October 20, 2021

Volume XI, Number 293

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FDA and FTC Coordination Appears to Be Escalating

Agencies of the federal government with a consumer protection mission have always tended to work closely together and to share information, but the COVID-19 pandemic has made those cooperative efforts even more visible to the general public. We blogged in 2020 about the increasing use of warning letters jointly issued by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) Division of Advertising Practices in the apparently never-ending fight against fraudulent COVID-19 products (see prior post here). While coordinated FDA and FTC enforcement activities specific to the ongoing public health emergency continue at a brisk pace – as of September 9, 2021, FDA has issued more than 200 warning letters to companies claiming that a product is an effective cure, treatment, or preventative for COVID and the FTC has issued more than 400 pertaining to unsubstantiated health claims for COVID-related products, with many of those being signed by both agencies – these powerhouse 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 marketers of consumer-facing products to be fully aware and compliant with all of their legal and regulatory obligations.

In particular, the dietary supplement industry writ large has been the target of several recent high-profile joint announcements made by FDA and FTC, in light of the shared jurisdiction the two agencies have over products that fall within this category. A long-standing Liaison Agreement between the two agencies ensures the non-duplication of efforts and assigns primary responsibility to FDA over the labeling of foods and dietary supplements shipped in interstate commerce, whereas the FTC has primary responsibility with respect to the regulation of the truth or falsity of all advertising (other than labeling) of those products. The joint warning letters that the agencies are issuing with more frequency of late make those jurisdictional lines very clear, for new entrants into the marketplace who may be less familiar with the 1971 Liaison Agreement.

With that as background, let’s return to the recent trends we are seeing in the enforcement space. So far in 2021, the cooperative agencies have joined forces in at least two multi-company sweeps involving unlawfully marketed dietary supplement products. On September 9, 2021, FDA and FTC announced that they sent joint warning letters to 10 companies for selling dietary supplements in order to cure, treat, mitigate, or prevent diabetes without supporting scientific evidence for the medical claims they were making. From the perspective of FDA, therefore, the products were illegal supplements because they were being marketed with “drug claims,” rendering them unapproved and misbranded drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) – the agency’s press release about this latest joint action with FTC is here. And from the FTC’s perspective, the various efficacy claims included in the companies’ advertisements were most assuredly not substantiated by competent and reliable scientific evidence, the applicable standard for efficacy claims under Section 5 of the FTC Act, rendering each of those ads deceptive – the Commission’s press release from the same day is available here. FTC’s portions of the joint warning letters also state unequivocally: “Notice is hereby given that you must cease and desist from making any claim that a product [can] prevent, treat, or cure diabetes without competent and reliable scientific evidence consisting of well-controlled human clinical studies substantiating 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 were selling dietary supplements that claimed to cure, treat, mitigate, or prevent infertility and other reproductive health disorders. The violations of the FD&C Act and the FTC Act were the same (unapproved and misbranded drugs, unsubstantiated efficacy claims) but the consumers being targeted were different and arguably more vulnerable to fraud schemes. Indeed, the FDA press release from this earlier FDA/FTC action noted:

“In general, consumers should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases. The FDA advises consumers to talk to their doctor, pharmacist, or other health care provider before deciding to purchase or use any dietary supplement or drug. Some supplements might interact with medicines or other supplements. Also, if claims sound too good to be true, they probably are.”

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

Outside of the significant partnership FDA and FTC (along with their partners at the Department of Justice’s Consumer Protection Branch) have had in tackling COVID-19 related fraud, we have not seen this kind of “bulk” joint warning letter announcement by the agencies since mid-2019, when they worked together on several flavored e-liquid tobacco product actions. We briefly discussed those joint warning letters and another FDA/FTC letter addressed to a cannabidiol (CBD) company issued in October 2019 in our year-end review of FDA’s consumer product priorities (see here).

In short, the two relatively large shared enforcement sweeps that have been announced this year, both of which focused on the dietary supplement marketplace, are significant and should put the entire industry on (further) notice that selling products in violation of the FDA and FTC laws and regulations will eventually land you in hot water with “the Feds.” So you should always make sure all your products and all your advertising, in any media form, are compliant! As we advised in one of our 2020 year-end review posts after summarizing some of FDA’s high-profile supplement and non-prescription drug enforcement actions from last year: “Don’t manufacture and distribute unapproved products that create serious safety risks to the U.S. public or federal regulators will take action to stop you.” A classic and timeless of recommendation, if there ever was one.

©1994-2021 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume XI, Number 258
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About this Author

Joanna Hawana, Mintz Levin, FDA Lawyer, Clinical Trials & Research Consumer Product Safety FDA Regulatory Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Health Care Transactional Due Diligence
Of Counsel

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. In recent years she has been advising clients in different industries regarding FDA’s approaches to...

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