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Too Little Too Late

Dietary Supplements,FDA,FTC,Marketing and Advertising,Regulatory

The Federal Trade Commission’s first probiotic claims case has concluded with Nestle HealthCare Nutrition agreeing to drop claims that its children’s drink, BOOST Kid Essentials, could reduce illness-related absences from school or daycare. In the first of what is shaping up to be several investigations centered on probiotic products, FTC concentrated on whether claims about BOOST’s immunity protection were backed by results from clinical studies.

FTC feels that the studies Nestle relied on to prove their case could not adequately link reduced absences to the alleged immunity-boosting properties of their product, citing issues such as the original cause of the absences and how that was related to the outcome.

FTC also took issue with the studies upon which the product claims were based, as they focused on a different strain of probiotic than was used in BOOST. This is a common problem facing marketers of dietary supplement products, as sometimes the published literature on an ingredient may differ from the type, amount or concentration that is contained in product.

Nestle has agreed to drop claims that BOOST could prevent upper respiratory tract infections, protect against cold and flu and reduce illness –related absences as part of the settlement.

This is not the first time BOOST’s claims have come under fire. Last year, FDA warned Nestle that their claims that the drink can be used for treatment and prevention of chronic illness and can be administered pre- and post-surgery classified it as an unapproved new drug.

This story is not a new one. The makers of Airborne face similar charges from the FTC in 2008. In both cases the FTC challenged the adequacy of the evidence supporting immune-boosting claims. However, Airborne was not as fortunate as Nestle.

Airborne Health, Inc. was already in the midst of a private class action lawsuit when the FTC challenged the company’s claims that their product could prevent colds and protect consumers who had been exposed to germs. After agreeing to pay the $23.51 million the class action suit was settled for, the makers of Airborne were made to pay an additional $6.5 million for consumer redress to satisfy the monetary judgment for the FTC’s suit, bringing the total settlement fund to $30 million. The inventor of the product, Victoria Knight-McDowell, and her husband, Thomas John McDowell, were also named in the suit.

The moral is this; when marketing any sort of supplement product, it is important to base claims on detailed, existing scientific support (the FTC requires indicates two human clinical studies). When manufacturers overstate a product’s benefits or fail to provide substantial support for claims regarding its use and efficacy, they endanger the reputation of their brand and run the risk of incurring high litigation costs, personal and corporate liability. It is best to rely on proven fact, not hope that one can fill in the blanks farther down the line.

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