Beware Dietary Deceit: FDA Warns Companies Allegedly Involved in Misrepresenting Supplements

February 26, 2021

A Jan. 27, 2021, McGuireWoods article discussed the Federal Trade Commission’s crackdown on deceptively marketed cannabidiol (CBD). The focus of the inquiry was to “send a clear message to the burgeoning CBD industry: Don’t make spurious health claims that are unsupported by medical evidence.” Less than a month later, the U.S. Food and Drug Administration (FDA) has followed a similar path with the dietary supplement industry.

As the business of dietary supplements and “nutritional” or “functional” foods has continued to proliferate, so has the regulatory scrutiny. FDA recently announced warning letters sent to 10 companies allegedly involved in “illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders,” in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Such supplements are considered “unapproved new drugs that could potentially harm consumers” who rely on those supplements “instead of seeking proven treatments from qualified health care providers.”

An FDA representative noted, “This is especially concerning during the ongoing pandemic, when consumers are even more susceptible to depression and mental health issues,” and said the agency is “committed to taking action to protect the public from unlawful dietary supplements.”

In its press release, the FDA made several important points regarding the FD&C Act and dietary supplements.

  1. Disease Claims Are Not Permissible: “Products intended to cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.” Unlike FDA-approved drugs, “the agency has not evaluated whether the unapproved products subject to the warning letters … are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.”

  2. Beware of Medication Interactions: “Consumers should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases” and “advises consumers to talk to their doctor, pharmacist, or other health care professional before deciding to purchase or use any dietary supplement or drug.” The FDA goes on to say that “some supplements might interact with medicines or other supplements” and cautions consumers to beware of “claims … too good to be true.”

  3. Report Adverse Reactions to FDA: Consumers who believe “a product might have caused a reaction or an illness … should immediately stop using the product and contact their health care provider.” FDA “encourages health care professionals and consumers to report adverse reactions associated with FDA-regulated products to the FDA using MedWatch or the Safety Reporting Portal.”

The 10 companies are required to provide responses within 15 working days and should include how the company will address the issue and the “reasoning and supporting information as to why they think the products are not in violation of the law.”

This is a strong reminder that companies should remain diligent about statements placed on labels of products and product marketing strategies. Specifically, dietary supplements and food products sold to consumers must comply with FD&C Act requirements for ingredients, labeling and health claims. This is particularly important with respect to products that may have new or novel ingredients that are not generally recognized as safe (GRAS), may not have scientific consensus or are being marketed without a notice of new dietary ingredient (NDI). In addition to complying with the FD&C Act, companies should carefully review applicable state law requirements for ingredient and labeling claims, such as compliance with California’s Proposition 65.

If you need assistance considering these risks and/or developing appropriate strategies, please consult one of the authors of this alert or your regular McGuireWoods attorney. Our team is ready to assist with any and all challenges involving the FDA, Federal Trade Commission and applicable state law requirements. Failure to correct potential or actual violations promptly may result in legal action, including class actions, product seizure and/or injunction, in addition to significant reputational risks.