C. THE FDA MUST FIND THAT WEIGHT LOSS CLAIMS FOR SUPPLEMENTS ARE DISEASE
CLAIMS UNDER ITS EXISTING REGULATIONS AND ON THE BASIS OF SUBSTANTIAL
LEGAL PRECEDENT GOVERNING STATEMENTS ABOUT OTHER RISK FACTORS
1. The FDA Has Consistently Taken the Position That a Supplement Bearing
Claims That It Will Prevent or Treat a Risk Factor Is a Disease Claim
To address the problems described above and thereby protect the public health, FDA
must treat weight loss claims for dietary supplements as “disease claims” under the FDCA.
Specifically, under Section 403(r)(6) of the FDCA, a manufacturer of a dietary supplement may
not claim that its product will “diagnose, mitigate, treat, cure or prevent a specific disease or
class of diseases.” 21 U.S.C. § 343(r)(6). That is, a supplement manufacturer may not make
disease claims about its product. On the other hand, this provision does allow dietary
supplement labeling to bear a statement that “describes the role of a nutrient or dietary ingredient
59
For the purposes of this study, the FTC defined the term “weight-loss” product to include nonprescription drugs,
dietary supplements, skin patches, creams, wraps, or earrings. Nonetheless, there can be no question that a
substantial percentage of products in this category consists of dietary supplements.
60
In November 2004, FDA issued a draft guidance entitled Guidance for Industry: Substantiation for Dietary
Supplement Claims Made under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, available at
http://www.cfsan.fda.gov/-dms/dsclmgui.html. See also FDA Announces Major Initiatives for Dietary
Supplements. November 4, 2004. (Accessed January 3, 2008, at
http://www.fda.gov/bbs/topics/news/2004/NEW01130.html).
61
In January 2007, the FTC recovered $25 million from four companies that had been engaged in deceptive
advertising of weight loss products. See Federal Trade Commission reaches “New Year’s” resolutions with four
major weight-control pill marketers. January 4, 2007. (Accessed January 3, 2008, at
http://www. ftc.gov/opa/2007/O 1 /weightloss.shtm).
62
Food and Drug Administration, Center for Food Safety and Applied Nutrition. List of distributors and
manufacturers receiving warning or advisory letters for unsubstantiated weight loss claims. November 4, 2004.
(Accessed January 3, 2008, at http://www.cfsan.fda.gov/-Vdms/wl-list2.html).
intended to affect the structure or function in humans” or that “characterizes the documented
mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.”
21 U.S.C. § 343(r)(6)(A). A manufacturer making such “structure/function claims” must also be
able to substantiate that such statements are truthful and not misleading. 21 U.S.C. §
343(r)(6)(B).
In January 2000, FDA promulgated regulations (“the structure/function rule”) that
established ten separate and independent criteria for determining whether a statement about a
dietary supplement is an impermissible disease claim or a permissible structure/function claim.
65 Fed. Reg. 1000 (January 6, 2000).63 In pertinent part, one of those criteria provides that a
statement will be.treated as a disease claim if it states, explicitly or implicitly, that the product
“has an effect on the characteristic signs or symptoms of a specific disease or class of diseases,
using scientific or lay terminology.” 21 C.F.R. § 101.93(g)(2)(ii). The FDA has indicated that
this criterion includes a statement “that a dietary supplement prevents or treats abnormal or
unhealthy conditions or clinical measurements that are not themselves diseases but are markers
of, or risk factors for, diseases.” 64 Fed. Reg. 36824, 36826 (July 8, 1999) (emphasis added).
When FDA considered adoption of the structure/function rule, it reviewed specifically
what could and could not be said about elevated levels of cholesterol. Following publication of
the proposed rule, the agency reopened the comment period to seek further input on whether
supplement manufacturers should be permitted to make claims such as “lowers cholesterol.” Id.
Based on an extensive review of this question, FDA concluded that “labeling [that] as a whole
implies that the product is intended to lower elevated cholesterol levels” would constitute a
disease claim. 65 Fed. Reg. at 1019. In support of that conclusion, FDA found that “an elevated
cholesterol level is a sign of hypercholesterolemia and an important risk factor for heart disease.”
Id. Accordingly, through its consideration of claims about cholesterol, FDA made clear that
Section 403(r)(6) of the FDCA and the agency’s implementing regulations do not allow
supplement manufacturers to state that their products will reduce a risk factor for a disease.
While establishing that fundamental principle, FDA clarified that it would not prohibit all
statements by supplement manufacturers about cholesterol. Rather, the agency indicated that
claims that a substance helps maintain normal function would ordinarily not be considered a
disease claim, unless other statements or pictures in the labeling imply prevention of a specific
disease or class of diseases. Under this exception to the general rule, FDA indicated that
supplement manufacturers could claim that their products “help to maintain cholesterol levels
that are already within the normal range.” Id. The agency reached this determination after
concluding that “a cholesterol level within the normal range is not a sign or risk factor of
disease.” Id. Therefore, in its analysis of disease claims and risk factors under the
structure/function rule, FDA also made clear that supplement manufacturers could claim that
their products help to maintain the levels of a condition that are already within the normal range.
Since issuance of the structure/function rule, FDA has consistently applied these
principles to statements claiming that a supplement lowers cholesterol levels or other risk factors
63 For the purposes of this rule, the term “disease” is defined to include a “state of health leading to” dysfunctioning
of an organ, part, structure, or system of the body. 21 C.F.R. § 101.93(g)(1).
or abnormal or unhealthy conditions.64 For example, in July 2002, FDA objected to the claim,
“nutritional support for borderline cholesterol,” because it implied that “the product is intended to
treat elevated blood cholesterol levels and reduce the risk of disease, namely coronary heart
disease.”65 Moreover, FDA has applied the rule to other abnormal or unhealthy conditions or
clinical measurements that are risk factors for diseases. Thus, during the past seven years, FDA
has repeatedly found that statements about reducing high levels of blood glucose66 or high blood
pressure 67 are disease claims because they purport to treat a risk factor for diabetes and
hypertension, respectively. As described next, in light of the close association between
overweight and particular chronic diseases, FDA must reach the same conclusion about weight
loss claims.
2. The FDA Must Treat Weight Loss Claims as Disease Claims Because They
Also Purport to Prevent or Treat a Risk Factor for Disease
Just as FDA has taken the position that statements about treating high cholesterol and
other risk factors for disease are impermissible disease claims, the agency must also determine
that weight loss claims are not permitted under Section 403(r)(6) of the FDCA. Many dietary
supplement manufacturers claim that use of their products will reduce weight in overweight
individuals – for example, by reducing body fat or by increasing metabolic rate – back to
“normal” levels. Put another way, weight loss supplements are marketed with claims that they
will bring an individual with an abnormal or high BMI down to a normal one. Weight loss
claims are, therefore, entirely analogous to claims that a product will reduce high cholesterol,
blood glucose, or blood pressure. Each of these types of claims indicate prevention or treatment
of abnormal or unhealthy conditions or clinical measurements that are not themselves diseases
but are markers of, or risk factors for, diseases.
When FDA reached its determination about claims that could be made by supplement
manufacturers about cholesterol, it was mindful of the conclusions that had been drawn in the
scientific community and at NIH about the risks associated with high cholesterol levels. There is
also substantial evidence in the scientific record documenting the risks of being overweight. As
demonstrated above, the past decade has witnessed the development of a substantial body of
scientific literature confirming that the state of being overweight is a major risk factor for several
serious and chronic diseases, including type 2 diabetes, cardiovascular disease, and cancer. In
light of that literature, both NIH and the CDC have indicated that being overweight is an
64
These decisions have been made by the agency in the context of reviewing marketing notifications from
supplement manufacturers under Section 403(r)(6) of the FDCA. The agency reviews such notifications of claims
and responds with a “courtesy letter” identifying any objectionable claims. See 21 U.S.C. § 343(r)(6).
6s
See e.g., Wellness International Network, Ltd. Courtesy Letter (Ltr. 945; June 12, 2007); New Chapter, Inc.
Courtesy Letter (Ltr. 888; June 5, 2006); Nutrition 21 Courtesy Letter (Ltr. 882; May 3, 2006); Source Naturals, Inc.
Courtesy Letter (Ltr. 619, June 21, 2002). (Exh. 31).
66
See e.g., Healing Power, Inc. Courtesy Letter (Ltr. 885; May 23, 2006); USANA Health Sciences, Inc. Courtesy
Letter (Ltr. 879; May 3, 2006); Anabolic Laboratories, Inc. Courtesy Letter (Ltr. 782; September 29, 2004). (Exh.
32).
6′ See e.g., New Chapter, Inc. Courtesy Letter (Ltr. 935; April 3, 2007); New Century Company Courtesy Letter (Ltr.
873, Mar. 29, 2006); KNature Corp. Courtesy Letter (Ltr. 807; February 4, 2005); NOW Foods Courtesy Letter (Ltr.
799; December 6, 2004); Michael’s Naturopathic Programs Courtesy Letter (Ltr. 730; October 15, 2003). (Exh. 33).
independent and significant risk factor for many diseases and other medical conditions.”8 Thus,
just as FDA relied on the scientific literature in deciding to regulate claims about high
cholesterol levels, the scientific record about the condition of overweight compels the same
regulatory determination about weight loss claims.
Moreover, as with elevated cholesterol levels, the health risks of being overweight are
now well-known, and there is a strong association in the public mind linking weight loss with
significant health benefits, including the prevention of certain diseases. That is important
because FDA also has previously indicated that public awareness and perception of an elevated,
level of a risk factor for a disease is a relevant factor in deciding whether to treat that statement
as a disease claim. In the structure/function rule, for example, FDA declared that “[flowering
cholesterol is inextricably linked in the public mind with treating elevated cholesterol and
preventing heart disease.” 65 Fed. Reg. at 1019. As documented by the Landmark Study, the
same can now be said of the link between weight gain and risk. Virtually all (94%) of the
individuals responding to that survey understood that being overweight increases the risk of
certain diseases, including diabetes and cardiovascular disease.
In addition, when FDA reached its determination about cholesterol, the agency also
recognized the “compelling importance” of preventing heart disease through the use of approved
drugs that have been shown to be safe and effective in lowering cholesterol levels. The FDA
declared that the “use of possibly ineffective therapies in persons with elevated cholesterol,
which can delay or prevent effective treatment, poses significant public health risks.” Id. at 1019.
This was particularly true because, as FDA acknowledged, it does not have the resources to
review substantiation of the myriad claims accompanying supplements. The same situation
applies to weight loss supplements. There is also compelling public health need to help
overweight Americans lose weight, and at least one over-the-counter drug product (Alli®) has
been approved by FDA as a safe and effective drug for that purpose. Because specious claims by
manufacturers of weight loss supplements are diverting Americans from effective ways to lose
weight, FDA must act to address these activities which undermine the public health.
Finally, while much of the foregoing has centered on FDA’s treatment of cholesterol as a
precedent for FDA action on weight loss claims under 21 C.F.R. § 101.93(g)(2)(ii), it should be
emphasized that the agency need not find complete consistency between the two claims to grant
the action requested in this petition. That is because the structure/function rule authorizes FDA
to find that a statement is a disease claim if it “otherwise suggests an effect on a disease or
diseases.” 21 C.F.R. § 101.93(g)(2)(x). In adopting this provision, FDA explained that this
criterion is necessary to capture disease claims that may not fit into the nine criteria expressly
enumerated in the regulation. 65 Fed. Reg. at 1030. Thus, FDA recognized that the nine criteria
set forth in its regulations do not constitute an exhaustive list, and there may be other types of
statements that imply disease treatment or prevention. To the extent that FDA believes that
weight loss claims do not sufficiently parallel high cholesterol claims, the agency must
nonetheless still restrict such claims under this separate provision in its regulations.
68
National Institute of Diabetes and Digestive and Kidney Diseases. Do you know the health risks of being
overweight? (Accessed January 3, 2008, at http://win.niddk.nih.gov/publications/health risks.htm); Centers for
Disease Control and Prevention. Overweight and obesity. (Accessed January 3, 2008, at
http://www.cdc.gov/nccdphp/dnpa/obesity/).
D. TREATING WEIGHT LOSS CLAIMS AS DISEASE CLAIMS WOULD BE CONSISTENT WITH
THE LEGISLATIVE HISTORY OF THE FDCA AND FDA’s EARLIER DETERMINATION
ABOUT THE CONDITION OF OVERWEIGHT
1. The Actions Requested in the Petition Are Fully Consistent with
Longstanding Congressional Intent to Protect the Public Health by
Regulating Weight Loss Claims

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