Kevin Trudeau Settles FTC Claims

Kevin Trudeau Settles FTC Claims

The Sept. 3 settlement closes a case brought in June 2003 against Trudeau, Robert “Bob” Barefoot and several associated companies related to the sale of coral calcium dietary supplements. Barefoot and his two companies settled with FTC in January 2004.

Trudeau’s history with FTC extends back to 1998, when he signed an FTC settlement regarding infomercials and health claims made for products including the Sable Hair Farming System, Mega Memory System and Howard Berg’s Mega Reading system. In July 2003, Trudeau entered into a stipulated preliminary injunction prohibiting him from making challenged claims for Coral Calcium Supreme and Biotape, a purported analgesic adhesive tape. Trudeau was found in contempt of court in July 2004 for violating the 2003 preliminary injunction.

AHPA Questions FDA on Bitter Orange AERs

AHPA filed a Freedom of Information Act (FOIA) request with FDA to obtain copies of any AERs regarding dietary supplements containing bitter orange. The association received and analyzed 147 reports, and found:

• 52 of the reports were apparent duplicates or did not provide any information to confirm bitter orange was an ingredient in the product;
• 70 reports were associated with products that contained both bitter orange and ephedra, which has since been removed from market by FDA as an ingredient with an unreasonable risk of illness or injury; and
• All but one of the remaining reports involved products that contained both bitter orange and a caffeine source.

AHPA noted the single AER involving a product containing bitter orange with neither ephedrine nor caffeine was received five years ago from a 74-year-old woman; the woman was taking three separate herbal products and five prescription drugs, and her adverse event was “felt very unwell, weak” and later, edema. “It appears as if FDA is willing to regulate by anonymous press release and to be quite cavalier in its approach to truthfully informing the public about the safety profile of bitter orange,” said Michael McGuffin, president of AHPA (www.ahpa.org).

“It was apparent in my conversation with the agency that FDA officials knew that many of these reported adverse reactions were associated with products that also contained ephedrine alkaloids when they provided numbers to the media, but did not consider it to be important to disclose that information. That information is material, and FDA’s failure to disclose it makes their unqualified statements misleading in the extreme.”

New Jersey Sues NVE for Consumer Fraud

The primary target of the lawsuit is NVE’s ephedra and ephedra-free weight loss product, Stacker 2, though the counts also address NVE’s “energy boosters,” allegedly sold as street drug alternatives. New Jersey officials allege NVE advertised its products as safe and effective for weight loss, despite a lack of scientific research on their effects and receipt of consumer complaints about side effects including high blood pressure, rapid heartbeat and seizures. The state is seeking civil penalties, restitution for affected consumers, and a permanent injunction against NVE enjoining the company from making unsubstantiated or false claims about the safety or efficacy of any of its dietary supplements.

A call to NVE’s attorney, Terry Gaffney, had not yet been returned at press time.

FDA Announces Qualified Health Claim for Omega-3 Fatty Acids

The Council for Responsible Nutrition (CRN) commended FDA’s action in extending this qualified health claim—which was previously available only for supplements—to include conventional foods, but suggested FDA fell short of recommending what the science supports. “We are disappointed that FDA established no minimum requirement for the amount of omega-3 EPA/DHA that a conventional food must contain in order to use the qualified health claim,” said Annette Dickinson, Ph.D., president of CRN (www.crnusa.org). “We further believe it will do consumers a disservice if foods with insignificant amounts of these fatty acids carry the claim.”

FDA recommends consumers not exceed more than a total of 3 g/d of EPA and DHA omega-3 fatty acids, with no more than 2 g/d from a dietary supplement. The qualified health claim comes in response to many petitions submitted to FDA. Petitioners, including CRN, requested a full health claim for omega-3 EPA/DHA and reducing the risk of CHD.

“This decision dramatically widens FDA’s former position regarding the relationship between dietary supplements containing omega-3 fatty acids and the resulting reduced risk of CHD,” said Jonathan Emord, legal counsel to American Longevity and Life Extension Foundation Buyer’s Club, one of the petitioners. “The former qualified health claim contained a substantively limiting disclaimer that failed to adequately assess the benefits of omega-3 fatty acids in reducing the risk of CHD. FDA’s current qualified health claim more accurately describes the current state of the scientific evidence on the benefits of omega-3 fatty acids.”

Dickinson said CRN is still hopeful FDA will move ahead on an unqualified health claim in the near future. “While it is logical for FDA to have extended the qualified health claim to conventional foods, as well as supplements, given they both provide the same beneficial nutrients, we hope that as the positive science continues to build, FDA will move towards a full health claim,” she said.

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