Privacyprotect.org – FDA Warning Letter, Jun 2, 2010

On June 2, 2010, the FDA issued a Warning Letter to PrivacyProtect.org concerning its website, www.fludefence.net, which was reviewed on May 3, 2010. The FDA determined that the website was marketing "Flu Defence," a product intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus in people. This product lacks FDA approval, clearance, or authorization for such uses, thereby violating the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, 352, and/or 355. The letter highlighted various unsubstantiated claims made on the website and through metatags, including "Natural Flu Remedy that Works" and claims of antiviral action against swine flu. Given the H1N1 public health emergency, the FDA emphasized the significant threat posed by unauthorized products. The firm was directed to immediately cease marketing unapproved H1N1-related products and to notify the FDA via email within 48 hours of the corrective actions taken or planned. Non-compliance could result in enforcement actions such as seizure, injunction, criminal prosecution, inclusion on FDA's public warning list, and detention of unapproved products offered for importation into the United States.