The petition was also filed on behalf of the American Dietetic Association (ADA), the Obesity Society, and Shaping America’s Health, a sister organization of the ADA. It notes that these three organizations have received grants from GSK for their participation in the petition process. The petition was filed by Bruce S. Manheim, Jr., of the law firm Ropes & Gray LLP, Washington, DC, which represents GSK.
GSK is the manufacturer of alliTM, an over-the-counter (OTC) non-prescription version (0.5 mg) of the drug orlistat (Xenical®, Roche) and the only FDA approved OTC drug for weight loss. Alli has become one of the highest-selling weight loss drugs in the world, with cumulative sales at approximately $315 million (USD) since its launch in June 2007 to March 2008, said Malesia Dunn, director of communications at GSK Consumer Healthcare (oral communication, June 20, 2008).
The primary objective of this 33-page petition is that dietary supplement claims about the ability to help a person lose weight should be treated as disease claims. The petition itself acknowledges that being overweight is not a disease: “Petitioners are not asking FDA to conclude that the state of being overweight is a disease…petitioners are requesting FDA to restrict weight loss claims because they purport to treat an unhealthy condition that is a risk factor for diseases—not the disease itself.”1 The petition cites the FDA ban on “cholesterol-lowering” claims for dietary supplements as a precedent. FDA policy states that a claim by a supplement to lower cholesterol implies that it could be used to treat hypercholesterolemia (high cholesterol levels), which is a disease.
The GSK petition claims that dietary supplements are ineffective in treating overweight conditions. It cites several review articles to support this contention, including a 2004 review by Harvard physicians Robert Saper and David Eisenberg,2 as well as another 2004 review by Max Pittler and Edzard Ernst of the Universities of Exeter and Plymouth.3
Concern and disagreement regarding the petition has been raised by members of the dietary supplement and alternative medicine communities, including members of industry and natural product researchers. The criticisms include denying that being “overweight” is necessarily a prelude to obesity and other morbidity, noting that the desire to lose weight is not necessarily related to attempts to prevent diseases related to obesity, and also the acknowledgement that the FDA itself, in its own regulations on structure-function claims authorized by the Dietary Supplement Health and Education Act of 1994 (DSHEA), acknowledged the legitimacy of weight-loss claims for supplements.
Alexander G. Schauss, PhD, president and CEO of American Institute of Biomedical Research (AIBMR) in Puyallup, Washington, a contract research organization that conducts toxicological, pharmacological, and clinical research on dietary supplement ingredients, provided the following comments:
“GlaxoSmithKline is incorrect in attributing ‘overweight’ to being unhealthy. In fact, a paper that appeared in the Journal of the American Medical Association in mid-April 2005, authored by the American Centers for Disease Control and Prevention, based on a three-decade study of health and nutrition surveys carried out in the 1970s, 1980s and 1990s, reported that people who are overweight are likely to live longer than people who are underweight or obese.4 People who had body mass indices that were higher than 25 but lower than 30 did not have a reduced life expectancy. Hence, to label this population as ‘unhealthy’ is unscientific and without competent and reliable substantiation.” (e-mail, June 19, 2008).
Paul Dijkstra, CEO of InterHealth, a producer and marketer of clinically-researched, patented dietary supplement ingredients such as Super CitriMax®, a proprietary form of hydroxycitric acid (HCA, derived from Garcinia cambogia), submitted comments on behalf of his company on June 3.5 He emphasized that people are motivated to lose weight for reasons other than the treatment or prevention of obesity (e.g., to improve self-image, look better in a swim suit, etc.).
Dijkstra also noted that “the FDA has already ruled that dietary supplement labels can include information describing the supplement’s effect on the body and its biological functions. These types of claims are referred to as structure/function claims, which should be substantiated, truthful, and not misleading. Many of the ingredients used in weight loss/management dietary supplements are backed by clinical research and sound scientific findings.”
Daniel Fabricant, PhD, vice president of scientific affairs at the Natural Product Association (NPA), an industry trade group, noted that NPA’s forthcoming comments on the petition will include mention that the FDA has previously approved the concept of weight loss claims for supplements in its publication of final regulations on dietary supplements claims (e-mail, June 16, 2008).6
The GSK petition lists the following dietary supplements as being ineffective in dealing with weight loss: bitter orange or zhi shi (Citrus aurantium, Rutaceae); chromium picolinate, a naturally occurring tryptophan derivative; guar gum, derived from the Indian cluster bean (Cyamopsis tetragonolobus, Fabaceae); hoodia (Hoodia gordonii, Asclepiadaceae); hydroxycitric acid contained in the extract of Garcina cambogia (Clusiaceae); conjugated linoleic acid (CLA), a derivative of a bacteria in some animal guts; pyurate, a carbon ketoacid created in the body during glycolysis; and chitosan, a polysaccharide derived from crustacean shells.1
The petition classifies these supplements into 5 categories of weight loss supplements that are said to do the following: increase energy expenditure, modulate carbohydrate metabolism, increase satiety or suppress appetite, increase fat oxidation or reduce fat synthesis, and block dietary fat absorption.
The petition then relies on data, particularly from one metaanalysis, to attempt to demonstrate that there is insufficient evidence for weight loss claims for dietary supplements if they were held to the standard required for an FDA-approved health claim under the Nutrition Labeling and Education Act of 1990 (NLEA). One of the reviews that the petition quotes often is the Pittler and Ernst publication.3 The petition quotes the Pittler-Ernst publication as concluding, “there is little convincing evidence that any specific dietary supplement is effective in reducing body weight.”1,3 However, the first part of this sentence in the cited meta-analysis, conveniently not quoted by the petition, states: “The data from published double-blind RCTs [randomized controlled trials], systematic reviews, and meta-analyses are encouraging in some cases…”3
Several supplements with encouraging evidence are not mentioned in this petition, though this petition never claims to have a complete list. Also, a number of clinical trials that support the effectiveness of the supplements are mentioned, but the petition claims that not enough evidence exists to support qualified health claims under NLEA and that there is insufficient evidence of safety.
An example of a supplement with encouraging evidence, unmentioned by this petition, is glucomannan, a derivative of konjac root (Amorphophallus konjac, Araceae) present in several dietary supplements used for weight management. A double-blind 8-week clinical trial on obese subjects indicated a “significant mean weight loss (5.5 lbs) using glucomannan.”7 Even the Pittler-Ernst metaanalysis, which the GSK petition points to continuously as proof that dietary supplements do not work, states that this double-blind study “suggests significantly greater weight loss in the treatment group than in the placebo group.”3 Another supplement the petition did not mention is the increasingly popular South American herb beverage yerba maté (Ilex paraguariensis, Aquifoliaceae), a natural source of caffeine. Again, the Pittler-Ernst meta-analysis acknowledges that a combination preparation of yerba maté, guarana (Paullinia cupana, Sapindaceae; also containing caffeine), and damiana (Turnera diffusa, Turneraceae) “might potentially be effective in lowering body weight.”3 It is also worth mentioning that both glucomannan and the yerba maté combination preparation, which are not mentioned in the petition, are not usually known to produce adverse effects.
Another ingredient omitted from the first category (supplements that increase energy expenditure) is green tea (Camellia sinensis, Theaceae). Green tea beverages and preparations have been shown in many clinical trials to be effective in aiding weight loss. For example, an RCT concluded that green tea can reduce body weight in obese subjects by increasing energy expenditure and fat oxidation,8 and a safety study by the US Pharmacopeia found tea to be safe when used properly.9 These are just a few examples of the many clinical trials suggesting evidence that weight loss supplements are effective (depending on the level of evidence required to confirm efficacy) and relatively safe. However, it remains to be seen whether enough evidence exists to support a qualified health claim and whether weight loss claims in principle should even be treated as disease claims.
“Many may be alarmed or even dismayed that the petition suggests that no dietary supplement meets even the lowest criteria to qualify for a level D FDA-approved qualified health claim under NLEA. This is probably a matter of interpretation and may become one of the focal points of intense debate on this entire issue,” said Mark Blumenthal, founder and executive director of the American Botanical Council (ABC). “Considering the significant role that overweight conditions play in modern public health, it is clearly in the American consumers’ interests for the door to stay open for truthfully-marketed and clinically-verified dietary supplements to continue to make weight loss structure-function claims under DSHEA, i.e., without requiring FDA pre-approval.”
The FDA is normally required to respond to such a petition within 180 days of receiving it.1 The public may comment about this issue at www.regulations.gov.
Note: An expanded version of this article was published in the June 2008 issue of HerbalEGram, the American Botanical Council’s monthly e-journal (available at www.herbalgram.org).
—Kelly E. Saxton
- Citizen Petition Requesting FDA to Treat Weight Loss Claims for Dietary Supplement as Disease Claims [citizen petition]. FDA 2008. P-2048-0001.
- Saper RB, Eisenberg DM, Phillips RS. Common dietary supplements for weight loss. Am Fam Physician. Nov 1, 2004;70(9):1731–1738.
- Pittler MH, Ernst E. Dietary supplements for body-weight reduction: a systematic review. Am J Clin Nutr. April 2004;79(4):529–536.
- Katherine M. Flegal K, Graubard B, Williamson D, Gail M. Excess Deaths Associated With Underweight, Overweight, and Obesity. JAMA. April 20, 2005;293(15):1861–1867.
- InterHealth’s Response to GSK’s Citizen Petition [comment to FDA]. Benicia, CA: InterHealth Nutraceuticals; June 3, 2008.
- Food and Drug Administration. Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body; Final Rule. Federal Register, Jan 6, 2000;65(4):999–1050. Available at: www.wais.access.gpo.gov [DOCID:fr06ja00-17]. Accessed June 18, 2008.
- Walsh DE, Yaghoubian V, Behforooz A. Effect of glucomannan on obese patients: a clinical study. Int J Obes.1984;8(4):289–293
- Auvichayapat P, Prapochanung M, Tunkamnerdthai O, et al. Effectiveness of green tea on weight reduction in obese Thais: A randomized, controlled trial. Physiol Behav. Feb 27, 2008;93(3):486–491.
- Sarma DN, Barrett ML, Chavez ML, et al. Safety of Green Tea Extracts: A Systematic Review by the US Pharmacopeia. Drug Saf. 2008;31(6):469–484.