FDA WARNING_LETTER - Vitalmax Vitamins - January 31, 2013

This FDA Warning Letter, issued in January 2013, addresses Vitalmax Vitamins' marketing of "BodyGuard" on www.vitalmaxvitamins.com and www.healthyanswers.com. The FDA determined that BodyGuard, labeled as a dietary supplement, is marketed with claims to diagnose, mitigate, prevent, treat, or cure the Flu Virus, rendering it an unapproved new drug.

Specific violations include claims like "Boost Your Immune System and Fight Cold and Flu - Naturally!" and "Safeguard you from deadly flu viruses." These claims cause the product to be considered a "new drug" under section 201(p) of the FFDC Act [21 U.S.C. § 321(p)], requiring FDA approval based on scientific data for safety and effectiveness. Since the product is for conditions not amenable to self-diagnosis and treatment, it is also misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(1)] due to inadequate directions for layperson use.

The letter demands immediate cessation of marketing unapproved products for Flu Virus treatment. Vitalmax Vitamins must email FDA within 15 days, detailing corrective actions. Failure to comply may result in enforcement actions like seizure, injunction, or criminal prosecution. The FTC also warns against unsubstantiated claims, requiring competent and reliable scientific evidence, and requests notification within 15