FDA WARNING_LETTER - Aluwe, LLC - August 18, 2009

The FDA issued a Warning Letter to Aluwe, LLC, and owner Raymond Kent Hann, following an inspection on August 17-18, 2009, and a review of their websites, www.aluwe.com and www.GermSlayer.net. The letter addresses violations related to the firm's product, Germ Slayer.

The primary violation is that Germ Slayer is promoted with claims that cause it to be an unapproved new drug under section 505 of the Federal Food, Drug, and and Cosmetic Act (the Act) [21 U.S.C. § 355]. Examples of drug claims include statements about treating Lyme disease, malaria, "foggy brain" syndrome, and various other maladies, as well as personal testimonials claiming cures for severe depression, chronic fatigue syndrome, and Amyotrophic Lateral Sclerosis. These claims establish the product's intent for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, making it a drug as defined in section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Since it is not generally recognized as safe and effective, it is an unapproved new drug under section 201(p) of the Act [21 U.S.C. § 321(p)], requiring an approved New Drug Application (