FDA WARNING_LETTER - Swinefludefence.org

On May 3, 2010, the FDA reviewed the website http://www.swinefludefence.org and determined it was marketing "Flu Defence," a product claiming to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus. This product is not FDA-approved, cleared, or authorized for such uses, violating the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, 352.

The letter cited various claims from the website, including "Flu defence is the first 100% natural general-purpose flu remedy that attacks the virus," and "[E]xhibits strong antiviral action against influenza A & B, birdflu ... swine flu." Testimonials also claimed prevention and cure of the flu. These claims, supplemented by metatags like "natural flu remedy" and "herbal tamiflu," are considered unapproved drug claims.

Given the public health emergency declared for H1N1, the FDA views the marketing of unauthorized H1N1-related products as a significant threat. The firm was ordered to immediately cease marketing these unapproved products. They must email [email protected] within 48 hours, detailing corrective actions. Failure to comply could result in enforcement actions like seizure, injunction, or criminal prosecution.