The pandemic has heightened consumer awareness of mental wellbeing and presented major opportunities for dietary supplement brands—however, the increased focus on mental health has also caught the FDA’s attention.
“The pandemic has been hard on many people's mental health, and the FDA is aware that many companies may be trying to address this,” noted Asa Waldstein, Principal, Supplement Advisory Group.
Waldstein, who puts out a weekly ‘Warning Letter Wednesday’ newsletter, explained that the FDA issued 95% more warning letters to companies making anxiety claims in 2021 than the previous year, and 75% of these letters included both words ‘anxiety’ and ‘depression.’
“This is a clear sign of the agency's enforcement priorities,” he said. “Anxiety and depression claims enforcement is a trend to watch, and I expect more of these warning letters to be issued.”
Structure and function claims
“Stress claims are structure/function claims under FDA rules. Structure/function claims can describe the role of a dietary ingredient intended to affect normal structure or function in humans or characterize the action by which a nutrient or dietary ingredient maintains such structure or Function,” explained Pooja Nair, Partner, Ervin Cohen & Jessup LLP. “FDA has specifically stated in industry guidance that 'relieves stress and frustration' is an appropriate structure/function claim if there is no context linking it to a specific disease, such as anxiety disorders."
However, Nair noted that in February 2021, FDA issued warning letters to ten companies for “illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders.” In these warning letters, FDA told the companies that the dietary supplements were unapproved new drugs and the companies could not market them using these claims.
“Those warning letters were some of the first guidance by FDA on what the agency considers to be crossing the line. Based on these warning letters, and the growing number of consumers using dietary supplements for mental health/stress relief purposes, companies should be analyzing their marketing and branding and anticipate closer agency monitoring of mental health structure/function claims,” suggested Nair.
Ivan’s stress-free rules
“The first rule of stress claims, like any claims for dietary supplements, is to ensure that the claim is supported by competent and reliable scientific evidence. If the evidence is on an ingredient in the product and not the ingredient itself, ensure that the ingredient is in the product at the clinically studied dosage, that it is clear to consumers that the claim is based on the ingredient, and consider whether any of the other ingredients in the product may counteract the calming effects,” explained Ivan Wasserman, Managing Partner of Amin Talati Wasserman. “Also, importantly, do not in advertising or labeling suggest that the calming effect is greater than what was shown in the study, and be sure that the subjects in the study match the target audience. Only on women? Don’t sell a men’s product! If a nutrient plays a role in the body’s response to stress, but there is no clinical evidence that supplementing with the nutrient has a relaxing effect, that should be carefully considered when crafting claims.”
He added that the second rule is staying on the structure/function side of the aisle. “We all get stressed from time to time. Lawyers in particular! And we all feel down sometimes too. Supplements can help with that. Avoiding medical-sounding words like ‘anxiety,’ ‘chronic,’ and ’depression’ is critical. To help guard against possibly implying a disease state, using words to qualify ‘stress’ can really help. Common qualifiers include ‘occasional’ and ‘day-to-day,’” Wasserman said. “FDA Warning Letters, FTC Investigations, and Class Action Lawsuits are incredibly stressful. Make your claims right and relax!”
Pooja’s do’s and don’ts
Asa’a Helpful hints
Waldstein explained that if truthful and substantiated, some low-risk alternatives for talking about supplements for mental health could be descriptions such as:
*Happy mood support
*Balanced state of mind
*Support when things get overwhelming
*Helps support smiles
Waldstein noted that the 2021 warning letters did not include the term "occasional anxiousness," which is, if substantiated, often considered not to be a disease claim.