The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently sent warning letters to dietary supplement companies who claim their products treat, prevent, mitigate, or cure COVID-19. For example, the federal agencies warned SpiceTac and Life Unlearned for allegedly marketing their Vitamin C and D products with COVID-19 benefits on Amazon.
Under federal law, only drugs can be marketed to treat or cure diseases. While dietary supplements do not require FDA pre-approval – like drugs do – they are not allowed to make such claims. For example, SpiceTac claimed that their Vitamin C supplement is a “secret weapon against the Coronavirus.”
FDA warning letters may generally include the following:
- Cite which law or regulation a company is violating
- Explain how the violation is a public concern
- Lay out corrective measures a company must take
- Provide a timeline for a company to comply
- Advise of the penalties for non-compliance
Companies are required to respond to warning letters by taking the corrective actions suggested by federal agencies and notify the COVID-19 Task Force headed by the United States Department of Health and Human Services. Failure to comply may lead to legal action, such as injunction or seizure.
At Collins Gann McCloskey & Barry PLLC, we provide experienced legal representation for dietary supplement makers who have received FDA warning letters for their products. Not only can our firm help companies properly respond to warning letters, but we can also review each claim prior to the start of product labeling and marketing, as well as help ensure other components required to meet industry regulations.
If you recently received an FDA warning letter, contact us today at (516) 218-5131 and request an initial consultation to allow our legal team to review your case and determine your available legal options.