Bayer "went too far" with weight-loss and -control claims for its One-A-Day WeightSmart product and violated a 1991 sanction the product's previous owner agreed to, the Federal Trade Commission said Jan. 4 when it announced a record $3.2 million fine against the consumer healthcare giant.

FTC also disclosed settlement agreements with firms and individuals marketing CortiSlim and CortiStress , TrimSpa and Xenadrine EFX .

"The common theme in these cases is that the marketers made claims that their products contained new, breakthrough ingredients which are proven to cause weight loss or control weight, but the claims aren't supported by sound science," FTC Chairwoman Deborah Platt Majoras said.

Although the other settlements involved larger amounts than Bayer's fine, they are for consumer refunds and asset forfeitures, rather than fines. Bayer's "is the highest civil penalty we've ever obtained in a health claims case," Majoras said.

A 1991 settlement with the previous marketer of One-A-Day products, Miles Inc., inflated the amount of Bayer's fine. The agreement required claims for One-A-Day products, which contain green tea extract and other ingredients, to be supported "by competent and reliable scientific evidence," Majoras said.

The fact that Bayer acquired the product line since that time did not cause FTC to hesitate to enforce violations of the settlement, she said, adding that firms of Bayer's size as well as larger and smaller operations must comply with regulations.

"In this particular instance we think [Bayer] went too far, but we're pretty confident that they've got the message for the future," she said.

"There's no question that a company like Bayer makes a lot of products that have improved peoples' health, but that doesn't immunize them from making sure that for every claim they make in these over-the-counter products, they have the science to back it up."

The FTC head also called attention to Bayer's advertising. "In one of their ads, Bayer offered users an easy exercise, 'just lift, twist and bend.' In other words, lift the bottle, twist the cap and bend your wrist. That's the exercise," Majoras said.

Bayer's settlement will draw more attention to the enforcement action, said Michael McGuffin, American Herbal Product Association president.

"That's a big deal, that really drives it home," McGuffin said. "It expands it beyond the idea that these are some rinky-dink products that are sold late at night on TV ads or only in health food stores."

The action shows dietary supplement firms how FTC will continue responding to unsubstantiated health claims no matter the ingredient in a product, he added.

"They're trying to make companies that sell weight-loss products to stop and think about whether they want their names mentioned at the next press conference, whether they want to be the [firm] that pushes the button within 40 days that transfers money in seven digits and greater from its bank account to the U.S. Treasury. I think that's a lot of the agency's thinking."

"This wasn't all just ephedra," McGuffin said. "This wasn't all just FTC acting against one ingredient," but "against a broad range of ingredients that are somewhat widely marketed in weight-loss products."

FTC did not call on FDA to investigate the safety of the products. And because the products are not considered unsafe, they can remain on the market.

"If we had determined that any of the products were actually dangerous to a person's health...we would have gone to the FDA," Majoras said.

The settlements the Justice Department filed Jan. 3 in Newark, N.J. federal court also call for marketers of Xenadrine EFX to pay at least $8 million and as much as $12.8 million for consumer refunds and to settle FTC allegations that the product's weight-loss claims were false and unsubstantiated.

The reformulation of a brand that previously contained ephedra, Xenadrine EFX includes green tea extract and other caffeine sources among its ingredients.

Majoras said defendants Robert Chinery Jr., Tracey Chinery and RTC Research & Development LLC marketed Xenadrine EFX with claims including it produced "such extraordinary" results, "even the researchers were shocked." However, their own studies showed users of the product lost less than placebo groups, she said.

Chinery's bankrupt firm Nutraquest (formerly Cytodyne) was not named in the suit.

Marketers of CortiSlim and CortiStress will surrender assets worth at least $12 million to settle charges of making false and unsubstantiated claims that their products cause weight loss and prevent serious health conditions, and for consumer redress. The defendants are Stephen F. Cheng and Window Rock Enterprises Inc., and Gregory S. Cynaumon and Infinity Advertising Inc.

CortiSlim includes bitter orange and green tea extract among its ingredients, while CortiStress contains magnolia bark extract as well as several vitamins.

TrimSpa marketers Goen Technologies Corp., Nutramerica Corp., TrimSpa, Inc. and Alexander Szynalski, also known as Alexander Goen, will pay $1.5 million to settle FTC allegations their weight-loss claims were unsubstantiated.

Goen Technologies in August 2005 agreed to a $750,000 settlement to close the second of three lawsuits New Jersey filed over TrimSpa marketing (¹ Also see "New Jersey Goen Settlement Bars Unsubstantiated Claims" - Pink Sheet, 29 August, 2005., p. 12).

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

Majoras noted TrimSpa marketers touted hoodia as a "secret ingredient used for centuries by African bushmen to suppress hunger during long hunting trips when food was scarce."

This is the first FTC health-claim enforcement concerning hoodia, but the agency has raised numerous questions about marketing pitches for hoodia products, said Mark Ullman, an attorney and partner with Ullman Shapiro & Ullman who represents dietary supplement firms, including CortiSlim marketers.

In August 2005, NutraCore agreed with the National Advertising Division to permanently discontinue some health claims for its hoodia-containing Nutrathin diet pills (² 'The Tan Sheet' Aug. 15, 2005, In Brief).

The FTC action against TrimSpa marketers, however, likely shows federal regulators are applying increased scrutiny to hoodia-related claims, Ullman added.

- Malcolm Spicer

FTC Supplement Settlements Spotlight Bayer, Mark First Hoodia Action

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