In an unusual step, a February 1, 2011 FDA Warning Letter to Tennessee Scientific, Inc./Scientific Formulations LLC, citing numerous website "therapeutic claims" for supplements as violating the Federal Food, Drug, and Cosmetic Act, also stated: "In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating the claims are true at the time they are made. See FTC v. Direct Mktg. Concepts… More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. See In re Daniel Chapter One, No. 9239, slip op. 18-20, 2009 WL 516000 (F.T.C.), 17-19 (Dec. 24, 2009)." The exact breadth of FDA's jurisdiction over websites has been the subject of some debate. Under the Memorandum of Understanding between the agencies, the FTC has primary responsibility over "the truth or falsity of all advertising (other than labeling) of foods, drugs, devices, and cosmetics." Although FDA has typically cited violations on websites when the URL for the site is found in product labeling or the site has product ordering capability — creating a nexus to labeling — it has generally asserted broad and overlapping jurisdiction with the FTC over website claims. FDA also works closely with the FTC on food and dietary supplement claim-related investigations, and cross-referrals between FDA and the Commission are common. This Warning Letter takes that collaboration a step further. Although it is signed by the Acting District Director of the FDA New Orleans District Office, it both calls out specific potential FTC advertising violations and specifically asks the recipients to respond to the FTC: "In addition, FTC strongly urges you to review all claims for your products and ensure those claims are supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order. An order also may require you pay back money to consumers. Please notify FTC, via electronic mail at healthproducts @ ftc.gov, within fifteen (15) working days of receipt of this letter of the specific actions you have taken to address FTC's concerns." Going forward, marketers should know that FDA District Offices may be on the hunt for both FDA and the FTC. On a related note, there has been much concern by companies due to changes in FTC consent order language regarding substantiation for health claims, including requirements that, for certain types of claims, the FTC would require companies under consent orders to obtain FDA approval before making the claims (see, e.g., Iovate, Nestle, and see prior blog on the consents here). At the recent ABA Consumer Protection Conference, David Vladeck participated in a panel discussing the new cases, and explained this "fencing in" relief negotiated in particular orders. He said it is not the FTC's position that all companies need FDA approval before making any disease claims in advertising. By way of example, he cited to the FTC's complaint against POM Wonderful, where the FTC accused POM of making unsubstantiated disease claims but did not allege it is a violation of Section 5 based on the absence of FDA approval. – Dan Kracov
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