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The GSK Petition:
ROPES &GRAV
ROPES & GRAY LLP
ONE METRO CENTER 700 12TH STREET, NW SUITE 900 WASHINGTON, DC 20005-3948 202-508-4600 F 202-508-4650
BOSTON NEW YORK PALO ALTO SAN FRANCISCO 0 T3)iC7C9 9uS4bHIN(AT&,D7 PWwwLr3pesgray.com
April 17, 2008
Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Citizen Petition Requesting FDA to Treat Weight Loss
Claims for Dietary Supplements as Disease Claims
Dear Sir or Madam:
Please find enclosed for filing an original and three copies of a citizen petition and
addendum of attachments. Any correspondence from FDA relating to this petition should be
sent to me at the address specified below.
Thank you for your attention to this request.
Sincerely,
Bruce S. Manheim, Jr.
Ropes & Gray LLP
One Metro Center
700 12th Street, N. W., Suite 900
Washington, D.C. 20005-3948
(202) 508-4600
CITIZEN PETITION
OF THE
73
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AMERICAN DIETETIC ASSOCIATION, THE OBESITY SOCIETY,
SHAPING AMERICA’S HEALTH, AND GLAXOSMITHKLINE
CONSUMER HEALTHCARE
REQUESTING
THE FOOD AND DRUG ADMINISTRATION
TO
DETERMINE THAT CLAIMS THAT DIETARY SUPPLEMENTS
PROMOTE, ASSIST, OR OTHERWISE HELP IN WEIGHT LOSS ARE
DISEASE CLAIMS UNDER SECTION 403(R)(6) OF THE FEDERAL
FOOD, DRUG AND COSMETIC ACT
APRIL 17, 2008
TABLE OF CONTENTS
I. Action Requested . ……………….. . … . . . . . . . . . . . . . . . . . . . . . . . . .. .. ……….. . . . … . . . . . . . . . . . .. .. .. …………… . . . . . . . . . . .1
II. Statement Of Grounds………. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. …………. . ….. . . . . . . . . . .. .. ………………. . . . . . . . . . . .3
A. Scientific Reports from the Past Decade Confirm That the Condition of
Overweight Is a Significant Risk Factor for Serious Chronic Diseases ……. . . . . . . . . . . .3
1. Numerous Epidemiological Studies Establish Overweight as a
Significant Risk Factor for Diabetes, Cardiovascular Disease,
Cancer, and Obesity . . . . . . . . . .. .. .. .. .. ……………. . . . . . . . . .. .. . . .. …………….. . . . . . . . . . . . . . . .. .4
2. Recent Studies of Pathophysiological Mechanisms Also
Confirm That Being Overweight Is a Significant Risk
Factor for Disease . . . . . . . . . . .. .. .. .. .. ……………. . . . . . . . . . . .. .. .. …………… . … . . . . . . . . . . . . . ….8
B. Overweight Americans Who Seek to Reduce Their Risk of
Disease Are Being Diverted from Effective Ways to Lose Weight
by Exaggerated and Unsubstantiated Claims Accompanying Weight Loss
Supplements …… . . . . . . . . . . . . . . . . . . . . .. .. .. ………………. . … . . . . . . . .. ………………… . . . . . . . . . . . . . . .. …..10
1. Consumer Survey Data Confirm That Individuals Understand
the Health Risks of Being Overweight and Many Use Dietary
Supplements to Lose Weight …………… . . . . . . . . . .. ………………. . . . . . . . . . . . . . . . . .. .. …10
2. Overweight Americans Are Being Bombarded and Misled by
Fantastic and Unsubstantiated Claims that Use of Dietary
Supplements Will Result in Effective Weight Loss 10 .. . … . … . . . . . . . . .. .. …….13
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 . . . . . . .. .. . . .. .. .. …………. . ….. . . . . . . . ………………. . . . . . . . . . . . . .. .. .. …..15
l. 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 ………….. . . . . . . . . . …………….. . . . . . . . . . . . . . . .. .. …..15
2. The FDA Must Treat Weight Loss Claims as Disease Claims Because
They Also Purport to Prevent or Treat a Risk Factor for Disease . . . . . . .. .. …17
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 …. . . . . . . . . . …. …………… . . . . . . . . . . . . .19
1. The Actions Requested in the Petition Are Fully Consistent with
Longstanding Congressional Intent to Protect the Public Health by
Regulating Weight Loss Claims ………………. . . . . . . . . . . . . . . . . . ………………….. . . . . .19
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 …….. . . . . . . . . . . . . . . . . . ………………….. . . . . .20
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 . . . . . . . . . . . . . . .. .. ………………………………… . . . . . . . . . . . . . . . . . .. ………………. . … .22
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 . . . . . . . . . . . . . . . . …… ………………. . . .22
2. There Is Currently No Credible Scientific Evidence That
Would Support a Qualified Health Claim for Any Ingredient
in Any of the Five Categories of Weight Loss Supplements …………… . . . . .24
111. Environmental And Economic Impact .. …………………………… . . . . . . . . . . . . . . . ………………….. . . . . .29
IV. Certification …………… . . . . . . . . . . . . . . . . . . . . .. .. ………………………………. . . . . . . . . . . . . . . . ………………….. . . . . .29
April 17, 2008
Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, MD 20852
I. ACTION REQUESTED
On behalf of the American Dietetic Association, The Obesity Society, Shaping America’s
Health, and G1axoSmithKline Consumer Healthcare, LP (“GSK”) (hereafter “petitioners”),’ the
undersigned submit this petition under the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21
U.S.C. §§ 301 et seq., to request the Commissioner of Food and Drugs to determine that dietary
supplements bearing claims that they promote, assist, or otherwise help in weight loss are
“disease claims” under Section 403(r)(6) of the FDCA. 21 U.S.C. § 343(r)(6). Specifically,
petitioners request FDA to treat weight loss claims as disease claims because such statements
purport to prevent or treat an abnormal or unhealthy condition that, while not itself a disease, is a
significant risk factor for disease. 2 As set forth herein, this action is necessary in light of new
information that was not available to FDA when it initially promulgated regulations
implementing Section 403(r)(6) in 2000. 21 C.F.R. § 101.93(g)(2).
In support of this action, petitioners present extensive scientific evidence and consumer
survey data that has been developed during the past decade. This new information conclusively
establishes three critical facts. First, the condition of being overweight is a significant risk factor
for several serious diseases, including diabetes, cardiovascular disease, and cancer. 3 Second,
I
The American Dietetic Association — the nation’s largest organization of food and nutrition professionals — serves
the public by promoting optimal nutrition, health and well-being. The Obesity Society is the leading scientific
society dedicated to the study of obesity and it is committed to keeping the medical community and public informed
of new advances. Shaping America’s Health (SAH) was founded by the American Diabetes Association to reverse
the obesity trends and overweight issues facing individuals, families, and communities. The mission of SAH is to
prevent and treat excess weight and obesity, and to facilitate a better understanding of weight management. GSK
has provided unrestricted grants to the American Dietetic Association, The Obesity Society, and SAH in support of
the missions of these organizations. 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.
2 For the purposes of this request, petitioners intend that the term “weight loss claims” be construed broadly and, at a
minimum, include the following types of statements: weight loss/burning fat/cellulite reduction; accelerated
metabolism/energy burning; appetite reduction or increases satiety; blocks fat/accelerates transit; increases fat
oxidation or reduces fat synthesis; blocks carbohydrates/enhances glucose metabolism; or blocks dietary fat
absorption.
3 In the discussion that follows throughout the petition, the terms “normal weight,” “overweight,” and “obese,” refer,
respectively, to individuals with a Body Mass Index (“BMI”) of 18.5-24.9, 25.0-29.9, and 30.0 and greater.
many Americans understand the health risks of being overweight and they rely on dietary
supplements to lose weight. Third, there is little, if any, evidence, indicating that dietary
supplements marketed for weight loss actually work. As a result of these three facts, many
Americans are being thwarted in their efforts to lose weight, and reduce the risk of disease, by
ineffective weight loss supplements. In fact, the Federal Trade Commission recently reported
that more consumers are defrauded by weight loss products than any other product it evaluated.
The FDA could substantially address this problem by taking the actions in this petition.
If FDA were to treat weight loss claims as disease claims, then manufacturers of weight loss
supplements would be required to obtain FDA review of their claims before rushing to market.
The FDA has established procedures allowing for consideration of certain types of “qualified
health claims” for dietary supplements. To the extent that any manufacturer of a weight loss
supplement seeks to avail itself of the health claims process, however, FDA may only review
claims that the risk of developing a disease could be reduced through the intake of a substance in
the supplement. The FDA may not review statements about a supplement where weight loss is
the “pivot” of the health claim.
Moreover, FDA is only authorized to allow certain types of qualified health claims for a
supplement where there is some credible scientific evidence that supports the claim. Yet, there is
no credible scientific evidence that would support any type of a claim accompanying a weight
loss supplement. Indeed, during the past decade, several independent scientific teams have
uniformly concluded that there is little, if any, evidence to support the efficacy of supplements
marketed for weight loss. And, there is no evidence that the use of such supplements would
reduce the risk of a particular disease. As a result, by taking the actions requested in this petition,
FDA would protect millions of Americans who are currently relying on unproven and ineffective
dietary supplements to lose weight.
The actions requested in this petition are fully consistent with, and required by,
longstanding regulatory precedent. During the past decade, FDA has repeatedly determined that
claims to reduce risk factors such as high cholesterol levels, high blood glucose, or high blood
pressure are disease claims. Given the close link between an increased risk of disease and the
condition of overweight, FDA must reach the same conclusion about weight loss claims. In this
context, petitioners note that, consistent with FDA’s earlier conclusions, this petition would not
preclude manufacturers from making fully substantiated claims that their products “help to
maintain weight that is already within the normal range.” This petition also would not apply to
conventional foods that may assist the general population in controlling weight.4
The finding requested by petitioners also would not conflict with FDA’s determination in
2000 that weight loss claims are not disease claims because the condition of being overweight is
4 The agency’s nutrient content claim regulations authorize qualifying foods to be promoted using descriptors such
as “low calorie,” “diet,” and similar terms. Claims addressing particular “dietary needs” relating to overweight are
regulated as “special dietary use” claims and are allowed for foods that comply with 21 C.F.R. § 105.66.
Significantly, such special dietary use claims are permitted for foods only to the extent that such products supply
particular dietary needs. Needs relating to weight control may reasonably be characterized as “dietary” only if they
relate to the traditional role of diet in reducing body weight (i.e., through control of caloric intake or other diet-based
measures, as opposed to a pharmacologic mode of action).
not a disease. Petitioners are not asking FDA to conclude that the state of being overweight is a
disease. Rather, in light of the new and much stronger evidence that has emerged since 2000
about the risks of being overweight, petitioners are requesting FDA to restrict weight loss claims
because they purport to treat an unhealthy condition that is a risk factor for disease – not the
disease itself. The FDA did not consider this question in 2000. The agency’s earlier finding
about weight loss claims under one factor in its regulations by no means precludes a
determination that such claims are disease claims under different and separate criteria in the
regulations.
