Dietary supplement industry faces coordinated FTC / FDA attention


Federal government agencies with a consumer protection mission have historically tended to work closely together and share information, but the COVID-19 pandemic has made these cooperative efforts even more visible to the general public. We blogged in 2020 about the increasing use of warning letters issued jointly by the Food and Drug Administration (FDA) and the Advertising Practices Division of the Federal Trade Commission (FTC) in the seemingly endless fight against COVID products. -19 fraudulent (see before post here). As coordinated FDA and FTC enforcement activities specific to the ongoing public health emergency continue at a steady pace – as of September 9, 2021, the FDA has sent over 200 warning letters to companies claiming a product is a cure, treatment or preventative for COVID and the FTC has made more than 400 unsubstantiated health claims for COVID-related products, many of which are signed by both agencies – these power regulators also appear to have become more comfortable with announcing joint actions in non-COVID contexts. This trend makes it even more important for manufacturers and distributors of consumer products to be fully aware of and comply with all of their legal and regulatory obligations.

In particular, the broader dietary supplement industry has been the target of several recent high-profile joint announcements by the FDA and FTC, in light of the two agencies’ shared jurisdiction over products falling into this category. A long-standing liaison agreement between the two agencies ensures non-duplication of effort and assigns primary responsibility to the FDA for labeling foods and dietary supplements shipped in interstate commerce, while the FTC has primary responsibility. regarding the regulation of truth. or the falsity of any advertising (other than labeling) of these products. The joint warning letters that agencies are issuing more frequently in recent times make these jurisdictional limits very clear, to new market entrants who may be less familiar with the 1971 linkage agreement.

Against this background, let us return to recent trends we are seeing in law enforcement. So far in 2021, cooperative agencies have joined forces in at least two multi-company sweeps involving illegally traded dietary supplement products. On September 9, 2021, the FDA and FTC announced that they had sent joint warning letters to 10 companies for selling dietary supplements to cure, treat, mitigate or prevent diabetes without supporting scientific evidence for medical claims. they were doing. From the point of view of the FDA, therefore, the products were illegal supplements because they were marketed with “drug claims”, which made them unapproved and mislabelled drugs under the Federal Food Act. , drugs and cosmetics (FD&C Act) – the agency’s press release on this latest joint action with the FTC is here. And from the FTC’s perspective, the various efficacy claims included in the companies’ advertisements were certainly not supported by competent and reliable scientific evidence, the applicable standard for efficacy claims under Article 5 of the FTC Act, making each of these advertisements misleading – the Commission press release of the same day is available here. The FTC parts of the joint warning letters also state unequivocally: [can] prevent, treat or cure diabetes without competent and reliable scientific evidence consisting of well-controlled human clinical studies proving that the claims are true.

A similar multi-company joint action was announced by the agencies on May 26, 2021 and involved 5 companies that sold dietary supplements that claimed to cure, treat, alleviate or prevent infertility and other reproductive health disorders. The FD&C and FTC violations were the same (unapproved and mislabelled drugs, unsubstantiated efficacy claims), but the targeted consumers were different and arguably more vulnerable to fraud schemes. Indeed, the FDA press release regarding this previous FDA / FTC action noted:

“In general, consumers should be wary of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure disease. The FDA advises consumers to speak with their doctor, pharmacist, or other health care provider before deciding to purchase or use any dietary supplement or medication. Some supplements can interact with medications or other supplements. Plus, if the claims sound too good to be true, they probably are. “

The last sentence being a common refrain in FTC consumer protection education materials, presentations by attorneys working in the Advertising Practices Division, and many other public information generated by the Commission.

Outside of the important partnership that the FDA and FTC (along with their partners in the Department of Justice’s Consumer Protection Branch) have had to tackle COVID-19 fraud, we haven’t seen this kind of joint “bulk” warning letter announced by the agencies since mid-2019, when they worked together on several actions of flavored e-liquid tobacco products. We briefly discussed these joint warning letters and another FDA / FTC letter to a cannabidiol (CBD) company published in October 2019 in our year-end review of FDA’s product priorities. consumption (see here).

In short, the two relatively large shared app scans that were announced this year, both focused on the dietary supplement market, are important and should put the entire industry (even more) in mind that selling products in violation of FDA and FTC laws and regulations will end up putting you in hot water with “the feds.” So you should always make sure that all of your products and advertising, in whatever form, is compliant! As we advised in one of our 2020 year-end review articles after summarizing some of the FDA’s high-profile supplement and non-prescription drug enforcement actions of the year last: State or federal regulators will take action to arrest you. A classic and timeless recommendation, if there is one.

© 1994-2021 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, PC All rights reserved.Revue nationale de droit, volume XI, number 258


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