Recently the U.S. Food and Drug Administration (FDA) announced warning letters to 10 companies for 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: Enlifta LLC; Lifted Naturals; Mountain Peak Nutritionals; SANA Group LLC.; Wholesome Wellness; Dr. Garber’s Natural Solutions; ProHealth Inc.; Blossom Nature LLC; FDC Nutrition Inc.; and Silver Star Brands, Inc.
“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. “The agency is committed to taking action to protect the public from unlawful dietary supplements.”
Depression
Depression is the leading cause of disability worldwide. Almost 75% of people with mental disorders remain untreated in developing countries with almost 1 million people taking their lives each year. In addition, according to the World Health Organization (WHO), 1 in 13 globally suffers from anxiety. The WHO reports that anxiety disorders are the most common mental disorders worldwide with specific phobia, major depressive disorder and social phobia being the most common anxiety disorders. It’s not uncommon for someone with an anxiety disorder to also suffer from depression or vice versa. Nearly one-half of those diagnosed with depression are also diagnosed with an anxiety disorder.
- Anxiety disorders are the most common mental illness in the U.S., affecting 40 million adults in the United States age 18 and older, or 18.1% of the population every year.
- Anxiety disorders are highly treatable, yet only 36.9% of those suffering receive treatment.
- People with an anxiety disorder are three to five times more likely to go to the doctor and six times more likely to be hospitalized for psychiatric disorders than those who do not suffer from anxiety disorders.
- Anxiety disorders develop from a complex set of risk factors, including genetics, brain chemistry, personality, and life events.
Dietary Supplements And FD&C Act
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. Unlike drugs approved by the FDA, 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.
“In general, consumers should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases. The FDA advises consumers to talk to their doctor, pharmacist, or other health care professional before deciding to purchase or use 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. If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider,” – The FDA warns.
