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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.

A. Background

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. 

© 2020 Beveridge & Diamond PC National Law Review, Volume X, Number 70
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About this Author

Alan J. Sachs Regulatory Attorney Beveridge & Diamond Washington, DC
Principal

Alan’s practice focuses on the wide range of regulatory issues faced by the global agriculture, food, biotechnology, and bioenergy industries.

Practicing environmental law provides him with daily opportunities to use his legal skills and training to help clients overcome often extremely technical business and regulatory challenges in order to ensure compliance with applicable environmental requirements.

He advises numerous Forbes Global 2000 companies on the legal and regulatory requirements associated with both domestic and foreign production, and the import, export, and...

202-789-6049
Mark N. Duvall Chemicals Regulation Attorney Beveridge & Diamond Washington, DC
Principal

Mark has over two decades of experience working in-house at large chemical companies. 

His focus is product regulation at the federal, state, and international levels across a wide range of programs, and occupational safety and health.

He leads the firm’s Chemicals group. His experience under the Toxic Substances Control Act (TSCA) includes enforcement actions, counseling, rulemaking, advocacy, and legislative actions. Since the enactment of TSCA amendments in 2016, he has been heavily involved in advocacy, compliance activity, and litigation arising from EPA's implementation of these amendments. He also works with foreign counterparts to TSCA, including REACH and CEPA.

He is also a leader of the firm’s Occupational Safety and Health practice. He has extensive experience with OSHA and state OSHA inspections, enforcement litigation, compliance counseling, advocacy, and rulemaking. He has counseled clients on the EPA risk management program requirements under Section 112(r) of the Clean Air Act and state worker protection programs, and on inspections by the Chemical Safety and Health Investigation Board.

He has extensive experience with the Federal Insecticide, Fungicide, and Rodenticide Act, particularly with respect to regulation of antimicrobials, and with the Biocidal Products Directive in Europe.

He heads the firm’s FDA practice, having worked on FDA regulation of food and food additives, dietary supplements, drugs, medical devices, and cosmetics, and European counterparts. He is knowledgeable about human testing requirements, having served as the Chair of an institutional review board for several years.

He has counseled clients on the regulation of consumer products by the Consumer Product Safety Commission and the Federal Trade Commission. He has reviewed hundreds of green marketing claims and counseled on federal, state, and international regulation of such claims.

He has worked on green chemistry issues at the federal and state levels, as well as a variety of voluntary programs that affect products. He has helped clients with the Emergency Planning and Community Right-to-Know Act, the Controlled Substances Act, the Chemical Weapons Convention, and other chemicals-related requirements.

He has advised clients and written and lectured on the regulation of the products of nanotechnology by FDA and by EPA under FIFRA and TSCA, and on related product stewardship issues.

Service Areas & Industries

  • Chemicals Regulation
  • Chemicals
  • Food, Beverage
  • Occupational Safety and Health
  • Pesticides
  • Industrial Hemp & Cannabis
202-789-6090
Jack B. Zietman Regulatory Environmental Attorney Beveridge & Diamond Washington, DC
Associate

Jack litigates and practices regulatory environmental law with a focus on groundwater issues and the agriculture, food, and chemical manufacturing industries.

His representative experience includes work on products liability and environmental tort litigation, as well as regulatory counsel for products regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). He is also familiar with fishery management issues, particularly pertaining to the conservation of endangered species, and the evolving U.S. regulations of...

202-789-6036
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