Dockets Management Branch (HFA)
Food and Drug Administration
12420 Parklawn Drive
Room 1-23
Rockville, MD 20857

Re:            Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body

            Docket No. 98N-0044

COMMENTS OF THE AMERICAN OBESITY ASSOCIATION

            The American Obesity Association (AOA), a non-profit corporation organized for the purpose of advocating on behalf of persons with obesity, submits these comments on the Food and Drug Administration's (FDA) proposed rules on statements that can be made concerning dietary supplements. The rules propose to define the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body, and to establish criteria for determining when a statement is a prohibited disease claim. (63 Fed. Reg. 23624) Numerous dietary supplements are manufactured and marketed for use in the treatment of obesity and for weight loss in overweight individuals. AOA supports the agency in taking this regulatory action, which will reduce consumer confusion about the safety and effectiveness of dietary supplements for weight loss and other goals.

The Proposed Definition of "Disease"

            Under the proposed § 101.93(f), dietary supplement labels and labeling may bear structure/function statements that are not disease claims within the meaning of proposed § 101.93(g). The agency has developed a definition of "disease" for these regulatory actions, relying upon standard medical and legal definitions of disease. Under proposed § 101.93(g)(1), a "disease" is "any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system (or combination thereof) of the body that is manifested by a characteristic set or one or more signs or symptoms, including laboratory or clinical measurements that are characteristic of a disease." AOA supports this broad definition in the context of the FDA's regulation of dietary supplements.

Obesity is a Disease

            Obesity is clearly a disease within the agency's proposed definition. Obesity is described as a disease by authoritative scientific bodies. The National Institutes of Health (NIH) published a consensus statement recognizing obesity as a disease "deeply rooted in biologic systems." (Health Implications of Obesity. NIH Consensus Development Conference Statement, 1985 Feb 11-13; 5 (9): 1-7) The World Health Organization (WHO) Consultation on Obesity has stated, "[o]besity is now well-recognized as a disease in its own right." (Press Release.  WHO Consultation on Obesity, Geneva.  1997 June 3-5.) "Obesity is a chronic stigmatized disease in the same sense that hypertension and hypercholesterolemia are defined as diseases." (Bray, G. "Drug Treatment of Obesity," Am J Clin Nutr 1998; 67: 1-4)

            Obesity has a severe impact on human health. Obesity is associated with an increased risk for insulin resistance, diabetes mellitus, degenerative joint disease (arthritis), hypertension, cardiovascular disease, dyslipidemia, gallbladder disease, respiratory dysfunction, and some forms of cancer. (Pi-Sunyer, FX, "Medical Hazards of Obesity," , Ann Intern Med. 1993; 119 (7 pt 2): 655-660) Poor diet and inactivity account for 300,000 deaths per year, making the combination the second leading cause of preventable death in the United States. (McGinnis JM, Foege, WH. "Actual Causes of Death in the United States." JAMA, 1993; 270: 2207-2212)

            Obesity is defined as a Body Mass Index (BMI) of 30 or greater.  (A BMI of 30 is about 30 lb overweight and equivalent to 221 lb in a 6'0" person and to 186 lb in one 5'6"). Overweight is defined as a BMI of 25 to 29.9. (NIH "Clinical Guidelines," Page 56) According to the Third National Health and Nutrition Examination Survey (NHANES III), conducted from 1988-1994, 59.4 percent of men and 50.7 percent of women in the United States are overweight or obese. The prevalence of overweight and obesity is much higher in non-Hispanic Black women (66.0 percent), in Mexican-American women (65.9 percent), and in Mexican-American men (63.9). (NIH "Clinical Guidelines," Page 7)

Weight Loss is the Only Treatment for Obesity

            The FDA specifically requested comment on the distinction between maintaining normal function (for a permissible structure/function claim), and preventing or treating abnormal function, potentially a disease claim. Weight loss is the only treatment for obesity and overweight. Further, it is not advisable for individuals who are maintaining a normal, healthy weight to lose weight. Consumers using dietary supplements to lose weight are not trying to maintain the "normal function" associated with a permissible structure/function claim. Rather, they are treating obesity, or, if merely overweight, preventing the onset of obesity.  Whenever a product makes a structure/function claim, there may be an unstated but implicit disease link. Yet in the area of weight loss, structure/function claims and disease claims are identical for both the treatment of obesity and for weight loss in the overweight individual.

Explicit or Implied Statements about the Formulation or Effect of a Product

            AOA supports proposed § 101.93(g)(2)(iv), prohibiting express or implied statements about a dietary supplement's effect on disease through its name, through citation of a publication or reference, or through its formulation. This proposal includes prohibiting claims that a product contains an ingredient that has been regulated by the FDA as a drug and is well known to consumers for its use in preventing or treating disease.

            Recently, the FDA issued a warning against drug promotion of "herbal fen-phen." (FDA Talk Paper, November 6, 1997) This warning was necessary because of the increasing promotion, over the Internet, through weight-loss clinics, print advertisements and retail outlets, of various dietary supplement-type products as "natural" herbal alternatives to the prescription drug combination of phentermine and fenfluramine, commonly known as "fen-phen." Fenfluramine and dexfenfluramine, two prescription anti-obesity drugs, were withdrawn by their manufacturers following concerns about their safety. Due to their nature as prescription drugs, both fenfluramine and dexfenfluramine were subject to far more stringent FDA review and control than are dietary supplements.

            Consumers are attracted to "herbal fen-phen" products due to the demonstrated effectiveness of phentermine and fenfluramine combined. "Herbal fen-phen" dietary supplements do not contain any prescription drugs, nor have they been shown to be safe or effective. In fact, the FDA has warned that the main ingredient of most "herbal fen-phen" products is ephedra. The FDA has estimated that the use of this amphetamine-like compound results in forty deaths and several hundred serious injuries annually.  Yet the word "herbal," when associated with drugs, falsely signals "safe," i.e., safer than the withdrawn prescription drugs.

            Any explicit or implied statement that associates dietary supplements with FDA regulated drugs is dangerous and deceptive. The proposed rule to prohibit statements about the formulation of a product will serve to protect consumers, the majority of whom are unaware of the lack of regulation over dietary supplements.

Certain Product Class Names

            AOA supports the proposed prohibition on the use of certain product class names strongly associated with the diagnosis, cure, mitigation, treatment or prevention of a disease or diseases. Under the proposal, a statement would be considered a prohibited disease claim if it claimed that the dietary supplement belonged in a class of products recognizable to health care professionals or consumers as intended for use to diagnose, mitigate, treat, cure, or prevent a disease. AOA submits that under the proposed criteria, "appetite suppressant" constitutes a prohibited disease claim. "Appetite suppressant" is a class name clearly recognizable to health care professionals and consumers as intended for use in the treatment or prevention of the disease of obesity. "Appetite suppressant" is categorized in Physician's Desk Reference (PDR), a reference work widely used by health care professionals and consumers. (Physician's Desk Reference, Ronald Arky, et al. eds., Medical Economics Co., Inc., 52nd edition, 1998)

Claims that Imply Product is a Substitute or Adjunct to a Drug or Disease Therapy

            AOA supports the prohibition on statements that imply that a dietary supplement has an effect on disease by claiming that the effect of the dietary supplement is the same as that of a recognized drug or disease therapy, or that a dietary supplement should be used as an adjunct to a recognized drug or disease therapy. AOA agrees with the FDA that in both cases, such statements imply that the dietary supplement is intended for the same purpose as the drug or disease therapy.  Therefore, such statements should be prohibited as disease claims.

            AOA urges reconsideration, however, of the FDA's position that a claim that does not identify a specific drug, drug action, or therapy (e.g., FDA's example "use as part of your weight loss plan" at 63 Fed. Reg. 23627) would not constitute a disease claim under this criterion.  As discussed above, weight loss is the only treatment for the disease of obesity.

Structure/Function Claims Related to Weight Loss

            Weight loss is the only treatment for the disease of obesity.  Because of the nature and progress of this disease, structure/function claims and disease claims are identical for weight loss in the treatment of obesity and weight loss for the overweight individual.

            According to some of the examples the FDA has published in this proposed rulemaking, it appears that the agency might find some of the following structure/function claims acceptable: (1) "helps maintain a healthy weight;" (2) "increases metabolism;" and (3) "fat-burning."

            Example (1): AOA cannot identify any reason for an individual to consume a dietary supplement in order to maintain a healthy weight. A claim such as "helps maintain a healthy weight" is probably interpreted by the consumer to mean that the product aids in weight loss.

            Examples (2) and (3): Most consumers appreciate that a faster metabolism would greatly aid them in losing weight. In fact, discovering ways to increase metabolism is one of the holy grails in obesity research. Claims that a product "increases metabolism" or is "fat-burning" are essentially claims to treat or prevent the onset of the disease of obesity.

            The structure/function claims still permissible under the proposed regulation threaten to put the large number of overweight and obese Americans at risk for the misuse of dietary supplements.

Obese Individuals Are at Special Risk for the Misuse of Dietary Supplements

            According to NHANES III, 59.4 percent of men and 50.7 percent of women in the United States are overweight or obese. Undoubtedly, obesity is a disease of epidemic proportions in our country. Many dietary supplements are promoted for weight loss. The active ingredients of supplements for weight loss range from dangerous stimulants to diuretics. The actual content of dietary supplements is uncertain, due to the voluntary nature of manufacturing standards for the supplement industry. Laboratory tests of dietary supplements have found that active ingredients range widely, even between brands labeled as containing identical content. ("Vitamins and Minerals and Herbs," Consumer Reports, April 1998, Page 6)

            There is a danger that individuals with potentially life-threatening illnesses will use the dietary supplements in place of standard medical treatments. Claims that are made about weight loss may lead individuals to pursue ineffective treatment.  Overweight and obesity are clearly associated with increased morbidity and mortality. Individuals with obesity are at high risk for insulin resistance, diabetes mellitus, degenerative joint disease (arthritis), hypertension, cardiovascular disease, dyslipidemia, gallbladder disease, respiratory dysfunction, and some forms of cancer.

Certification Requirements

            The present certification requirement for structure/function claims for dietary supplements, codified in 21 C.F.R. § 101.93(a)(3), is inadequate to assure proper FDA review. The certification requirement, providing the text of claims, attesting to the truthfulness and accuracy of those claims, and stating that the manufacturer has substantiation for such claims, has not proven effective in preventing consumer fraud. Just as retail sales of dietary supplements have increased sharply since the passage of the Dietary Supplement Health and Education Act of 1994, misleading claims have also proliferated. (Canedy, D. "Real Medicine or Medicine Show?" N. Y. Times, July 23, 1998, at C4)

            AOA urges that the FDA maintain a substantiation file for dietary supplement claims. AOA also urges that the FDA adopt the "significant scientific agreement" standard to evaluate these claims. AOA urges that substantiation files be made available to the public.

Consumer Research

            AOA urges the FDA to conduct consumer research to evaluate the way in which consumers interpret structure/function claims. Consumers who have chronic health problems may interpret claims differently than healthy consumers (e.g., an individual with obesity may interpret a claim that a supplement "helps maintain a healthy weight" as one that promotes weight loss in individuals with obesity). It is important that the FDA understand the impact of these claims. AOA appreciates the opportunity to comment in this area that effects so many overweight and obese Americans. 

Sincerely,