FDA warns 10 companies to stop selling supplements they claim can treat depression
Patriot-NewsFeb 22, 2021
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The FDA said the companies are “illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
The warning letters were issued to:
Lifted Naturals - Mood Boosting Probiotic","type":"text
Mountain Peak Nutritionals - Mood Support ","type":"text
Wholesome Wellness - Natural Anxiety & Depression Relief ","type":"text
Dr. Garber’s Natural Solutions - Dr. Garber’s Depression Relief","type":"text
“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.
“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
“The agency is committed to taking action to protect the public from unlawful dietary supplements.”
According to the FDA, “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.”
While the FDA evaluates drugs, 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.”
The FDA said consumers “should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases.”
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