FDA’s stance on mental health claims

The COVID-19 pandemic put a strain on everyone. In fact, the “2020 CRN Consumer Survey on Dietary Supplements” indicated 13% of Americans turned to dietary supplements for mental health support, and stress management was top of mind for 38% of supplement users.

The use of structure/function claims on product labeling helps consumers find products they desire. Confusion can exist, however, among manufacturers, marketers and retailers about what claims can be made for the mental health category in light of recent FDA actions.

In February 2021, FDA issued 10 warning letters to companies selling dietary supplements claiming to treat or prevent depression and other mental health disorders. Many of the claims are obvious, impermissible disease claims, including, “relieves feelings of depression,” “natural antidepressant” and “remedy severe anxiety.” However, in presenting all the labeling evidence that imply disease treatment or prevention (as is often done to illustrate an overall impression), FDA listed some claims that, standing alone, would be acceptable structure/function claims—for example, “helps to manage stress,” “reduces anxiety” and “supporting emotional health.” Without clarification on what structure/function claims are permissible if not linked to disease claims, these warning letters could lead consumers, retailers and other stakeholders to misunderstand that claims about mental health, mood and well-being are generally off-limits for dietary supplements.

Historically, it has been acceptable for supplements to bear structure/function claims that refer to stress, mild anxiety, mood, and mental and emotional well-being. FDA has noted that anxiety disorders and depression are diseases, but has also acknowledged some symptoms may be characteristic of these diseases that can be associated with non-disease states. In guidance, FDA noted these structure/function claims are appropriate: “relieves stress and frustration,” “promotes relaxation,” “gently soothes away tension,” “when you're under occasional stress, helps you work relaxed” and “resolving that irritability that ruins your day.” According to the agency, these symptoms are not long-term or chronic mood changes (which can be characteristics of disease) when talked about in general settings.

Further, FDA has not objected to general claims about mental health submitted in required 30-day structure/function notifications. When notifications include statements that FDA considers to be disease claims, the agency issues courtesy letters objecting to those claims. The agency has objected to claims that directly mention “depression” and “anxiety disorders” and/or imply that the products are intended to treat, prevent or mitigate these diseases. However, many submitted structure/function claims were never objected to, including claims about relieving occasional stress, reducing mild anxiety, promoting positive mood and emotional well-being, and achieving a state of relaxation.

Crafting appropriate structure/function claims can be challenging at times, but it can be done for products promoting mental health. Numerous examples are available in 30-day notifications already submitted by supplement companies and in FDA guidance.

Editor’s Note: CRN will be presenting a related webinar, “The New Frontier for Claims: The Disease-ification of Anxiety, Mood & Sleep,” on Wednesday, Sept. 15, 2021, from 2-4 p.m. ET. Click the link for more information or to register.

Megan Olsen is vice president and associate general counsel for the Council for Responsible Nutrition (CRN), a leading trade association for the dietary supplement and functional food industry. Haiuyen Nguyen serves as senior director of scientific and regulatory affairs for the organization.