Pyruvate: This three carbon ketoacid is created in the body during glycolysis. Pyruvate
is believed to manipulate fat metabolism by increasing fat oxidation and decreasing
carbohydrate oxidation. Some studies have reportedly shown positive results with
pyruvate but they had small sample sizes with short treatment periods, and patients
greatly restricted their caloric intake during the study period. On the other hand, two
double blind randomized clinical trials involving patients with a BMI greater than 25
found no significantly greater effects on weight reduction than were seen with
placebo. 104 The results of these “rigorous clinical trials” have led investigators to
conclude that the case for pyruvate as an aid to weight loss is “weak.” 105
99
Joyal SV. A perspective on the current strategies for the treatment of obesity. Current Drug Targets – CNA &
Neurological Disorders 2004;3:341-56. (Exh. 51).
100
Heymsfield SB, Allison DB, Vasselli JR, Pietrobelli A, Greenfield D, Nunez C. Garcinia cambogia
(hydroxycitric acid) as a potential antiobesity agent. JAMA 1998;280:1596-600. (Exh. 52); Rothacker DQ, Waitman
BE. Effectiveness of a Garcinia cambogia and natural caffeine combination in weight loss: a double-blind, placebo-
controlled pilot study. Int J Obes 1997;21(Supp12):53. (Exh. 53); Antonio J, Colker CM, Tornia GC, Shi Q, Brink
W, Kalman D. Effects of a standardized guggulsterone phosphate supplement on body composition in overweight
adults: a pilot study. Curr Ther Res 1999;60:220-7. (Exh. 54); Thom E. A randomized, double-blind, placebo-
controlled trial of a new weight-reducing agent of natural origin. J Int Med Res 2000;28:229-33. (Exh. 55).
lol
Dwyer JT, Allison DB, Coates PM. Dietary supplements in weight reduction. J Am Diet Assoc 2005;105(5
Supl 1):S80-6. (Exh. 34).
102
Blankson H, Stakkestad JA, Fagertun H, et al. Conjugated linoleic acid reduces body fat mass in overweight and
obese humans. J Nutr 2000;130:2943-8. (Exh. 56); Ris6rus U, Berglund L, Vessby B. Conjugated linoleic acid
(CLA) reduced abdominal adipose tissue in obese middle-aged men with signs of metabolic syndrome: a
randomized controlled trial. Int J Obes 2001;25:1129-35. (Exh. 57); Smedman A, Vessby B. Conjugated linoleic
acid supplementation in humans: metabolic effects. Lipids 2001;36:773-81. (Exh. 58); Risdrus U, Smedman A, et al.
Metabolic effects of conjugated linoleic acid in humans: the Swedish experience. Am J Clin Nutr 2004;79:1146S-
8S. (Exh. 59).
103
Larsen TM, Toubro S, Astrup A. Efficacy and safety of dietary supplements containing CLA for the treatment of
obesity: evidence from animal and human studies. J Lipid Res 2003;44:2234-41. (Exh. 60).
104
Kalman D, Colker CM, Wilets I, Roufs JB, Antonio J. The effects of pyruvate supplementation on body
composition in overweight individuals. Nutrition 1999;15:337-40. (Exh. 61); Kalman D, Colker CM, Stark R,
Minsch A, Wilets 1, Antonio J. Effects of pyruvate supplementation on body composition and mood. Curr Ther Res
1998;59:793-802. (Exh. 62).
105
Pittler MH, Ernst E. Dietary supplements for body-weight reduction: a systematic review. Am J Clin Nutr
2004;79:529-36. (Exh. 36).
(S) Supplements that Block Fat Absorption
Chitosan: This cationic polysaccharide is derived from chitin harvested from the
exoskeleton of crustaceans. Several studies involving well-designed, randomized
controlled trials have failed to show any differences in weight loss.’ 06 Moreover, to the
very limited extent that other studies may suggest efficacy for chitosan, investigators
found “serious methodological limitations of the clinical evidence” and results that were
“conflicting and short-term” and based on “poorly designed studies.” 107 One report
declared that “claims that chitosan is a fat-trapping weight-loss aid are not merely
unsubstantiated, they are false.” 1°g Thus, there is also “considerable doubt” that chitosan
is effective in reducing body weight in humans. 109
In sum, the foregoing analysis demonstrates that there is no credible scientific evidence to
support any type of qualified health claim for a weight loss supplement for use by an overweight
population. As a result, if FDA were to take the actions requested in this petition, manufacturers
would not be able to market weight loss supplements without demonstrating, through additional
scientific studies, that their products actually work. This requirement would obviously advance
the public health since millions of Americans are currently relying on unproven and ineffective
dietary supplements to lose weight and reduce the risk of disease. Moreover, the actions
requested in this petition would also help address concerns about the safety of weight loss
supplements. Adverse events have been reported in connection with a number of weight loss
supplements.’ 10 By requiring weight loss supplements to undergo pre-market review, FDA
would shift the burden to manufacturers to show that their products are safe. 111 In light of the
adverse events associated with ephedra, such action would obviously have significant public
health benefits.
106
Pittler MH, Abbott NC, et al. Randomized, double blind trial of chitosan for body weight reduction. Eur J Clin
Nutr 1999;53:379-81. (Exh. 63); Mhurchu CN, Poppitt SD, et al. The effect of the dietary supplement, chitosan, on
body weight: a randomised controlled trial in 250 overweight and obese adults. Int J Obes 2004;28:1149-56. (Exh.
64); Ho SC, Tai ES, et al. In the absence of dietary surveillance, chitosan does not reduce plasma lipids or obesity in
hypercholesterolaemic obese Asian subjects. Singapore Med J 2001;42:6-10. (Exh. 65).
Pittler MH, Ernst E. Dietary supplements for body-weight reduction: a systematic review. Am J Clin Nutr
2004;79:529-36. (Exh. 36); Lenz TL, Hamilton WR. Supplement products used for weight loss. J Am Pharm Assoc
2004;44:59-68. (Exh. 37).
108
Gades MD, Stern JS. Chitosan supplementation and fat absorption in men and women. J Am Diet Assoc
2005;105:72-7. (Exh. 66).
109
Pittler MH, Ernst E. Dietary supplements for body-weight reduction: a systematic review. Am J Clin Nutr
2004;79:529-36. (Exh. 36).
110
Pittler MH, Schmidt K, Ernst E. Adverse events of herbal food supplements for body weight reduction:
systematic review. Obesity Reviews 2005;6:93-111. (Exh. 67).
111
Under 21 C.F.R. § 101.14(b)(3)(ii), if the substance is to be consumed at other than decreased dietary levels, the
substance must be a food or a food ingredient or a component of a food ingredient whose use at levels necessary to
justify a claim must be demonstrated by the proponent of the claim, to FDA’s satisfaction, to be safe and lawful
under applicable food safety provisions of the Act.
111. ENVIRONMENTAL AND ECONOMIC IMPACT
The actions requested in this petition are subject to a categorical exclusion from
environmental assessment under 21 U.S.C. § 25.30(h) and 21 C.F.R. § 25.31. As provided under
21 C.F.R. § 10.30(b), petitioners will provide data concerning the economic impact of the actions
requested herein if such information is requested by FDA.
IV. CERTIFICATION
The undersigned certifies that, to the best knowledge and belief of the undersigned, this
petition includes all information and views on which the petition relies, and that it includes
representative data and information known to the petitioners which are unfavorable to the
petition. 112
Stephanie Patrick
Vice President
Policy Initiatives & Advocacy
American Dietetic Association
1120 Connecticut Avenue NW, Suite 480
Washington, D.C.20036
(202) 775-8277
G. Gary Deverman
Executive Vice President and CEO
Shaping America’s Health
Association for Weight Management
And Obesity Prevention
1701 North Beauregard Street
Alexandria, VA 22311
(703) 253-4800
Morgan Downey
Executive Vice President
The Obesity Society
8630 Fenton Street, Suite 814
Silver Spring, Maryland 20910
(301) 563-6526
C~ w P 1A…Q.. -)-,
Bruce S. Manheim, Jr.
Ropes & Gray LLP on behalf of
G1axoSmithKline Consumer Healthcare
One Metro Center
700 12th Street, N.W., Suite 900
Washington, D.C. 20005-3948
(202) 508-4600
112
Any correspondence from FDA relating to this petition should be sent to Bruce Manheim, Ropes & Gray LLP, 700 12th Street, N. W., Washington, D.C. 20005.

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