FDA WARNING_LETTER - Everclr3 - March 31, 2011

The FDA and FTC issued a Warning Letter to Mr. Ortwein following a March 2011 review of his websites, goodbyeherpes.com and everclr3.net, promoting the product EverCLR3. The FDA determined that EverCLR3 is an unapproved new drug under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 321(g)(1)(B), 321(p)] because its therapeutic claims for conditions like herpes, cold sores, and HPV establish it as a drug not generally recognized as safe and effective, and it lacks prior FDA approval under section 505(a) [21 U.S.C. § 355(a)]. Furthermore, the product is misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(1)] as it is offered for conditions not amenable to self-diagnosis, thus lacking adequate directions for layperson use. Introducing this misbranded drug into interstate commerce violates section 301(a) [21 U.S.C. § 331(a)]. The FTC also cited violations of the FTC Act, 15 U.S.C. § 41 et seq., for advertising disease claims without competent and reliable scientific evidence, including well-controlled human clinical studies. The letter demands prompt corrective action. Mr. Ortwein must notify the FDA Seattle District Office and the FTC ([email protected]) within fifteen working days, detailing steps taken to correct violations and ensure future compliance. Failure to comply could lead to FDA enforcement actions like product seizure and injunctions, and FTC legal action, including consumer restitution.