FDA Warning Against Supplements for Depression

Apr 14, 2021 | Product Liability


For several months, mental health researchers have been tracking a surge in reported cases of depression tied to the global pandemic. A recent US Census Bureau survey suggests that four times as many people were coping with symptoms of anxiety and depression in 2020 than in the previous year. Unfortunately, that’s prompted some consumers to seek out supposedly “natural” remedies that may do more harm than good.
The U.S. Food and Drug Administration recently sent warning letters to ten companies for selling dietary supplements “that claim to cure, treat, mitigate, or prevent depression and other mental health disorders.” Under the federal Food, Drug and Cosmetic Act, such products are considered unapproved new drugs that may cause a range of adverse reactions — and potentially harm consumers by discouraging them from seeking proven treatments from qualified health providers.
The companies targeted by the FDA make a variety of claims on their websites about their products, suggesting that certain ingredients can alter brain chemistry or boost your mood or can be “just as effective as pharmaceutical antidepressants.” The FDA claims that such statements are misleading, unproven, and dangerous to the health of consumers who may be self-diagnosing and treating their perceived symptoms without any medical supervision.
“In general, consumers should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases,” the FDA advised in a press statement about the warning letters. “If claims sound too good to be true, they probably are.”
The agency urges consumers to consult with doctors, pharmacists, or other health care professionals before purchasing any dietary supplement—particularly since some products may interact with other supplements or drugs.
The targeted companies have a 15-day time period to respond to the allegations and provide support for their claims. Failure to comply with the terms of the federal law can result in legal action, including seizure of the product. Consumers who have questions or complaints about dietary supplements are encouraged to contact the FDA on its website or by calling 1-888-INFO-FDA.


If you or a loved one has suffered injuries as the result of a defective medical device or a dangerous prescription drug, the product liability lawyers at Franklin D. Azar & Associates may be able to help. We have been helping injured people receive the compensation they deserve for more than thirty years. We are currently investigating reports of serious side effects involving the diabetes drug Actos, the chemotherapy drug Tasigna, Zantac and other heartburn drugs, the gout drug Uloric, and several other medications. Call us today or contact us here for a free, no-obligation consultation.