You may not be selling cures for COVID, but if you’re selling dietary supplements that purport to provide treatment for COVID-induced depression, expect to hear from the FDA.
In a recent announcement, the FDA said that it sent warning letters to 10 companies for selling dietary supplements marketed to treat depression and other mental health disorders. By making such claims, these companies were effectively marketing unapproved new drugs, in violation of law.
As always, the FDA was concerned that dietary supplements sold as drugs (i.e., with claims that the supplements could cure, mitigate or prevent a disease) could potentially harm consumers and keep consumers from seeking proven treatments from qualified health care providers. The FDA also expressed a particular concern that consumers are especially susceptible to mental health issues right now, during the pandemic.
Marketed to help with depression, anxiety and other mental health problems, the supplements were not only unapproved drugs, but were also “misbranded” according to the warning letters. The FDA explained that since the diseases cited in the companies' marketing were “not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner…it is impossible to write adequate directions for a layperson to use [the] product safely for its intended purposes." Therefore, the products could not include "adequate directions for their intended use."
While there is nothing novel about the FDA warning dietary supplement sellers about making disease prevention and treatment claims, it is important to take note that such claims are on the FDA’s radar. The pandemic may be bringing out the worst kinds of marketers hoping to profit from human suffering, but regulators (and self-regulators) are watching.
(Description of graphic for visually-impaired readers: photograph of various pills and tablets.)
"This is especially concerning during the ongoing pandemic, when consumers 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.” Steven Tave, Director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition.