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 )**

**)**

**)**

**)**

# REPLY COMMENTS OF

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

## [Jonathan W. Emord]{.underline};

Claudia A. Lewis-Eng;

Andrea G. Ferrenz;

Jonathan R. Goodman;

Kathryn E. Balmford,

Legal Counsel

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

## [1050 Seventeenth Street, N.W.]{.underline}

## [Suite 600]{.underline}

Washington, D.C. 20036

**•**

## [5282 Lyngate Cour]{.underline}t

Burke, VA 22015

## [Phone: 202-466-6937 • Fax: 202-466-6938]{.underline}

<jemord@emord.com>

Table of Contents

Introduction 2

I. When Less Speech Restrictive Alternatives Exist, They Must Be Adopted
3

**II. Requirement of Conclusive or Near Conclusive Proof as a
Condition**

**Precedent for the Right to Speak Violates the First Amendment 4**

III\. The First Amendment Requires Use of Disclaimers as a Less Speech
Restrictive

Alternative, Policy Preferences to the Contrary Notwithstanding 11

A. Rights of the Speaker v. Rights of the Listener 13

B. Testing Disclaimers on Consumers 18

C. Disclaimers and the Western States and Pearson Decisions 18

D. The First Amendment Strictures on FDA Speech Suppression Apply
Equally to

Health Claims for Dietary Supplements and Foods 20

### 

### IV. The First Amendment Forbids Speech Suppression Effected by Excessive 

###  Burdens on Truthful Speech, Such as FDA's Present Policy of Prohibiting 

###  Treatment Claims for Dietary Supplements and Foods Without New Drug

###  Approval 21

**V. FDA Suppression of Off-Label Use Information Concerning Approved
Drugs**

**Violates the First Amendment 24**

VI\. Conclusion 29

**Table of Authorities**

+-----------------------------------------------------------+----------+
| **Cases**                                                 |          |
+-----------------------------------------------------------+----------+
| *Supreme Court*                                           |          |
+-----------------------------------------------------------+----------+
| [44 Liquormart v. Rhode Island]{.underline}, 517 U.S. 484 | 6, 8     |
| (1996)..................................                  |          |
+-----------------------------------------------------------+----------+
| [Abrams v. United States]{.underline}, 250 U.S. 616       | 16       |
| (1919)..........................................          |          |
+-----------------------------------------------------------+----------+
| [Bates v. State Bar of Arizona]{.underline}, 433 U.S. 350 | 8, 15    |
| (1977)....................................                |          |
+-----------------------------------------------------------+----------+
| [Bolger v. Youngs Drug Products Corp.]{.underline}, 463   | 8, 14,   |
| U.S. 60 (1983)..........................                  | 15       |
+-----------------------------------------------------------+----------+
| [Butler v. Michigan]{.underline}, 352 U.S. 380            | 14       |
| (1957)................................................    |          |
+-----------------------------------------------------------+----------+
| [Central Hudson Gas & Elec. Corp. v. Public Serv.         | 6, 8, 9, |
| Comm'n]{.underline}, 447 U.S. 557                         | 20       |
| (1980)..................................                  |          |
| .....................................................\... |          |
+-----------------------------------------------------------+----------+
| [Cincinnati v. Discovery Network, Inc.]{.underline}, 507  | 8        |
| U.S. 410 (1993)..........................                 |          |
+-----------------------------------------------------------+----------+
| [Edenfield v. Fane]{.underline}, 507 U.S. 761             | 5, 8, 15 |
| (                                                         |          |
| 1993)................................................\... |          |
+-----------------------------------------------------------+----------+
| [Elrod v. Burns]{.underline}, 427 U.S. 347                | 18       |
| (197                                                      |          |
| 6)...................................................\... |          |
+-----------------------------------------------------------+----------+
| [Florida Bar v. Went For It, Inc.]{.underline}, 515 U.S.  | 9        |
| 618 (1995)..................................              |          |
+-----------------------------------------------------------+----------+
| [Friedman v. Rogers]{.underline}, 440 U.S. 1              | 8        |
| (                                                         |          |
| 1979)................................................\... |          |
+-----------------------------------------------------------+----------+
| [Ibanez v. Florida Dep't of Business and Prof'l           | 7, 8, 10 |
| Regulation]{.underline}, 512 U.S. 136                     |          |
| (1994)..................................                  |          |
| .....................................................\... |          |
+-----------------------------------------------------------+----------+
| [In Re R.M.J.]{.underline}, 455 U.S. 191                  | 7, 10    |
| (1982                                                     |          |
| )........................................................ |          |
+-----------------------------------------------------------+----------+
| [Lakewood v. Plain Dealer Publ'g Co.]{.underline}, 486    | 18       |
| U.S. 750 (1988)........................\...               |          |
+-----------------------------------------------------------+----------+
| [Linmark Associates, Inc. v. Willingboro]{.underline},    | 8        |
| 431 U.S. 85 (1977)........................                |          |
+-----------------------------------------------------------+----------+
| [Marbury v. Madison]{.underline}, 5 U.S. 137              | 20       |
| (1803)..................................................  |          |
+-----------------------------------------------------------+----------+
| [Miami Herald Pub. Co. v. Tornillo]{.underline}, 418 U.S. | 17       |
| 241 (1974)...........................\...                 |          |
+-----------------------------------------------------------+----------+
| [Peel v. Attorney Registration and Disciplinary           | 7, 10    |
| Comm'n]{.underline}, 496 U.S. 91 (1990)...\...            |          |
+-----------------------------------------------------------+----------+
| [Posadas de Puerto Rico Associates v. Tourism Co. of      | 8        |
| P.R.]{.underline}, 478 U.S. 328 (1986)..                  |          |
+-----------------------------------------------------------+----------+
| [Rubin v. Coors Brewing Co.]{.underline}, 514 U.S. 476    | 5, 8     |
| (1995).....................................               |          |
+-----------------------------------------------------------+----------+
| [Thompson v. Western States Medical Center]{.underline},  | *passim* |
| 122 S. Ct. 1497 (2002)............\...                    |          |
+-----------------------------------------------------------+----------+
| [United States v. Edge Broadcasting Co.]{.underline}, 509 | 8        |
| U.S. 418 (1993).....................\...                  |          |
+-----------------------------------------------------------+----------+
| [Virginia State Board of Pharmacy, et. al. v. Virginia    | 5, 6,    |
| Citizen's Consumer]{.underline}                           | 13, 16   |
|                                                           |          |
| [Council, Inc., et.al.]{.underline}, 425 U.S. 748         |          |
| (1976)................................................    |          |
+-----------------------------------------------------------+----------+
| [Zauderer v. Office of Disciplinary Counsel of the        | 8, 14    |
| Supreme Court of Ohio]{.underline},                       |          |
|                                                           |          |
| 471 U.S. 626                                              |          |
| (1985)................                                    |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
|                                                           |          |
+-----------------------------------------------------------+----------+
| *Federal Court*                                           |          |
+-----------------------------------------------------------+----------+
| [National Association for the Advancement of Colored      | 13       |
| People v. Jones]{.underline},                             |          |
|                                                           |          |
| 131 F.3d 1317 (9^th^ Cir.                                 |          |
| 1997).......                                              |          |
| .....................................................\... |          |
+-----------------------------------------------------------+----------+
| [Nutritional Health Alliance v. Shalala]{.underline}, 144 | 18       |
| F.3d 220 (2^nd^ Cir. 1998)................                |          |
+-----------------------------------------------------------+----------+
| [Pearson v. Shalala]{.underline}, 164 F.3d 650 (D.C. Cir. | *passim* |
| 1999).....................................                |          |
+-----------------------------------------------------------+----------+
| [Pearson v. Shalala]{.underline}, 172 F.3d 72 (D.C. Cir.  | 4        |
| 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)...........................                  |          |
+-----------------------------------------------------------+----------+
| [Washington Legal Foundation v. Kessler]{.underline}, 880 | 25       |
| F. Supp. 26 (D.D.C. 1995).........                        |          |
+-----------------------------------------------------------+----------+
|                                                           |          |
+-----------------------------------------------------------+----------+
|                                                           |          |
+-----------------------------------------------------------+----------+
| **Statutes and Regulations**                              |          |
+-----------------------------------------------------------+----------+
| 21 C.F.R. §                                               | 9, 19    |
| 101.14...................                                 |          |
| .....................................................\... |          |
+-----------------------------------------------------------+----------+
| 21 C.F.R. §                                               | 17       |
| 101.79...................                                 |          |
| .....................................................\... |          |
+-----------------------------------------------------------+----------+
| 21 C.F.R. §                                               | 19       |
| 190.6.................                                    |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
| 21 C.F.R. §                                               | 9        |
| 314.50...................                                 |          |
| .....................................................\... |          |
+-----------------------------------------------------------+----------+
| 21 U.S.C. §                                               | 18       |
| 101.70...................                                 |          |
| .....................................................\... |          |
+-----------------------------------------------------------+----------+
| 21 U.S.C. §                                               | 19, 22   |
| 321.....................                                  |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
| 21 U.S.C. §                                               | 7, 19    |
| 331.....................                                  |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
| 21 U.S.C. §                                               | 19       |
| 342.....................                                  |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
| 21 U.S.C. §                                               | *passim* |
| 343.....................                                  |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
| [Request for Comment of First Amendment                   | 2        |
| Issues]{.underline}, 67 Fed. Reg. 34,942                  |          |
|                                                           |          |
| (May 16,                                                  |          |
| 2002)......................                               |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
|                                                           |          |
+-----------------------------------------------------------+----------+
| **Miscellaneous**                                         |          |
+-----------------------------------------------------------+----------+
| Annette Dickinson, [Benefits of Folic Acid: Protection    | 18       |
| Against Neural Tube Defects]{.underline}                  |          |
| (2002).......................                             |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
| General Accounting Office Report No. T-HEHS-96-212        | 25       |
| (September 12, 1996)...                                   |          |
+-----------------------------------------------------------+----------+
| Green, ML, [Evidence-based medicine training in internal  | 27       |
| medicine residency programs a national                    |          |
| survey]{.underline}, 15 [J Gen Intern]{.smallcaps}        |          |
| M[ed]{.smallcaps}, Feb. 2000.......................       |          |
+-----------------------------------------------------------+----------+
| <http://www.acgme.org/IRC/IRCpr900.asp> (visited on Oct.  | 27       |
| 21, 2002)...............                                  |          |
+-----------------------------------------------------------+----------+
| Medio, FJ, et al., [Implementation of a college-wide GME  | 27       |
| core curriculum]{.underline}, 76 [Acad Med]{.smallcaps},  |          |
| Apr.                                                      |          |
| 2001.............                                         |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
| [Nutrition Business Journal]{.underline}, Annual Business | 22       |
| Review (September 1998).........\...                      |          |
+-----------------------------------------------------------+----------+
| S. Rep. No. 103-410                                       | 17, 22   |
| (1994).......                                             |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
| Shayana Kadidal, Note, [Plants, Poverty, and              | 22       |
| Pharmaceutical Patents]{.underline}, 103 [Yale            |          |
| L.J.]{.smallcaps} 223                                     |          |
| (1993)......................                              |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
| Steven R. Simon, et al., [Teaching First-Year Students    | 27       |
| the Building Blocks of Evidence-Based                     |          |
| Medicine,]{.underline}                                    |          |
| <http://www.hms.harvard.edu/oed/MENEWS/V3N1/CRITICAL.HTM> |          |
| (visited Oct. 21,                                         |          |
| 2002).........................                            |          |
| .....................................................\... |          |
+-----------------------------------------------------------+----------+
| V. Henry, [Problems with Pharmaceutical Regulations in    | 22       |
| the United States]{.underline}, 14 [J. Leg.               |          |
| Med.]{.smallcaps} 617                                     |          |
| (1993)..............                                      |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
| William E. Connor, [n-3 Fatty Acids From Fish and Oil:    | 17       |
| Panacea or nostrum?]{.underline}, 74 [Am J Clin           |          |
| Nutr]{.smallcaps} 415                                     |          |
| (2001)......                                              |          |
| ......................................................... |          |
+-----------------------------------------------------------+----------+
|                                                           |          |
+-----------------------------------------------------------+----------+
|                                                           |          |
+-----------------------------------------------------------+----------+
|                                                           |          |
+-----------------------------------------------------------+----------+

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 )**

**)**

**)**

**)**

# REPLY COMMENTS OF

**JULIAN M. WHITAKER, M.D.; DURK PEARSON AND SANDY SHAW; PURE
ENCAPSULATIONS, INC.; WELLNESS LIFESTYLES, INC.; SUAREZ [CORPORATION
INDUSTRIES, 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.; and the Life Extension Foundation (hereinafter "Joint
Commenters") hereby submit their reply comments to various parties'
submissions filed in response to FDA's request for evaluation of First
Amendment issues arising from agency speech regulation.

Comments from groups that advocate retention of existing speech
restrictive rules, policies, and practices, or greater imposition of
restrictions on protected speech, ignore or misinterpret apposite legal
precedent. Several of those commenters advocate speech suppression when
obvious, less speech restrictive, and nonspeech related, regulatory
alternatives exist to achieve government objectives. Certain of those
commenters have presented [ad hominem]{.underline} argument, neither
relevant to any aspect of the FDA's present inquiry nor the First
Amendment issues at stake. Below the Joint Commenters explain in detail
the legal failings in the comments that favor suppression and reiterate
the command of apposite precedent that disclosure, not suppression, must
immediately become the general rule of construction if FDA is to comply
with the First Amendment.

**[Introduction]{.underline}**

In direct response to the Supreme Court's decision in [Thompson v.
Western States Medical Center]{.underline}, 122 S. Ct. 1497 (2002), FDA
invited public comment to determine the extent to which its speech
regulation complies with the First Amendment. [Request for Comment of
First Amendment Issues]{.underline}, 67 Fed. Reg. 34,942 (May 16, 2002).
In response to that request, the Joint Commenters presented a
comprehensive analysis of FDA speech regulation under the applicable
First Amendment standards, finding systemic violations. The Joint
Commenters recommended less speech restrictive regulatory alternatives
for each unconstitutional regulation, policy, and practice. The
recommended alternatives favor disclosure over suppression and rely on
disclaimers, consistent with the Supreme Court, our Court of Appeals,
and the federal district courts' constitutional mandates to this agency.

Although many comments filed with FDA favor First Amendment compliance,
including most notably those from the Grocery Manufacturers'
Association, Comment No. C21 and the Consumer Healthcare Products
Association, Comment No. C67, certain comments advocate either retention
of unconstitutional regulations or imposition of new speech restrictions
in violation of the First Amendment. Many of those submissions, such as
those made by the American Medical Association, the American Academy of
Pediatrics, and the Association of Food and Drug Officials include [ad
hominem]{.underline} argument. Such argument is neither germane to the
legal issues raised by FDA nor competent legal justifications for a
departure from controlling First Amendment precedent. That controlling
precedent forbids reliance on regulatory strictures in excess of obvious
less speech restrictive alternatives and compels adherence to a general
rule of disclosure over suppression. [See generally, Thompson v. Western
States Medical Center]{.underline}, 122 S. Ct. 1497 (2001); [Pearson v.
Shalala]{.underline}, 164 F.3d 650 (D.C. Cir. 1999). While the [ad
hominem]{.underline} arguments state each respective organization's
public policy objectives, they do not explain how FDA institution of new
speech suppressive rules, policies, and practices to implement those
objectives can comply with controlling First Amendment precedent.
Accordingly, they may be dismissed without further ado as irrelevant.
Shorn of [ad hominem]{.underline} argument, the remaining comments that
advocate steps in violation of the First Amendment are analyzed below.

**I.**

**[WHEN LESS SPEECH RESTRICTIVE ALTERNATIVES EXIST, THEY MUST BE
ADOPTED]{.underline}**

One commenter claimed that "FDA needs [more]{.underline} regulatory
authority to control the untruthful and misleading speech of food and
supplement companies." Comment No. C1 at 3 (emphasis in original). That
commenter fails to appreciate that FDA already has statutory authority
to prohibit false and misleading claims. The Federal Food, Drug, and
Cosmetic Act deems a food or dietary supplement to be misbranded if its
labeling or advertising contains any false or misleading statement. 21
U.S.C. § 343. Further, as explained [infra]{.underline}, existing law
allows FDA to suppress outright speech that the agency proves to be
"inherently misleading," i.e., speech which cannot be rendered truthful
and nonmisleading through the addition of a disclaimer (where there is
no credible evidence to support a claim and the weight of credible
evidence is against it). However, as explained [infra]{.underline},
First Amendment issues arise not when FDA suppresses "inherently
misleading" statements, but, rather, when it restricts, burdens, or
suppresses "potentially misleading" statements and nonmisleading
statements. Thus, existing law more than adequately provides FDA with
authority to ban inherently misleading speech in the food and dietary
supplement industry, but forbids FDA from trenching on potentially
misleading and truthful speech. In those latter areas, FDA must choose
nonspeech related regulatory alternatives or less speech restrictive
regulatory alternatives. [See, e.g. Western States]{.underline}, 122 S.
Ct. at 1510.

**II.**

**[REQUIREMENT OF CONCLUSIVE OR NEAR CONCLUSIVE PROOF]{.underline}**

**[AS A CONDITION PRECEDENT FOR THE RIGHT TO SPEAK]{.underline}**

**[VIOLATES THE FIRST AMENDMENT]{.underline}**

Certain commenters demand that FDA prohibit the use of any health claims
unless FDA concludes that they are backed by conclusive or near
conclusive scientific evidence. [See, e.g.]{.underline}, Comment No.
C13; Comment No. C35; Comment No. C37; Comment No. C40; and Comment No.
C68. That position has been soundly rejected in the controlling
precedent of [Pearson v. Shalala]{.underline}, 164 F.3d 650 (D.C. Cir.
1999) ("[Pearson]{.underline} I"), [rehearing denied]{.underline},
[Pearson v. Shalala]{.underline}, 172 F.3d 72 (D.C. Cir. 1999); [Pearson
v. Shalala]{.underline}, 130 F. Supp. 2d 105 (D.D.C. 2001)
("[Pearson]{.underline} II"); and [Pearson v. Thompson]{.underline}, 141
F. Supp. 2d. 105 (D.D.C. 2001) ("[Pearson]{.underline} III"). In the
[Pearson]{.underline} line of cases the Courts have made it abundantly
clear that suppression of claims that are based on credible but
inconclusive scientific evidence violates the First Amendment.
[See]{.underline} [Pearson]{.underline} I, 164 F.3d at 658;
[Pearson]{.underline} II, 130 F. Supp. 2d at 114; and
[Pearson]{.underline} III, 141 F. Supp. 2d at. 111. So long as the
claims are backed by credible scientific evidence, and scientific
evidence against the claims does not outweigh scientific evidence for
them, our federal courts demand that this agency allow the claims to be
made and rely on accurate and succinct disclaimers to correct for
potential misleadingness. [See]{.underline} [Pearson]{.underline} II at
118, and [Pearson]{.underline} III at 111 .

Under our First Amendment, disclosure of all information that is or can
be rendered nonmisleading (and governmental reliance on disclaimers,
rather than suppression, whenever possible) is the bare minimum
operating requirement. Under our First Amendment, the burden of proof
(indeed, the great onus of the law) is squarely against
[any]{.underline} act of speech suppression unless [proof]{.underline}
reveals censorship the only way to avoid misleadingness. The First
Amendment compels Government to tread very lightly in matters of speech,
forever circumspect and cautious to avoid disallowing a private message
that harbors truth, even if masked in language that may convey a
potentially misleading connotation. The Constitution protects
potentially misleading information and places on government a very high
burden to avoid suppression of that information. [See]{.underline}
[Western States]{.underline}, 122 S. Ct. at 1507 ("\[i\]f the First
Amendment means anything, it means regulating speech must be a
last---not a first---resort"); [Id.]{.underline} at 1503; [see
also]{.underline} [Edenfield v. Fane]{.underline}, 507 U.S. 761 (1993);
[Rubin v. Coors Brewing Co.]{.underline}, 514 U.S. 476 (1995).

The aforementioned commenters' position not only contradicts the
controlling precedent, it proceeds from an erroneous paternalistic
assumption, contrary to the most basic principles that undergird our
First Amendment, that consumers of foods, dietary supplements, drugs,
medical devices, and cosmetics will generally act against their own
self-interests if accurately informed of scientific evidence. That
argument lacks support in fact and logic and it affronts the very strong
presumption that has been a part of First Amendment law for over
twenty-five years: i.e., "that people will perceive their own best
interests if only they are well enough informed." [Virginia State Board
of Pharmacy v. Virginia Citizen's Consumer Council, Inc.]{.underline},
425 U.S. 748, 770 (1976), *cited in* [Western States]{.underline} 122 S.
Ct. at 1508. Moreover, the argument is a non-sequitur, because, on the
one hand, those commenters would allow claims proven to a near
conclusive degree without fear of consumers acting with that information
in ways counter to their own best interests, yet have no faith in
consumers to evaluate less than conclusive evidence qualified to impress
upon consumers the existence of that inconclusiveness.

The commenters present no sound empirical evidence to prove that legally
available dietary supplements carrying truthful claims are in any way
dangerous to consumers. Indeed, it stands to reason that consumers are
best able to discern their own self-interest in the purchase of legally
available products if adequately informed, and the best means to allow
pursuit of consumer self-interest is through opening communication
channels rather than closing them. That, at any rate, is the clear
requirement of apposite First Amendment precedent. [See]{.underline}
[Virginia Bd. of Pharmacy v. Virginia Citizens Consumer Council,
Inc.]{.underline}, 425 U.S. 748, 770 (1976); [Western
States]{.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. 484, 503
(1996) ("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");

The Federal Trade Commission's empirical data makes clear that consumers
do indeed pursue their own interests with greater efficiency and
effectiveness if the channels of communication are open to accurate
information on the health and disease mitigation, prevention, and cure
effects of foods, dietary supplements, drugs, medical devices, and
cosmetics. [See]{.underline} Comment No. EMC163.

Certain commenters would prefer that FDA eliminate the court-mandated
disclaimer approach of [Pearson]{.underline} and return to the
unconstitutional requirement that no health claim for a dietary
supplement or food be allowed unless pre-approved by FDA upon finding
"significant scientific agreement." [See]{.underline} Comment No. C13
and Comment No. C80. That view, like the aforementioned demand for
conclusive or near conclusive scientific evidence as a condition
precedent for claim allowance, ensures suppression of protected speech,
of accurate claims concerning less than conclusive proof of
nutrient-disease relationships.

Under the First Amendment there is no justification for adopting a
general rule that favors suppression of truthful or potentially
misleading but correctable claims. The Court has consistently struck
down blanket speech bans of that kind insisting that government rely on
less speech restrictive means, such as disclaimers. [See]{.underline}
[In Re R.M.J.]{.underline}, 455 U.S. 191 (1982); [Ibanez v. Florida
Dep't of Business and Prof'l Regulation]{.underline}, 512 U.S. 136
(1994); [Peel v. Attorney Registration and Disciplinary
Comm'n]{.underline}, 496 U.S. 91 (1990).

One commenter wants FDA to prohibit structure/function claims that are
not backed by "significant scientific agreement." [See]{.underline}
Comment No. C80. That approach exceeds the scope of FDA's statutory
authority. Congress has only required that FDA be served with notice of
the filing of structure/function claims within 30 days of first
marketing supplements with those claims. [See]{.underline} 21 U.S.C. §
343(r)(6)(C). Congress has not seen fit to authorize pre-clearance
procedures for structure/function claims. By contrast, Congress has
required pre-market evaluation of health claims and has specified a
scientific review process. [See]{.underline} 21 U.S.C. § 343(r)(5)(D).
Subjecting the former to the requirements of the latter would deny
opportunities for speech Congress meant to preserve against prior
restraint and review. FDA has the power, of course, to enforce the Act's
provisions against false and misleading claims of any kind (including
false structure/function claims) and, so, FDA can put an end to falsity
in that realm through enforcement of those provisions of the Act.
[See]{.underline}, 21 U.S.C. § 331.

Concerning health claims, FDA must determine whether each claim it
chooses not to "authorize" under "significant scientific agreement" is
"inherently misleading" or only "potentially misleading."
[Pearson]{.underline} I clearly held that a health claim lacking
"significant scientific agreement" is not *per se* inherently misleading
and must be evaluated under all parts of the [Central
Hudson]{.underline} test as modified by its progeny.
[Pearson]{.underline} I at 655 (Court rejected FDA's argument that
health claims lacking "significant scientific agreement" are inherently
misleading by that fact alone). Thus, in [Pearson]{.underline} I, the
Court found that health claims backed by credible but inconclusive
scientific evidence and lacking "significant scientific agreement" might
only be deemed "potentially misleading," [Id.]{.underline} at 655, and
would therefore be protected speech under the First Amendment,
suppressible only if no conceivable disclaimer could be found to avoid
potential misleadingness. With such "potentially misleading" speech, the
[Pearson]{.underline} I Court reminded FDA that "the preferred remedy is
more disclosure, rather than less," (*citing* [Bates v. State Bar of
Arizona]{.underline}, 433 U.S. 350, 375 (1977); [Cf.]{.underline} [44
Liquormart]{.underline} 116 S. Ct. at 1517, *citing* [Linmark
Associates, Inc. v. Willingboro]{.underline}, 431 U.S. 85, 96-97 (1977);
[Friedman v. Rogers]{.underline}, 440 U.S. 1, 8-9 (1979); [Bolger v.
Youngs Drug Products Corp.]{.underline}, 463 U.S. 60, 79 (1985)
(Rehnquist, J., for two Justices, concurring in judgment); [Zauderer v.
Office of Disciplinary Counsel of Supreme Court of Ohio]{.underline},
471 U.S. 626, 646 (1985); [Posadas de Puerto Rico Associates v. Tourism
Co. of P.R.]{.underline}, 478 U.S. 328, 350-51 (1986) (Brennan, J., for
three Justices, dissenting); [Cincinnati v. Discovery Network,
Inc.]{.underline}, 507 U.S. 410, 421-22 (1993) (Blackmun, J.,
concurring); [Edenfield v. Fane]{.underline}, 507 U.S. 761, 767 (1993);
[United States v. Edge Broadcasting Co.]{.underline}, 509 U.S. 418,
437-39 (1993) (Stevens, J., for two Justices, dissenting); [Ibanez v.
Florida Dept. of Business and Professional Regulation, Bd. of
Accountancy]{.underline}, 512 U.S. 136, 142-43 (1994); [Rubin v. Coors
Brewing Co.]{.underline}, 514 U.S. 476, 481-82 (1995) (Stevens, J.,
concurring in judgment); [Florida Bar v. Went For It, Inc.]{.underline},
515 U.S. 618, 639-40 (1995) (Kennedy, J., for four justices,
dissenting)) and disclaimers are "constitutionally preferable to
outright suppression." [Pearson]{.underline} I at 657.

One of the commenters advocates nevertheless that FDA expand the
definition of "inherently misleading" speech to embrace every claim not
authorized by FDA under its scientific review standards ("substantial
scientific evidence" for drugs, 21 C.F.R. § 314.50, and "significant
scientific agreement" for foods and dietary supplements, 21 C.F.R. §
101.14(c)). [See]{.underline} Comment No. C53. The effect of the
commenter's position is to revert to the pre-[Pearson]{.underline}
condition in which all disease prevention and treatment claims not
deemed by FDA proven to a near conclusive degree were held "inherently
misleading" by the agency and suppressed outright. [See]{.underline}
Comment No. C53.

The argument presumes that FDA's scientific review standards may
substitute for the analysis prescribed under the First Amendment.
[Pearson]{.underline} makes clear they may not. [See,
Pearson]{.underline} I at 658-659. As discussed [supra]{.underline},
that very view was a centerpiece in FDA's defense in [Pearson v.
Shalala;]{.underline} it was rejected by our Court of Appeals.
[See]{.underline} [Pearson]{.underline} I. 163 F.3d at 657. The
[Pearson]{.underline} Court, relying on an unbroken line of
post-[Central Hudson]{.underline} decisions, explains that claims backed
by credible but inconclusive scientific evidence are protected speech
under the First Amendment and must be allowed by FDA when disclaimers
can cure misleadingness. [Id.]{.underline} at 659. [See
also]{.underline}, [Pearson]{.underline} II, 130 F. Supp. 2d at 115. The
Court explained that FDA's proper resort is not suppression but
disclosure with disclaimers. [Pearson]{.underline} I at 659. The Court
prescribed the full [Central Hudson]{.underline} multi-part analysis for
the assessment of such speech. The Court explained---consistent with
controlling Supreme Court precedent---that "potentially misleading"
speech (such as claims backed by credible yet inconclusive evidence) are
fully distinguishable from "inherently misleading" speech such that the
former is protected from government suppression, while the latter is
not. [See id.]{.underline} at 655, *citing* [In re R.M.J.]{.underline},
455 U.S. 191, 203 (1982); [Ibanez v. Florida Dep't of Business and
Prof'l Regulation]{.underline}, 512 U.S. 136, 144-46 (1994); [Peel v.
Attorney registration and Disciplinary Comm'n of Illinois]{.underline},
496 U.S. 91, 99-111 (1990).

This same commenter makes the hasty generalization that all health and
drug claims that fail FDA's scientific authorization standards fail by
that fact alone the First Amendment standard. Any force or effect
[that]{.underline} illogical argument once had is no more after
[Pearson]{.underline} I. [See]{.underline}, 164 F.3d at 659. Utterly
rejected in that case, the position is not a legitimate basis upon which
to justify claim suppression. Disclosure over suppression (with
disclaimers as necessary to avoid potential misleadingness) is
emphatically the constitutional order of the day.

Thus, in response to the comments cited [supra]{.underline}, the Joint
Commenters urge FDA to adhere strictly to the holdings of the
[Pearson]{.underline} line of cases and ensure that the agency no longer
relies on its authorization standards to avoid evaluation under, and
compliance with, the governing First Amendment standards. The language
of a health claim is protected speech under the First Amendment and may
not be suppressed absent a strong showing by the Government that the
claim is inherently misleading (not backed by credible scientific
evidence [and]{.underline} specifically outweighed by scientific
evidence [against]{.underline} the claim). [Pearson v.
Shalala]{.underline}, 130 F. Supp. 2d 105 (D.D.C. 2001) (FDA can only
ban claim when there is no credible evidence to support the claim and
the weight of the credible evidence is against it).

The Joint Commenters also urge FDA not to succumb to calls for new
paternalistic rules driven by policy preferences devoid of First
Amendment analysis (ever the bane of free speech) and instead to
facilitate a free flow of commercial information to allow consumers to
make their own educated choices concerning nutrition and disease. All
truthful and nonmisleading claims, as well as all potentially misleading
claims correctable by disclaimer, must be allowed to reach the American
people if we are to enjoy the freedom the First Amendment was designed
to ensure.

**III.**

**[THE FIRST AMENDMENT REQUIRES USE OF DISCLAIMERS AS]{.underline}**

**[A LESS SPEECH RESTRICTIVE ALTERNATIVE, POLICY
PREFERENCES]{.underline}**

**[TO THE CONTRARY NOTWITHSTANDING]{.underline}**

A number of comments claim that the use of disclaimers on the labels and
in the labeling of foods, dietary supplements, medical devices, and
cosmetics is usually insufficient to cure potential misleadingness. On
that premise, they advocate outright suppression of any statement which
may be deemed only potentially misleading. Several of those comments
contend that consumers are either too ignorant or too distracted at the
point of sale to comprehend disclaimers. [See, e.g.]{.underline} Comment
No. C40; Comment No. C13 Supp. 1; Comment No. C53; Comment No. C65; and
Comment No. C80.

All of the foregoing comments, in essence, allege in a conclusory
fashion that disclaimers are ineffective means to eliminate potential
misleadingness and should not be allowed. None of the comments presents
empirical evidence to support that supposition. Moreover, the comments
do not recognize the constitutional implications of what then amounts to
maintenance of a complete ban on protected speech, and do not provide or
recommend any less speech restrictive alternatives, contrary to the
mandate of our federal courts.

As discussed [supra]{.underline}, the [Pearson]{.underline} line of
cases require the FDA to review whether a particular health claim must
be allowed with disclaimers even if not authorized under "significant
scientific agreement" if it is at worst only "potentially misleading"
(i.e., backed by credible but inconclusive scientific evidence).

In opposing disclaimers, the aforementioned commenters make a second,
this time legal, assumption that is in reality contrary to prevailing
First Amendment law. They presume the rights of each speaker secondary
to those of listeners. They presume speakers' rights may be abridged or
denied by government based on an assumed lack of comprehension harbored
by the listener. They also presume that the speech rights of each
speaker may be postponed for an indefinite period to "test" each
possible disclaimer until one is found that is, presumably,
understandable by all (or possibly almost all) or one is found
incomprehensible. In [Pearson]{.underline}, the D.C. Circuit expected
disclosure to be the rule and suppression the rare exception.
[See]{.underline} [Pearson]{.underline} I, 164 F.3d at 658. The Court,
with skepticism, did leave open the possibility that on occasion no
disclaimer may suffice to correct for the deceptiveness of a potentially
misleading claim. In such a circumstance, the Court expected FDA to
"demonstrate with empirical evidence" that no conceivable disclaimer
would suffice. [Id.]{.underline} at 659-660. Certain of the commenters
presume [that]{.underline} empirical evidence to be surveys of public
perception of the meaning of disclaimers. In the context of
[Pearson]{.underline}, however, it is clear that the Court was assessing
whether a claim would yield no disclaimer that (1) corrects
deceptiveness in the claim [and]{.underline} (2) avoids bewildering
consumers. [Id.]{.underline}

Thus, to justify claim suppression, FDA must not only demonstrate with
empirical evidence that a scientific proposition in a health claim
cannot be rendered nonmisleading through plain language disclaimers but
also that the claim itself utterly bewilders consumers. In the words of
our Court of Appeals, such a circumstance is doubtful, and both elements
must be present:

> ...\[W\]hile we are skeptical that the government could demonstrate
> with empirical evidence that disclaimers similar to the ones we
> suggested above would bewilder consumers and fail to correct for
> deceptiveness, we do not rule out the possibility.

[Id.]{.underline} at 659-660.

Thus, the fact that a scientific proposition, albeit true, is beyond the
understanding of consumers is not enough. Government must prove
[both]{.underline} that the claim is deceptive and incurable by
disclaimer and that it bewilders consumers. Reliance on lack of public
comprehension alone is not enough to suppress a speaker's right to speak
the truth. This is especially critical in the case of scientific speech,
which might frequently be beyond the immediate comprehension of many
members of the public.

A. [Rights of the Speaker v. Rights of the Listener]{.underline}

Two commenters assert the hasty generalization, contradicted by the
empirical evidence presented in the FTC's comments, that disclaimers are
always ineffective because consumers are easily confused or the speech
in disclaimers is itself too complex. [See]{.underline}, Comment No.
C40; Comment No. C53. Such assertions fail to recognize that First
Amendment protections do not favor the rights of the listener over those
of the speaker but, rather, recognize listener rights as secondary and
attendant to those of the speaker---only present to the extent that the
listener wishes to receive a message from a willing speaker.
[See]{.underline} [Virginia State Board of Pharmacy]{.underline}, [et.
al. v. Virginia Citizen's Consumer Council, Inc., et. al.]{.underline},
425 U.S. 748, 756 (1976) (stating that "freedom of speech presupposes a
willing speaker," and "the protection afforded is to the communication,
to its source and to its recipients both."). Speaker's rights may not be
abridged to serve the government's perception of listener's interests,
needs, or preferences. [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."). [See
also]{.underline} [Miami Herald Pub. Co. v. Tornillo]{.underline}, 418
U.S. 241 (1974).

FDA cannot suppress a proper disclaimer or a truthful and nonmisleading
health claim simply because some or many in the intended audience do not
comprehend the speaker's message. As the Joint Commenters have
previously explained, the Supreme Court has held the complexity of
speech no justification for suppressing it. [See,]{.underline} [Bolger
v. Youngs Drug Products Corp.]{.underline}, 463 U.S. 60, 74 (1983)
(Speech cannot be abridged solely on the listener's level of
understanding, as "the level of discourse in reaching a mailbox simply
cannot be limited to that which would be suitable for a sandbox."). In
addition, such complex speech cannot be "dumbed down" to make the
information more widely understood. [See,]{.underline} [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 the process of "dumbing down," information is removed:
hence, whatever understanding emerges applies to that lesser amount of
information, not the original message.

Moreover, disclaimers cannot be designed to be a remedial education
lesson or a tool for propounding government political orthodoxy or
scientific dogma rather than a corrective to avoid potential
misleadingness inherent in claim language. The Supreme Court has
explained that disclaimers must be "reasonable" and cannot engender a
"chilling effect" upon the willingness of others to communicate the
speech disclaimed. [See]{.underline} [Zauderer v. Office of Disciplinary
Counsel of the Supreme Court of Ohio]{.underline}, 471 U.S. 626, 651
(1985) ("We recognize that unjustified or unduly burdensome disclosure
might offend the First Amendment by chilling protected commercial
speech"). In [Pearson]{.underline} II, the United States District Court
required FDA to employ a succinct and accurate disclaimer.
[See]{.underline} 130 F. Supp. 2d at 121. If a claim is only potentially
misleading, it must be the precise aim of the agency to correct for that
potential. In that regard, FDA must resort to plain language.
Undoubtedly, every claim (including ones previously approved by FDA)
will not be universally understood. Nutrition and pharmaceutical science
requires advanced education to be understood in all respects. Likewise
disclaimers appended to claims will not be universally understood. Yet
those facts alone do not justify suppression of protected speech because
our Supreme Court has held the complexity of a message no appropriate
ground for censorship. [See]{.underline} [Bolger v. Youngs Drug Products
Corp.]{.underline}, [supra]{.underline}.

Our First Amendment presumes it the province of private parties, not
government, to determine the relevant worth of a message.
[See]{.underline} [Edenfield v. Fane,]{.underline} 507 U.S. 761, 767
(1993) ("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").
Scientific speech (such as nutrient --disease relationships or off-label
use claims for FDA-approved drugs) necessarily penetrates different idea
and information markets at different rates. Among those who study in
these areas, comprehension can be expected to be more complete, while
among those with little or no prior exposure to the subject,
comprehension may be more limited. Nevertheless, the audience's
unfamiliarity and lack of professional expertise are no appropriate
ground for suppressing a willing speaker's truthful message. The fact of
low comprehension for some, or even many, is merely a truism present in
all instances of innovation and speech related to it, not a
distinguishing principle that can justify lessened protection. The ready
solution to lack of comprehension lies in the dissemination of more
information, not in enforced maintenance of ignorance or lessened
sophistication in discourse, reducing all speech to a level deemed
universally understood by government. [See]{.underline} [Bates v. State
Bar of Arizona]{.underline}, 433 U.S. 350, 372-375 (1977) ("...if the
naiveté of the public will cause advertising by attorneys to be
misleading, then it is the bar's role to assure that the populace is
sufficiently informed as to enable it to place advertising in its proper
perspective."). The marketplace of ideas theory, which characterizes the
environment created by the First Amendment, rests on the proposition
that the best test of truth is the power of thought to gain acceptance
in a free and open exchange. [See]{.underline} [Abrams v. United
States]{.underline}, 250 U.S. 616, 630 (1919) (Holmes, J. dissenting).
Our First Amendment rests on the proposition that education and
intellectual evolution must take place by free exchange of ideas and
information for our society to advance. This is no less true in
commercial information markets than in political (and, indeed, our
Supreme Court has found the two interconnected, and commercial
information often to be of far greater import to consumers than the
day's most urgent political debate). [See]{.underline} [Virginia State
Board of Pharmacy v. Virginia Citizen's Consumer Council,
Inc.]{.underline}, 425 U.S. 748, 763 (1976)).

However, one commenter finds it insufficient to rely, at all, on the
idea and information market (and, indeed, on FDA counterspeech),
explaining that consumers lack equal bargaining power with drug company
speakers. [See]{.underline} Comment No. C53. The commenter neglects to
point out that consumers are at an even greater disadvantage with
powerful government agencies: hence, the First Amendment. To be sure,
those who make goods of every kind and description having performance
characteristics that are not self-evident (from drugs to household
cleansers) will generally have greater knowledge of those
characteristics than first-time buyers. But rather than constitute a
powerful argument for speech suppression, as this commenter would have
it, the disparity serves as a powerful argument for providing consumers
open access to more truthful information on those performance
characteristics to ensure the highest prospect for truly informed
decisionmaking in each individual case. While a manufacturer may know
his product best, the consumer knows his needs best, and it is only
through the communication of truthful information that the consumer can
conclude with confidence an economic exchange. Clearly the alternative,
suppression, leaves the regulated product on the market in an
unfortunate information void, increasing, not lessening, opportunities
for false information to be believed (and misuse or misallocation of
resources to occur).

Accordingly, FDA should depend not on expensive consumer perception
surveys to adjudge whether a claim may be allowed (predicated on FDA's
perceived degree of public comprehension of the claim and the
disclaimer). Rather, FDA should focus on whether the claim (according to
its plain language meaning) is true or, at worst, only potentially
misleading. If the latter, FDA should rely on plain language in a
disclaimer to eliminate the precise potential to mislead and thereafter
rely on public education to rectify disparities in comprehension. If FDA
finds comprehension lacking, it should participate in idea markets by
publishing (and encouraging others to publish) to the public
explanations of the meaning of the science involved. That approach
comports with the First Amendment preference for disclosure over
suppression and is clearly a less speech restrictive alternative to
suppression of protected speech or to prolonged delays in allowing
protected speech to enter the market.[^1] Moreover, that approach gives
no credit to the idea market where the claim will invariably be bandied
about, evaluated, and tested. An open exchange will affect public trust
in the statement far more than will the claim itself or FDA's opinion of
it. The claim is, in effect, a catalyst to debate, not the conclusion of
all discussion on the topic as those who harbor paternalistic desires
for suppression seem to believe.

B. [Testing Disclaimers on Consumers]{.underline}

Two commenters urge FDA to consider testing disclaimers on consumers to
determine their impact before the claims are ever allowed to reach the
market. [See]{.underline} Comment No. C13 Supp. 1 and Comment No. C80.
Such a request runs contrary to First Amendment jurisprudence which
unequivocally states that "the loss of First Amendment freedoms, even
for minimal periods of time, unquestionably constitutes irreparable
injury." [Pearson]{.underline} II, 130 F. Supp. 2d. at 119 (*citing*
[Elrod v. Burns]{.underline}, 427 U.S. 347, 373 (1976). [See
also]{.underline} [Lakewood v. Plain Dealer Publ'g Co.]{.underline}, 486
U.S. 750, 758 (1988) (noting that "opportunities for speech," if
suppressed, "are irretrievably lost."). Potentially misleading claims
cannot be suppressed beyond the 540 days held to be the point at which
FDA's evaluative process becomes an unconstitutional prior restraint.
[See]{.underline} [Nutritional Health Alliance v. Shalala]{.underline},
144 F.3d 220 (2^nd^ Cir. 1998); 21 U.S.C. § 101.70 (setting 540 day
limit on health claim review). The less speech restrictive alternative
is for FDA to encourage by its example greater public awareness of the
meaning of the approved and allowed claims and disclaimers, not to
suppress them in search for an unachievable universal or near universal
government "accepted" or "desired" understanding of claim meaning.

C. [Disclaimers and the Western States and Pearson
Decisions]{.underline}

One commenter misinterprets the courts' decisions in the [Western States
Medical Center]{.underline} and [Pearson]{.underline} cases. Comment No.
C80. Notably, that commenter asks FDA to misapply the holdings of those
cases to make new regulations inconsistent with legal precedent. The
commenter falsely represents that the [Pearson]{.underline} opinion
relieves FDA of the need to "consider using the disclaimer approach if a
proposed health claim not based on significant scientific agreement
pertains to an essential organ or a serious health condition."
[See]{.underline} Comment No. C80 at 19-20. The commenter goes on to
argue that this alleged exception also pertains to claims regarding risk
factors for cancer, heart disease, and Alzheimer's disease, among other
health conditions. It also asserts that "the court recognized in
situations where either consumer health or safety is involved, claims
supported by preliminary scientific evidence would be inappropriate even
if accompanied by a disclaimer." [Id.]{.underline} Nowhere in [Western
States]{.underline} or [Pearson]{.underline} did the respective courts
state such propositions, albeit it is unremarkable (and not a matter of
First Amendment concern) that FDA has statutory authority to prohibit
the sale of any unsafe product. [See, e.g.]{.underline} 21 U.S.C. § 331;
21 U.S.C. § 342. As a practical matter, safety in this sense precludes
lawful sale and, thus, prevents claims attendant to sale. In addition,
the point made is a non-sequitur because unsafe dietary supplements are
not lawful for sale and are thus ineligible for health claims.
[See]{.underline} 21 C.F.R. § 190.6; 21 C.F.R. § 101.14. Contrary to the
commenter's misread of [Pearson]{.underline} and [Western
States]{.underline}, dietary supplements that are lawful for sale yet
include adverse effects are not ones for which our Court of Appeals
finds claim suppression appropriate. To the contrary, the Court found
appropriate "a prominent disclaimer setting forth those adverse
effects." [Pearson]{.underline} I, 164 F.3d at 659. Quite clearly,
[Pearson]{.underline} I contemplates allowance of dietary supplement
claims on products that are not adulterated, but may, in some
circumstances, produce adverse effects. Again, full information
(disclosure over suppression) is the rule.

Moreover, nowhere in [Pearson]{.underline} is there any support for
suppression of a claim solely because it may deal with an "essential
organ" or "serious health condition." The Court in [Pearson]{.underline}
recognized without equivocation that the health claims rule is "a safe
harbor from designation as a 'drug' for certain dietary supplements
whose labels and labeling advertise a beneficial relationship to a
disease or health related condition: If the FDA authorizes or allows a
label claim under 21 U.S.C.A. § 343(r), the product is not considered a
drug under 21 U.S.C.A. § 321(g)(1)." [Id.]{.underline} at 652.

> D. [The First Amendment Strictures on FDA Speech Suppression Apply
> Equally to Health Claims For Dietary Supplements and
> Foods]{.underline}

In addition, outside the scope of disclaimers, one commenter argues
generally that the [Western States]{.underline} decision applies only to
compounded drugs and that the First Amendment principles and standards
expounded upon in that decision have no applicability beyond the facts
of the case. [See]{.underline} Comment No. C80. That same commenter
likewise argues that the [Pearson v. Shalala]{.underline} decision
applies only to dietary supplements and the First Amendment principles
and standards expounded upon in that decision have no general
applicability beyond the facts of the case.

In short, the commenter would have this agency view the two cases as if
the First Amendment principles (drawn from the Supreme Court's
professional advertising and other advertising precedent, not just
decisions on FDA regulations, and from the very test the Court applies
in [all]{.underline} cases of commercial speech suppression, [Central
Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of N.Y.]{.underline},
447 U.S. 557(1980)) applied only to the Food and Drug Modernization Act
drug compounding provisions (in [Western States]{.underline}) and to the
regulation of dietary supplement health claims (in [Pearson v.
Shalala]{.underline}) and cannot be applied yet again to other instances
of state suppression of commercial speech. That argument for crabbed
construction lacks logic; what is more, it ignores the basic
requirements of *stare decisis* in the application of our constitutional
law. The precedent plainly applies to all instances of state suppression
of commercial speech.

FDA suppression of health claims for foods must satisfy the same First
Amendment standard as the [Pearson]{.underline} Court applied to FDA
suppression of health claims for dietary supplements. Ruling otherwise
would require proof that the Constitution itself permits a "food
labeling exemption" from the First Amendment or that statutory
construction contrary to First Amendment precedent trumps that precedent
(rendering our Constitution inferior to laws passed in pursuance of it).
[Marbury v. Madison]{.underline}, 5 U.S. 137 (1803) for the contrary
position, a bedrock principle of constitutional law. The very same First
Amendment standard and principles in [Western States]{.underline} must
be evaluated whenever FDA attempts to suppress speech. It is the
suppression of a private message that triggers First Amendment scrutiny
and it is those very cases, applying the same standard in the dietary
supplement and drug contexts, that provide the necessary teachings for
assessment of the application of the First Amendment in all other FDA
speech regulatory contexts. The commenter's advocacy of a simplistic
fact-specific restriction on the broad holdings and reasoning in these
cases belittles their far-reaching import and robs decisionmakers of the
very "like cases" which they must construe to analyze the
constitutionality of the laws, rules, and principles in issue. The
federal courts draw upon this precedent to assess FDA speech
restrictions and so must this agency.

**IV.**

**[The First Amendment Forbids Speech Suppression Effected by Excessive
Burdens on Truthful Speech, Such as FDA's Present Policy of Prohibiting
Treatment Claims for Dietary Supplements AND FOODS Without New Drug
Approval]{.underline}**

Consistent with the FDA's current interpretation, one of the commenters
opposes allowing health claims for dietary supplements if those claims
relate to an effect of a supplement on an existing disease.
[See]{.underline}, Comment No. C13. The commenter argues that this will
blur the distinction between dietary supplements and drugs, will confuse
consumers, and will not promote the public health.

The commenter's preference for (and the FDA's current policy of)
disallowing dietary supplement health claims that include disease
amelioration or treatment effects violates the plain and intended
meaning of the health claims provision of the Nutritional Labeling and
Education Act ("NLEA"), 21 U.S.C. § 343(r)(5)(D); wherein Congress
intended the provision to exempt from drug regulation nutrient-disease
claims of prevention, treatment, mitigation, and cure if evaluated by
FDA in advance of market use. [See]{.underline} S. Rep. 103-410
(September 12, 1994). This general exception was observed by the Court
of Appeals in [Pearson]{.underline} I, 164 F.3d at 652 (The FDCA
"creates a safe harbor from designation as a 'drug' for certain dietary
supplements whose labels or labeling advertise a beneficial relationship
to a disease or health related condition: If the FDA authorizes a label
claim under 21 U.S.C.A. § 343(r), the product is not considered a drug
under 21 U.S.C.A. § 321(g)(1)").

Moreover, the Solicitor General has explained that the cost of new drug
approval exceeds \$200 million. [See,]{.underline} Brief for Petitioners
at 26, [Thompson v. Western States Medical Center]{.underline}, 122 S.
Ct. 1497 (2002) ([citing]{.underline} V. Henry, [Problems with
Pharmaceutical Regulations in the United States]{.underline}, 14 [J.
Leg. Med.]{.smallcaps} 617 (1993)). Thus, requiring every dietary
supplement to undergo new drug approval before allowing any truthful
claim of that supplement's effect on an existing disease imposes an
extraordinary and prohibitive tax that virtually ensures the permanent
suppression of all truthful claims to that effect. Few if any dietary
supplement companies have annual gross revenues of \$200 million let
alone sums that high which could be put at risk in the process.
[See]{.underline}, [Nutrition Business Journal]{.underline}, Annual
Business Review at 18 (September 1998) (Published demographics for all
United States manufacturers and marketers of dietary supplements reveals
that only 16 companies have revenues exceeding \$100 million; only 38
have revenues between \$20 and \$100 million; and fully 996 have
revenues less than \$20 million). Furthermore, most dietary supplements
are unpatentable nutrients, thus, unlike drug products, recoupment of
the vast sums needed to satisfy the drug approval standard is impossible
to achieve. [See e.g.,]{.underline} Shayana Kadidal, Note, [Plants,
Poverty, and Pharmaceutical Patents]{.underline}, 103 [Yale
L.J.]{.smallcaps} 223 (1993). Under apposite precedent, FDA cannot
constitutionally impose this effective ban on treatment claims because
the less speech restrictive alternative of relying on extant health
claims approval is a necessary and sufficient alternative.
[See]{.underline} [Pearson I]{.underline}, 164 F.3d at 652-653.

The argument that allowing health claims of disease treatment blurs the
drug-supplement distinction makes little sense. The distinction exists
by virtue of statute which defines dietary supplements based on the
substances that comprise them and drugs based on the claims made for
them. Even without the present issue, supplements sold with unauthorized
health claims on disease risk reduction are presumptively drugs based on
the content of the claims but are exempt from that drug categorization
if FDA approves or allows the claims in question following health claim
review. Dietary supplements bearing FDA approved or allowed health
claims remain dietary supplements and not drugs under the Act. Indeed,
all dietary supplements are required to carry on their labels prominent
references to the fact that they are dietary supplements, must carry a
supplement facts panel, and are sold over-the-counter. Consequently, the
public can readily discern supplement-drug distinctions.

If, however, it is the crux of the commenter's argument that it dislikes
communication of health claims on supplements and would prefer new drug
approval for all supplements so situated, the ready answer is that
Congress disagrees, has codified the difference, and FDA has no choice
but to comply with the statute. Moreover, if indeed proof can be adduced
showing public misperception that supplements bearing health claims are
drugs, the solution---consistent with the First Amendment---is not to
suppress truthful information on supplement labels or to tax that
information out of existence but to add more speech, to require on the
label a disclaimer stating that the product in question is not an FDA
approved drug for the treatment of the disease in question.

Far from failing to promote public health, the greater amount of
truthful information the public is permitted to receive on
nutrient-disease and food-disease associations, the more likely it is
that people will make informed, health enhancing choices in the
marketplace. At a minimum, the information needed to make informed
elections will be available to them. Thus, such information reasonably
leads to exercise of informed choice with positive health effects. The
FTC's comments provide empirical evidence corroborating the foregoing
logical observation. [See]{.underline} Comment No. EMC 163 at 4
("Empirical evidence suggests that if consumers receive more and better
information about nutrition and health, consumers are able to make
better-informed choices about the food products they purchase").

**V.**

**[FDA SUPPRESSION OF OFF-LABEL USE INFORMATION
CONCERNING]{.underline}**

**[APPROVED DRUGS VIOLATES THE FIRST AMENDMENT]{.underline}**

One commenter opposes lessening strictures on drug manufacturer
dissemination of peer-reviewed literature on off-label uses of approved
drugs. [See,]{.underline} Comment No. C41. That comment argues that
physicians lack the expertise necessary to assess the safety and
efficacy of off-label uses, cannot fully comprehend the relative
significance of peer-reviewed journal articles, and are essentially
bribed by pharmaceutical companies (through paid attendance at
conferences where off-label uses are discussed) to prescribe the drugs
in question. Comment No. C41 at 5, 11. Moreover, the commenter presumes
pharmaceutical companies control the content of peer-reviewed journal
articles on their respective drugs, propound falsehoods to physician's
about those drugs, and induce physicians to write off-label
prescriptions that harm patients. [Id.]{.underline} On this basis, the
commenter favors greater FDA control over dissemination of off-label use
information.

Although the commenter lacks proof to corroborate that the complained of
acts of malfeasance are typical (or even exist), the commenter
nevertheless calls for a blanket restriction on drug manufacturer
dissemination of all off-label use information rather than on targeted
prosecution of those engaged in misbranding or fraud.

The commenter ignores the overwhelming evidence underlying FDA's
off-label use policy ([See, e.g.,]{.underline} [Washington Legal
Foundation v. Kessler]{.underline}, 880 F. Supp. 26, 28 (D.D.C. 1995)),
that physicians, particularly in the fields of pediatrics and oncology,
routinely prescribe FDA-approved drugs for off-label uses. Indeed, it is
undoubtedly true that hundreds of thousands of lives have been saved and
suffering averted by such practices which are indispensable to the
practice of medicine in an environment burdened by certain diseases for
which known cures do not exist. In short, off-label prescribing is an
inextricable part of contemporary medical practice.

The issue then centers on whether the general rule should favor
disclosure of off-label use information or its suppression. The
commenter favors suppression based on a few alleged instances of abuse.
Mass suppression of peer-reviewed journal evidence on safety and
efficacy of off-label uses ensures, however, that that the vast majority
of physicians and patients who could benefit from such uses will be
deprived of that information and, thus, of the chances for effective
treatment in certain circumstances. [See]{.underline}, General
Accounting Office Report No. T-HEHS-96-212 (September 12, 1996) (stating
more than half of cancer patients in GAO survey (56%) were prescribed at
least one drug off-label as part of their chemotherapy regimen and
California researchers reported more than 80% of AIDS patients received
at least one drug off-label as part of their treatment and that 40% of
all drugs that were given were provided off-label).

The commenter presumes peer-reviewed scientific works to be commonly
unreliable but presents no evidence to support that assertion. Likewise
the commenter presumes peer-reviewed scientific works to have had, at
least on one occasion, pre-determined false outcomes based on a
presumption of pharmaceutical company control of the publications.
Again, evidence to support that assertion is lacking. Finally, the
commenter presumes that physicians are not educated in statistics and
are thereby incapable of appreciating the relative significance of
studies and, presumably, only FDA can discern whether a study ought to
be relied upon by a physician. That paternalistic viewpoint is again
without evidentiary support.

To be sure, not all peer-reviewed articles are of equal quality, but the
debate centers not on whether every prescription practice that could be
made based on any such articles would be appropriate, but, rather, on
whether the First Amendment protects the right of a drug manufacturer to
send to a physician and a physician to receive off-label use information
in the form of peer-reviewed journal articles. The answer is
emphatically yes.

The view that physicians lack the sophistication needed to comprehend
and evaluate peer reviewed scientific literature is counterintuitive and
illogical. The physician is a trained skeptic who depends upon
information from many sources to determine the prudence of a
prescription in any single case. The commitment of physicians to the
betterment of their patients and the constant risk of malpractice
liability form a powerful carrot and stick dissuading physicians from
use of drugs in circumstances that are untried and unproven (be they
labeled uses or off-label uses). While particular prescriptions may fall
beneath the standard of care and invite state medical boards to police
the physician in question, the free exchange of off-label use
information does not inextricably lead to inappropriate prescription
practices. To the contrary, the information (whether given by a
manufacturer or retrieved and circulated by physician practice groups)
is the start of scientific inquiry (not just for the physician but for
physician groups such as the American Medical Association, the American
Heart Association, the American Cancer Society, and universities, among
many others). The practice of medicine is not mechanical; it is still
very much an art. Disease resistant to conventional treatment requires
the application of new approaches. Ethical physicians are not at liberty
to turn away patients because they present hard cases. In that
environment, they must participate in the evaluation and application of
science in the treatment of diseases. Finally, modern medical practice
(and education) does indeed involve (and educate) concerning the
scientific evaluation of peer-reviewed research. [See
generally,]{.underline} Medio, FJ, et al., [Implementation of a
college-wide GME core curriculum]{.underline}, 76 [Acad
Med]{.smallcaps}, Apr. 2001, 331-6;
<http://www.acgme.org/IRC/IRCpr900.asp> (visited on Oct. 21, 2002);
Green, ML, [Evidence-based medicine training in internal medicine
residency programs a national survey]{.underline}*,* 15 [J Gen
Intern]{.smallcaps} M[ed]{.smallcaps}, Feb. 2000, 129-33; Steven R.
Simon, et al., [Teaching First-Year Students the Building Blocks of
Evidence-Based Medicine]{.underline},
<http://www.hms.harvard.edu/oed/MENEWS/V3N1/CRITICAL.HTM> (visited Oct.
21, 2002). Far from lacking the skills needed, physicians generally have
them, are complemented in their valuations by support groups
representing the best scientific minds in the country employed by
universities and private groups, and continue to serve as the best line
of defense for patient interests.

There is no sound basis for concluding that on average the practice of
medicine (including the pediatric and oncological practices where
off-label prescription is common) is characterized by unsafe and
inappropriate prescription practices. Physicians do depend on continual
review of the latest research developments to help guide them in their
prescription and treatment practices. They depend on diverse information
inputs (are not beholden to any one source) and are keenly sensitive to
the need to protect the best interests of their patients. In this
environment, it is highly presumptuous and counterintuitive to presume
greater dissemination of off-label use information will cause physicians
to march in lock step to prescribe drugs inappropriately. To the
contrary, we have every reason to believe the same cautious,
professional approach toward prescription that generally characterizes
modern medical practice will continue, whether the prescription is for a
labeled or off-label use.

**VI.**

**[CONCLUSION]{.underline}**

For the reasons stated above, and those contained in the Joint
Commenters' original submission, they respectfully request immediate
implementation of all reforms called for in their joint comments filed
September 12, 2002 to cause FDA's speech regulations to comply with the
strictures on government action prescribed by the First Amendment to the
United States Constitution.

Respectfully submitted,

JULIAN M. WHITAKER, M.D.;

DURK PEARSON AND SANDY SHAW;

PURE ENCAPSULATIONS, INC.;

WELLNESS LIFESTYLES, INC.;

SUAREZ CORPORATION INDUSTRIES, INC.; AND

LIFE EXTENSION FOUNDATION,

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

Jonathan W. Emord

Claudia A. Lewis-Eng

Andrea G. Ferrenz

Jonathan R. Goodman

Kathryn E. Balmford

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: October 25, 2002

[^1]: Consider, for example, the effect of this approach in the folic
    acid neural tube defect context. FDA chose suppression rather than
    disclosure as its preferred remedy to alleged problems of public
    perception of the claim. Congress found that FDA's action
    contributed to an estimated 2,500 preventable neural tube defect
    births each year of the FDA speech ban. [See]{.underline} S. Rep.
    No. 103-410 at 7 (1994). Since allowance of the claim, public
    education has increased awareness, netting significant decreases in
    the incidence of NTDs. [See]{.underline}, Annette Dickinson,
    [Benefits of Folic Acid: Protection Against Neural Tube
    Defects]{.underline} (2002) (Gallup poll shows 80% of women surveyed
    were aware of folic acid). In addition, within the context of
    omega-3 fatty acids, 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). FDA suppressed that claim from 1999 to 2002.