The warning letters were issued toEnlifta LLC;Lifted Naturals;Mountain Peak Nutritionals;SANA Group LLC.;Wholesome Wellness;Dr. Garber’s Natural Solutions;ProHealth Inc.;Blossom Nature LLC;FDC Nutrition Inc.; andSilver Star Brands, Inc.
The letters warn against statements including “Benefit: For the relief of temporary depression or occasional feelings of sadness and melancholy,” made by Dr. Garber’s, as well as a video from the same company titled “Dealing with post partum depression, naturally.” Part of the reasoning laid out in that warning letter states that the Depression Relief product is intended for treatment of “diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, your Dr. Garber’s Depression Relief product fails to bear adequate directions for its intended use and, therefore, the product is misbranded.”
Another letter, sent to Lifted Naturals, pointed to an about page describing the owner’s “tough go-around with postpartum depression” and resulting search for a probiotic “specifically designed to help with mood and anxiety.” FDA also pulled a quote from a July 2020 blog post that stated: “Our vision for the future of mental health is that we reach for probiotics as a first line of defense and even prevention for mental health issues.” Another red-flag statement: “Our blend is especially potent with our PREBIOTIC, GOS—the ONLY prebiotic that’s been proven to help with anxiety.”
Related: Industry Reacts to FDA’s ODSP Leadership Change House Resolution Recognizes Vitamin D for Decreasing the Severity of COVID-19 “Critical” Bill to Legalize Hemp, CBD Introduced in CongressSome of the claims covered conditions beyond depression and anxiety: SANA Group received a letter pointing to claims made regarding the use of GABA and L-tryptophan to treat ADHD and Tourette’s syndrome. In this company’s case, FDA also called out a statement not directly referencing a product: “Your body may produce melatonin either earlier or later in the day than usual. This change can lead to symptoms of seasonal affective disorder, or winter depression.” FDA explained that the statement was made on the webpage for two of the company’s products, and that those products contain melatonin.
"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 who use these products instead of seeking proven treatments from qualified health care providers. This is especially concerning during the ongoing pandemic, when consumers are even more susceptible to depression and mental health issues,” said Steven Tave, Director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition, in the press release. “The agency is committed to taking action to protect the public from unlawful dietary supplements.”