FTC settles Xenadrine weight loss case
The FTC affirmed a 2006 US District Court for the District of New Jersey ruling that RTC Research & Development (RTC) was guilty of “false and unsubstantiated advertising” of the weight loss product, Xenadrine EFX.
Much of the offending material was in the form of testimonials and comes at a time when the FTC is mulling over potential amendments to the laws that govern such marketing so that companies may find it more difficult to employ them.
The ruling
The 2006 ruling stated RTC, along with its owners, Tracy Chinery, and her husband Robert Chinery, Jr, who were also defendants in the case, had to pay $8m to compensate deceived consumers and to limit future advertising claims.
Xenadrine EFX was marketed as being clinically proven to cause rapid and substantial weight loss and was said to be more effective than ephedrine-based diet products that were banned by the Food and Drug Administration (FDA) in 2004.
The final agreement had been delayed because of a dispute about the culpability of Tracy Chinery and her conduct as an employee of Nutraquest, Inc, which had marketed Xenadrine before RTC and which may have made her personally liable for the advertising under the FTC Act.
“The court denied Tracy Chinery’s motion to dismiss in July 2007, ordered discovery to proceed, and then denied her motion for summary judgment in March 2009,” FTC said. “Tracy Chinery signed the settlement agreement, which the court has now entered.”
FTC continued: “Under the final order, all three defendants are barred from making any claims about the health benefits, performance, efficacy, safety, or side effects of any weight-loss product, dietary supplement, food, drug, or device, unless the representation is true, not misleading, and substantiated by competent and reliable scientific evidence.”
“The order also prohibits misrepresentations about any test or study, and about the actual experience of any user or endorser. Finally, it requires clear and prominent disclosure of any relationship that would materially affect the weight or credibility given to a testimonial or endorsement provided by a user of the product.”
Xenadrine is referenced in rapper, Eminem’s recent song, We Made You, where the rapper rhymes the supplement’s moniker with the Alaskan politician and former US vice presidential candidate, Sarah Palin.
Ephedra
The FDA last year recalled nine dietary supplement products made by Herbal Science International containing ephedra despite the 2004 ban on the grounds that it does not present a significant health benefit to outweigh the reported increased risk of heart attack, stroke and death.
Ephedra supplements were popular with those seeking to lose weight and was particularly popular with young women and sports people.
At the time, dietary supplement industry organization Council for Responsible Nutrition (CRN) commented that this was an "isolated incident" and reiterated that consumers should buy products from "companies and sources you know and trust".
Ephedra is a source of ephedrine alkaloids, which are adrenaline-like stimulants that can have potentially dangerous effects on the heart.
In April 2005, the ban was successfully challenged by Nutraceutical Corporation, since the 1994 Dietary Supplements Health and Education Act (DSHEA) does not make mention of risk-benefit balance in establishing whether a supplement presents an unreasonable risk. Rather, the FDA drew on the medical devices provisions of the Food Drug and Cosmetics Act, which does state that this is a determining factor.
However, this was then overturned by the federal appeals court decision in August of the same year.
