and a paper summarizing these
findings has been accepted in the publication, Obesity. 51 In this study, more than 12,000
households were reached via telephone, and a sample of 3,500 adults completed an in-depth
telephone interview about weight loss practices, including the use of dietary supplements for
weight loss and a reduced risk of disease. The maximum expected sampling error associated
with a sample of this size is 1 .66 percentage points at a 95 percent confidence level.
The results were striking: overall, consumers who identified themselves as overweight
believe that weight loss is directly related to improvement of their health and reducing the risk of
disease. Specifically, of those surveyed who described themselves as “slightly overweight” or
“very overweight” (n=1,707), the Landmark Survey found that:
92% of overweight individuals believe that losing weight will improve their health;
94% of overweight individuals believe that being overweight increases their risk of
certain diseases;
94% of overweight individuals believe that an overweight person is more likely to
develop chronic illnesses such as diabetes or high blood pressure compared to
someone who is not overweight; and
83% of overweight individuals believe that being overweight negatively impacts
other aspects of their health.
At the same time, of those who indicated that they had made at least one attempt to lose weight
(n=1,582), the Landmark Study found that 43% stated that the most important benefit that they
hoped to gain by losing weight was to improve their health. That compared with just 10% who
indicated that they hoped to look better by losing weight.
There is no question that, in recognition of the risks associated with being overweight,
many Americans are using dietary supplements to reduce weight. In March 2007, researchers
49
Financial support for this study was provided by GSK.
so
See e.g., First of its kind national survey finds misinformed consumers rely on unproven weight loss products.
October 22, 2006. (Accessed January 3, 2008, at http://www.csra.uconn.edu/pdf/National_Dietary_Survey.pdf). See
also abstracts of Pillitteri JL, Shiffman S, Rohay JM, Harkins AM, Wadden TA, Pettinico G, Burton SL. Interaction
with physicians among overweight adults in the United States. Poster session presented at: NAASO, The Obesity
Society 2006 Annual Meeting; October 2006; Boston, MA; Pillitteri JL, Shiffman S, Rohay JM, Wadden TA,
Harkins AM, Burton SL, Pettinico G. Dietary supplement use for weight loss among US adults. Poster session
presented at: NAASO, The Obesity Society 2006 Annual Meeting; October 2006; Boston, MA; Pillitteri J, Burton S,
Shiffinan S, Rohay J, Harkins A, Pettinico G. Consumers’ use and beliefs about dietary supplements for weight loss.
Poster session presented at: 10th International Congress on Obesity; September 2006; Sidney, Australia. (Exh. 27).
5 1 Pillitteri JP, Shiffinan S, Rohay JM, Harkins AM, Burton SL, Wadden TA. Use of dietary supplements for weight
loss in the United States: results of a national survey. Obesity. Forthcoming 2008.
from the CDC reported that the use of supplements for weight loss is common among many
segments of the U.S. adult population and that many adults are long-term users of weight loss
supplements. 52 Moreover, it is also evident that a substantial percentage of adolescents (ages 14-
19) also use supplements. One recent study found that almost half of the adolescents in the study
had used supplements in their lifetime and that almost a third had used supplements in the past
month.53 Similarly, the Landmark Survey found that, of those adults who have made a serious
weight loss attempt, at least one-third (34%) used dietary supplements to lose weight. It appears
that many overweight individuals are so desperate to lose weight that they frequently try one
supplement product after the other in their quest to improve their health.
Significantly, while many Americans use dietary supplements to lose weight, they are
also confused and misinformed in their reliance on such products. The Landmark Survey
revealed that:
54% of respondents believe that weight loss supplements have been tested and
proven to be safe before they can be sold to the public;
46% of respondents believe that weight loss supplements must be tested and
proven to be effective before they can be sold to the public;
64% of respondents believe that FDA requires the labels of weight loss
supplements to include warnings about potential side effects;
50% of respondents believe that weight loss supplements are either very effective
or somewhat effective in helping people lose weight; and
37% of respondents believe that herbal supplements are safer than over-the-
counter and prescription medicines.
These figures are especially troubling because it is not at all clear that this confusion
could be corrected when patients see their healthcare professionals. The CDC has found that
most patients do not discuss the use of supplements with their physicians. 54 That finding was
confirmed by the Landmark Survey, which reported that less than a third of those surveyed
indicated that they would consult a physician about weight control. And, of those who would
consult a physician, only 24% used FDA-approved treatments to aid in weight loss while almost
twice as many (46%) had used weight loss supplements. The latter results are, perhaps, not that
surprising in light of another recent survey that evaluated physicians’ level of understanding of
the regulation of dietary supplements. That study, which was conducted by researchers at Johns
Hopkins University School of Medicine, found that almost one-third of physicians who had
52
Blanck HM, Serdula MK, Gillespie C, et al. Use of nonprescription dietary supplements for weight loss is
common among Americans. J Am Diet Assoc 2007;107:441-7. (Exh. 28).
53
Wilson KM, Klein JD, Sesselberg TS, et al. Use of complementary medicine and dietary supplements among
U.S. adolescents. J Adolesc Health 2006;38:385-94. (Exh. 29).
54
Blanck HM, Serdula MK, Gillespie C, et al. Use of nonprescription dietary supplements for weight loss is
common among Americans. J Am Diet Assoc 2007;107:441-7. (Exh. 28).
completed internal medicine residency programs were unaware that dietary supplements did not
require FDA approval or submission of safety and efficacy data before being marketed. 55
2. Overweight Americans Are Being Bombarded and Misled by Fantastic and
Unsubstantiated Claims That Use of Dietary Supplements Will Result in
Effective Weight Loss
As demonstrated by the studies cited above, including the Landmark Survey, many
Americans are increasingly looking to dietary supplements as a way to lose weight, improve
their health, and reduce their risk of disease. At the same time, however, it is clear that many
patients (and apparently even physicians) lack a basic understanding of dietary supplements and
FDA’s authority to ensure the safety and efficacy of such products. Those who market weight
loss supplements appear to be acutely aware of this confusion and, to drive sales, 56 are repeatedly
making “magic bullet” claims about their products that promise rapid and effective weight loss.
Of course, manufacturers also aggressively advertise their supplements over the airwaves, with
some companies running extensive “infomercials” about their products. In both venues,
supplement manufacturers capitalize on the fact that such products are available without a
prescription and they present a “natural” solution that is less demanding than special diets and
increased physical activity.
As can be seen from the handful of examples below, the manufacturers of weight loss
supplements have not hesitated to extol the purported benefits of their products:
“. . . a new category of bifurcated weight loss compounds providing both quick
weight loss and incredible energy combined into a single, powerful Super Pill.”
“. . . a breakthrough in the fight to lose weight” and “works to help your body
burn fat and calories, while also helping you fight cravings and boosting your
energy.”
”
.
. .
a weight loss supplement formulated to address key factors involved in
effective weight control including metabolism, appetite, satiety, and nutrition.”
“. . . helps the body’s insulin metabolize fat, convert protein into muscle, and turn
sugar into energy, supporting weight loss and the development of lean body
mass.”
“. . . flips your hunger switch on demand so you just don’t want to eat. Result –
caloric intake is reduced. . . . fat disappears automatically. Fires up your fat-
burning engine (without ephedra) causing significant, undeniable weight loss!”
55
Ashar BH, Rice TN, Sisson SD. Physicians’ understanding of the regulation of dietary supplements. Arch Intern
Med 2007;167:966-9. (Exh. 30).
56
In 2000, total sales of weight loss supplements in the United States were reported to be $4.7 billion. See
Consumer Healthcare Products Association. (Accessed January 3, 2008, at www.CHPA-info.org). This figure
underestimates actual sales since many sales of supplements over the internet and through direct response television
are not easily tracked or captured. In 2005, the Institute of Medicine estimated that Americans spent $18 billion per
year on dietary supplements. Institute of Medicine. Dietary supplements: a framework for evaluating safety.
Washington, DC: National Academy of Sciences, 2005. (Accessed January 3, 2008, at
http://books.nap.edu/openbook.php?record id=10882&page=l).
“. . . the first reliable diet pill with lipotropic ingredients and powerful appetite
suppressants to greatly increase energy, burn fat and crush cravings – all at the
same time.”
In addition to making such fantastic claims about their products, supplement
manufacturers also frequently state outright or imply that their products have been clinically
tested or proven to be safe and effective for weight loss. For example:
“. . . a patented, breakthrough Ephedra Free formula, combines an effective
complex of clinically proven ingredients to increase metabolic rate, promote
weight loss, and increase energy.”
“Extensive research on our product has shown that there are literally no side
effects . . . . This product is safe and can effectively burn fat to help with weight
loss.”
“But now, a revolutionary, all-natural weight-control compound offers new
hope. . . . the first and only clinically proven, safe, and effective weight-control
compound designed for children and adolescents. . . .”
“The results of a clinical research study conducted on . . . weight loss and weight
management solutions are revealed – proving that [this product] helps people lose
twice as much weight than with diet and exercise alone.”
“Clinically proven to deliver weight loss results. . . . . You’ll be looking and
feeling great in no time!”
“. . . a truly powerful, safe, clinically proven fat-loss tool, perfect for anyone . . . .”
Despite such claims, most supplement manufacturers have little, if any, credible evidence
or studies that support such statements. 57 As a result, millions of U.S. consumers are being
victimized by manufacturers of fraudulent weight supplements. Indeed, that was precisely the
conclusion of the Federal Trade Commission (“FTC”), which reported in October 2007 that more
Americans are being defrauded by weight loss products than any other fraudulent activity studied
by the agency.s8 In this consumer survey, the FTC found that 2.1% of consumers – almost 5
million U.S. adults – purchased and used fraudulent weight loss products in 2004. The FTC
further reported that there were an estimated 8.3 million total purchases of weight loss products
57 See infra at notes 75-109.
58 Federal Trade Commission. Consumer fraud in the United States: the second FTC survey. Washington, DC:
Federal Trade Commission, October 2007. (Accessed January 3, 2008, at
http://www.ftc.gov/opa/2007/10/fraud.pdf). That conclusion follows the FTC’s report in 2002 finding that 55% of
claims within advertisements for over-the-counter weight loss products were either false or misleading and there was
a much higher frequency of questionable claims being made in 2001 than in 1992. See Federal Trade Commission.
Weight loss advertising: an analysis of current trends. Washington, DC: Federal Trade Commission, September
2002. (Accessed January 3, 2008, at http://www.ftc.gov/bcp/reports/weightloss.pdf).
during that year. 59 For the purposes of this survey, the FTC only considered individuals to be
victims of fraud if they lost only a little of the weight that they had expected to lose or they did
not lose any weight at all. Thus, the FTC figure is a conservative assessment of the magnitude of
these fraudulent activities.
To be sure, in recognition of this problem, FDA and the FTC have ursued enforcement
actions and other measures against weight loss supplement manufacturers. ° In October 2004,
for example, FDA issued warning letters to numerous manufacturers and distributors of weight
loss supplements advising them that their claims were in violation of the FDCA because they
could be not be substantiated. The FTC has also brought numerous actions against supplement
manufacturers for making unsubstantiated claims in their advertising about weight loss
products. 61 Yet, while certain firms have stopped making unsubstantiated statements about
weight loss supplements, others have not. 62 Moreover, still other companies have sprung up to
make similar, but not identical, claims that almost certainly also cannot be substantiated. As a
result, despite the laudable efforts of FDA and the FTC to stem the tide of misleading claims
made for weight loss supplements, many overweight Americans who are seeking to reduce their
risk of disease by losing weight are, instead, being lured into using supplements for which little
or no scientific evidence exists to demonstrate that they actually work.

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