FDA WARNING_LETTER - Saurabh Overseas

On May 10, 2010, the FDA reviewed the website http://www.f1udefence.com and determined it offered "Flu Defence" (also "Swine Flu Defence") for sale, claiming to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus. This product is not FDA-approved, cleared, or authorized for such uses.

The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, 352, and/or 355. Examples of violative claims include "Swine Flu Defence - #1 Natural Swine Flu Cure," "[A]ttacks the virus," "general-purpose cure for swine flu is HERE! Swine Flu Defence will prevent and stop swine influenza," and claims of increasing antiviral action and immune system boosting against various flu types, including H1N1. Testimonials also asserted the product cured or prevented H1N1. Metatags like "swine flu defence, natural flu remedy, natural tamiflu" further supported these claims.

Given the H1N1 public health emergency, the FDA considers the marketing of unapproved H1N1-related products a significant public health threat. The firm must immediately cease marketing unapproved, uncleared, or unauthorized products for H1N1.