FDA warns 10 companies over unsubstantiated mental health claims on supplements

22 Feb 2021 --- The US Food and Drug Administration (FDA) has 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.

The move comes as concerns over mental health are becoming more significant than ever with industry players seeking to tap into this market. Echoing this, “Mood: The Next Occasion” has been tipped as a Top Trend for 2021 by Innova Market Insights.

According to the agency, these claims are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

The warning letters were issued to Enlifta, Lifted Naturals, Mountain Peak Nutritionals, SANA Group, Wholesome Wellness, Dr. Garber’s Natural Solutions, ProHealth, Blossom Nature,  FDC Nutrition and Silver Star Brands.

“Dietary supplements that claim to cure, treat, mitigate or prevent depression and other mental health disorders are unapproved new drugs that could potentially harm consumers,” says Steven Tave, director of the office of dietary supplement programs in the FDA’s Center for Food Safety and Applied Nutrition.

“Consumers use these products instead of seeking proven treatments from qualified health care providers and this is especially concerning during the ongoing pandemic when they are even more susceptible to depression and mental health issues.” 

“The agency is committed to taking action to protect the public from unlawful dietary supplements,” notes Tave.

Cautious of marketing claims
Under the FD&C Act, 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 drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today 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.

“Consumers should be cautious of such products. The FDA 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 agency underscores.

“Dietary supplements that claim to cure, treat, mitigate or prevent depression and other mental health disorders are unapproved new drugs that could potentially harm consumers,” says FDA.The FDA also 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 FDA has requested responses from the companies within 15 working days stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law. 

Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.

COVID-19 inspires focus on mental health
Innova Market Insights reports that consumers increasingly see physical and mental health with equal importance. A 2019 Innova Market Insights consumer survey found that 32 percent of UK consumers and 39 percent of US consumers claimed to experience stress at least once a day. 

Due to this, product launches with nootropics are having a moment, reflected by an average annual growth of 70 percent in product launches (Global, CAGR 2015 to 2019).

NPD around mood is seeing rapid growth, with rising use of on-pack claims relating to specific mood platforms, according to Innova Market Insights.

Adaptogens combat stress
The use of adaptogenic herbal extracts for combating the mental and physical effects of stress is also trending.

Previously NutritionInsight reported that functional ingredients that can mitigate stress, improve sleep and focus are high on consumers’ agendas as the COVID-19 pandemic presses on. 

Adaptogens such as ginseng, Rhodiola, Bacopa monnieri or holy basil can be positioned to help consumers dynamically cope with whatever difficult situation at hand.

Innova Market Insights is also highlighting how botanical ingredients are increasingly featuring in brain health-related NPD. 

For example, the use of Ginkgo biloba jumped by 21 percent from 2014 to 2018, while hemp increased by 16 percent in relevant launches.

NPD to boost the mood
Many players are tapping into this space, with OptiBiotix funding research into how microbiome modulation technologies could affect sleep, stress and anxiety. 

Moreover, FrieslandCampina Ingredients (FCI) is addressing stress and anxiety with its D-Stress sachet and Re-lax health shot, while Lipogen is introducing CognoLipid to the mental health market with a particular focus on alleviating women’s stress.

In the same spirit, HUM Nutrition unveiled vegan anti-stress gummies that can reduce symptoms of insomnia and anxiety.

By Kristiana Lalou