The Food and Drug Administration (“FDA”) recently issued a series of warning letters to companies marketing products unapproved by the Agency that claim to prevent the flu. Some companies advertised the product would “Safeguard you from deadly flu viruses” or “fight off influenza.” Others claimed to be generic Tamiflu or “the most effective alternative to the flu shot.” The problem? None of the products have been proven to prevent or fight the flu, none are approved by the FDA, and no generic form of FDA-approved Tamiflu exists. (See the warning letters, issued Feb. 7-11, 2013, here.)
Drugs are defined as products intended to diagnose, cure, mitigate, treat, or prevent disease. 21 USC § 321(g)(1). Unless a drug falls within a “monograph” – a recipe-like description of products that are already recognized as safe and effective – it must be pre-approved by the FDA.
When the FDA finds a product that it believes is making drug claims without approval, the agency issues a warning letter to the seller. The seller then has 15 days to respond and take corrective action. Sellers who do not comply risk civil and criminal penalties. See 21 USC §§ 331, 333.