FDA WARNING_LETTER - Nature'S Gift Inc

On November 2, 2009, the FDA and FTC reviewed www.naturesgift.com and found the website offering unapproved products, including Flu Foil Synergy, Flu Foil Synergy with Inhaler, Ravensara, and Ravintsara, for sale with claims to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus. These claims violate the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, 352, as the products lack FDA approval, clearance, or authorization for H1N1-related uses.

Examples of violative claims cited include promotional statements in newsletters and blog entries linking products to H1N1 defense, treatment, and prevention. The FTC also noted that claims of preventing, treating, or curing H1N1 must be supported by well-controlled human clinical studies, and making unsubstantiated health claims violates the FTC Act, 15 U.S.C. § 41 et seq. Violations of the FTC Act may lead to legal action, including injunctions, administrative orders, and consumer restitution.

Given the H1N1 public health emergency, the FDA is taking urgent measures to protect consumers from unauthorized products. Nature's Gift is required to immediately cease marketing these unapproved products and send an email to FDAFLUTASKFORCECDER@fda.h