Before the

**FOOD AND DRUG ADMINISTRATION**

**Rockville, MD**

**In re: Guidance for Industry: )**

**Qualified Health Claims in the ) Docket No. 02D-0515**

**Labeling of Conventional Foods )**

**And Dietary Supplements )**

# COMMENTS OF

**DURK PEARSON AND SANDY SHAW;**

**LIFE EXTENSION FOUNDATION, INC.; AND**

**[JULIAN M. WHITAKER, M.D.]{.underline}**

On behalf of Durk Pearson and Sandy Shaw; Life Extension Foundation,
Inc.;

and Julian M. Whitaker, M.D. (hereinafter collectively, "Commenters"),
we hereby submit the following additional comments on FDA's December 18,
2002 Guidance "Qualified Health Claims in the Labeling of Conventional
Foods and Dietary Supplements" (hereinafter "Qualified Claims Guidance")
in response to those of Public Citizen and the Center for Science in the
Public Interest (hereinafter collectively "CSPI") and to those of the
Grocery Manufacturers of America, The Snack Foods Association, The
Institute of Shortening & Edible Oils, Inc., and the National Restaurant
Association (hereinafter collectively "GMA").

I.  **SUMMARY OF COMMENT**

In the Qualified Claim Guidance, FDA seeks to implement the
constitutional mandate of the U.S. Court of Appeals for the D.C. Circuit
found in [Pearson v. Shalala]{.underline}, 164 F.3d. 650 (D.C.Cir. 1999)
("[Pearson I]{.underline}"). For the reasons that follow, the Commenters
find CSPI's comments to call for action contrary to the constitutional
mandate in [Pearson v. Shalala]{.underline} and its progeny. The
Commenters support the substantive recommendations in the GMA comments,
as explained below.

CSPI argues that the Qualified Claims Guidance is contrary to FDA's
statute and regulations. It is wrong on both accounts; indeed, were its
position adopted, FDA would be directly at odds with several federal
court rulings and would cause the statute to be interpreted to effect
unconstitutional outcomes, contrary to the avoidance doctrine.[^1] CSPI
asks the agency to withdraw the Qualified Claims Guidance, not to
sanction health claims unless authorized pursuant to the NLEA health
claims approval process, 21 U.S.C. § 343(r)(hereinafter "NLEA health
claims approval process") (of which there are currently six[^2] nutrient
disease relationships), and to enforce NLEA's health claim approval
process, including notice and comment rulemaking, before allowing
constitutionally protected qualified claims to enter the market. Because
CSPI asks FDA to act contrary to controlling precedent and in
contravention of the First Amendment, its request for action must be
denied.

CSPI would have the agency withdraw the Qualified Claim Guidance and
[only]{.underline} permit on labels and in labeling health claims that
meet the significant scientific agreement (SSA) standard and are the
subjects of notice and comment rule making pursuant to the NLEA health
claims approval process. 21 U.S.C. § 343(r)(1)(B). [Pearson
I]{.underline}, 164 F.3d 650, speaks directly to that point and
forecloses that alternative. CSPI ignores the plain import and teachings
of that decision (and its progeny[^3]) and of the First Amendment.
Indeed, CSPI ignores the First Amendment entirely, despite the
significant First Amendment issues its requests create. [Pearson
I]{.underline} teaches that FDA must favor disclaimers over outright
speech suppression where speech that is, at worst, only potentially
misleading can be cured through the addition of a reasonable disclaimer
even if the claim in issue is one not authorized under the NLEA health
claims provision. [Pearson I]{.underline}, 164 F.3d at 654 ("...even if
'significant scientific agreements' were given a more concrete meaning,
appellants might be entitled to make health claims that do not meet that
standard---with proper disclaimers"). Indeed, the four NLEA
"unauthorized" claims in [Pearson]{.underline} were found by the Court
to be speech protected by the First Amendment. [Pearson I]{.underline}
at 658-59. The Court inverted the normal order of review, addressing the
First Amendment claims first, cognizant of the fact that the First
Amendment trumps all contrary law. [Pearson I]{.underline} at 654. The
Court understood that there was no necessary conflict between the higher
law of the First Amendment and the NLEA health claims authorization
process, reasoning that claims that failed to pass muster under the
process (i.e., are not "authorized") but were, at worst, only
potentially misleading could not be suppressed but would have to be
permitted with appropriate disclaimers by FDA. The Court recited, among
the disclaimers FDA could use as a less speech restrictive alternative,
that "The FDA does not approve this claim," thus plainly contemplating a
two-tiered analysis where claims not satisfying the NLEA SSA standard
(and thus not achieving FDA "approval" under the NLEA health claim
review process) would nevertheless be "permitted" by FDA (to comply with
the higher law requirements of the First Amendment). [Pearson
I]{.underline} at 659. This critical distinction in the law entirely
eludes CSPI. Under the First Amendment FDA cannot suppress a claim that
is supported by "credible evidence" despite the fact that the claim
fails the SSA standard of the NLEA. [See, e.g.]{.underline}, [Whitaker
v. Thompson]{.underline}, 248 F. Supp. 2d 1, 27 (D.D.C. 2002).

CSPI's interpretation of the NLEA, that any claim appearing on a food or
supplement label must be a claim authorized under the NLEA health claims
approval provision and promulgated pursuant to a notice and comment
rulemaking is not the law in the advent of [Pearson]{.underline} and is
an unconstitutional interpretation of the statute in light of that
decision. That approach was precisely the law articulated by FDA
pre-[Pearson I]{.underline}. Under the avoidance doctrine, laws must be
interpreted not to conflict with the Constitution, if at all possible.
[Edward J. DeBartolo Corp. v. FL Gulf Coast Bldg. & Const. Trade
Council]{.underline}, 485 U.S. 568, 575 (1988); [Univ. of Great Falls v.
NLRB]{.underline}, 278 F.3d 1335, 1340-41 (D.C. Cir. 2002). Contrary to
CSPI's argument, there is no constitutional obligation for a notice and
comment rulemaking for claims not authorized or approved by FDA under
the NLEA health claims provision. That is, there is no such requirement
for qualified health claims. Because the agency lacks constitutional
power to restrict protected speech in the form of qualified claims, it
also lacks constitutional power to open a comment period for that very
purpose. Once the agency determines that the speech in issue is
protected by the First Amendment, i.e., that it lacks a constitutional
power under [Pearson I]{.underline} and [Whitaker v.
Thompson]{.underline}, 248 F. Supp. 2d 1 (D.D.C. 2002), to suppress it,
then FDA must take no action to block entry of the
constitutionally-protected speech into the market. Any delay, burden,
restriction, or limit to the contrary is intolerable under the First
Amendment. [See]{.underline} [Elrod v. Burns]{.underline}, 427 U.S. 347,
373 (1976) (plurality opinion) ("the loss of First Amendment freedoms,
for even minimal periods of time, unquestionably constitutes irreparable
injury") (citing [New York Times Co. v. U.S.]{.underline}, 403 U.S. 713
(1971)); [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"); [Pearson v.
Shalala]{.underline}, 130 F. Supp. 2d 105, 119 ("the case law makes it
very clear that Plaintiffs are harmed by the FDA's suppression of the
Folic Acid Claim"). Having a notice and comment period as contemplated
by CSPI before permitting a qualified health claim to enter the market
invites others to use FDA's administrative machinery to restrict speech.

Any member of the public may contribute science and comments to any
health claim docket at any time. CSPI has that same right. If new
science or safety issues should arise after FDA permits a qualified
claim, any member of the public can submit that information to the
docket. CSPI thus has had no impediment to being heard and has none to
being heard in the future. It need only file a comment in the docket to
acquire FDA's attention. CSPI also relies on a false factual predicate.
The four [Pearson I]{.underline} claims (four of the six) were fully
vetted in notice and comment rulemaking proceedings not once but twice.
[See]{.underline} 58 Fed. Reg. 53,296 (Oct. 14, 1993); 64 Fed. Reg.
48,841 (Sept. 8, 1999); [see also]{.underline} [Pearson II]{.underline},
130 F. Supp. 2d at 110. That point eludes CSPI. The remaining two
claims, one concerning selenium and cancer/ anticarcinogenic effects,
and the other concerning phosphatidylserine and cognitive dysfunction/
dementia, were assigned public docket numbers, and all correspondence
concerning them was posted on FDA's web site and in the FDA public
reference room. [See]{.underline} http://www.fda.gov/
ohrms/dockets/dailys/02/Sep02/091302/091302.htm#02P-0413%20Health%20Claim:%20
Phosphatidylserine%20;
http://www.fda.gov/ohrms/dockets/dailys/02/Oct02/101802/101802.
htm#\_Toc22944690. Any member of the public could file comments in these
proceedings as well.

Of the six current qualified health claims for which there are no
corresponding regulations, four are direct responses to court orders.
Apparently, CSPI ignores the fact that the federal court orders in those
cases are binding on the agency. A long history of post-[Pearson
I]{.underline} cases dictate otherwise. [Pearson v.
Shalala]{.underline}, 130 F. Supp. 2d 105 (D.D.C. 2001) ("[Pearson
II]{.underline}"); [Pearson v. Thompson]{.underline}, 141 F. Supp. 2d
105 (D.D.C. 2001) ("[Pearson III]{.underline}"); [Whitaker v.
Thompson]{.underline}, 248 F. Supp. 2d 1 (D.D.C. 2002). As with every
health claim petition, any member of the public, including CSPI, had a
right to file comments with FDA concerning those claims (and, indeed,
may still do so). CSPI elected not to take that course, but it certainly
was not foreclosed from doing so by FDA and is not to this day.

Unlike CSPI's comment, GMA's calls not for a notice and comment
rulemaking that limits grants to NLEA approvals, but a public
notification process following a submission of a qualified claim
petition, permitting any interested person to file information and
comments that could help guide FDA in the evaluation of, and
promulgation of, the qualified claim. The GMA comment puts a 180-day
limit on the entire process (and a 60-day limit on comments) from
qualified claim submissions to final qualified claim allowances and,
thus, ensures rapid market access for protected speech consistent with
the First Amendment. The Commenters endorse GMA's recommended approach.

In summary, CSPI's requests for FDA to withdraw the Qualified Claims
Guidance, not to sanction qualified health claims unless authorized
pursuant to the NLEA health claims approval process, and to require
NLEA's procedural requirement of notice and comment rulemaking for
claims that fail SSA are requests for unconstitutional agency action.
All CSPI's requests should therefore be denied.

II. **SUMMARY OF QUALIFIED CLAIMS GUIDANCE**

The Qualified Claims Guidance, as modified by [Whitaker]{.underline}, is
an implementation of the U.S. Court of Appeals decision in [Pearson
I]{.underline}. It describes how FDA plans to exercise its enforcement
discretion to permit health claims that do not meet the SSA standard of
evidence and describes the process and standards that FDA intends to use
to respond to future health claim petitions for both conventional foods
and dietary supplements.[^4]

III. **CSPI'S REQUEST FOR WITHDRAWAL OF THE THE GUIDANCE ASKS THE AGENCY
     TO ACT UNCONSTITUTIONALLY AND CONTRARY TO LAW**

CSPI states that there are statutory and regulatory violations in the
Qualified Claims Guidance, principally: (1) the qualified claim
procedure is improperly outside of the notice and comment rulemaking
prescribed by Congress; (2) the Guidance creates an incentive to make
health claims based on preliminary evidence, undermining consumer
protection, and is contrary to the structure and purpose of the NLEA;
(3) the Qualified Claims Guidance is an improper use of enforcement
discretion; and (4) it is inconsistent with prior agency policy on
health claims and interpretation of the NLEA.

As discussed in detail below, each of those arguments fail because
allowance of qualified claims is a constitutional imperative imposed on
FDA by the federal courts, and the NLEA health claims provision does not
compel a contrary result. Indeed, were such a conflict to exist, the
statutory provision would be rendered unconstitutional.

A.  **THE QUALIFIED CLAIMS GUIDANCE IMPLEMENTS THE FIRST AMENDMENT
    MANDATE OF [PEARSON I]{.underline}**

In [Pearson I]{.underline}, the U.S. Court of Appeals defined
constitutional limits on FDA's power to suppress health claims, holding
that FDA may not suppress claims that could be rendered non-misleading
through the addition of a disclaimer. [Whitaker]{.underline}, 248 F.
Supp. 2d at 28. CSPI appears to have missed that point entirely, failing
to address the First Amendment protections for health claims in the
least.

**1. Health Claims Are Commercial Speech Protected By the First
Amendment**

[Pearson I]{.underline} and its progeny establish that health claims are
commercial speech protected by the First Amendment. [Pearson
I]{.underline}, 164 F.3d. at 655; [e.g.,]{.underline}
[Whitaker]{.underline}, 248 F. Supp. 2d at 23. Conspicuously absent from
CSPI's analysis is any acknowledgment that health claims on conventional
foods and dietary supplements are scientific speech and commercial
speech, both protected by the First Amendment.

2.  **FDA Cannot Limit Health Claims to Those Only Authorized Pursuant
    to the NLEA Health Claims Provision; It Must Permit Qualified Health
    Claims that Fail SSA When Required to Do So by the First Amendment**

[Pearson I]{.underline} affirmed the law that there is a general First
Amendment preference for disclosure over suppression and specified those
limited instances when FDA may prohibit health claims. [See]{.underline}
[Pearson I]{.underline}, supra, at 658-658. To wit,

> The Pearson court established clear guidelines for the FDA in
> determining whether a particular health claim may be deemed
> "inherently misleading" and thus entirely banned. The Court implied,
> though it did not declare explicitly, that when "credible evidence"
> supports a claim, such as the Folic Acid Claim, that claim may not be
> absolutely prohibited.

[Pearson II]{.underline}, supra at 114 citing [Pearson I]{.underline},
164 F.3d at 659. [Pearson I]{.underline} identified only two
circumstances in which a complete ban on a health claim would be
reasonable:

> First, when the "FDA has determined that no evidence supports \[a
> health claim\] it may ban the claim completely." Id., 164, F.3d at
> 659-660 (emphasis in original. Second, when the FDA determines that
> "evidence in support of the claim is qualitatively weaker than
> evidence against the claim -- for example, where the claim rests on
> only one or two old studies," it may impose an outright ban. Id. 164
> F.3d at 659, n.10 (emphasis added).

[Whitaker]{.underline}, 248 F. Supp. 2d at 27-28. Even in those two
situations a complete ban is [only]{.underline} constitutionally
permissible where "the government \[can\] demonstrate with empirical
evidence that disclaimers similar to the ones \[the
[Pearson]{.underline} Court\] suggested above \['The evidence in support
of this claim is inconclusive' or 'The FDA does not approve this
claim'\] . . . bewilder consumers and fail to correct for
deceptiveness." [Whitaker]{.underline}, supra, citing [Pearson
I]{.underline}, 164 F.3d at 659-660 (emphasis added). Since [Pearson
I]{.underline}, each time the agency has attempted to limit health
claims to those that meet the SSA standard, it has been rebuked by the
federal courts on First Amendment grounds. [See]{.underline} [Pearson
II]{.underline}, [Pearson III]{.underline}, and [Whitaker]{.underline},
supra. The courts have said repeatedly the agency must permit health
claims that do not meet the SSA standard when the claims can be made
nonmisleading through addition of a reasonable disclaimer.

According to CSPI, the "Guidance demonstrates that the agency
consciously and expressly adopted a general policy that is in effect an
abdication of its statutory duty," citing [Adams v.
Richardson,]{.underline} 480 F.2d 1159, 1162 (D.C. Cir. 1973)(en banc).
Again, CSPI considers the Guidance as if it arose in a vacuum and the
First Amendment and the [Pearson I]{.underline} mandate did not exist.
CSPI's argument would posit a conflict between the NLEA health claims
provision and the First Amendment when one does not exist under the
controlling precedent of [Pearson I]{.underline} progeny. The Qualified
Claims Guidance is an adoption of the court directive to the agency that
FDA must consider allowance of constitutionally-protected qualified
claims in lieu of outright suppression; the directive of no less than
four federal court decisions on the health claim process backs the
agency's approach.

CSPI's remaining arguments, that consumers are at greater risk of
confusion and that qualified claims are an improper use of enforcement
discretion also fail to withstand scrutiny. Even if those arguments were
supported in the law they are secondary to the interests, rights, and
protections that the First Amendment accords speakers and cannot
overcome the supremacy of the First Amendment. [See]{.underline}
[Whitaker]{.underline}, 248 F. Supp. 2d at 45 ("Even if \[a health
claim\] is in some respects 'potentially' misleading, the resulting
injury that could flow to consumers cannot compare, as a matter of law,
with the First Amendment injury Plaintiffs have continually borne in the
more than three years since [Pearson I]{.underline} was decided").

Notwithstanding CSPI's position to the contrary, health claims that do
not meet the SSA standard but are supported by credible evidence and
made nonmisleading by a disclaimer are protected from government
suppression by the First Amendment and must be allowed as a matter of
constitutional law. FDA cannot use the NLEA offensively to prohibit
qualified claims that the First Amendment requires be allowed. The First
Amendment is, after all, the higher law, and FDA---like the
courts---must interpret the NLEA health claims provision to be
consistent with, not in opposition to, the outcomes directed by the
higher law.

> **B. THE NLEA DOES NOT PRECLUDE QUALIFIED CLAIMS**

The NLEA health claims provision defines when FDA
[authorizes]{.underline} health claims. 21 U.S.C. §§ 343(r)(1)(B),
(r)(3); and (r)(5)(D). To be sure, FDA endorses [authorized]{.underline}
claims, determining that they meet SSA, and publishing them in the
Federal Register in rule form following a notice and comment rulemaking.
By contrast, FDA does not authorize qualified claims but allows them to
be made when accompanied by the agency's disclaimer, despite the absence
of FDA approval. Qualified claims are not created by statute nor do they
conflict with it because they do not constitute an act of authorization
which is prescribed in 21 U.S.C. § 343(r)(1)(B). "Allowance" of
qualified claims is a recognition by the courts and by FDA that it lacks
a constitutional power to suppress certain unauthorized claims
that---while failing SSA---nevertheless are protected from suppression
by the First Amendment.

As discussed below, if CSPI's interpretation of the law were correct
then the NLEA health claims process would be unconstitutional to the
extent that it conflicted with the teachings of [Pearson I]{.underline}
and its progeny. Those sections of the statute concerning health claims
cannot stand if they preclude qualified health claims on conventional
foods and dietary supplements. Applying the traditional tools of
statutory construction, and the avoidance doctrine, however, CSPI's
interpretation of the law is necessarily incorrect.

**1. The NLEA Defines FDA Authorized Claims But Does Not Preclude**

**Qualified Claims**

CSPI interprets the NLEA to limit strictly health claims to authorized
claims (and to exclude qualified claims. [Chevron U.S.A., Inc. v.
Natural Resources Defense Council, Inc.]{.underline}, 467 U.S. 837
(1984), dictates the rules for judicial review of agency statutory
construction to determine whether Congress has expressed a clear intent
on the issue at hand. [Id.]{.underline} at 843, n.9. The issue at hand
is whether Congress intended the authoritative health claim process,
that requires notice and comment rulemaking, to be the exclusive basis
for health claims to appear on conventional foods and dietary
supplement.

The first step in a Chevron analysis involves assessment of the actual
words of the statute. [E.g.,]{.underline} [Arkansas AFL-CIO v.
FCC]{.underline}, 11 F.3d 1430 (8th Cir. 1993) citing
[Chevron]{.underline}, 467 U.S. at 843. "If the intent of Congress is
clear from the plain language of the statutory provision, that will be
the end of the judicial inquiry." [E.g., Arkansas AFL-CIO]{.underline},
11 F.3d at 1440 citing [Chevron]{.underline}, supra.

The plain language of the NLEA is clear. It defines a process that FDA
must follow to "authorize" health claims on conventional foods and
dietary supplements. It does not limit claims appearing on conventional
foods and dietary supplements to only claims authorized by the FDA.
Hence, the mandate of [Pearson I]{.underline} that the FDA must permit
qualified health claims, claims that are potentially misleading but can
be rendered non-misleading by the addition of a disclaimer, is not in
conflict with the NLEA but is separate and apart from it (as our Court
of Appeals necessarily determined when it rejected FDA's statutorily
based argument that claims failing SSA are by that fact alone
suppressible). [Pearson I]{.underline}, 164 F.3d at 658.

The NLEA defines a procedure for "authorization" of health claims (21
U.S.C. § 343(r)(1)(B)) for conventional foods (21 U.S.C. § 343(r)(3))
and for dietary supplements (21 U.S.C. § 343(r)(5)(D)). Congress
required that regulations be promulgated for "authorizing" food health
claims, thus compelling FDA to use rulemaking to adopt final regulations
[after]{.underline} it had first determined that the totality of
publicly available scientific evidence revealed "that there is
significant scientific agreement among experts..., that the claim is
supported by such evidence." 21 U.S.C. § 343(r)(3). Congress left the
standard for dietary supplements health claims review up to the agency.
21 U.S.C. § 343(r)(5)(D). FDA adopted the statutory food standard as its
standard for dietary supplement health claims. 21 C.F.R. § 101.14
(applicable to both foods and dietary supplements); [see
also]{.underline} [Pearson I]{.underline}, 164 F.3d at 654, n.2.

The FDCA states that a food is misbranded if it is one

> for which a claim is made in the label or labeling of the food which
> expressly or by implication---
>
> \* \* \*
>
> \(B\) characterizes the relationship of any nutrient ... to a disease
> or a health-related condition unless the claim is made in accordance
> with subparagraph (3) or (5)(D).

21 U.S.C. § 343(r)(1). The health claim statutory provision for
conventional foods is, in pertinent part, Section 343(r)(3):

(A) Except as provided in subparagraph (5), a claim described in
    subparagraph (1)(B) may only be made---

```{=html}
<!-- -->
```
(i) if the claim meets the requirements of the regulations of the
    Secretary promulgated under clause (B), and

> \*\*\*
>
> (B)(i) 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 scientific
> agreement, among experts qualified by scientific training and
> experience to evaluate such claims, that the claim is supported by
> such evidence.

The FDCA section for health claims on dietary supplements states:

> A subparagraph (1)(B) claim made with respect to a dietary supplement
> of vitamins, minerals, herbs, or other similar nutritional substances
> shall not be subject to subparagraph (3) but shall be subject to a
> procedure and standard, respecting the validity of such claim,
> established by regulation of the Secretary.

21 U.S.C. § 343(r)(5)(D). Moreover, conventional foods and dietary
supplements,

> for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) of
> this title or sections 403(r)(1)(B) and 403(r)(5)(D) of this title, is
> made in accordance with the requirements of section 403(r) of this
> title is not a drug solely because the label or the labeling contains
> such a claim.

The statutory section plainly prescribes a process for FDA
"authorization" of health claims. It makes no reference to nutrient
disease claims that FDA does not authorize. Thus, applying
[Chevron]{.underline} step one examining the plain language of the
statute, qualified claims do not conflict with the NLEA procedures for
authorized claims because they are not approved or authorized by FDA.
There is no statutory obligation that FDA act against qualified claims
failing the SSA test, only that it not "authorize" them. The question
thus becomes whether FDA in the exercise of administrative discretion
may elect to suppress unauthorized qualified claims. The answer given to
the agency by the Courts is a decidedly negative one with rare
exceptions. The First Amendment forbids suppression unless FDA shows (1)
no scientific evidence supports the claim or (2) the weight of the
scientific evidence against the claim outweighs the weight of the
evidence for it and, in both cases, (3) that no disclaimer exists that
can eliminate potential misleadingness. [Whitaker]{.underline}, 248 F.
Supp. 2d at 27. Thus, separate and apart form the NLEA health claims
provision stands a First Amendment bar to the exercise of FDA
enforcement against qualified claims. Compliance with that bar is a
constitutional order imposed on FDA by not one, but four, federal court
decisions. Not a one found the bar incongruous with the NLEA health
claims provision because each, in line with [Pearson I]{.underline}, is
based on the understanding that the statute deals with health claims
"authorization," whereas the First Amendment dictates not the terms for
placing FDA's imprimatur on a claim but, rather, the limits of the
exercise of FDA power to take enforcement action against unauthorized,
qualified claims.

2.  **The Avoidance Doctrine Requires that the NLEA Be Interpreted To
    Permit Unauthorized, Qualified Health Claims**

In neither [Pearson I]{.underline}; [Pearson II]{.underline}; [Pearson
III]{.underline}; nor [Whitaker]{.underline} did any of the federal
courts assessing FDA health claim denials under the NLEA health claims
provision find any statutory conflict with the constitutional ban on
suppression of unauthorized, qualified health claims. 164 F.3d at
659("The government's general concern that, given the extensiveness of
government's regulation of the sale of drugs, consumers might assume
that a claim on a supplement's label is approved by the government,
suggests an obvious answer: the agency could require the label to state
that "The FDA does not approve this claim").

CSPI (citing a 1993 Federal Register) states that FDA's
pre-[Pearson]{.underline} interpretation of the statute "remains
accurate: In the absence of a regulation, either final or interim
(pending completion of a public comment period), the statute does not
authorize the FDA to countenance health claims." Were that
interpretation correct, then the statute would conflict with the First
Amendment as explained in [Pearson I]{.underline}, [Pearson
II]{.underline}, [Pearson III]{.underline}, and [Whitaker]{.underline}.
Under the avoidance doctrine, however, if the statute reasonably can be
interpreted to avoid conflict with the Constitution, it must be. [U.S.
ex rel. Atty. Gen. v. Del. & Hudson Co.]{.underline}, 213 U.S. 366, 408
(1909); [Edward J. DeBartolo Corp. v. FL. Gulf Coast Bldg. & Const.
Trades Council]{.underline}, 485 U.S. 568, 575 (1988) (It is beyond
debate that a court will construe a statute to avoid constitutional
problems unless such construction is plainly contrary to the intent of
Congress); [Univ. of Great Falls v. NLRB]{.underline}, 278 F.3d 1335,
1340-41 (D.C. Cir. 2002). Following that doctrine, and in light of
[Pearson I]{.underline} and its progeny, section 343(r) must be read as
requiring notice and comment rulemaking [only]{.underline} for those
health claims [authorized]{.underline} by FDA. To interpret the NLEA
otherwise, as CSPI has done, unnecessarily causes the NLEA health claims
provision to violate the First Amendment. FDA has thus protected the
constitutional validity of the NLEA health claims provision by avoiding
the statutory interpretation urged upon it by CSPI and must continue to
do so---not only because [Pearson I]{.underline} and its progeny require
that approach but also because it is the agency's duty to defend the
validity of its enabling statute. [Cf.]{.underline} [Johnson v.
Robinson]{.underline}, 415 U.S. 361, 368 (1974) ("\[A\]djudication of
the constitutionality of congressional enactments has generally been
thought beyond the jurisdiction of administrative agencies").

**C. QUALIFIED HEALTH CLAIMS ARE IN THE PUBLIC INTEREST**

**1. Health Information in the Marketplace Furthers Consumers Ability to
Make Informed Choices at the Point of Sale**

It is more than a little strange for a public interest organization that
purports to advance the interests of consumers to advocate government
suppression of constitutionally protected health information.[^5] Yet
that is what CSPI aims to do. Such an approach redounds to consumers'
great detriment because it denies them at the point of sale useful
information that may guide them in making informed choices. The FDA
Commissioner has recognized officially the indispensable need for access
to accurate health information and has committed the agency to that end
with his Consumer Health Information for Better Nutrition initiative.
[See]{.underline} http://www.fda.gov/oc/mcclellan/chbn.html.

CSPI argues that "the new policy" of qualified claims undermines the
consumer protection arising from limiting health claims to those meeting
the SSA standard.[^6] There is, however, no proof that consumers are in
any way harmed by the qualified claims FDA has permitted. CSPI argues
that there is a consumer protection interest in denying consumers access
to emerging science, even when communicated in a nonmisleading manner.
That kind of paternalism is antithetical to the core values protected by
our First Amendment precedent and has been rejected, repeatedly, by the
federal courts.[^7] It is a canon of First Amendment law that courts
will reject the paternalistic argument that government must deny the
public access to information on the supposition that people cannot be
trusted to act responsibly with it. The U.S. Supreme Court recently
reiterated its condemnation of "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." [Western States]{.underline}, 535 U.S.
at 374.

> There is, of course, an alternative to this highly paternalistic
> approach. That alternative is to assume that this 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...But the choice among these alternative approaches is not ours
> to make or the \[legislature's\]. 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. \[The government\] is free to require whatever professional
> standards it wishes of its \[speakers\]...But it may not do so by
> keeping the public in ignorance of the entirely lawful \[speech at
> issue\].

[Western States]{.underline}, citing [Virginia State Board]{.underline},
supra, at 770 (citation omitted); [see also]{.underline} [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"(citations omitted)).

Moreover, any tenuous interest in consumer protection from qualified
health claims does not outweigh the interest in protecting the free
speech rights of speakers. In [Pearson II]{.underline} the court stated,

> It is especially important to recognize that, in the present case, the
> potential harm to consumers from deception is severely limited ... At
> worst, any deception resulting from Plaintiffs' health claim will
> result simply in consumers spending money on a product that they might
> not otherwise have purchased, or perhaps spending more money on a
> product with a higher folic acid content. This type of injury, while
> not insignificant, cannot compare to the harm resulting from the
> unlawful suppression of speech.

[Id.]{.underline} at 119. [Pearson II]{.underline} also noted, in
response to Plaintiffs' application for a preliminary injunction
preventing FDA from suppressing their claim about the effect of folic
acid supplementation on neural tube defects:

> The public interest would be served in two ways by the issuance of an
> injunction. First, it is clearly within the public interest to ensure
> that governmental agencies, such as the FDA, fully comply with the
> law, especially when that law concerns the parameters of a party's
> First Amendment rights to effectively communicate its health message
> to consumers.
>
> Second the public health risk from neural tube defects is undeniably
> substantial...Given that the scientific consensus, even as
> acknowledged by the FDA, confirms that taking folic acid substantially
> reduces a woman's risk of giving birth to an infant with a neural tube
> defect, the public interest is well served by permitting information
> about the folic acid/NTD connection to reach as wide a public audience
> as possible.

[Id.]{.underline} at 119-120. Thus, qualified claims are in the public
interest, CSPI's preference for state paternalism notwithstanding.

**2. Qualified Claims Do Not Eliminate the Incentive for Authorized
Claims**

CSPI states there is a "perverse incentive created by the Guidance" to
make qualified claims as opposed to authorized claims. To the contrary,
there is a significant incentive to seek authorized claims. The
Commenters find qualified claims generally disadvantageous from an
advertising perspective because their length and inconclusiveness often
not only make it difficult to place them on product labels but also do
not likely increase consumer purchases to any degree comparable to that
experienced when FDA authorizes a claim. While to be sure the Commenters
value qualified claims because their informational content aids
consumers and may improve marketing of products, they value authorized
claims much more and will always prefer an authorized claim to an
unauthorized one and only thereafter an unauthorized one to none at all.
Indeed, the two-tiered claim approach has the effect of encouraging
research because rather than an all-or-nothing SSA option, the fact that
a qualified claim exists affords enough security to justify risking
capital in the process. Thus there is a significant incentive to seek
authorized claims over qualified claims whenever feasible and, in any
event, the duality of authorized and qualified claims maximizes
financial incentives for nutrition science research to support claim
submissions.

**3. The Petitions for Qualified Claims Are, and Shall Be, Publicly
Available.**

In another public interest argument (stated in its first footnote) CSPI
argues that petitions for qualified claims may not be made publicly
available because "the statute does not permit the FDA to make available
to the public petitions that have been denied" and cites 21 C.F.R. §
101.70(j)(2) for that proposition.[^8] Again CSPI shows its
misunderstanding of the law. Under 21 C.F.R. § 101.70(j)(2) FDA does not
make publicly available petitions that have been denied and not filed
(i.e., not accepted for comprehensive review). Those petitions are
denied because they fail to meet the "preliminary requirements" of Part
A explaining "how the substance conforms to the requirements of §
101.14(b)." 21 C.F.R. § 101.70(j)(2). However, meeting the requirements
of Section 101.14(b) and being accepted for comprehensive review under
21 C.F.R. § 101.70(j)(2) is the [very first requirement]{.underline} for
a qualified claim under the Qualified Claims Guidance. [See]{.underline}
[id]{.underline}. at 3. Thus, there is no conflict between the qualified
claims process and 21 C.F.R. §101.70(j)(2) because qualified claims have
historically and continue to be accepted for comprehensive review.
CSPI's argument is thus based on a false factual predicate and is,
therefore, erroneous.

**D. EXERCISE OF ENFORCEMENT DISCRETION TO AVOID ACTION AGAINST
QUALIFIED CLAIMS IS AN APPROPRIATE RESPONSE TO FIRST AMENDMENT
REQUIREMENTS**

CSPI cites [Heckler v. Chaney]{.underline}, 470 U.S. 821, 831 (1985) for
the proposition that "the decision not to prosecute or enforce, whether
through civil or criminal process, is a decision generally committed to
an agency's absolute discretion." CSPI's implied argument is that it
fears FDA will take the position in the future that its allowance of a
qualified health claim is unreviewable (part of FDA's absolute
discretion).

CSPI offers [Cutler v. Kennedy]{.underline}, 475 F. Supp. 838 (D.D.C.
1979) for the analogy that "just as FDA lacked authority to approve
drugs that were safe but of questionable efficacy, FDA lacks authority
to waive requirements for qualified health claims." [Cutler]{.underline}
is inapposite. Unlike in [Cutler]{.underline}, here federal courts have
specifically stated that on First Amendment grounds FDA cannot suppress
health claims even if they do not meet the SSA standard so long as they
can be made nonmisleading. [See e.g.]{.underline}, [Pearson
I]{.underline}, 164 F.3d 650.

For lack of a better phrase FDA has described in the Qualified Claims
Guidance its process for permitting qualified health claims as an
"exercise of enforcement discretion." In the qualified claims context,
however, once FDA finds under [Pearson I]{.underline} that the First
Amendment prohibits suppression of a claim, the FDA at that point lacks
any power whatsoever to deny the claim market entry. It in fact
exercises no enforcement discretion except to prohibit its personnel
from taking any action against use of the claim.

**2.** **Announcing in a Guidance an Intent to Use Enforcement
Discretion When Evaluating Qualified Claims Is Entirely Appropriate**

FDA regularly uses Guidance Documents to announce its intent to use
enforcement discretion in future agency actions of a particular type.
[See]{.underline} 65 Fed. Reg. 59,855 (Oct. 6, 2000); 66 Fed. Reg.
36,794 (July 13, 2001). CSPI objects to the Guidance stating that it
goes well beyond a decision not to pursue enforcement action in a
particular case. A policy statement concerning the law determined by a
federal court, the Guidance is not required to be the subject of notice
and comment rulemaking. 5 U.S.C. § 553(b)(3)(A); [see also]{.underline}
[Syncor Int'l Corp v. Shalala]{.underline}, 127 F.3d 90, 94-95 (D.C.Cir.
1997). The December 18, 2002 Guidance does not impose any new rights or
obligations. [See]{.underline} [American Bus Assoc. v.
U.S.A.]{.underline}, 627 F.2d 525, 529 (D.C.Cir. 1980) citing [Texaco v.
FPC]{.underline} , 412 F.2d 740, 744 (3d Cir. 1969). It recognizes First
Amendment rights defined by the federal courts and it properly prevents
use of agency power to violate those rights. The Guidance explains the
agency's position, updates the industry on its implementation of
[Pearson I]{.underline}, and describes a process that the agency will
follow to ensure that FDA does not violate the First Amendment by
suppressing a claim that is, at worse, only potentially misleading. The
Guidance is not a binding norm, nor does it finally determine the issues
or rights of future petitioners. [See]{.underline} [American Bus Assoc.
v. U.S.A.]{.underline}, 627 F.2d 525, 529 (D.C.Cir. 1980) citing
[Pacific Gas & Electric Co. v. FPC]{.underline}, 506 F.2d 33, 38
(D.C.Cir. 1974).

In this circumstance, FDA is under no legal obligation whatsoever to
rely on rulemaking. Indeed, to do so in the face of a finding that the
speech in issue was -- at worst -- only potentially misleading is to
deny the speakers' rights pending the resolution of a long and drawn out
solicitation of comment. When initiated after FDA has evaluated the
health claimant's submission and has determined that it is backed by
credible evidence (and assuming the food or supplement is otherwise
lawfully saleable), the exercise is unjustifiably burdensome and
ultimately futile because regardless of others' sentiments about the
claim, it may not constitutionally be suppressed or restricted. Thus,
use of that method, would maintain suppression of protected speech
longer than necessary when the First Amendment precedent defines such
delays as intolerable. [See]{.underline} [Elrod v. Burns]{.underline},
427 U.S. 347, 373 (1976)(plurality opinion)("the loss of First Amendment
freedoms, for even minimal periods of time, unquestionably constitutes
irreparable injury") (citing [New York Times Co. v. U.S.]{.underline},
403 U.S. 713 (1971)); [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");
[Pearson v. Shalala]{.underline}, 130 F. Supp.2d 105, 119("the case law
makes it very clear that Plaintiffs are harmed by the FDA's suppression
of the Folic Acid Claim").

**IV. No Notice and Comment rulemaking Proceeding Is Necessary Prior to
Permitting Qualified Health Claims**

CSPI objects to the agency permitting qualified claims on conventional
foods and dietary supplements without a notice and comment rulemaking.
There is, however, no constitutional or legal requirement for notice and
comment rulemaking for qualified claims. The point is substantially
superfluous because all claims filed to date and all filed under the
Guidance are given public dockets and may be commented upon by the
public. Any member of the public may file at any time information in
those dockets for FDA consideration. CSPI, thus, has no cognizable
injury because it, too, could file comments in any one of the dockets.
Extending the NLEA formal notice and comment rulemaking proceeding to
qualified claims would effect no added benefit but would infringe the
petitioner's speech rights where FDA has determined prior to the notice
and comment that the claim is backed by credible evidence. In fact, once
FDA determines that a claim is permissible as a qualified claim, it
lacks legal power to suppress the claim or restrict its entry into the
market. It thus follows that if FDA lacks legal power to suppress the
claim, it also lacks legal power to delay its entry into the market
(suppressing it for a time) to conduct a formal notice and comment
rulemaking. As explained below, while not legally required, the better
approach is the notification recommended by the GMA in its Comments. The
Commenters support that alternative.

Moreover, the Administrative Procedure Act (APA) 5 U.S.C. § 553, the
section on rulemaking, states,

> Except when notice or hearing is required by statute, this subsection
> does not apply --
>
> \(A\) to interpretative rules, general statements of policy, or rules
> of agency organization, procedure, or practice; or
>
> \(B\) when the agency for good cause finds (and incorporates the
> finding and a brief statement of reasons therefore in the rules
> issued) that notice and public procedure thereon are impracticable,
> unnecessary, or contrary to the public interest.

As explained above, the NLEA health claims provision does not apply to
qualified claims, and the First Amendment prohibits unreasonable delay
in allowing qualified claims to enter the market. Once FDA finds a
qualified claim constitutionally protected, that claim cannot be
suppressed or denied entry into the market through unreasonable delay.
Thus, the APA does not require a rulemaking.

> **V. AGENCY POLICY AND REGULATIONS THAT ARE NOT INACCORDANCE WITH
> [PEARSON I]{.underline} AND ITS PROGENY ARE UNENFORCEABLE**

CSPI argues that the Qualified Claims Guidance conflicts with prior
agency policy and with the agency's health claims regulations. To the
extent that qualified claims and the teachings of [Pearson
I]{.underline} and its progeny conflict with 21 C.F.R. § 101.14, those
regulations are unenforceable.

For example, 21 C.F.R. § 101.14(e) states, in pertinent part:

> 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
> \[subpart E is where all the regulations for authorized health claims
> appear\]...

The six currently permitted qualified health claims do not appear in
subpart E of Part 101.

However, 101.14(e) cannot be enforced against manufacturer's using those
qualified health claims because to do so would be an unconstitutional
restriction of the speaker's First Amendment rights and would violate
the orders in [Pearson I]{.underline} and its progeny.

CSPI cites to FDA's 2000 Guidance on implementing [Pearson
I]{.underline} for the suggestion that [Pearson I]{.underline} does not
apply to conventional foods (as if the First Amendment contains a
conventional foods exclusion) and for the proposition that the
procedural requirements of the NLEA are unaffected by [Pearson
I]{.underline}. It also cites to a 1993 Federal Register, 58 Fed. Reg.
2478, 2423, for an interpretation of the NLEA health claim provisions.
The 1993 discussion by the agency of how it interprets the NLEA health
claims provisions is totally irrelevant to the extent that it conflicts
with [Pearson I]{.underline}. To the extent that the agency's 1993
policy conflicts with the teachings of [Pearson I,]{.underline} the
agency's policy has no further legal force or effect. Even the
post-[Pearson]{.underline} 2000 Guidance is unenforceable and
inapplicable to the extent that it conflicts with
[Whitaker]{.underline}, 248 F. Supp. 2d 1.

**IV. THE COMMENTERS ENDORSE GMA'S COMMENT**

The Commenters endorse GMA's May 29, 2003 Comments. GMA proposes a
program whereby applicants for qualified claims would submit information
substantively identical to that required for health claim petitions but
entitled "premarket notifications." Premarket notifications would not be
subject to notice and comment rulemaking. Moreover, the premarket
notification process would also be available to health claimants who
failed SSA but desired a qualified claim instead. Contrary to CSPI, GMA
acknowledges that the First Amendment and [Pearson I]{.underline} apply
equally to qualified claims and understands the First Amendment
requirements apply to conventional foods and dietary supplements alike.
Under GMA's proposed rule, within 30 days of receipt of the premarket
notification for a qualified health claim, FDA would publish a notice of
filing in the Federal Register. This notice of filing would specify that
within 60 days, any interested person could submit to FDA any comments,
data, or information, including additional proposed claims, expanded
claims, and additional categories of food or dietary supplements to
which the claim would also apply. In addition, all contents of the
premarket notification for a qualified health claim would become public
upon FDA's publication of the notice of the filing in the Federal
Register. FDA would then take into account all of the additional
submitted information as part of its consideration of the premarket
notification for a qualified health claim. Throughout the review period,
the notifying party or parties could engage in informal discussions in
an attempt to reach an agreement on an appropriate qualified claim.
Within 180 days of FDA's publication of the notice of filing, FDA would
inform the person submitting the premarket notification for a qualified
health claim of its decision. Even after a qualified claim is agreed to
by FDA, any interested party would be able to submit comments or
information on the claim, as is the case with the current qualified
claims. GMA's proposed procedure for qualified claims thereby does not
impose the strictures and delays of notice and comment rulemaking but
does codify in the regulations a formal opportunity for comment in lieu
of the informal opportunity now present.

IV. **CONCLUSION**

The Qualified Claims Guidance is a lawful method for implementing the
mandate of [Pearson I]{.underline}. CSPI asks FDA to ignore the First
Amendment and [Pearson I]{.underline} and to limit health claims to only
those that are "authorized" under the NLEA health claims provision,
following notice and comment rulemaking. CSPI's request calls for
unconstitutional and unlawful agency action and thus cannot be followed.
GMA, by contrast, offers a notification process with a 180-day time
limit that is a lawful and reasonable approach endorsed by the
Commenters.

> Respectfully submitted,
>
> DURK PEARSON & SANDY SHAW;
>
> LIFE EXTENSION FOUNDATION, INC.; and DR. JULIAN WHITAKER
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Jonathan W. Emord

Andrea G. Ferrenz

Emord & Associates, P.C.

5282 Lyngate Court

Burke, VA 22015

\(202\) 466-6937

fax: (202) 466-6938

<jemord@emord.com>

Date submitted: July 1, 2003

**[Exhibit A]{.underline}**

Attached File: OMB Press Release on Omega-3.pdf

[^1]: [Univ. of Great Falls v. NLRB]{.underline}, 278 F.3d 1335, 1340-41
    (D.C. Cir. 2002) ("Although we normally defer to an agency's
    interpretation of ambiguous statutory language under
    [Chevron]{.underline}, . . . here another even more important
    principle of judicial restraint weighs upon us, which is that
    Federal courts traditionally have sought to avoid constitutional
    questions if at all possible . . . In other words, the
    constitutional avoidance canon of statutory interpretation trumps
    Chevron deference.") (internal quotes omitted).

[^2]: Antioxidants and cancer; Folic acid in supplement form and neural
    tube defects; Folic acid, Vitamin B6, and Vitamin B12 and
    cardiovascular disease; Omega-3 fatty acids and coronary heart
    disease; Phosphatidylserine and cognitive dysfunction/dementia;
    Selenium and cancer/anticarcinogenic effects.

[^3]: [Pearson v. Shalala]{.underline}, 130 F. Supp. 2d 105 (D.D.C.
    2001)("[Pearson II]{.underline}"); [Pearson v.
    Thompson]{.underline}, 141 F. Supp. 2d 105 (D.D.C. 2001) ("[Pearson
    III]{.underline}"); [Whitaker v. Thompson]{.underline}, 248 F. Supp.
    2d 1 (D.D.C. 2002).

[^4]: It should be noted that the Guidance was promulgated before the
    U.S. District Court for D.C. issued [Whitaker v.
    Thompson]{.underline}, 248 F. Supp. 2d 1 (D.D.C. 2002). Thus,
    [Whitaker]{.underline} trumps the Guidance to the extent of any
    conflicting analysis. In particular, [Whitaker]{.underline} forbids
    FDA from suppressing any claim unless the following standard is met:

    > "First, when the FDA has determined that no evidence supports \[a
    > health\] claim, it may ban the claim completely . . . Second, when
    > the FDA determines that evidence in support of the claim is
    > qualitatively weaker than evidence against the claim -- for
    > example, where the claim rests on only one or two old studies, it
    > may impose an outright ban . . . Even in those two situations a
    > complete ban is only appropriate where the government could
    > demonstrate with empirical evidence that disclaimers similar to
    > the ones \[the [Pearson]{.underline} Court\] suggested above
    > \["The evidence in support of this claim is inconclusive" or "The
    > FDA does not approve this claim"\] would bewilder consumers and
    > fail to correct for deceptiveness." [Whitaker]{.underline}, 248 F.
    > Supp. 2d at 27-28, citing [Pearson I]{.underline}, 164 F.3d at
    > 659-660 (internal quotations omitted).

[^5]: That information can prove indispensable to the exercise of
    informed choice in the market and can save lives by diminishing the
    incidence of disease. For example, the qualified Omega-3 fatty acid
    and cardiovascular disease claim has the potential to help prevent
    150,000 sudden death heart attacks per year in America.
    [See]{.underline} Exhibit A.

[^6]: CSPI believes the "new policy" a product of the Guidance but it is
    not. The "new policy" follows directly from the First Amendment
    mandates in [Pearson I]{.underline} and its progeny. CSPI's
    persistence in ignoring the First Amendment belies its apparent
    effort to undermine it. It is unlikely to achieve such a momentous
    goal and cannot do so [sub silentio]{.underline}.

[^7]: [E.g.,]{.underline} [Pearson I]{.underline}, 164 F.3d at 655
    citing [Peel v. Attorney Registration and Disciplinary Comm'n of
    Illinois]{.underline}, 496 U.S. 91, 105 (1990).

[^8]: CSPI notably makes no mention of the six qualified health claims
    currently permitted, for which all six petitions are publicly
    available in FDA's Docket. [See]{.underline} FDA Dockets Management
    Branch Dockets No. 91N0101 (Antioxidants); 91 N 0103 (Omega-3 Fatty
    Acids); 91N100H (Folic Acid in Supplement Form); 99P3029 (B
    Vitamins); 02P0413 (Phosphatidylserine); and 02P0457 (Selenium).