FDA and FTC Warn Dietary Supplement Manufacturers Against Making Fraudulent Anti-Coronavirus Claims
Beware of fraudulent claims that products will kill the coronavirus (officially, the Novel Coronavirus SARS-CoV-2) or cure the disease caused by that virus (Novel Coronavirus Disease 2019, abbreviated as COVID-19). The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have jointly issued warning letters to seven dietary supplement manufacturers for selling products with claims against the disease while reaffirming that dietary supplements may not make any claims to prevent or treat a disease. There are currently no drugs or vaccines approved to safely and effectively treat or prevent COVID-19, though several potential treatments are under development. In the face of public anxiety, the action by FDA and FTC is intended to protect consumers against fraud and from relying on unsafe or ineffective dietary supplement products in lieu of appropriate medical treatment. The agencies continue to monitor social media, online marketplaces, and consumer complaints for additional unapproved products or fraudulent anti-coronavirus claims.
1. Drug Products
The Federal Food, Drug, and Cosmetics Act (FD&C Act) defines a “drug” as any article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” or any article “(other than food) intended to affect the structure or any function of the body of man or other animals.” A “new drug” is any drug that “is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof.” No new drug may be sold without first undergoing FDA’s stringent pre-market approval process for ensuring both its safety and its effectiveness for its intended use. Additionally, no drug may be sold if it is “misbranded,” meaning that its labeling is “false or misleading in any particular.”
2. Dietary Supplement Products
By contrast, a dietary supplement is a tablet, capsule, powder, energy bar, or liquid that contains a vitamin, mineral, herb or other botanical, amino acid, or other dietary substance intended to supplement the diet. Though intended to affect the structure or function of the human body, dietary supplements are regulated as foods for most purposes, rather than as drugs. As such, they do not require pre-market safety or effectiveness approval by FDA. However, a food (including a dietary supplement) is “misbranded” and may not be sold if it characterizes the relationship of any nutrient to a disease or a health-related condition without FDA approval. In other words, a purported dietary supplement that claims to diagnose, cure, mitigate, treat, or prevent any disease is in fact a “new drug” requiring FDA review and approval prior to sale.
3. Unfair or Deceptive Practices
Separately, the Federal Trade Commission Act (FTC Act) prohibits “unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices involve “a material representation, omission or practice that is likely to mislead a consumer acting reasonably in the circumstances.” It is thus a violation of the FTC Act to advertise that a product can prevent, treat, or cure a human disease without rigorous scientific evidence to substantiate such a claim.
B. Product Claims for the Treatment or Prevention of COVID-19
The seven products addressed in the joint FDA and FTC warning letters are a variety of teas, essential oils, tinctures, and colloidal silver (the latter of which FDA and other federal and state agencies have previously warned is neither safe nor effective for treating any disease or condition). These products were marketed as dietary supplements. However, because the products were promoted on company websites and social media with claims to “protect against,” “kill,” or “fight” the coronavirus or to prevent the COVID-19 disease, FDA and FTC determined that the products cannot be distributed as dietary supplements and instead require FDA approval as new drugs. In addition, because the companies’ anti-coronavirus claims lacked competent and reliable scientific evidence, those claims also violated the FTC Act. The agencies required the seven manufacturers to take immediate action to cease their sale of the illegal products and to detail their steps to remove anti-COVID-19 claims to the agencies within 48 hours of the letters’ receipt.
In addition to sending the warning letters, FDA has posted images of the offending products online in order to inform consumers against fraudulent sales.
Beveridge & Diamond’s Food and Beverage practice has worked for forty years with U.S. and international clients who research, develop, obtain government approvals for, manufacture, promote, and use food additive and dietary supplement products. We represent large and small companies with an emphasis on entities that invest in research to discover, develop, and defend new technology. Our Food and Beverage practice helps clients identify business objectives and implement the most effective regulatory, commercial, litigation, and legislative strategies to achieve or exceed those objectives. If you have any questions, please contact the authors.