FDA has issued warning letters to the companies for violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
The US Food and Drug Administration (FDA) has issued warning letters to ten companies that are illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders.
The companies including Enlifta, Lifted Naturals, Mountain Peak Nutritionals, SANA Group, Wholesome Wellness, Dr. Garber’s Natural Solutions, ProHealth, Blossom Nature, FDC Nutrition and Silver Star Brands have received warning letters.
FDA has issued warning letters to the companies for violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
According to the FD&C Act, products intended to cure, treat, mitigate, or prevent disease are considered drugs, even if they are labelled as dietary supplements, subject to the requirements that apply to drugs.
FDA Centre for Food Safety and Applied Nutrition director Steven Tave said: “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. The agency is committed to taking action to protect the public from unlawful dietary supplements.”
The agency has not evaluated the unapproved products, with relation to their effectiveness for intended use, proper dosage, possible interactions with FDA-approved drugs or other substances, along with dangerous side effects or other safety concerns.
FDA urged consumers to be cautious about products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases.
Also, consumers are advised to consult their doctor, pharmacist, or other health care professional before purchasing or using any dietary supplement or drug.
For example, some supplements might interact with medicines or other supplements. Also, if claims sound too good to be true, they probably are.
The agency is expecting responses from the companies, stating how they address the issues or prove that their products are not in violation of the law, within 15 working days.
The companies that fail to correct violations are expected to face legal action, including product seizure and/or injunction.
In February 2019, FDA has sent warning letters to companies selling dietary supplements, which claim that their products can cure diseases such as diabetes, cancer and Alzheimer’s, without scientific evidence.