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FTC Fines Weight-Loss Pill Pushers

Companies Pay $25 Million, Agree to Limit Ad Claims





January 4, 2006

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Four promoters of weight control pills are losing fiscal heft the hard way. The marketers of Xenadrine EFX, CortiSlim, TrimSpa, and One-A-Day WeightSmart will pay $25 million to settle federal charges that their advertising claims were not supported by scientific evidence.

The companies are also agreeing to limit their claims in the future.

"You won't find weight loss in a bottle of pills that claims it has the latest scientific breakthrough or miracle ingredient," said FTC Chairman Deborah Platt Majoras. "Paying for fad science is a good way to lose cash, not pounds."

Xenadrine EFX

Two marketers of Xenadrine EFX will pay at least $8 million and as much as $12.8 million to settle FTC allegations that Xenadrine EFX's weight-loss claims were false and unsubstantiated. The funds will be used for consumer redress.

In a bankruptcy case not involving the Commission, the defendants have also agreed to pay at least an additional $22.75 million to settle claims brought by creditors and consumers, including personal injury claims for an earlier ephedra-based product.

Xenadrine EFX, which contains, among other ingredients, green tea extract (EGCG), caffeine, and bitter orange (Citrus aurantium), was advertised heavily in print and on television, including in such publications as People, TV Guide, Cosmopolitan, and Men's Fitness. Xenadrine EFX advertising also appeared in Spanish-language publications.

The FTC's complaint alleged that the defendants made false or unsubstantiated claims for Xenadrine EFX, including that it was clinically proven to cause rapid and substantial weight loss and clinically proven to be more effective than leading ephedrine-based diet products.

According to the complaint, Robert Chinery commissioned several studies of Xenadrine EFX, none of which showed substantial weight loss. The complaint alleged that in one of these studies, subjects taking Xenadrine EFX lost an average of only 1.5 pounds over the 10-week study, while a control group taking a placebo lost an average of 2.5 pounds over the same period.

The complaint also alleged that Xenadrine EFX advertisements falsely represented that persons appearing in the ads achieved the reported weight loss solely by using Xenadrine EFX. According to the FTC complaint, consumer endorsers lost weight by engaging in rigorous diet and/or exercise programs. In addition, the endorsers were paid from $1,000 to $20,000 in connection with their testimonials; according to the complaint, Xenadrine EFX advertisements failed to disclose those payments.

CortiSlim and CortiStress

The seven marketers of CortiSlim and CortiStress will surrender, in total, assets worth at least $12 million to settle FTC charges that they made false and unsubstantiated claims that their products can cause weight loss and reduce the risk of, or prevent, serious health conditions.

In the final three settlement agreements announced today, the FTC will recover $8.4 million in cash, along with proceeds from the sale of a residence acquired with CortiSlim profits.

In two earlier settlement agreements, the defendants turned over $1.5 million in cash, a boat, a truck, a real estate interest, and proceeds from a tax shelter. The funds recovered from the seven defendants will be used for consumer redress.

The advertising campaign for CortiSlim ran nationwide, including ads on broadcast and cable television, radio, print media, and the Internet.

The FTC's complaint alleged that advertising claims about CortiSlim's ability to cause rapid, substantial, and permanent weight loss in all users were false or unsubstantiated, as were claims about CortiStress's ability to reduce the risk of osteoporosis, obesity, diabetes, Alzheimer's disease, cancer, and cardiovascular disease.

The FTC also alleged that CortiSlim and CortiStress infomercials were deceptively formatted to appear as talk shows rather than advertisements.

TrimSpa

The marketers of TrimSpa will pay $1.5 million to settle FTC allegations that their weight-loss claims were unsubstantiated.

According to the FTC's complaint, the marketers had inadequate scientific evidence to support their advertising claims that TrimSpa causes rapid and substantial weight loss and that one of its ingredients, Hoodia gordonii, enables users to lose substantial amounts of weight by suppressing appetite.

Many ads for "TrimSpa Completely Ephedra Free Formula X32" featured testimonials. Celebrity Anna Nicole Smith claimed to have lost 69 pounds in eight months by using TrimSpa. Other advertising claims included "Your high speed dream body diet pill" and "It makes losing 30, 50, even 70 pounds (or however many pounds you need to lose) painless."

TrimSpa ads appeared on television, in magazines, on radio, and in local newspapers. TrimSpa was also promoted on a Web site, at some NASCAR events, and other live events.

One-A-Day WeightSmart

The Bayer Corporation will pay a $3.2 million civil penalty to settle FTC allegations that advertisements for One-A-Day WeightSmart multivitamins violated an earlier Commission order requiring all health claims for One-A-Day brand vitamins to be supported by competent and reliable scientific evidence.

Bayer ran a national advertising campaign for One-A-Day WeightSmart, which contains EGCG (epigallocatechin gallate), a green tea extract. Bayer also advertised on television, radio, and the Internet, and in newspapers and magazines, such as RedBook, Family Circle, and TV Guide.

Advertising claims included statements such as:

"Just in! Most women over 30 can gain 10 pounds a decade, due in part to slowing metabolism.… So eat right, exercise, and take One-A-Day WeightSmart. The complete multi-vitamin with EGCG to enhance metabolism."

"One-A-Day WeightSmart. The first and only complete multivitamin with an ingredient to enhance your metabolism. EGCG, a natural green tea extract, to help you while you manage your weight."

The complaint alleges that Bayer Corporation marketed One-A-Day WeightSmart with unsubstantiated claims that it

• increases metabolism;
• enhances metabolism through its EGCG content;
• helps prevent some of the weight gain associated with a decline in metabolism in users over age 30; and
• helps users control their weight by enhancing their metabolism.

The FTC alleges that these unsubstantiated claims violate a 1991 Commission order against Bayer's predecessor, Miles Inc., that require all claims about the benefits of One-A-Day brand products to be substantiated by competent and reliable scientific evidence.

In addition to the $3.2 million civil penalty, Bayer is prohibited from violating the FTC order and from making unsubstantiated representations regarding the benefits, performance, efficacy, safety, or side effects of any dietary supplement, multivitamin, or weight-control product.



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