When FDA issued the structure/function rule in January 2000, it allowed supplement
manufacturers to make weight loss claims. That earlier determination, however, is entirely
distinguishable from the actions requested in this petition. Specifically, in connection with
issuance of its proposal for the structure/function rule in April 1998, FDA considered weight loss
in the context of two of the ten criteria it had proposed for identifying whether particular
statements constitute disease claims. These proposed criteria focused on statements claiming
that a supplement is a substitute for another product that is a therapy for a disease and statements
claiming that the supplement augments a particular therapy or drug. 63 Fed. Reg. 23624 at
23632 (discussing 21 C.F.R. §§ 101.93(g)(2)(vi) and (g)(2)(vii)). In the preamble describing
these proposed criteria, FDA stated that a “claim that did not identify a specific drug, drug action
or therapy (e.g., “use as part of your weight loss plan”) would not constitute a disease claim
under this criterion.” Id.
In response to this proposal, several parties objected to FDA’s position that supplement
manufacturers could state that their products may be used as part of a weight loss plan. One
party maintained that the reference to weight loss implies treatment of a disease – obesity.
Another comment asserted that the legislative history underlying the FDCA shows that Congress
intended weight loss claims to be treated as disease claims. 65 Fed. Reg. at 1027. In the
preamble to the final rule, FDA agreed that supplement manufacturers could not claim that their
products helped treat obesity since it is a disease. On the other hand, the agency indicated that
being overweight is not a disease. Because “it is commonly understood that’weight loss plans’
relate to a broad range of overweight statuses,” FDA reasoned that such plans “are not so
narrowly associated with a disease treatment that a reference to use as part of a weight loss plan
should be considered a disease claim.” Id. Thus, in evaluating the application of two criteria in
its regulations, FDA found that the statement “use as part of a weight loss plan” is an acceptable
structure/function claim.
In connection with this determination and in response to one comment, FDA indicated
that the legislative history underlying the FDCA does not require the agency to determine that
weight loss claims must be treated as disease claims. On the other hand, FDA did not conclude
that the legislative history precludes the agency from regulating weight loss claims under the
Act. 69 To be sure, the 1938 amendments to the FDCA added the structure/function clause to the
statutory definition of “drug” so that FDA had express authority to regulate deceptive weight loss
69
The FDA also considered whether the case law “compels the conclusion” that weight loss products must be
regulated as drugs. On the basis of its analysis of several cases, including Nutrilab, Inc. v. Schweiker, 713 F.2d 335
(7th Cir. 1983), American Health Products Co. v. Hayes, 744 F.2d 912 (2d Cir. 1984), and United States v. Ten
Cartons, More or Less, of an Article Ener-B Vitamin B-12, 72 F.3d 285 (2d Cir. 1995), FDA stated that it “does not
agree that . . . dietary supplements making weight loss claims must necessarily be regulated as drugs.” 65 Fed. Reg.
1000, 1027 (January 6, 2000) (emphasis added).
products. 70 It does not follow, however, that with passage of the Dietary Supplement Health and
Education Act (“DSHEA”) (Pub. Law 103-417), Congress intended that weight loss claims only
be treated as structure/function claims. 71 Nothing in the legislative history surrounding the
FDCA precludes FDA from treating such statements as disease claims, particularly where, as
here, there is new information and a growing body of evidence indicating that the supplement is
meant to treat a disease or a risk factor for a disease. That is precisely the conclusion that FDA
reached when it determined that weight loss claims referring to obesity are disease claims; it
should be no different for statements that a supplement will treat an abnormal or unhealthy
condition that is a risk factor for disease.
The concepts of obesity and overweight have changed dramatically since the
structure/function clause was added to the FDCA almost 70 years ago. If Congress were
redrafting the statute with the benefit of today’s science, it would not need the structure/function
clause at all since weight loss claims would be viewed as disease claims. The fact that Congress,
in enacting the structure/function clause, was limited by the science available in 1938 does not
require FDA to limit itself in a similar manner. Rather, on the basis of current scientific
information, FDA must seek to effectuate Congressional intent. Here, there is a longstanding
intent of Congress to protect consumers from unsafe and/or ineffective products. The Senate
report to the 1938 Amendments explained that FDA must regulate such products “if the
consumer is to be protected against . . . pre
~arations . . . which are worthless at best and some of
which are distinctly dangerous to health. “~ Given the close resemblance between the landscape
of 1938 and the situation today, action by FDA to regulate weight loss claims would be fully
consistent with Congressional intent to regulate claims that falsely promise weight loss.
2. The FDA’s Previous Determination About Weight Loss Supplements Does
Not Preclude the Agency from Treating Weight Loss Claims as Disease
Claims Under Different Criteria in the Structure Function Rule
On the basis of the foregoing analysis, at least four key distinguishing points emerge and
make clear that FDA’s narrow decision about weight loss claims in 2000 does not serve as a
precedent that prevents the agency from taking the actions requested in this petition.
70
S. REP. NO. 74-361, at 3 (1935), reprinted in 3 A LEGISLATIVE HISTORY OF THE FEDERAL FOOD, DRUG, AND
COSMETIC ACT AND ITS AMENDMENTS 662. On the House side, one member captured the situation, declaring “these
products have been known to cause death as well as serious illness-and yet they continue to be advertised and sold
as’safe.’ Even though they may not be harmful, many of them are worthless.” See Extension of Remarks of Hon.
Caroline O’Day of New York in the House of Representatives, Feb. 24, 1937, 81 CONG. REC. A321 (1937),
reprinted in 5 A LEGISLATIVE HISTORY OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND ITS AMENDMENTS
490.
71
There is no indication that Congress, when enacting DSHEA, knew of the historical references to weight loss
associated with the structure/function clause. After all, the FDCA was amended more than twenty times between
1938 and 1994, and Congress’s thoughts on weight loss and the structure/function clause were not reflected in the
statutory text, but rather hidden in the legislative history. These circumstances, combined with the fact that the
FDCA is a voluminous statute, undermine the notion that the structure/function clause in DSHEA must be
interpreted identically to the original structure/function clause in the FDCA.
72 S. REP. No. 74-361, at 3 (1935), reprinted in 3 A LEGISLATIVE HISTORY OF THE FEDERAL FOOD, DRUG, AND
COSMETIC ACT AND ITS AMENDMENTS 662.
(1) In 2000, FDA authorized supplement manufacturers to make weight loss
claims after determining that the condition of being overweight is not a disease.
Here, petitioners are not asking FDA to reverse its finding that overweight is not a
disease. Rather, petitioners are requesting the agency to take action on the basis
of substantial scientific evidence establishing that the condition of being
overweight is not itself a disease but rather a risk factor for disease.
(2) In 2000, scientific data linking the risk of disease with being overweight was
not fully developed. Nor was there any information available about consumer
perceptions and use of weight loss supplements to reduce risks. As a result, FDA
did not then consider whether weight loss claims should be treated as disease
claims under 21 C.F.R. § 101.93(g)(2)(ii) – the criterion that led FDA to regulate
statements about risk factors such as high cholesterol and high blood pressure.
(3) In 2000, FDA reached its decision about weight loss supplements under two
different criteria in the structure/function rule. That determination does not
preclude FDA from now determining that such statements are disease claims
under a separate and distinct criterion in the regulations. The regulations
contemplate that each of the ten criteria was meant to be applied independently
and prospectively in an evaluation of claims accompanying dietary supplements.
(4) In 2000, FDA found that neither the legislative history nor the case law
“necessarily requires” the agency to determine that weight loss claims are disease
claims. On the other hand, FDA did not (and could not) take the position that it
lacks authority to treat such statements as disease claims. Indeed, that
determination would be inconsistent with longstanding Congressional intent.
Accordingly, although FDA decided not to prohibit weight loss claims in 2000, that
determination was based on then-existing scientific information and different regulatory criteria
in the structure/function rule. Nothing precludes the agency from now finding, on the basis of
new scientific information developed during the past decade, that weight loss claims are disease
claims under criteria in FDA’s regulations that were not previously considered by the agency.
The FDA announced in its January 9, 2002 “Structure/Function Claims Small Entity Compliance
Guide” that dietary supplement manufacturers “can look to medical texts and other objective
sources of information about disease to determine if a label statement implies treatment or
prevention of a disease.”73 This guidance and the rule itself therefore clearly contemplate the
fact that as medical science evolves so, too, will the conditions that constitute the signs or
symptoms of disease.
Finally, in this context, petitioners must emphasize that FDA is not required to engage in
notice and comment rulemaking under the Administrative Procedures Act (“APA”), 5 U.S.C. §
553, before implementing the actions requested in this petition. That is because petitioners are
not asking FDA to change its earlier interpretation of the way that two of the criteria in the
73 Food and Drug Administration, Center for Food Safety and Applied Nutrition. Structure/function claims small
entity compliance guide. January 9, 2002. (Accessed January 3, 2008, at
http://www.cfsan.fda.gov/-dms/sclmguid.html).
structure/function rule apply to weight loss claims. Rather, petitioners are requesting FDA to
apply a particular provision in its existing regulations to weight loss claims in light of the
substantial body of scientific literature and consumer survey data developed during the past
decade. An agency’s application of its regulations to particular factual scenarios certainly does
not require notice and comment rulemaking under the APA. Moreover, to the extent that FDA
concludes that granting this petition would require the agency to modify its earlier statements
about weight loss claims in the preamble to the structure/function rule, such statements constitute
“advisory opinions” that can be modified at any time following notice in the Federal Register. 74
E. GRANTING THE PETITION WOULD SUBSTANTIALLY ADVANCE THE PUBLIC HEALTH BY
REQUIRING MANUFACTURERS OF WEIGHT LOSS SUPPLEMENTS TO SUPPORT THEIR
CLAIMS WITH SCIENTIFIC EVIDENCE BEFORE GOING TO MARKET
1. Manufacturers of Weight Loss Supplements Might Seek to Make Qualified
Health Claims But Systematic Reviews Indicate That There Is Currently No
Credible Scientific Evidence to Support Such Claims
If FDA were to treat weight loss claims as disease claims, then supplement manufacturers
might seek to make weight loss claims for their products pursuant to the health claims process
established under the Nutrition Labeling and Education Act (“NLEA”). Pub. L. No. 101-535,
104 Stat. 2353. The NLEA amended the FDCA to authorize the sale of dietary supplements
pursuant to “health claims” that “characterize[ ] the relationship of any nutrient … to a disease or
health-related condition . . . . .. 21 U.S.C. § 343(r)(1)(B). That provision has been construed by
FDA only to authorize supplement manufacturers to make health claims directed at the reduction
of the risk of contracting a disease.75 And, that interpretation has been upheld by the courts. See
Whitaker v. Thompson, 353 F. 3d 947 (D.C. Cir. 2004). Accordingly, to the extent that any
manufacturer of a weight loss supplement seeks to avail itself of the health claims process, FDA
may only approve claims that the risk of developing a disease could be reduced through the
intake of a substance in the supplement. The FDA may not approve statements about a
supplement where weight loss is the “pivot” of the health claim.
Moreover, to the extent that FDA is authorized to approve health claims under the NLEA,
it may do so only “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). To that end, FDA has
promulgated regulations allowing for health claims where significant scientific agreement
(“SSA”) exists about the diet-disease relationship. 21 C.F:R. § 101.14. To satisfy the SSA
standard, there must be relevant and high quality studies that provide qualified scientists with a
74 Under FDA’s regulations, statements in a preamble accompanying a proposed or final rule constitute “advisory
opinions.” 21 C.F.R. § 10.85(d)(1). The regulations provide that advisory opinions may be amended or revoked at
any time, and notice of such action may simply be given in the Federal Register. 21 C.F.R. § 10.85(g); Perry v.
Novartis, 456 F. Supp. 2d 678, 684 (E.D. Pa. 2006) (stating that an advisory opinion can be changed at any time and
a change does not require notice and comment). Of course, FDA has the option of soliciting public comment on this
citizen petition, as it has done with other petitions. The agency need not, however, engage in notice and comment
rulemaking.
75 See Letter from Joseph Levitt, Director, Center for Food Safety and Applied Nutrition, FDA to Jonathan Emord,
Emord & Associates, Dietary Supplement Claim for Saw Palmetto Extract and Benign Prostatic Hyperplasia, May
26, 2000, at http://www.cfsan.fda.gov/-dms/dspltrOl.html.
“high level of comfort” that the claimed relationship between the substance and the disease is
scientifically valid. The FDA has also established interim provisions to govern pre-market
review of “qualified health claims.” 76 For these types of claims, FDA exercises its enforcement
discretion based on the nature of the scientific evidence that exists to support such claims.
Specifically, under these latter procedures, FDA applies a sliding scale approach and
determines, on a case-by-case basis, the degree of qualification needed so that consumers are not
misled. Examples of FDA’s sliding scale of qualifications are: Category B claims that may read
“although there is scientific evidence supporting the claim, the evidence is not conclusive”;
Category C claims that may read “some scientific evidence suggests . . . however, FDA has
determined that this evidence is limited and not conclusive”; and Category D claims that may
read “very limited and preliminary scientific research suggests . . . FDA concludes that there is
little scientific evidence supporting this claim.” The FDA has also denied outright a number of
proposed qualified health claims because of the lack of “credible evidence” supporting the claims.
Petitioners have reviewed the standards set forth in FDA’s interim guidance governing
authorization of qualified health claims 77 and believe there is no credible evidence whatsoever to
support any type of a qualified health claim for a weight loss supplement. In that guidance, FDA
describes the nature and quality of scientific evidence that must exist to support particular types
of qualified health claims. 78 In order to qualify for even the weakest of the qualified health
claims (i.e., a Category D claim), a weight loss supplement manufacturer must demonstrate that
studies of different design would generally result in similar findings even if some uncertainties
exist. At the same time, a manufacturer must show that there is not a strong body of evidence
against the claim – that is, a study or studies of high persuasiveness, quality, and relevance that
do not detect an effect. If such studies exist, then FDA has “a sound basis for concluding that the
claim is not valid. ,79 In the case of weight loss supplements, there is no credible evidence to
indicate that supplements themselves assist in weight loss or, even if they do so, that there is a
commensurate risk reduction of disease from the use of any such supplements.
Indeed, during the past decade, several independent teams of researchers have undertaken
extensive reviews of the scientific literature purportedly supporting the efficacy of weight loss
supplements. Each of these studies has concluded that there is little, if any, evidence to support
the efficacy of supplements marketed for weight loss. In 2005, scientists from the Office of
Dietary Supplements at NIH declared that evidence supporting the efficacy of weight loss
supplements is “inconclusive at present.” 80 Similarly, researchers from Harvard Medical School
76 Food and Drug Administration, Center for Food Safety and Applied Nutrition. Interim procedures for qualified
health claims in the labeling of conventional human food and human dietary supplements. July 10, 2003. (Accessed
January 3, 2008, at http://www.cfsan.fda.gov/-dms/hclmgui3.html).

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