoons or less,
per 50 g. For dehydrated foods that must have water added to them prior
to typical consumption, the per 50-g criterion refers to the as prepared
form. Any one of the levels, on a per reference amount customarily
consumed, a per label serving size or, when applicable, a per 50 g
basis, will disqualify a food from making a health claim unless an
exception is provided in subpart E of this part, except that:\
\
(i) The levels for a meal product as defined in § 101.13(l) are 26.0 g
of fat, 8.0 g of saturated fat, 120 mg of cholesterol, or 960 mg of
sodium per label serving size, and\
\
(ii) The levels for a main dish product as defined in § 101.13(m) are
19.5 g of fat, 6.0 g of saturated fat, 90 mg of cholesterol, or 720 mg
of sodium per label serving size.\
\
(5) Disease or health-related condition means damage to an organ, part,
structure, or system of the body such that it does not function properly
(e.g., cardiovascular disease), or a state of health leading to such
dysfunctioning (e.g., hypertension); except that diseases resulting from
essential nutrient deficiencies (e.g., scurvy, pellagra) are not
included in this definition (claims pertaining to such diseases are
thereby not subject to § 101.14 or § 101.70).\
\
(b) Eligibility. For a substance to be eligible for a health claim:\
\
(1) The substance must be associated with a disease or health-related
condition for which the general U.S. population, or an identified U.S.
population subgroup (e.g., the elderly) is at risk, or, alternatively,
the petition submitted by the proponent of the claim otherwise explains
the prevalence of the disease or health-related condition in the U.S.
population and the relevance of the claim in the context of the total
daily diet and satisfies the other requirements of this section.\
\
(2) If the substance is to be consumed as a component of a conventional
food at decreased dietary levels, the substance must be a nutrient
listed in [21 U.S.C.
343](http://www.lexis.com/research/buttonTFLink?_m=b2677baf1f013115ceaa6a4d97833dd7&_xfercite=<cite cc%3D"USA"><!%5BCDATA%5B21 CFR 101.14 %5D%5D><%2Fcite>&_butType=4&_butStat=0&_butNum=1&_butInline=1&_butinfo=21 USC 343 )(q)(1)(C)
or (q)(1)(D), or one that the Food and Drug Administration (FDA) has
required to be included in the label or labeling under [21 U.S.C.
343](http://www.lexis.com/research/buttonTFLink?_m=b2677baf1f013115ceaa6a4d97833dd7&_xfercite=<cite cc%3D"USA"><!%5BCDATA%5B21 CFR 101.14 %5D%5D><%2Fcite>&_butType=4&_butStat=0&_butNum=2&_butInline=1&_butinfo=21 USC 343 )(q)(2)(A);
or\
\
(3) If the substance is to be consumed at other than decreased dietary
levels:\
\
(i) The substance must, regardless of whether the food is a conventional
food or a dietary supplement, contribute taste, aroma, or nutritive
value, or any other technical effect listed in § 170.3(o) of this
chapter, to the food and must retain that attribute when consumed at
levels that are necessary to justify a claim; and\
\
(ii) The substance must be a food or a food ingredient or a component of
a food ingredient whose use at the levels necessary to justify a claim
has been demonstrated by the proponent of the claim, to FDA\'s
satisfaction, to be safe and lawful under the applicable food safety
provisions of the Federal Food, Drug, and Cosmetic Act.\
\
(c) Validity requirement. FDA will promulgate regulations authorizing a
health claim only when it determines, based on the totality of publicly
available scientific evidence (including evidence from well-designed
studies conducted in a manner which is consistent with generally
recognized scientific procedures and principles), that there is
significant scientific agreement, among experts qualified by scientific
training and experience to evaluate such claims, that the claim is
supported by such evidence.\
\
[(d) Claim allowance. FDA will allow use of a health claim not
authorized under the validity requirements of paragraph (c) of this
section if the claim is backed by credible scientific evidence, if the
weight of the credible scientific evidence in support of the claim is
not outweighed by credible scientific evidence against the claim, and if
the claim can be rendered nonmisleading through the addition of a
reasonable disclaimer.]{.underline}

~~(d)~~ [(e)]{.underline} General health claim labeling requirements.
(1) When FDA determines that a health claim meets the validity
requirements of paragraph (c) of this section, FDA will propose a
regulation in subpart E of this part to authorize the use of that claim.
If the claim pertains to a substance not provided for in § 101.9 or §
101.36, FDA will propose amending that regulation to include declaration
of the substance.\
\
(2) When FDA has adopted a regulation in subpart E of this part
providing for a health claim, firms may make claims based on the
regulation in subpart E of this part, provided that:\
\
(i) All label or labeling statements about the substance-disease
relationship that is the subject of the claim are based on, and
consistent with, the conclusions set forth in the regulations in subpart
E of this part;\
\
(ii) The claim is limited to describing the value that ingestion (or
reduced ingestion) of the substance, as part of a total dietary pattern,
may have on a particular disease or health-related condition;\
\
(iii) The claim is complete, truthful, and not misleading. Where factors
other than dietary intake of the substance affect the relationship
between the substance and the disease or health-related condition, such
factors may be required to be addressed in the claim by a specific
regulation in subpart E of this part;\
\
(iv) All information required to be included in the claim appears in one
place without other intervening material, except that the principal
display panel of the label or labeling may bear the reference statement,
\"See - - - - - - - for information about the relationship
between - - - - - - - and - - - - - - ,\" with the blanks filled in with
the location of the labeling containing the health claim, the name of
the substance, and the disease or health-related condition (e.g., \"See
attached pamphlet for information about calcium and osteoporosis\"),
with the entire claim appearing elsewhere on the other labeling,
Provided that, where any graphic material (e.g., a heart symbol)
constituting an explicit or implied health claim appears on the label or
labeling, the reference statement or the complete claim shall appear in
immediate proximity to such graphic material;\
\
(v) The claim enables the public to comprehend the information provided
and to understand the relative significance of such information in the
context of a total daily diet; and\
\
(vi) If the claim is about the effects of consuming the substance at
decreased dietary levels, the level of the substance in the food is
sufficiently low to justify the claim. To meet this requirement, if a
definition for use of the term \"low\" has been established for that
substance under this part, the substance must be present at a level that
meets the requirements for use of that term, unless a specific
alternative level has been established for the substance in subpart E of
this part. If no definition for \"low\" has been established, the level
of the substance must meet the level established in the regulation
authorizing the claim; or\
\
(vii) If the claim is about the effects of consuming the substance at
other than decreased dietary levels, the level of the substance is
sufficiently high and in an appropriate form to justify the claim. To
meet this requirement, if a definition for use of the term \"high\" for
that substance has been established under this part, the substance must
be present at a level that meets the requirements for use of that term,
unless a specific alternative level has been established for the
substance in subpart E of this part. If no definition for \"high\" has
been established (e.g., where the claim pertains to a food either as a
whole food or as an ingredient in another food), the claim must specify
the daily dietary intake necessary to achieve the claimed effect, as
established in the regulation authorizing the claim; Provided That:\
\
(A) Where the food that bears the claim meets the requirements of
paragraphs (d)(2)(vi) or (d)(2)(vii) of this section based on its
reference amount customarily consumed, and the labeled serving size
differs from that amount, the claim shall be followed by a statement
explaining that the claim is based on the reference amount rather than
the labeled serving size (e.g., Diets low in sodium may reduce the risk
of high blood pressure, a disease associated with many factors. A
serving of - - - - ounces of this product conforms to such a diet.\").\
\
(B) Where the food that bears the claim is sold in a restaurant or in
other establishments in which food that is ready for immediate human
consumption is sold, the food can meet the requirements of paragraphs
(d)(2)(vi) or (d)(2)(vii) of this section if the firm that sells the
food has a reasonable basis on which to believe that the food that bears
the claim meets the requirements of paragraphs (d)(2)(vi) or (d)(2)(vii)
of this section and provides that basis upon request.\
\
(3) Nutrition labeling shall be provided in the label or labeling of any
food for which a health claim is made in accordance with § 101.9; for
restaurant foods, in accordance with § 101.10; or for dietary
supplements, in accordance with § 101.36.\
\
~~(e)~~ [(f)]{.underline} Prohibited health claims. No expressed or
implied health claim may be made on the label or in labeling for a food,
regardless of whether the food is in conventional food form or dietary
supplement form, unless:\
\
(1) The claim is specifically provided for in subpart E of this part;
and\
\
(2) The claim conforms to all general provisions of this section as well
as to all specific provisions in the appropriate section of subpart E of
this part;\
\
(3) None of the disqualifying levels identified in paragraph (a)(4) of
this section is exceeded in the food, unless specific alternative levels
have been established for the substance in subpart E of this part; or
unless FDA has permitted a claim despite the fact that a disqualifying
level of a nutrient is present in the food based on a finding that such
a claim will assist consumers in maintaining healthy dietary practices,
and, in accordance with the regulation in subpart E of this part that
makes such a finding, the label bears a disclosure statement that
complies with § 101.13(h), highlighting the nutrient that exceeds the
disqualifying level;\
\
(4) Except as provided in paragraph (e)(3) of this section, no substance
is present at an inappropriate level as determined in the specific
provision authorizing the claim in subpart E of this part;\
\
(5) The label does not represent or purport that the food is for infants
and toddlers less than 2 years of age except if the claim is
specifically provided for in subpart E of this part; and\
\
(6) Except for dietary supplements or where provided for in other
regulations in part 101, subpart E, the food contains 10 percent or more
of the Reference Daily Intake or the Daily Reference Value for vitamin
A, vitamin C, iron, calcium, protein, or fiber per reference amount
customarily consumed prior to any nutrient addition.\
\
~~(f)~~ [(g)]{.underline} The requirements of this section do not apply
to:\
\
(1) Infant formulas subject to section 412(h) of the Federal Food, Drug,
and Cosmetic Act, and\
\
(2) Medical foods defined by section 5(b) of the Orphan Drug Act.\
\
~~(g)~~ [(h)]{.underline} Applicability. The requirements of this
section apply to foods intended for human consumption that are offered
for sale, regardless of whether the foods are in conventional food form
or dietary supplement form.

[(i) Disclaimer requirements. If a health claim is allowed under
paragraph (d) of this section, FDA shall draft a succinct, accurate, and
reasonable disclaimer for use with the claim as needed to avoid a
potentially misleading connotation.]{.underline}

[(1) If FDA finds the claim may mislead the public as to the extent of
scientific proof in support of it, FDA shall rely on a disclaimer the
same or substantially similar to the following: "The evidence in support
of this claim is inconclusive."]{.underline}

[(2) If FDA finds the claim may mislead the public into believing FDA
has authorized it, FDA shall rely on a disclaimer the same or
substantially similar to the following: "The FDA does not approve this
claim."]{.underline}

**B. STRUCTURE/FUNCTION CLAIMS** (**DIETARY SUPPLEMENTS**)

To comply with the First Amendment, 21 C.F.R. § 101.93 should be changed
in the following respects: 21 C.F.R. § 101.93(g)(2);(3) should be
amended to read as follows:

\(2\) FDA will find that a statement about a product claims to diagnose,
mitigate, treat, cure, or prevent disease (other than a classical
nutrient deficiency disease) under [21 U.S.C.
343](http://www.lexis.com/research/buttonTFLink?_m=59beef9817bae211dc837103b3a12870&_xfercite=<cite cc%3D"USA"><!%5BCDATA%5B21 CFR 101.93 %5D%5D><%2Fcite>&_butType=4&_butStat=0&_butNum=2&_butInline=1&_butinfo=21 USC 343 )(r)(6)
if it meets one or more of the criteria listed below. These criteria are
not intended to classify as disease claims statements that refer to the
ability of a product to maintain healthy structure or function.~~,
unless the statement implies disease prevention or treatment.~~ In
determining whether a statement is a disease claim under these criteria,
FDA will consider the context in which the claim is presented. A
statement claims to diagnose, mitigate, treat, cure, or prevent disease
if it claims~~,~~[;]{.underline} ~~explicitly or implicitly,~~ that the
product:\
\
(i) Has an effect on a specific disease or class of diseases;\
\
(ii) Has an effect on the characteristic signs or symptoms of a specific
disease or class of diseases, using scientific or lay terminology;\
\
(iii) Has an effect on an abnormal condition associated with a natural
state or process, if the abnormal condition is uncommon or can cause
significant or permanent harm;\
\
(iv) Has an effect on a disease or diseases through one or more of the
following factors:\
\
(A) The name of the product;\
\
(B) A statement about the formulation of the product, including a claim
that the product contains an ingredient (other than an ingredient that
is an article included in the definition of \"dietary supplement\" under
[21 U.S.C.
321](http://www.lexis.com/research/buttonTFLink?_m=59beef9817bae211dc837103b3a12870&_xfercite=<cite cc%3D"USA"><!%5BCDATA%5B21 CFR 101.93 %5D%5D><%2Fcite>&_butType=4&_butStat=0&_butNum=3&_butInline=1&_butinfo=21 USC 321 )(ff)(3))
that has been regulated by FDA as a drug and is well known to consumers
for its use or claimed use in preventing or treating a disease;\
\
~~(C) Citation of a publication or reference, if the citation refers to
a disease use, and if, in the context of the labeling as a whole, the
citation implies treatment or prevention of a disease, e.g., through
placement on the immediate product label or packaging, inappropriate
prominence, or lack of relationship to the product\'s express claims;~~\
\
~~(D)~~ [(C)]{.underline} Use of the term \"disease\" or \"diseased,\"
except in general statements about disease prevention that do not refer
explicitly or implicitly to a specific disease or class of diseases or
to a specific product or ingredient; or\
\
~~(E)~~ [(D)]{.underline} Use of pictures, vignettes, symbols, or other
means;\
\
(v) Belongs to a class of products that is intended to diagnose,
mitigate, treat, cure, or prevent a disease;\
\
(vi) Is a substitute for a product that is a therapy for a disease;\
\
(vii) Augments a particular therapy or drug action that is intended to
diagnose, mitigate, treat, cure, or prevent a disease or class of
diseases;\
\
(viii) Has a role in the body\'s response to a disease or to a vector of
disease;\
\
(ix) Treats, prevents, or mitigates adverse events associated with a
therapy for a disease, if the adverse events constitute diseases; or\
\
(x) Otherwise suggests an effect on a disease or diseases.

[(3) If a statement implies disease prevention or treatment, and is not
inherently]{.underline}

[misleading, FDA shall not restrict use of the claim in any way
whatsoever except to require use with the statement of an accurate,
succinct, and reasonable disclaimer, as needed, to avoid the disease
prevention or treatment connotation. FDA may require use of a reasonable
disclaimer worded the same or similar to the following, where the blanks
are disease states: "This product is not FDA-approved for the treatment
of \_\_\_\_\_\_\_\_\_\_\_\_\_. If you have
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_, see a doctor for diagnosis and proper
medical treatment." That disclaimer shall be in addition to the one
required in paragraph (C) of this section.\
]{.underline}

**C. STRUCTURE/FUNCTION CLAIMS (FOODS)**

There is no codified rule for the use of structure/function claims in
association with foods in common form. In 65 Fed. Reg. 1,000, 1,021
(Jan. 6, 2000), the FDA explained:

The types of claims listed in section 403(r)(6) of the act are similar,
but not identical to the claims permitted for foods under section
201(g)(1)(C) of the act. Under [Nutrilab v. Schweiker]{.underline}, 713
F.2d 335 (7^th^ Cir. 1983), conventional food claims are limited to
structure/function effects that derive from the states, aroma, or
nutritive value of the food. Dietary supplement claims are not subject
to that limitation.

Accordingly, in any eventual rulemaking stemming from this proceeding,
FDA should be sure to revise its position on structure/function claims
for foods to make clear that if a structure/function claim permitted for
a food appears to the agency to imply a disease treatment, FDA will not
suppress the claim (or effectively do so by requiring the party in
question to file a new drug application to make it); rather, FDA will
require the party in question to accompany the claim with an accurate,
succinct, and reasonable disclaimer that disabuses the public of the
notion that the product is an FDA-approved treatment for the disease.
FDA may require use of a reasonable disclaimer worded the same or
similar to the following, where the blanks are disease states: "This
product is not FDA-approved for the treatment of
\_\_\_\_\_\_\_\_\_\_\_\_\_. If you have
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_, see a doctor for diagnosis and proper
medical treatment."

D.  **HEALTH CLAIMS FOR ANIMAL FOODS AND ANIMAL SUPPLEMENTS**

There is presently no statutory or regulatory provision for the
regulation of health claims for animal foods and dietary supplements. As
a general rule, they are disallowed except by the ad hoc (and largely
arbitrary) exercise of case by case determinations in the discretion of
the Department of Veterinary Medicine. By rule, FDA should adopt a
simple provision stating that health claims for animal foods and dietary
supplements shall be subject to the same review, procedures, and
precedent as apply to health claims for human foods and dietary
supplements, namely 21 C.F.R. §§ 101.14; 101.70; [Pearson]{.underline}
I, II, and III.

E.  **STRUCTURE/FUNCTION CLAIMS FOR ANIMAL FOODS AND ANIMAL DIETARY
    SUPPLEMENTS**

There is presently no statutory or regulatory provision for the
regulation of structure/function claims for animal foods and dietary
supplements. As a general rule, they are disallowed except by the ad hoc
(and largely arbitrary) exercise of case by case determinations in the
discretion of the Department of Veterinary Medicine. By rule, FDA should
adopt a simple provision stating that structure/function claims for
animal foods and dietary supplements shall be subject to the same
notification procedures and treatment as apply to structure/function
claims for human foods and dietary supplements, namely 21 C.F.R. §
101.93.

**F. NUTRIENT CONTENT CLAIMS** **(FOODS AND DIETARY SUPPLEMENTS)**[\
]{.underline}

To comply with the First Amendment, FDA should amend the end of 21
C.F.R. § 101.13(q) with the following:

(9) The FDA shall allow use of any nutrient content claim not authorized

> under this section if the claim is truthful and nonmisleading can be
> rendered nonmisleading through the addition of an accurate, succinct,
> and reasonable disclaimer.
>
> **G. AUTHORITATIVE STATEMENTS FOR FOODS AND DIETARY SUPPLEMENTS**
>
> The FDA should withdraw its Guidance for Industry, "Notification of a
> Health

Claim or Nutrient Content Claim Based on an Authoritative Statement of a
Scientific Body," issued June 11, 1998. For the reasons stated
[supra]{.underline} that guidance erroneously requires "significant
scientific agreement" as a condition precedent to allowance of
authoritative statement claims. It was the very purpose of the FDAMA
authoritative statement provision to provide an alternative to
significant scientific agreement review. A new guidance should be
adopted that allows use of all statements that meet the statutory
criteria in FDAMA for food and dietary supplements and that permits FDA
to require use of an accurate, succinct, and reasonable disclaimer as
needed to avoid a misleading connotation. If the statutory criteria are
met, FDA should impose no regulatory burdens on use of an authoritative
statement beyond an accurate, succinct, and reasonable disclaimer. FDA
should act on the pending proposed rule, "Food Labeling: Use on Dietary
Supplements of Health Claims Based on Authoritative Statements," 64 Fed.
Reg. 3,250 (Jan. 21, 1999), limiting its final rule to a determination
that the FDAMA provisions should be interpreted to apply with equal
force and effect for dietary supplements; to a determination that FDA
shall not require satisfaction of "significant scientific agreement"
review as a condition precedent to authorization to use an authoritative
statement; and to a determination that FDA may require use of an
accurate, succinct, and reasonable disclaimer to accompany an
authoritative statement for the purpose of eliminating a potentially
misleading connotation arising from the statement.

H.  **OFF-LABEL AND EXTRALABEL USE CLAIMS FOR HUMAN AND ANIMAL DRUGS AND
    MEDICAL DEVICES**

> To comply with the First Amendment, 21 C.F.R. § 99.101, "Information
> that may

be disseminated," should be revoked in substantial part, replacing it
with the following constitutional regulation:

Sec. 99.101 Information that may be disseminated.

(a) A manufacturer may disseminate written information concerning the
    safety, effectiveness, or benefit of a use not described in the
    approved labeling for an approved drug or device or in the statement
    of intended use for a cleared device, provided that the information
    is not false or misleading.

(b) Information that may be disseminated under this part shall be
    accompanied by the following disclaimer to be appended to the first
    page of each separate document: "The uses described in the attached
    document have not been evaluated by the Food and Drug Administration
    and have not been proven safe and effective."

To comply with the First Amendment, and in light of the recommended new
section 99.101(b), 21 C.F.R. § 99.103 should be revoked in its entirety.

To comply with the First Amendment, 21 C.F.R. § 99.201, "Manufacturer's
submission to the agency," should be revoked in substantial part,
replacing it with the following constitutional regulation:

Sec. 99.201 Manufacturer's submission to the agency.

(a) Sixty days before disseminating any written information concerning
    the safety, effectiveness, or benefit of a new use for a drug or
    device, a manufacturer shall submit to the agency three identical
    copies of:

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(1) the information to be disseminated, and

(2) all scientific evidence upon which the claim is based.

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```
(b) The manufacturer shall send the submission to:

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```
(1) the Center for Biologics Evaluation and Research, the Advertising
    and Promotional Labeling Staff (HFM-602), Center for Biologics
    Evaluation and Research, Food and Drug Administration, 1401
    Rockville Pike, Rockville, MD 20852 (for new use claims for
    biological products and devices regulated by this Center);

(2) the Division of Drug Marketing, Advertising, and Communications
    (HFD-40), Center for Drug Evaluation and Research, Food and Drug
    Administration, 5600 Fishers Lane, Rockville, MD 20857 (for new use
    claims for human drug products);

(3) the Promotion and Advertising Policy Staff (HFZ-302), Office of
    Compliance, Center for Devices and Radiological Health, Food and
    Drug Administration, 2098 Gaither Rd., Rockville, MD 20850 (for new
    use claims for medical devices).

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```
(c) The 60-day period shall begin when FDA receives a manufacturer's
    submission.

> To comply with the First Amendment, the regulatory prohibition on
> extralabel use

claims for animal drugs should be revoked: 21 C.F.R. § 530.4. In its
place, a revised Section 530.4 should be added which provides:

Sec. 530.4 Advertising and promotion.

(a) A manufacturer or distributor of FDA approved animal drugs may
    advertise and promote animal drugs with extralabel claims of drug
    safety and efficacy, provided that:

> \(1\) the extralabel claims are truthful and nonmisleading; and
>
> \(2\) the extralabel claims are accompanied by the following
> disclaimer: "The uses described have not been evaluated by the Food
> and Drug Administration andhave not been proven safe and effective."

(b) Sixty days before use in any advertising or promotion of an
    extralabel claim, a manufacturer or distributor shall submit to the
    Center for Veterinary Medicine, Food and Drug Administration, 7500
    Standish Place, Rockville, MD 20855, three identical copies of:

> \(1\) the promotional material or advertisement including the
> extralabel claim and the associated disclaimer, and
>
> \(2\) all scientific evidence upon which the claim is based

(c) The 60-day period shall begin when FDA receives a manufacturer's or

> distributor's submission.

I.  **INDUSTRY-SPONSORED EDUCATIONAL ACTIVITIES**

> To comply with the First Amendment, FDA should revoke the Guidance for

Industry, "Industry-Supported Scientific and Educational Activities,"
dated November 1997. In its place, the FDA should adopt a simple rule,
reading as follows:

Disclosure Requirements for Industry-Supported Scientific and
Educational Activities.

> A manufacturer or distributor of a drug or medical device may provide
> financial support for scientific and educational activities that
> include comment on uses of the FDA-approved drugs and medical devices
> owned by that manufacturer or distributor that are not contained in
> FDA approved labeling for those drugs or devices provided that:

(1) the claims made concerning the safety, effectiveness, or benefit of
    the drug or device are not false or misleading;

(2) during any presentation concerning the uses, the audience is
    unambiguously informed that "the uses described in this presentation
    have not been evaluated by the Food and Drug Administration and have
    not been proven safe and effective."

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```
J.  **DIRECT TO CONSUMER ADVERTISING**

> To comply with the First Amendment, the FDA should revoke the
> "adequate

provision" requirement in 21 C.F.R. § 202.1(e)(1) ("adequate provision .
. . for dissemination of the approved or permitted package labeling in
connection with the broadcast presentation"). FDA should also revoke the
related Guidance for Industry, "Consumer-Directed Broadcast
Advertisements."

K.  **SECONDARY THERAPEUTIC CLAIMS FOR COSMETICS**

To comply with the First Amendment, FDA should adopt a new rule for the
regulation of cosmetics that reads:

Secondary therapeutic claims for Cosmetics.

(a) A manufacturer or distributor of a cosmetic product may include on
    that product's label and in its labeling a secondary therapeutic
    claim provided that the claim:

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```
(1) is not false and misleading;

(2) is accompanied on the same page or panel with the following
    referenced disclaimer in prominent type (where the blank is the name
    of a disease): "This product is not FDA approved as safe and
    effective for the treatment of \_\_\_\_\_\_\_\_. If you have
    \_\_\_\_\_\_\_\_, see a doctor for diagnosis and appropriate medical
    treatment."; and

(3) sixty days before first making use of the secondary therapeutic
    claim on labels and in labeling, the manufacturer or distributor
    files a sample label containing the claim and disclaimer with the
    Food and Drug Administration, Center for Food Safety and Applied
    Nutrition, Office of Cosmetics and Colors, along with all scientific
    evidence the manufacturer or distributor possesses in support of the
    secondary therapeutic claim.

> \(b\) A "secondary therapeutic claim" is one that concerns a
> therapeutic effect of a cosmetic product but does not change the
> identity of the product on the label from a cosmetic to a drug and is
> placed after and in less prominence than information pertaining to the
> cosmetic effects of the product.

L.  **SECONDARY COSMETIC CLAIMS FOR DRUGS**

> To comply with the First Amendment, FDA should adopt a new rule for
> the

regulation of drugs that reads:

(b) A manufacturer or distributor of a drug product may include on that
    product's label, in its labeling, and in its advertising a secondary
    cosmetic claim provided that the claim:

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```
(1) is not false and misleading; and

(2) sixty days before first making use of the secondary cosmetic claim
    on labels and in labeling, the manufacturer or distributor files a
    sample label or advertisement, if intended for use in advertising
    sample, containing the claim with the Food and Drug Administration,
    Center for Drug Evaluation and Research, along with all scientific
    evidence the manufacturer or distributor possesses in support of the
    secondary cosmetic claim. During its sixty day review, FDA may
    require that the drug manufacturer place an accurate, concise, and
    reasonable disclaimer in association with the claim to avoid
    potential misleadingness that may arise from the claim.

> \(b\) A "secondary cosmetic claim" is one that concerns a cosmetic
> effect of a drug product and is placed after and in less prominence
> than information pertaining to the drug effects of the product.

M.  **FDA INJUNCTION PRACTICES**

> To comply with the First Amendment in its injunction practices, FDA
> should

adopt the guidance for FDA speech regulators below and, in particular,
part 780.8 of that guidance.

**PART VII: PROPOSED FIRST AMENDMENT GUIDANCE FOR FDA SPEECH
REGULATORS**

**VII.**

# PROPOSED FIRST AMENDMENT GUIDANCE FOR FDA SPEECH REGULATORS

# To alert DHHS employees of the need to avoid violations of the First Amendment in their evaluation and review of private speech on labels, in labeling, and in drug advertising, the Joint Commenters recommend that FDA adopt the following internal guidance, publish it in the agency's Investigations Operations Manual, and make it available to all employees who have any role in that evaluation and review. In addition to dissemination of the guidance to all such employees, the Joint Commenters recommend that designated legal counsel in the Chief Counsel's Office with expertise in First Amendment law conduct one or more training sessions with employees who have any role in evaluation and review of private speech on labels, in labeling, and in drug advertising to educate those employees about the First Amendment limits on those employees' actions and to sensitize them to the need to favor disclosure over suppression and to employ accurate, succinct, and reasonable disclaimers as less speech restrictive alternatives to suppression.

# SUBCHAPTER 780 -- CONSTITUTIONAL LIMITS ON THE EXERCISE OF AUTHORITY

## Significance of Oath to Support and Defend Constitution

> Each employee of the Department of Health and Human Services must, by
> law \[5

U.S.C. § 3331\], swear the following oath:

> I, \_\_\_\_\_\_\_\_\_, do solemnly swear (or affirm) that I will
> support and defend the Constitution of the United States against all
> enemies, foreign and domestic; that I will bear true faith and
> allegiance to the same; that I take this obligation freely, without
> any mental reservation or purpose of evasion; and that I will well and
> faithfully discharge the duties of the office on which I am about to
> enter. So help me God.

That oath is a condition precedent to federal employment in DHHS. It is
a solemn duty of each employee therefore to become aware of and
knowledgeable concerning the contents of the Constitution of the United
States and to refrain from taking any action that would violate the
civil liberties of any American citizen. Each DHHS employee should
question the exercise of authority when that exercise may threaten civil
liberties, and no employee may be placed in jeopardy of losing his or
her job or of receiving any reprimand or other penalty for asking such
questions.

780.1 Limits on Discretion of Employees who Review Labels and Labeling

Employees in each FDA center, in the Office of the Chief Counsel, in the
Office of the Commissioner, and in the Office of Regulatory Affairs are
among those called upon from time to time to review the contents of
labels, labeling, or in drug advertising in fulfillment of duties under
the FD&C Act or regulations adopted by FDA. Each employee should be
alerted to the fact that a regulatee's chosen content for use on labels
and in labeling is speech within the meaning of the First Amendment of
the United States Constitution. That speech is entitled to a presumption
that it is protected against government action by the United States
Constitution. That speech may not be suppressed except where it is
proven, with empirical evidence, to be inherently misleading.

2.  First Amendment Presumption in Favor of Disclosure over Suppression

> The First Amendment favors disclosure of information over its
> suppression.

Therefore, DHHS employees must not take any action that would cause the
suppression of speech on labels, in labeling, or in drug advertising if
there is a non-speech alternative or a less speech restrictive
alternative available to achieve FDA's statutory or regulatory
objective.

3.  Duty to Avoid Acts that Violate Rights to Private Speech

> When reviewing or evaluating regulatee speech for use on labels, in
> labeling,

and in drug advertising, DHHS employees must be mindful of the fact that
FDA has a very high threshold burden of proof that must be satisfied
before any such speech may be restricted or suppressed. It is therefore
the duty of each DHHS employee called upon to review or evaluate that
content to endeavor to fulfill FDA's statutory and regulatory objectives
without restricting or suppressing that speech.

4.  Duty to Choose Less Speech Restrictive Alternatives to Suppression
    of Private

Speech, including Speech that Harbors a Potential to Mislead

If speech for use on labels, in labeling, or in drug advertising is
potentially misleading in that it may convey a meaning that is false or
misleading, the duty of each DHHS employee called upon to review or
evaluate that speech is to favor use of an accurate, concise, and
reasonable disclaimer for association with that speech aimed precisely
at eliminating the identified false or misleading connotation.

5.  Authority to Suppress Inherently Misleading Speech

> If speech on labels, in labeling, or in drug advertising is inherently
> misleading,

i.e., is false and misleading and incapable of being rendered
nonmisleading through the addition of an accurate, concise, and
reasonable disclaimer, upon proof of that condition a DHHS employee may
take actions that will result in the suppression of the speech.

6.  Final Review before Action to Suppress Inherently Misleading Speech

> If a DHHS employee has determined that speech on labels, in labeling,
> or in drug

advertising is false and misleading and cannot be rendered nonmisleading
through the addition of an accurate, concise, and reasonable disclaimer,
that employee shall not act to suppress the speech in question until
after a full legal review of the First Amendment implications of that
proposed action by appropriate attorneys in FDA's Office of the Chief
Counsel. Only upon their determination that the act of suppression will
not violate the First Amendment may the speech suppressive action be
taken.

7.  Of Record Explanation for Each Act to Suppress Inherently Misleading
    Speech

> If the Office of the Chief Counsel has determined that speech for use
> on labels, in

labeling, or in drug advertising is inherently misleading, i.e., is
false and misleading and incapable of being rendered nonmisleading
through the addition of an accurate, concise, and reasonable disclaimer,
that Office shall draft a detailed legal explanation of both the
applicable First Amendment legal standards and the constitutional
authority of FDA to act against the speech in question. That detailed
explanation shall be served upon the party affected at the time the
action is taken to suppress the inherently misleading speech.

8.  First Amendment Limits on Injunctions Against Unlawful Drug
    Marketing

> Injunctions must be narrowly tailored to enjoin the marketing of
> substances as

drugs that have not been approved for drug use by the FDA. The FDA must
avoid seeking injunctions that prohibit the sale of substances sold
unlawfully as drugs from being sold altogether if those same substances
could lawfully be sold as foods, dietary supplements, or cosmetics under
the Act. Instead, injunctive relief should be narrowly tailored to
prohibit the sale of the substances as drugs until such time, if ever,
as FDA has granted pre-market drug approval for the sale of the
substances as drugs. The FDA must also avoid seeking injunctions that
prohibit the use of disease prevention or treatment claims unless
granted drug pre-market approval, for substances that may also be sold
as foods and dietary supplements, to avoid suppression of FDA approved
or allowed health claims, structure/function claims, and authoritative
statement claims.

**PART VIII: CONCLUSION**

**VIII.**

**CONCLUSION**

For the foregoing reasons, the Joint Commenters respectfully request
that FDA act expeditiously to eliminate all First Amendment violations
identified herein arising from its regulation of speech on labels, in
labeling, and in drug advertising by adopting the reforms the Joint
Commenters have recommended.

Respectfully submitted,

JULIAN M. WHITAKER, M.D.;

DURK PEARSON AND SANDY SHAW;

PURE ENCAPSULATIONS, INC.;

WELLNESS LIFESTYLES, INC.;

SUAREZ CORPORATION INDUSTRIES, INC.;

LIFE ENHANCEMENT PRODUCTS, INC.; AND

LIFE EXTENSION FOUNDATION,

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Jonathan W. Emord

Claudia A. Lewis-Eng

Andrea G. Ferrenz

Jonathan R. Goodman

Counsel

**Emord & Associates, P.C.**

Burke Professional Center

5282 Lyngate Court

Burke, VA 22015

P: (202) 466-6937

F: (202) 466-6938

E-mail: <jemord@emord.com>

Dated: September 12, 2002

**Exhibit 1**

Background and Interests of Joint Commenters

**[Julian M. Whitaker, M.D.]{.underline}**: Julian M. Whitaker, M.D. is
a physician licensed to practice medicine in the states of California
and Washington. He graduated from Dartmouth College in 1966 with a B.S.
degree and from Emory University in 1970 with an M.D. degree. He
received additional training in surgery as a resident at the University
of California Medical School. From 1975 to 1976 he worked as a physician
at the Pritikin Institute in California. Since that time he has been the
Clinical Director of the Whitaker Wellness Institute in Newport Beach,
California. He is the author of five books: ***Reversing Heart
Disease*** (1985), ***Reversing Diabetes*** (1987), ***Reversing Health
Risk*** (1989), ***Natural Healing*** (1994), and ***What Your Doctor
Won't Tell You About Bypass*** (1995). Since 1991 he has been the editor
of ***Health and Healing***, currently the nation's largest single
editor health newsletter. In 1998, ***Health and Healing*** had over
500,000 subscribers. He receives royalties from the distribution and
sale of a wide variety of dietary supplements based on formulas he
develops and licenses. Dr. Whitaker was a plaintiff in the [Pearson v.
Shalala]{.underline} case. FDA's failure to follow the First Amendment
mandate in [Pearson v. Shalala]{.underline} by allowing health claims
backed by credible evidence adversely affects Dr. Whitaker, who has been
a plaintiff in each of the successful First Amendment challenges to FDA
health claim suppression and is lead plaintiff in two suits presently
pending against the agency for health claim suppression, [Whitaker v.
Thompson]{.underline}, Case No. 99-CV-3247 (D.D.C. 1999) and [Whitaker
v. Thompson]{.underline}, Case No. 00-CV-123 (D.D.C. 2000). Dr. Whitaker
would recommend use on his products' labels and in their labeling
structure/function claims informing consumers of the
cholesterol-lowering effects; blood pressure-lowering effects; and
urinary flow enhancing effects in men over 50 of certain dietary
supplement products he licenses for sale. Because FDA will not allow use
of disclaimers to eliminate a disease treatment connotation and because
FDA will only allow such claims upon the filing of a new drug
application, Dr. Whitaker's preferred communication cannot reach those
who buy his licensed products. Dr. Whitaker cannot afford the hundreds
of millions of dollars required to pursue each new drug application.

Dr. Whitaker is also directly and adversely affected by FDA's
restrictions upon dissemination of off-label use information to
physicians. In his medical practice he depends upon such information to
aid him in evaluating how best to treat patients whose conditions cannot
adequately be resolved relying exclusively on approved uses for approved
drugs and devices.

**[Durk Pearson and Sandy Shaw]{.underline}**: Pearson and Shaw are
scientists residing in Nevada. They design dietary supplement
formulations and license them to manufacturing and retailing companies.
They are authors of four books on aging and age-related diseases,
including the number one, million-plus copy best seller ***Life
Extensions: A Practical Scientific Approach*** (1982). They have also
published three other health books, two of which were best sellers:
***the Life Extension Companion*** (1984); ***The Life Extension Weight
Loss Program*** (1986); and ***Freedom of Informed Choice---FDA Versus
Nutritional Supplements*** (1993).

Pearson and Shaw presently wish to make the following claim for their
supplements but are precluded due to FDA's current regulatory scheme:
"Adequate amounts of Vitamin C are necessary for proper wound healing."
Durk Pearson and Sandy Shaw were Plaintiffs in the successful [Pearson
v. Shalala]{.underline}, 164 F.3d 650 (D.C. Cir. 1999), [Pearson v.
Shalala]{.underline}, 130 F. Supp. 2d. 105 (D.C. 2001), and [Pearson v.
Thompson]{.underline}, 141 F. Supp. 2d 105 (D.C. 2001) cases against
unconstitutional FDA health claim suppression. They also have a keen
interest in reform of FDA's effective ban on structure/function claims
that (FDA believes) imply disease treatment. They favor the less speech
restrictive alternative of disclaimers as recommended herein. For
example, in connection with the niacin-containing dietary supplement
formulas Pearson and Shaw license to their licensees, they would like to
inform the public about niacin's LDL cholesterol lowering effect,
potassium-containing health food's blood pressure lowering effect, and
omega-3 fatty acid-containing health food's cardiac protective
anti-sudden death heart attack effect but cannot because FDA regards
those claims as implied disease treatment claims and will not allow
their use with disclaimers as recommended herein. Moreover, Pearson and
Shaw have a keen interest in First Amendment protection for nutrient
content claims for the reasons discussed herein. They would ask their
licensees to use such claims if commonly understood terms could be used
without the requirement that they conform to government-established
orthodoxies. Likewise, they have a keen interest in receipt of off-label
use information to understand the full potential benefits they may
receive from medical care. Moreover, as pet owners, they also want
access to extralabel use information to ensure evaluation of all care
options for their pets. Pearson and Shaw are also plaintiffs in the two
[Whitaker v. Thompson]{.underline} cases pending for decision in the
U.S. District Court for the District of Columbia (Case Nos. 99-CV-3247
and 00-CV-123).

**[Pure Encapsulations, Inc.]{.underline}**: Pure Encapsulations (Pure)
is a Massachusetts corporation engaged in the business of manufacturing,
distributing, and selling over 250 dietary supplements for human and
companion animal consumption. Pure seeks freedom to include on labels
and in labeling certain structure/function claims now effectively
prohibited by FDA on the basis that they imply disease treatment. In
particular, Pure would like to inform purchasers of cholesterol-lowering
effects; blood pressure-lowering effects; and urinary flow enhancing
effects in men over 50 of certain dietary supplements it now sells,
relying on the form of disclaimer recommended herein. Pure also desires
freedom to use nutrient content claims based on their common meanings,
rather than government-mandated definitions. Pure desires to make
structure/function and health claims on its companion animal dietary
supplement labels and in their labeling based on the same terms and
conditions for human dietary supplements. All of those recommended
reforms directly and materially affect Pure because it now abides by FDA
restrictions that prevent it from informing its customers of truthful
information on the actual and potential benefits of its dietary
supplement products. Pure is also a plaintiff in the following cases
against FDA health claim suppression. [Whitaker v.
Thompson]{.underline}, Case No. 99-CV-3247 (D.D.C. 1999) and [Whitaker
v. Thompson]{.underline}, Case No. 00-CV-123 (D.D.C. 2000). Those cases
are pending in the United States District Court for the District of
Columbia.

**[Wellness Lifestyles, Inc.:]{.underline}** Wellness Lifestyles, Inc.,
d/b/a/ American Longevity, a California company, has been a leading
marketer of human and animal dietary supplements and cosmetics for over
five years. American Longevity markets over 50 dietary supplement and
personal care products ranging from vitamin and mineral supplements to
skin care products.

Claims that Wellness would like to make but is currently prohibited from
making on labels and in labeling of its products include: "Folic Acid
may help reduce the risk of Alzheimer's disease"; "Vitamins A and E may
help reduce the risk of Alzheimer's disease"; "Selenium has been shown
to reduce the risk of certain cancers"; "Selenium may reduce the risk of
certain cancers;" and "Selenium may produce anticarcinogenic effects in
the body." American Longevity has pending before FDA a health claim
petition seeking agency approval or allowance of the aforementioned
Selenium claims. Because the extent to which American Longevity may
communicate truthful nutrient-disease information on its product labels
and in its products' labeling depends directly on FDA's compliance with
the First Amendment, American Longevity has a profound interest in the
nature and outcome of these proceedings.

American Longevity has a keen interest in the reforms recommended herein
for structure/function claims. In particular, American Longevity would
like to place on its products' labels and in its products' labeling
truthful claims concerning blood pressure-lowering and
cholesterol-lowering effects of certain of its products. It presently
cannot do so because FDA would regard the claims as implied drug claims
and American Longevity cannot afford the cost of new drug approval.
American Longevity favors the disclaimer approach recommended in these
comments. American Longevity would also make use of nutrient content
claims presently prohibited if it could do so via the method recommended
in these comments.

**[Suarez Corporation Industries, Inc.]{.underline}**: Suarez
Corporation Industries, Inc. (Suarez), is a direct marketing company
based in Canton, Ohio that has been in business since 1968. The company
is divided into several divisions with Biogenesis, part of the Pro Tour
Sports division, engaging in the development, manufacture, and promotion
of an entire line of health, fitness, and weight loss products including
exercise programs, weight loss programs, vitamins and nutritional
supplements, and exercise equipment. Because the extent to which Suarez
may communicate truthful nutrient-disease information on its products'
labels and in its products' labeling depends directly on FDA's
compliance with the First Amendment, Suarez has a profound interest in
the nature and outcome of these proceedings. Suarez presently refrains
from making use of certain truthful structure/function claims, health
claims, and nutrient-content claims because of the FDA's speech
restrictions. If the reforms recommended herein were made, Suarez would
include those truthful claims on its labels and in its labeling.

**[Life Enhancement Products, Inc.]{.underline}**: Life Enhancement
Products, Inc. (Life Enhancement), a California company, manufactures
and sells a wide variety of dietary supplements for human and animal
use. Because the extent to which Life Enhancement may communicate
truthful nutrient-disease information on its products' labels and in its
products' labeling depends directly on FDA's compliance with the First
Amendment, Life Enhancement has a profound interest in the nature and
outcome of these proceedings. Life Enhancement presently refrains from
making use of certain truthful structure/function claims, health claims,
and nutrient-content claims because of the FDA's speech restrictions. If
the reforms recommended herein were made, Life Enhancement would include
those truthful claims on its labels and in its labeling.

**[Life Extension Foundation]{.underline}**: The Life Extension
Foundation (Life Extension), incorporated in 1980, is dedicated to
finding scientific methods for preventing and treating disease, aging,
and death. Life Extension also funds extensive research aimed at helping
to prevent disease and slow premature aging. In addition, Life Extension
develops and markets a wide range of dietary supplements. Because the
extent to which Life Extension may communicate truthful nutrient-disease
information on its products' labels and in its products' labeling
depends directly on FDA's compliance with the First Amendment, Life
Extension has a profound interest in the nature and outcome of these
proceedings. Life Extension presently refrains from making use of
certain truthful structure/function claims, health claims, and
nutrient-content claims because of the FDA's speech restrictions. If the
reforms recommended herein were made, Life Extension would include those
truthful claims on its labels and in its labeling.

[^1]: Attached as Exhibit 1 is a detailed statement of the backgrounds
    and interests of the Joint Commenters.

[^2]: [See generally]{.underline} Cynthia Susan Clegg, [Press Censorship
    in Jacobian England]{.smallcaps} (2001).

[^3]: Congress has estimated that approximately 2,500 preventable neural
    tube defect births occurred each year FDA's folic acid/neural tube
    defect ban remained in place. In addition, a lead editorial in the
    [Journal of Clinical Nutrition]{.underline} estimated 150,000 sudden
    death heart attacks per year could be prevented if people were
    informed about the cardiac protective effects of omega-3 fish oils.
    [See]{.underline} William E. Connor, [n-3 Fatty acids from fish and
    fish oil: panacea or nostrum?]{.underline}, 74 [Am J Clin
    Nutr]{.smallcaps} 415-6 (2001).

[^4]: Suppression of truthful health information on disease risk
    reducing effects necessarily increases the incidence of preventable
    disease and associated death.

[^5]: In an address to Parliament, Areopagitica (1644), John Milton
    advocated an end to the Licensing Act of 1643. He there first
    articulated the critical importance of an open idea and information
    market to the discovery and spread of truth:

    > And though all the winds of doctrine were let loose to play upon
    > the earth, so Truth be in the
    >
    > field, we do injuriously by licensing and prohibition to misdoubt
    > her strength. Let her and Falsehood grapple; who ever knew Truth
    > put to the worse, in a free and open encounter.

    [Quoted in]{.underline}, M. Hughes, John Milton Complete Poems and
    Major Prose 746 (1957).

    In his 1859 classic [On Liberty]{.underline}, John Stuart Mill
    expounded upon Milton's thesis favoring open idea and information
    contests, adding the concept that speech that may be erroneous, yet
    contains at least a kernel of truth, is nevertheless of value in
    promoting the search for truth in the idea and information market.

    > \[I\]f any opinion is compelled to silence, that opinion may, for
    > ought we can certainly know,
    >
    > be true. To deny this is to assume our own
    > infallibility...\[T\]hough the silenced opinion be
    >
    > an error, it may, and very commonly does, contain a portion of
    > truth; and since the general or prevailing opinion on any subject
    > is rarely or never the whole truth, it is only by the collision
    >
    > of adverse opinions that the remainder of the truth has any chance
    > of being supplied...\[E\]ven
    >
    > if the received opinion be not only true, but the whole truth;
    > unless it is suffered to be, and actually is, vigorously and
    > earnestly contested, it will, to most of those who receive it, be
    >
    > held in the manner of a prejudice, with little comprehension
    > \[of\] or feeling \[for\] its rational grounds.

    J. Mill, [On Liberty]{.underline} 52 (S. Beer & O. Hardison, Jr.,
    eds. 1947).

    The so-called marketplace of ideas principle undergirding the
    constitutional presumption favoring disclosure over suppression
    achieved its most famous incarnation in American law in Justice
    Oliver Wendell Holmes' dissent in [Abrams v. United
    States]{.underline}, 250 U.S. 616, 630 (1919) (Holmes, J.
    dissenting):

    > \[W\]hen men have realized that time has upset many fighting
    > faiths, they may come to
    >
    > believe even more than they believe the very foundations of their
    > own conduct that the
    >
    > ultimate good is better reached by free trade in ideas---that the
    > best test of truth is the power
    >
    > of the thought to get itself accepted in the competition of the
    > market...

    By 1964, Justice William J. Brennan, Jr. was able to state (in the
    context of reviewing a protest advertisement soliciting public
    contributions) what had become a central tenet of First Amendment
    jurisprudence: that there exists a "profound national commitment to
    the principle that debate on public issues should be uninhibited,
    robust, and wide-open, and that it may well include vehement,
    caustic, and sometimes unpleasantly sharp attacks on government and
    public officials." [New York Times v. Sullivan]{.underline}, 367
    U.S. 254, 270 (1964).

[^6]: That reluctance describes an agency mindset antithetical to First
    Amendment principles and underscores the need for fundamental
    reform. Without sincere commitment to respect and honor in conduct
    and action the governing law of the First Amendment, the staff of
    the agency cannot be counted upon to ensure compliance with the
    amendment's restraints on FDA power.

[^7]: The four claims are: (1) "Consumption of antioxidant vitamins may
    reduce the risk of certain kinds of cancers;" (2) "Consumption of
    fiber may reduce the risk of colorectal cancer;" (3) "Consumption of
    omega-3 fatty acids may reduce the risk of coronary heart disease;
    and (4) ".8 mg of folic acid in a dietary supplement is more
    effective in reducing the risk of neural tube defects than a lower
    amount in foods in common form." [Pearson]{.underline} I, 164 F.3d
    at 652.

[^8]: As explained below, that fact provides the agency with an
    important, indeed indispensable, distinguishing principle that will
    enable the agency to interpret its statutory duties under 21 U.S.C.
    § 343 for food and dietary supplement claims in harmony, and in
    compliance with the First Amendment. Of course, were the statute
    unavoidably in conflict with the First Amendment, the Supremacy
    Clause compels one outcome: the statute may not be given effect to
    the extent of the conflict. [See, e.g. Chapman v. Houston Welfare
    Rights Organization]{.underline}, 441 U.S. 600, 613 (1979)
    (Supremacy Clause "secure\[s\] federal rights by according them
    priority whenever they come in conflict with state law.").

[^9]: Judge Kessler found the harm suffered by Plaintiffs during the two
    years post-Pearson I in which FDA maintained its suppression of the
    Folic Acid Claim "irreparable injury," explaining that Plaintiffs
    had "continually borne I\[irreparable injury\] in the two years
    since Pearon was decided." 130 F. Supp. 2d at 119.

[^10]: This suppression has contributed to an estimated 1,000,000
    preventable sudden cardiac deaths. [See]{.underline} note 2
    [infra]{.underline}.

[^11]: Note well that this last factor ensures violation of the
    [Pearson]{.underline} I decision. [Pearson]{.underline} I held
    claims that were inconclusive, backed by credible evidence,
    protected speech---allowable with disclaimers clarifying that
    inconclusiveness. A claim need not be consistent with the weight of
    scientific evidence to be true. Indeed, it is often a significant
    minority view that while inconclusive holds important information
    that may guide consumer choice.

[^12]: The now classic example of how FDA speech suppression works to
    harm the public arose in the folic acid context. Congress has found
    that FDA's refusal to allow a claim associating folic acid with a
    reduction in the risk of neural tube defects contributed to an
    estimated 2,500 preventable neural tube defect births each year that
    FDA left its speech ban in place. [See]{.underline} S. Rep. No.
    103-410 at 7 (1994).

[^13]: [See, e.g., Pearson]{.underline} I, 164 F.3d at 655
    (characterizing FDA argument as depending on the view that consumers
    lack the sophistication necessary to evaluate any health claims
    except those authorized by the agency).

[^14]: [See, e.g., Id]{.underline} (characterizing FDA argument as
    dependent on the view that consumers "have difficulty independently
    verifying...claims").

[^15]: [See, e.g., Id.]{.underline} at 656 (characterizing FDA argument
    as depending on the view that consumers are best served by
    suppression of claims unless they concern products that are
    "indisputably health enhancing").

[^16]: The regulations are thus premised on the paternalistic (and
    presumptuous) notion that regulators are better able to perceive
    consumers' best interests than consumers are themselves.

[^17]: While "several Members of the Court have expressed doubts about
    the [Central Hudson]{.underline} analysis," [Western States
    Medical]{.underline} Center, 122 S.Ct. at 1504, the test crafted by
    the Court in [Central Hudson Gas & Elec. Corp.]{.underline}, 447
    U.S. 557 (1980), as modified by [Central Hudson's]{.underline}
    progency, is still in use. Justice Thomas favors full First
    Amendment protection for speech heretofore deemed commercial, [44
    Liquormart]{.underline}, 517 U.S. at 518; [Western States Medical
    Center]{.underline}, 122 S. Ct. at 1584. Justices Stevens, Kennedy,
    and Ginsburg generally favor full First Amendment protection for
    speech heretofore deemed commercial when the government "entirely
    prohibits dissemination of truthful, nonmisleading commercial
    messages for reasons unrelated to the preservation of a fair
    bargaining process," [44 Liquormart]{.underline}, 517 U.S. at 501.
    Justice Scalia experiences "discomfort" with the [Central
    Hudson]{.underline} test ("which seems to \[him\] to have nothing
    more than policy intuition to support it," [44
    Liquormart]{.underline}, 517 U.S. at 517)), preferring a new test
    but one he has not yet defined.

[^18]: As explained [supra]{.underline}, the speech here in issue is, by
    any measure, of a high order, conveying scientific information on
    matters of health and disease to consumers. As such, even if the
    agency's regulation were not aimed at the content communicated, it
    would nevertheless be inappropriate to apply less exacting scrutiny.

[^19]: FDA has defined a health claim as "any claim made on the label or
    in labeling of a food, including a dietary supplement, that
    expressly or by implication, including 'third party' references,
    written statements (e.g. a brand name including a term such as a
    "heart"), symbols (e.g. a heart symbol) or vignettes, characterizes
    the relationship of any substance to a disease or health-related
    condition." "Implied health claims" include those "statements,
    symbols, vignettes, or other forms of communication that suggest,
    within the context in which they are presented, that a relationship
    exists between the presence or level of a substance in the food and
    a disease or health-related condition." 21 C.F.R. § 101.14(a)(1).
    FDA is attempting to acquire judicial sanction for a post hoc
    regulatory limitation on that definition to exclude all claims
    except those pertaining to the effect of a nutrient on an existing
    disease. That circumscription of the health claim definition
    violates the plain and intended meaning of 21 U.S.C. § 343. This
    issue is before the United States District Court for the District of
    Columbia in [Whitaker v. Thompson]{.underline}, \[Case No.
    99-CV-3247\]. Importantly, for present purposes, that
    circumscription of the health claims definition violates the First
    Amendment, as explained herein.

[^20]: See the immediately preceding note. By taking the aforementioned
    approach and defining "disease" broadly, FDA leaves little room for
    health claims.

[^21]: Few credible scientific studies ever reach "conclusiveness"
    (i.e., certainty). Nevertheless, inconclusive evidence backed by
    credible science enables consumers to exercise informed choice in
    the market and may be responsible for averting disease or saving
    lives.

[^22]: Article VI, Clause 2 of the United States Constitution provides:

    > This Constitution, and the Laws of the United States which shall
    > be made in Pursuance thereof; and all Treaties made, or which
    > shall be made, under the Authority of the United States, shall be
    > the supreme Law of the Land; and the Judges in every State shall
    > be found thereby, anything in the Constitution or Laws of any
    > State to the Contrary notwithstanding.

    U.S.[Const.]{.smallcaps} art. VI, cl.2. When federal law is contrary
    to the constitution, the Supremacy Clause ensures that the law is
    immediately void:

    > Certainly those who have framed written constitutions contemplate
    > them as forming the fundamental and paramount law of the nation,
    > and consequently the theory of every such government must be, that
    > an act of the legislature, repugnant to the constitution, is void.
    > This theory is essentially attached to a written constitution, and
    > is consequently to be considered by this court, as one of the
    > fundamental principles of our society.
    >
    > \* \* \*
    >
    > It is also not entirely unworthy of observation, that in declaring
    > what shall be supreme law of the land, the constitution itself is
    > first mentioned; and not the laws of the United States generally,
    > but those only which shall be made in pursuance of the
    > constitution, have that rank.

    [Marbury v. Madison]{.underline}, 5 U.S. 137, 177; 180 (1803). Once
    held repugnant to the Constitution, a law may not thereafter be
    given any force or effect for the obvious reason that countenancing
    the enforcement of such a law "would declare that an act, which,
    according to the principles and theory of our government, is
    entirely void; is yet in practice, completely obligatory."
    [Id.]{.underline} at 178.

[^23]: In assessing whether content of a structure/function claim
    implies disease treatment, FDA also examines scientific citations.
    If the citation "implies treatment or prevention of a disease" in
    context, it renders the structure/function claims a drug claim. 21
    C.F.R. § 101.93(g)(2)(C). To include such a citation, a manufacturer
    or ditributor would have to obtain new drug approval from FDA. The
    extraordinary cost of that process forms an effective barrier to the
    use of the citation. FDA thus discourages manufacturers and
    distributors from providing consumers access at the point of sale to
    accurate, scientific citations that include disease references or
    disease treatment terminology in their titles. It thus engages in
    content-based suppression of speech that reduces the quantity of
    scientific substantiation available to the public, thwarting the
    search for truth and scientific inquiry by the lay public. The
    disclaimer approach recommended for structure/function claims that,
    according to FDA, imply disease treatment provide an obvious, less
    speech restrictive alternative that, at once, disabuses consumers of
    the disease treatment connotation (regardless of its source).
    Relying on that approach, FDA need not interfere with the use of
    scientific citations and may, thus, not obstruct the search for
    truth and scientific inquiry. As explained herein, FDA has no lawful
    power under the First Amendmnet to impose this effective ban on the
    use of the citations in question. Accordingly, 21 C.F.R. §
    101.93(g)(2)(C) should be stricken.

[^24]: Indeed, no company could recoup the expense for a nonpatentable
    product.

[^25]: Note well that a consumer of a dietary supplement or food may
    well need to know precisely how that product affects a body
    structure or function to determine the propriety of consumption.
    Thus, a person on anticoagulants, blood pressure lowering drugs, or
    cholesterol lowering drugs may not wish to take dietary supplement
    products that reduce platelet aggregation, lower blood pressure, or
    lower cholesterol, respectively. Moreover, as a general
    matter---regardless of one's health---a known effect upon a body
    structure or function is important to consumers in evaluating
    whether to purchase a food or dietary supplement.

[^26]: Those definitions also include many synonyms for the defined
    terms. [Id.]{.underline}

[^27]: Nutrient content claims describe the level of a nutrient or
    dietary substance in the product, using terms such as "good source,"
    "high" or "free."

[^28]: Health claims describe a relationship between a food substance
    and a disease or health-related condition.

[^29]: In the Authoritative Statement Guidance FDA states that along
    with the National Academy of Sciences and all of its subdivisions,
    the following federal scientific bodies may be sources of
    authoritative statements: the Centers for Disease Control; the
    National Institutes of Health; the Surgeon General within the
    Department of Health and Human Services; the Food and Nutrition
    Service; the Food Safety and Inspection Service; and the
    Agricultural Research Service within the Department of Agriculture.

[^30]: To be sure, FDA's second-guessing of the scientific integrity of
    other federal health agencies' public pronouncements tends to erode
    public confidence not only in those agencies but also in the FDA
    (due to resulting confusion as to which of the government agencies
    is correct).

[^31]: The Solicitor General of the United States recently estimated the
    total cost for NDA approval of a drug not closely similar to an
    approved one, to be on average in excess of \$200 million, citing V.
    Henry, [Problems with Pharmaceutical Regulations in the United
    States]{.underline}, 14 J. Leg. Med. 617 (1993); JA Henderson Jr. &
    A.D. Twerski, [Drug Designs are Different]{.underline}, 111 Yale
    L.J. 151, 164-165 (2001). [See]{.underline} Brief for Petitioners in
    [Thompson v. Western States Medical Ctr. et al.]{.underline}, Case
    No. 01-344 at 26 (Dec. 31, 2001). The Solicitor General estimated
    the cost for NDA approval of a new drug that closely resembles an
    approved drug (approval under an ANDA) to range from \$300,000 to
    \$500,000 citing Balaji, K., [Generics: the Opportunity
    Beckons]{.underline} (July 2001)
    [http:///www.inpharm.com/intelligence/frost010701.html]().
    [See]{.underline} Brief for Petitioners at 26-27.

[^32]: All FDA policies discussed in this section are universally
    applied to human and animal drugs. [See]{.underline} 21 U.S.C. §§
    352 (misbranded drugs and devices) and 351 (adulterated drugs and
    devices). Under the FDCA the term "drug" includes articles intended
    for use in the diagnosis, cure, mitigation, treatment, or prevention
    of disease in man or other animals. 21 U.S.C. § 321(g). Similarly
    drugs and medical devices are regulated under the same statutory and
    regulatory policies discussed in this section. [See]{.underline}
    [Washington Legal Foundation v. Henney]{.underline}, 202 F.3d 331
    (D.C.Cir. 2000) (citations omitted)(hereinafter
    "[WLF]{.underline}"). In the following analyses of the First
    Amendment implications of FDA's drug policies the use of the word
    "drug" includes human drugs, animal drugs, and medical devices.

[^33]: For purposes of this section the term manufacturer includes both
    the actual manufacturer of the product and any distributors.

[^34]: It is the costliness and lengthiness of the new drug approval
    process that has generated the industry custom of off-label uses in
    healthcare. In some instances with rapidly proliferating disease, as
    was seen with AIDS, doctors cannot wait for the FDA to complete a
    new drug approval before using drugs on patients for when there are
    no alternatives. In other situations there are so few potential
    users of a drug that a manufacturer has no incentive to incur the
    extraordinary costs of new drug approval for an off-label use
    because it has no hope of recouping those costs. In the case of
    pediatric drugs, manufacturers are reluctant for obvious ethical
    reasons to conduct clinical trials on children to show safety and
    effectiveness of a drug and argue that it is difficult, if not
    impossible, to obtain permission from parents to use their children
    as participants.

[^35]: [U.S. v. Batchelder]{.underline}, 442 U.S. 114, 122
    (1979)(stating the "maxim that a statute should be construed to
    avoid constitutional questions").

[^36]: Part 99 of the C.F.R. applies to prescription drugs, devices, and
    biologics. 21 C.F.R. § 99.1(a) (2002). Hereinafter any reference to
    "drug" includes also devices and biologics.

[^37]: The requirements governing the dissemination of information were
    created in the Food, Drug and Modernization Act of 1997, Pub. L. No.
    105-115, 111 Stat. 2296, Section 551 (hereinafter "FDAMA").

[^38]:
    #  The D.C. Circuit left open whether such an enforcement action would violate the First Amendment, refusing to consider the question without a true case or controversy before it. [See]{.underline} [WLF]{.underline}, supra, at 336. "A manufacturer, of course, may still argue that the FDA's use of a manufacturer's promotion of off-label uses as evidence in a particular enforcement action violates the First Amendment." [Id.]{.underline} at 336 n6.

[^39]: [See]{.underline} Part II above at 16 for explanation of legal
    prohibition on agency enforcement of unconstitutional law.

[^40]: The same constitutional analysis applies when manufacturers use
    the Internet for the dissemination of scientific literature.

[^41]: In [WLF]{.underline} the parties agreed that the Educational
    Activities Guidance did not facially violate the law, eliminating
    the constitutional controversy between the parties.
    [Id.]{.underline} at 336.

[^42]: The same constitutional analysis applies when manufacturers use
    the internet for educational activities that they sponsor.

[^43]: Advertising is generally the jurisdiction of the FTC but in 1962
    Congress gave jurisdiction over the advertising of prescription
    drugs to the FDA. Drug Amendments of 1962 See 21 U.S.C. § 502(n).

[^44]: Participants may have said "yes" to more than one answer to that
    question. [Id.]{.underline}

[^45]: Print advertisers must include a copy of the labeling with the
    ad. [Id.]{.underline}

[^46]: The term is a misnomer. The brief summary is anything but brief.

[^47]: In April, 2001, FDA proposed a draft guidance for comment on
    using FDA-approved patient-labeling in consumer directed print
    advertisements. See <http://www.fda.gov/cber/gdlns/consumad.htm>
    (last visited 8/19/02). FDA proposed to accept patient-friendly
    labeling approved by FDA for use as the brief summary so long as the
    labeling contained 1) all the contraindications; 2) all the
    warnings; 3) all the major precautions; and 4) all other frequently
    occurring side effects that are likely to be drug related. FDA
    patient approved labeling with a narrow focus such as those that
    focus on a single warning or on giving instructions for use would
    not be acceptable substitutions for the brief summary requirement.
    [See id.]{.underline}

[^48]: Advertisements broadcast through media such as radio, television,
    or telephone communications systems must include information
    relating to the major side effects and contraindications of the
    advertised drugs in the audio or audio and visual parts of the
    presentation. Unless adequate provision is made for dissemination of
    the approved or permitted package labeling in connection with the
    broadcast presentation, those advertisements must contain a brief
    summary of all necessary information related to side effects and
    contraindications. [See]{.underline} 21 C.F.R. § 202.1(e)(1). The
    disclosure of the major risks is sometimes called the major
    statement.

[^49]: If any part or theme of the advertisement would make the
    advertisement false or misleading by reason of the omission of
    appropriate qualification or pertinent information, that part or
    theme must include the appropriate qualification or pertinent
    information, which may be concise if it is supplemented by a
    prominent reference on each page to the presence and location
    elsewhere in the advertisement of a more complete discussion of such
    qualification or information. [Id.]{.underline} at 202.1(e)(3)(i).

[^50]: A manufacturer may choose to submit an advertisement to FDA for
    pre-approval for the FDA's comments. 21 C.F.R. § 202.1(j)(4).

[^51]: We hasten to note that the pharmacist forms another layer of
    protection for patients. Pharmacists routinely apprise patients of
    adverse reactions possible from drugs and of drug-drug, drug-food,
    and drug-nutrient interactions.

[^52]: 21 U.S.C. § 379h(b)(1)(A).