FDA Continues Action Against Unapproved, Misbranded Products Related to Coronavirus
04.06.20
Dietary supplement industry urges continued aggressive prosecution against products promoted with illegal claims about prevention or treatment of COVID-19.
Since March, the FDA has sent warning letters to 16 companies responding to claims their products can prevent, treat or cure COVID-19, the disease caused by the novel coronavirus SARS-CoV-2. Nine of the 16 warning letters have been issued since Mar. 26.
The agency has cited language on the companies’ websites and social media channels as evidence of deceptive claims. FDA pressed companies to take immediate action to correct the violations, and gave firms 48 hours to respond with specific corrective steps taken.
The U.S. dietary supplement industry commended the agency for taking action to protect consumers by calling out marketers that make illegal and unsubstantiated drug claims.
“We applaud FDA for taking swift action and urge continued aggressive prosecution against products being promoting with illegal and unsubstantiated claims of prevention or treatment of COVID-19,” four trade groups said in a statement—the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA).
“As we face the unprecedented threat of this global pandemic, illegal and unsubstantiated drug claims misdirect consumers toward ineffective products, divert them from seeking critical medical care, and endanger the public health,” the groups said.
FURTHER READING: FEDERAL AGENCIES CRACK DOWN ON FRAUDULENT COVID-19 PRODUCTS
While research supports the use of certain dietary supplements to maintain healthy immune system responses, the trade groups said they are not aware of any clinical research studies that demonstrate the efficacy of using a dietary supplement specifically to prevent or to treat COVID-19.
Even if research is conducted and published on this topic, the law that regulates dietary supplements in the U.S., the Dietary Supplement Health and Education Act of 1994, prohibits marketers of dietary supplements from promoting any dietary supplement product by making disease prevention or treatment claims.
In February, AHPA, CHPA, CRN, and UNPA endorsed the following advisory for marketers and retailers, as well as for consumers of dietary supplements:
Each trade association and its member companies prioritizes the safety and well-being of consumers above all else, the groups said. “The responsible industry is committed to providing the public with safe, high-quality dietary supplement products that provide many positive benefits to promote better health and wellness.”
The agency has cited language on the companies’ websites and social media channels as evidence of deceptive claims. FDA pressed companies to take immediate action to correct the violations, and gave firms 48 hours to respond with specific corrective steps taken.
The U.S. dietary supplement industry commended the agency for taking action to protect consumers by calling out marketers that make illegal and unsubstantiated drug claims.
“We applaud FDA for taking swift action and urge continued aggressive prosecution against products being promoting with illegal and unsubstantiated claims of prevention or treatment of COVID-19,” four trade groups said in a statement—the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA).
“As we face the unprecedented threat of this global pandemic, illegal and unsubstantiated drug claims misdirect consumers toward ineffective products, divert them from seeking critical medical care, and endanger the public health,” the groups said.
FURTHER READING: FEDERAL AGENCIES CRACK DOWN ON FRAUDULENT COVID-19 PRODUCTS
While research supports the use of certain dietary supplements to maintain healthy immune system responses, the trade groups said they are not aware of any clinical research studies that demonstrate the efficacy of using a dietary supplement specifically to prevent or to treat COVID-19.
Even if research is conducted and published on this topic, the law that regulates dietary supplements in the U.S., the Dietary Supplement Health and Education Act of 1994, prohibits marketers of dietary supplements from promoting any dietary supplement product by making disease prevention or treatment claims.
In February, AHPA, CHPA, CRN, and UNPA endorsed the following advisory for marketers and retailers, as well as for consumers of dietary supplements:
- Marketers and retailers of dietary supplements should refuse to stock or sell any supplements that are presented as treating, curing or preventing COVID-19.
- Marketers and retailers should refrain from promoting any dietary supplement as a cure, treatment or prevention for COVID-19.
- Consumers should avoid any product that is claiming to treat, cure or prevent COVID-19 and report such products to the Food and Drug Administration.
- Anyone who believes they may have COVID-19 or may have come in contact with the novel coronavirus should contact a healthcare professional immediately. The Centers for Disease Control and Prevention has more information on the coronavirus disease and the proper actions to take if you suspect you are ill.
Each trade association and its member companies prioritizes the safety and well-being of consumers above all else, the groups said. “The responsible industry is committed to providing the public with safe, high-quality dietary supplement products that provide many positive benefits to promote better health and wellness.”
