HEALTH

FDA attacks ‘lose pounds quick’ weight-loss frauds

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday outlined a new campaign attacking fraudulent weight-loss products marketed as dietary supplements, especially those companies that proffer a “magic pill” that almost immediately achieves weight loss.

“These products are not legal dietary supplements,” stated Michael Levy, director of the FDA’s Division of New Drugs and Labeling Compliance. “They are actually very powerful drugs masquerading as ‘all-natural’ or ‘herbal’ supplements, and they carry significant risks to unsuspecting consumers. We have seen deaths associated with these weight-loss products. … Make no mistake — they can kill you.”

To help drive home that message, the FDA has pieced together a series of commercials warning consumers against the dangers associated with these products. The commercials are located here, and an up-to-date consumer Web page can be found here.

In some cases, the FDA has found weight-loss products tainted with the prescription drug ingredient sibutramine. This ingredient was in an FDA-approved drug called Meridia, which was removed from the market in October 2010 because it caused heart problems and strokes. The FDA also has found other prescription drug ingredients that have been removed from the market or never were approved at all.

“We’ve found other weight-loss products marketed as supplements that contain dangerous concoctions of hidden ingredients, including seizure medications, blood-pressure medications and other drugs not approved [in the United States],” Levy said.

Many of these tainted products are imported and sold through the Internet, but some also can be found on store shelves. The FDA has made it a priority to seek out these dangerous products, stop them from being imported and take legal action against firms that manufacture and distribute them, the agency stated.

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NAD refers Patent Health claims to FTC

BY Michael Johnsen

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Monday referred advertising for the dietary supplement Trigosamine Fast Acting (Trigo FA) to the Federal Trade Commission for further review following Patent Health’s failure to modify claims.

The referral follows an initial NAD decision, a ruling from the National Advertising Review Board and complaints from Nutramax Labs, which initially challenged Patent Health’s claims that appear in an advertorial — specifically, the sub-headline of a new Trigosamine advertorial claim: “Clinical trial: participants began to feel noticeable results in just days.”

In addition, the advertising included the claim that “81% of the participants started feeling better just days after taking the recommended dosage,” and “100% reported their joints felt better just midway through the [eight]-week clinical trial.”

This “fast-relief” message is compounded further by the name of the product itself, “Trigosamine Fast Acting.”

In its initial decision, the NAD found that the advertiser’s “speed” claims, based on a “six-minute walk test” during a single clinical study, were not supported by the results of that study. The NAD recommended that the advertiser discontinue all claims based on the results of the six-minute walk test as measured at three days, discontinue using the term “rapid relief” and discontinue all claims that compared the performance of Trigo FA with glucosamine supplementation alone.

The NAD also addressed the advertorial format of advertising for Trigo FA and recommended the advertiser take additional steps to make it clear that what consumers were seeing was advertising, not news.

Patent Health had accepted portions of the NAD decision and stated it would discontinue claims that included speed-of-action claims, direct glucosamine comparison claims and claims that the product, when combined with glucosamine, “improves absorption of nutrients and works quickly to improve mobility and flexibility.” Patent Health, however, believed that its study supported a claim of results in as few as three days of beginning supplementation and sought the NARB’s review of this claim, as well as the NARB’s position on its advertorial, NAD reported. NARB upheld the NAD’s decision in both respects.

The NAD opened two compliance reviews of advertising for the product in August 2010 and again in January 2011, following complaints from the original challenger in the case.

Although the NAD noted that the advertiser implemented some of the changes recommended by both the NAD and NARB, recently published advertising contained many of the same claims, presented in the same advertorial format.

The current advertising, the NAD noted in its compliance decision, disregards “the spirit and the letter of both the NAD and NARB decisions. Accordingly, since the advertiser has not made a bona fide attempt to bring its advertising into compliance with the recommendations in the NAD or NARB decision, NAD [has] concluded that the self-regulatory process has been exhausted and is referring the matter to the FTC for possible enforcement action.”

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Medela kicks off online contest

BY Michael Johnsen

MCHENRY, Ill. — Medela on Tuesday announced the launch of a new online Keep the Connection contest, giving moms a chance to win Medela breast-pumping and breast-feeding products.

"The Keep the Connection photo contest is an extension of our new Keep the Connection print campaign, which features a real mom and dad experiencing a true connection with their baby," stated Rachel Mennell, director of communications at Medela. "We wanted a way to showcase other moms keeping their connection — both physically through the life-giving benefits of breast milk and emotionally."

From March through December, two grand-prize winners per month will receive a complete Medela breast-pump prize package, including the Freestyle breast-pump and breast-feeding accessories valued at $500. Ten additional second-prize winners will receive a Harmony breast-pump and breast-feeding accessories valued at $100.

To enter, new and expectant moms can upload a favorite prenatal or post-partum photo to MedelaConnection.com that visually captures an emotional connection shared with their baby.

Contestants also will need to describe in 25 words or less their special "connecting moment," and can encourage family and friends to vote for their picture. At the end of each month, two grand-prize winners will be announced — one based on a random selection and the other a result of the photo with the most votes. Ten second-prize winners also will be randomly selected.

For full details, please visit MedelaConnection.com.

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