**Before the**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES**

**FOOD AND DRUG ADMINISTRATION**

**In re: Views and Comments )**

**From Interested Stakeholders ) Public Docket 03N-0069**

**)**

**JOINT COMMENTS OF**

**JULIAN M. WHITAKER, M.D.**

**AND**

**[WELLNESS LIFESTYLES, INC. d/b/a AMERICAN LONGEVITY]{.underline}**

Julian M. Whitaker, M.D. and Wellness Lifestyles, Inc. d/b/a American
Longevity, by counsel and in response to the notice seeking stakeholder
comment on six questions posed by the Task Force on Consumer Health
Information for Better Nutrition ("Task Force"), hereby submits the
following.

**I. [BACKGROUND OF COMMENTERS]{.underline}**

***Julian M. Whitaker, M.D.*** Julian M. Whitaker, M.D. is a physician
licensed to practice medicine in the states of California and
Washington. He was graduated from Dartmouth College in 1966 with a B.S.
degree and from Emory University in 1970 with an M.D. degree. He
received additional training in surgery as a resident at the University
of California Medical School. From 1975 to 1976 he worked as a physician
at the Pritikin Institute in California. Since that time he has been the
Clinical Director of the Whitaker Wellness Institute in Newport Beach,
California. He is the author of eight books, including: ***Reversing
Heart Disease*** (1985), ***Reversing Diabetes*** (1987), ***Reversing
Health Risk*** (1989), ***Natural Healing*** (1994), and ***What Your
Doctor Won't Tell You About Bypass*** (1995). He is also the author of a
widely read monthly newsletter: ***Health & Healing***. Dr. Whitaker's
newsletter was recognized by ***Time*** magazine as one of the top-ten
newsletters in the country. Dr. Whitaker is among those who have filed
health claim petitions and has served as a plaintiff in successful
challenges to FDA health claim petition denials. Dr. Whitaker has been a
plaintiff in the following successful First Amendment decisions
appealing FDA actions that suppress health claims: *Whitaker v.
Thompson*, 2002 U.S. Dist. LEXIS 25255 (D.D.C. 2002) (antioxidant/cancer
claim); *Pearson v. Shalala*, 130 F.Supp.2d 105 (D.D.C. 2001); and
*Pearson v. Thompson*, 141 F.Supp.2d 105 (D.D.C. 2001).

***Wellness Lifestyles, Inc. d/b/a American Longevity.*** Wellness
Lifestyles, Inc. d/b/a American Longevity ("American Longevity"), a
California company, has been a leading marketer of human and animal
dietary supplements and cosmetics for over five years. American
Longevity markets over 50 dietary supplement and personal care products
ranging from vitamin and mineral supplements to skin care products.
American Longevity has filed health claim petitions with the FDA and has
served as a plaintiff in a successful challenge to an FDA health claim
petition denial. American Longevity has been a plaintiff in the
following successful First Amendment decision appealing an FDA action
that suppressed a health claim: *Whitaker v. Thompson*, 2002 U.S. Dist.
LEXIS 25255 (D.D.C. 2002).

**II. [RESPONSES TO FDA QUERIES]{.underline}**

FDA asks stakeholders to respond to the following six questions: (1)
What body of scientific evidence do you think should be adequate for a
qualified health claim?; (2) what types of safety concerns should be
factored into FDA decision-making?; (3) what specific claims do you
think are currently ready for consideration under the new guidance?; (4)
on what issues are disclaimers valuable, or not valuable, in preventing
consumers from being misled, and do you have the data to support your
view?; (5) what kinds of empirical data should FDA rely upon to show
that consumers are, or are not, misled by claims?; and (6) should
conventional foods and dietary supplements be treated the same or
treated differently, and why?

Q.  **What body of scientific evidence do you think should be adequate
    for a qualified health claim?**

> The question presumes that a defined level of scientific evidence can
> serve as a

general standard or rule for allowance of qualified health claims. That
presumption is in error. In *Pearson v. Shalala*, 164 F.3d at 659-660
(D.C. Cir. 1999), the agency tried to convince the Court of Appeals that
"significant scientific agreement" defined a standard for claim
allowance and that were the FDA to find such agreement not present, it
had no First Amendment obligation to permit a health claim to be made
with disclaimers. The Court rejected that argument. It rejected the
notion that a defined scientific standard could substitute for the
case-by-case First Amendment assessment of misleadingness required under
*Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of N.Y.*, 447
U.S. 557 (1980) and its progeny. *Pearson v. Shalala*, 164 F.3d at 654
(". . . \[E\]ven if 'significant scientific agreement' were given a more
concrete meaning, appellants might be entitled to make health claims
that do not meet the standard---with proper disclaimers"). That point is
reinforced by the disclaimers the Court of Appeals recommended to the
agency. Those disclaimers state that the scientific evidence in support
of the claim or claims is "inconclusive." *See Pearson v. Shalala*, 164
F.3d at 653. Thus, inconclusiveness of science does not make a claim
suppressible under the First Amendment; rather, it merely begs the
ultimate First Amendment question: Can the claim be qualified or
disclaimed in a way that will eliminate misleadingness? If it can be
rendered nonmisleading through the addition of a disclaimer,
qualification, or warning statement, it must be.

Consistent with the Court of Appeals' decision in *Pearson*, the United
States District Court for the District of Columbia has explained that "
. . . when 'credible evidence' supports a claim, that claim may not be
absolutely prohibited." *Whitaker v. Thompson*, 2002 U.S.Dist. LEXIS
25299, \*27 (2002). One may better discern "credible evidence" by
determining what it is not; that is because our federal courts address
the question in precisely that way. Our federal courts compel FDA to
allow a qualified claim (and, thus, find "credible evidence") unless the
FDA proves, with empirical evidence, that (1) there is no scientific
evidence to support the health claim or the scientific evidence in
support of the claim is qualitatively weaker than evidence that is
specifically against the claim *and* (2) no reasonable disclaimer can be
found to eliminate misleadingness.

In *Whitaker v. Thompson*, the court explained that there were but "a
very narrow set of circumstances in which suppression \[of a claim\]
would be permissible under the First Amendment," *id* at \*25. Viewed
from the vantage point of what FDA must prove in order to meet its First
Amendment burden to justify claim suppression,[^1] one may readily see
that so long as the claim is backed by some scientific evidence and a
disclaimer can suffice to eliminate misleadingness, the claim must be
allowed with that disclaimer. The point is made succinctly in *Whitaker
v. Thompson*, 2002 U.S. Dist. LEXIS 25299 at \*27-28 (2002), which by
law defines the assessment FDA must undertake to comply with the First
Amendment strictures on its actions:

> Specifically, [Pearson I]{.underline} identified two situations in
> which a complete ban would be reasonable. First, when the "FDA has
> determined that [no]{.underline} evidence supports \[a health\]
> claim," it may ban the claim completely. [Id.]{.underline}, 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]{.underline}," it may impose an outright
> ban. [Id.]{.underline}, 164 F.3d at 659 n.10 (emphasis added). Even in
> these two situations, a complete ban would only be appropriate when
>
> The government could demonstrate [with empirical evidence]{.underline}
> that disclaimers similar to the ones \[the Court\] 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 v. Thompson,* 2002 U.S. Dist. LEXIS 25299 at \*27-\*28 (2002),
*citing* *Pearson v. Shalala,* 164 F.3d at 659-660. In sum, then, so
long as a health claim is backed by some credible evidence and a
disclaimer or qualification can suffice to eliminate misleadingness, the
claim must be allowed with that disclaimer.

Q.  **What type of safety concerns should be factored into FDA
    decision-**

> **making?**

Safety is an issue only if the product is not lawfully saleable as a
dietary supplement under the Food Drug and Cosmetic Act (due to
adulteration). If a petitioner were to seek agency health claim approval
for a dietary supplement that contained ingredients that were
adulterated within the meaning of 21 U.S.C. §§ 342, 348, or 350 (2003),
then the FDA would fulfill its statutory duty without offense to the
First Amendment by denying the petition. That is because the denial
would be based on the unlawful status of the product, a statutory
determination that can be rendered without regard to the content of what
is communicated. If, however, the dietary supplement contained
ingredients lawfully saleable but known to cause adverse effects in a
subset of the American population or to cause adverse effects at some
level of ingestion, then the FDA would act properly by requiring an
appropriate disclaimer but improperly by denying the petition. That is
because use of a disclaimer in such a circumstance is an obvious, less
speech restrictive alternative to outright suppression and, thus,
constitutionally required. *See, e.g.,* *Pearson v. Shalala*, 164 F.3d
at 638, *citing* *Board of Trustees of the State University of N.Y. v*.
Fox, 492 U.S.469, 480 (1989), *citing* *Shapero v. Kentucky Bar Ass'n*,
486 U.S. 466, 476 (1988). Indeed, that is one of the teachings of
*Pearson v. Shalala*, 164 F.3d at 659: ". . .\[T\]he government's
interest in preventing the use of labels that are true but do not
mention adverse effects would seem to be satisfied---at least
ordinarily---by inclusion of a prominent disclaimer setting forth those
adverse effects"). Were the FDA to deny a health claim petition in those
latter circumstances, it would act without a statutory predicate, would
undermine the intended meaning of the health claims provision of the Act
(which is designed to ensure that consumers receive as much accurate
information as possible about the nutrient-disease relationship) and
would necessarily offend the First Amendment because it is undoubtedly
the case that a truthful claim could be made about a lawfully saleable
dietary supplement.

Q.  **What specific claims do you think are currently ready for
    consideration under the new guidance?**

> The potential claims are as numerous as the credible evidence on
> nutrient-disease

relationships contained in the publicly available scientific literature.
Few, if any, commenters will likely volunteer the precise claims they
wish to submit because those decisions involve proprietary concerns,
scientific research, and business planning that many prefer not to
divulge publicly before actually filing a petition. Suffice it to say
that several potential claims are undergoing scientific review by
independent scientists commissioned by the commenters, and the
commenters understand that several other parties are performing that
same kind of exercise in anticipation of filing health claim petitions.
If those reviews confirm the existence of credible scientific evidence
in support of the claims, the commenters would be predisposed to filing
appropriate petitions.

In general, the principal impediment to the filing of health claim
petitions arises from economic considerations (the extent to which the
claim may edify consumers and respond to their demand for products of
high quality and utility, the cost of obtaining detailed scientific
reviews of the evidence to support a petition, and the time associated
with FDA evaluation of claims). Full use of the 540 days statutorily
permitted for health claim review creates an enormous disincentive to
the filing of claims for most parties. That is because the dietary
supplement market is a highly competitive one, and those in that market
must be extremely sensitive to ever changing consumer demands to
survive. In the dietary supplement market, consumer demand ascertainable
today is not a reliable predictor of demand a year and a half from now.
Therefore, a significant reduction in the time expended for claim review
would likely increase private resort to use of the health claim petition
process and would thereby fulfill the purposes of the statute and of the
health information for better nutrition initiative by increasing the
quantity and variety of accurate health information available to
consumers. A significant reduction in review time would also quite
likely reduce the incentive for, and thus the number of, unapproved
claims in the market, redounding to the benefit of consumers due to a
reduction in the number of false or unsubstantiated market claims.

Q.  **On what issues are disclaimers valuable, or not valuable, in
    preventing consumers from being misled, and do you have data to
    support your view?**

> The Supreme Court and the lower federal courts define disclaimers,

qualifications, and warning statements as the only means available to
the government to alter potentially misleading commercial speech, speech
the Court has held protected by the First Amendment. *See Pearson v.
Shalala,* 164 F.3d 650, 655; *citing In re R.M.J.*, 455 U.S. 191, 203
(1982); *Ibanez v. Florida Dept. of Business*, 512 U.S. at 144-46; *Peel
v. Attorney Registration and Disciplinary Comm'n of Illinois*, 496 U.S.
91, 110; *see also* *Whitaker v. Thompson*, 2002 U.S. Dist. LEXIS 25255
at \*26 (D.D.C. 2002) . Government is thus left with a choice of either
mandating or not use of a disclaimer, qualification, or warning
statement in those instances where it can *prove* the existence of a
*potential* to mislead.[^2] Because a health claim is, by statutory
definition, one that cannot enter the market without FDA approval,
market survey data is of little use in ascertaining whether consumers
will be misled once the claim has entered the market. That is because
the presence of the claim in the market has its own edifying effects. It
triggers consumer interest, leads to inquiry, inspires public debate,
and invites critical analysis---all of which lead to greater public
understanding. Moreover, claims are presented in a greater commercial
context that tends to define parameters for public understanding that
are not present in the pre-market context. To be sure, interpretation of
pre-market survey data (as opposed to post-market survey data) is
extremely difficult, if not impossible, because it necessarily involves
guesswork as to consumers' scientific aptitude and likely future
reactions. Today's consumer may know far less about a nutrient-disease
relationship than tomorrow's or may harbor misconceptions that may
disappear through the rapid information exchange (and resulting debate)
that normally takes place in the modern marketplace.

It is thus most prudent (and, in fact, essential from a First Amendment
standpoint) for each claim to be evaluated based on its plain language
meaning. If in light of the scientific evidence reviewed, the plain
meaning of the claim conveys a misleading connotation or omits material,
then a succinct, accurate and tailored disclaimer, qualification, or
warning statement may be added to avoid misleadingness.

The Supreme Court has circumscribed the discretion of commercial speech
regulators in this context by prohibiting use of unreasonable
disclaimers, i.e., ones that would engender a chilling effect on the
willingness of others to communicate the same claim. *See Zauderer v.
Office of Disciplinary Counsel of the Supreme Court of Ohio*. 471 U.S.
626, 651 (1985) ("We recognize that unjustified or unduly burdensome
disclosure requirements might offend the First Amendment by chilling
protected commercial speech."). It is thus imperative for the agency to
craft disclaimers, qualifications, and warning statements with the
utmost care and with a due regard for the potential of the disclaimer,
qualification, or warning statement to dissuade others from
communicating the same information. In short, succinct and accurate
disclaimers, qualifications, and warning statements are essential, as
the federal courts have repeatedly informed the agency. *See Pearson v.
Shalala*, 164 F.3d at 657 ("Pearson I"); *Pearson v. Shalala*, 130 F.
Supp. 2d 105, 114 (D.D.C. 2001) ("Pearson II"); *Pearson v. Thompson*,
141 F. Supp. 2d 105, 112 (D.D.C. 2001) ("Pearson III"); *Whitaker v.
Thompson*, No.01-1539, 2002 U.S. Dist. LEXIS 25299 (D.D.C. Dec. 26,
2002).

Empirical data on the role of disclaimers, qualifications, and warning
statements on claims that have not yet entered the market is largely
unavailable and would likely be of little utility for the reasons stated
above. From the folic acid/neural tube defect claim, however, we do know
that public awareness of that association was, at the first release of
the claim, low and, thus, misunderstanding of the relationship was high.
*See* CDC.  "Knowledge and use of folic acid by women of childbearing
age--United States, 1995 and 1998."  *MMWR* 1999; Vol.48, No.16: 325-327
(13 percent of women in 1998 knew that folic acid reduces the risk for
NTDs.) After years of use of the claim in the market, and broad
dissemination of information concerning it, it now appears that many
more women of childbearing age comprehend the relationship. *See id.*
(30 percent of women in 2003 know that folic acid reduces the risk for
NTDs.) The empirical evidence from the folic acid claim is revealing. It
informs us that information of scientific complexity (such as that
commonly found in nutrient-disease relationship claims) may not be well
understood in the market at the outset but may become so through greater
public exposure to the claim and through the workings of free idea and
information markets. It would therefore be expected that in the
pre-market context, reliance on a survey of potential future consumer
claim perception would be unreliable.

Moreover, under the First Amendment, government has no constitutional
power to suppress a true message on the basis that recipients of the
message do not comprehend it. *See Bates v. State Bar of Arizona*, 433
U.S. 350, 374-75 (1977). Rather, as the *Pearson* Court emphasized,
information disclosure, not suppression, is the preferred First
Amendment remedy. *See Pearson v. Shalala*, 164 F.3d at 657.

We may derive from the foregoing the following principles consistent
with the First Amendment mandates the Courts have imposed on this
agency. Claims submitted to this agency before they have entered the
market must be evaluated based on their plain language meaning. When
assessed against the empirical data (i.e., the scientific evidence) if
it is clear that the claim, through either its plain meaning or omission
of material information, may mislead, FDA may require use of succinct
and accurate disclaimers, qualifications, or warning statements to avoid
that potential misleadingness.

Because health claims communicate scientific speech, we can expect
consumers to have more difficulty comprehending them when they first
enter the market. The solution to this problem lies principally in the
free idea and information market where the claims will be bandied about
naturally without aid of government. FDA may, however, enter the market
and promote dissemination of accurate health information. The
experiential model for useful dissemination of information occurs in the
folic acid/neural tube defect context. There, while the initial presence
of the folic acid/neural tube defect claim in the market did not yield
evidence of widespread comprehension, publication of the claim and
persistent private and public communication about it has led to greater
public awareness. We should view the claim and the disclaimer as the
start of public debate, not the end of it. It is the catalyst for
critical thinking, not the ultimate resolution of debate on the
nutrient-disease relationship.

Q.  **What kinds of empirical data should FDA rely upon to show that**

> **consumers are, or are not, misled by claims?**

As explained above, the relevant empirical data in the prior restraint
context of health claims exists in all publicly available scientific
literature germane to the claim and in the plain language of the claim.
With that information in hand, FDA may determine if the claim as worded
is backed by credible evidence, does not convey a misleading
connotation, and does not omit material information necessary to avoid
misleadingness. If the language of the claim may mislead or if a
material omission is present that could mislead, then FDA may require
the addition of a reasonable disclaimer, qualification, or warning to
avoid the misleading connotation. As stated above, empirical data from
the market will not provide accurate consumer perception information
concerning nutrient-disease information not present in the market. From
the folic acid/neural tube defect example, we may readily see that the
*Pearson* Court's command that FDA favor disclosure over suppression and
the provision of more information, not less, on the nutrient-disease
relationship is the best way to eliminate misleadingness associated with
lack of comprehension or misunderstanding. We may expect lack of
understanding and misunderstanding to occur when a health claim first
enters the market because health claims are scientific speech, often at
a high level, and public education will have to occur to achieve greater
comprehension. As explained above, the First Amendment forbids
government censorship of truthful communication on the basis that the
recipient cannot comprehend or misunderstands the message. *See National
Association for the Advancement of Colored People v. Jones*, 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 Miami Herald Pub. Co. v. Tornillo*, 418 U.S. 241 (1974) (The
Supreme Court rejected the notion that listeners have an independent
First Amendment right to edit speech to suit their interests or needs.).

Q.  **Should conventional foods and dietary supplements be treated the
    same**

> **or treated differently, and why?**

The First Amendment applies equally to commercial speech concerning
dietary supplements and foods. Nutrient-disease claims for both should
be treated under the same First Amendment standard; the *Pearson*
decision and its progeny rest on First Amendment principles that apply
to all manner of commercial speakers (from beer salespeople (*Rubin v.
Coors Brewing Co.*, 514 U.S. 476 (1995)) to lawyers who are also
certified public accountants (*Ibanez v. Florida Dept. of Business and
Professional Regulation, Bd. of Accountancy*, 512 U.S. 136 (1994)).
Consequently, there is no sound

legal basis for affording any less First Amendment protection to
nutrient-disease claims for foods than nutrient-disease claims for
dietary supplements. Claims for each should be evaluated under the same
First Amendment standard.

Sincerely,

Jonathan W. Emord

Kathryn E. Balmford

Counsel to Julian M. Whitaker, M.D.;

Wellness Lifestyles, Inc. d/b/a

American Longevity

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

1050 Seventeenth Street, N.W.

Suite 600

Washington, D.C. 20036

P: (202) 466-6937

F: (202) 466-6938

Email: <jemord@emord.com>

Dated: April 24, 2003

[^1]: *See Edenfield v. Fane,* 507 U.S. 761, 770 (1993) ("\[I\]t is well
    established that the party seeking to uphold a restriction on
    commercial speech carries the burden of justifying it"). The FDA's
    burden to justify claim suppression is a very high one. *Pearson v.
    Shalala*, 130 F.Supp.2d 105, 118 (D.C.D.C. 2001) (". . . the FDA has
    simply failed to adequately consider the teachings of Pearson: that
    the agency must shoulder a very heavy burden if it seeks to totally
    ban a particular health claim"); *Pearson v. Thompson*, 141
    F.Supp.2d 105, 112 (D.C.D.C. 2001) (reiterating that FDA has "a very
    heavy burden \[that it\] must satisfy if \[it\] wish\[es\] to
    totally suppress a particular health claim").

[^2]: The Court of Appeals and the lower federal courts expect FDA to
    rely on empirical evidence, not supposition, as a basis for finding
    the existence of a potential to mislead. *See* *Pearson v. Shalala*,
    164 F.3d at 659. To date, that evidence has come in the form of the
    scientific data considered during the health claim review process,
    not on public perception survey data (which, as explained *infra*,
    suffers from inherent risks of inaccuracy in the pre-market
    context).