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Mar 19

FTC Prevails Against Marketers of Medical Foods

On March 7, 2014, the Federal Trade Commission (“FTC”) reported that the Agency had prevailed in federal court in its action against the Wellness Support Network. In particular, the U.S. District Court for the Northern District of California entered a final judgment, finding that Wellness Support Network had violated Section 5 of the Federal Trade Commission Act (“FTCA”) by making claims about its products that were considered false and/or unsupported by scientific evidence at the time the claims were made. As part of its judgment, the Court ordered the Company to pay nearly $2.2 million dollars in restitution, which will in turn be used by the FTC to reimburse consumers who relied on these marketing claims and purchased the products. The full report from the FTC may be accessed here.

Marketers of the diabetes products Insulin Resistance and Diabetic Pack, Wellness Support Network (“the Company”), attempted to market their products as medical foods. However, both the FTC and FDA took issue with the Company’s statements in advertising and targeted the Company in connection with the marketing of these products. In particular, in September 2005 and October 2006, the FDA issued two separate warning letters to the co-owners of Wellness Support Network, Robert and Robyn Held, warning the Company that their products, as advertised, were deemed unapproved drugs by the FDA. When the Helds did not stop marketing their products, the FTC then stepped in and ultimately filed a complaint for permanent injunction in federal court, arguing that the Company’s advertising claims pertaining to diabetes were deceptive, in that the representations made about the products were false and/or were not supported by the requisite level of substantiation when made.

In sum, both the FDA and FTC were involved in the issuance of this Warning Letter, highlighting the overlapping jurisdiction of the FDA and FTC with respect to product claims, and the importance of considering the requirements of both agencies in this context. The responsibilities of each agency are outlined in a Memorandum of Understanding, found here. Where, the FDA has primary responsibility for regulating the labeling of food, drugs, devices, and cosmetics, the FTC has primary responsibility for regulating the advertising for these types of products. Accordingly, compliance with both regulatory authorities is essential. For more information about compliance with both FDA and FTC regulations, please contact us at: contact@giannamore-law.com.

FDA Attorney

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