FDA WARNING_LETTER - Fludefence.org

On April 28, 2010, the FDA reviewed the website http://www.fludefence.org and determined it offered "Flu Defence," an unapproved product marketed to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus. This violates the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, 352.

The website made numerous unproven claims, including "Flu defence is the first 100% natural general-purpose flu remedy that attacks the virus," "will also neutralize various viruses," and "exhibits strong antiviral action against influenza A & B, birdflu, herpes, swine flu, and even HIV." It also claimed to "neutralize the activity of the hemagglutinin spikes" and minimize symptoms, suggesting use as both a preventative and treatment. Customer testimonials further supported these unapproved claims. Metatags like "natural flu remedy, herbal tamiflu" also contributed to the violations.

Given the H1N1 public health emergency, the FDA is taking urgent measures against unapproved H1N1-related products. The firm must immediately cease marketing such products and ensure future compliance with the FFDC Act. A response detailing corrective actions is required via email within 48 hours to FDAFLUTASKFORCECFSAN@fda.hhs.gov