FDA WARNING_LETTER - Gemtronics Inc

The FDA issued Warning Letter 08-ATL-07 to Mr. Isely after reviewing websites http://www.agaricus.net and http://raaxagaricus.com. The agency determined that products such as "Agaricus dried Grade A," "Agaricus Capsules," and various "Agaricus" and "RAAX" extracts are promoted for conditions that cause them to be unapproved new drugs. Therapeutic claims on the websites, including destroying cancer cells, treating leukemia, and shrinking tumors, establish the products' intended use in the cure, mitigation, treatment, or prevention of disease, violating section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. Evidence included specific product claims, general Agaricus claims, scientific publication citations, and metatags like "alternative cancer therapies." As these products are not generally recognized as safe and effective, they are considered "new drugs" under section 201(p) and cannot be legally marketed without prior FDA approval per section 505(a). Additionally, the products are misbranded under section 502(f)(1) because their labeling lacks adequate directions for use. The FDA requires prompt corrective action, including reviewing all promotional materials, and a written response within fifteen working days detailing steps taken to correct violations and prevent recurrence. Failure to comply may lead to enforcement actions like product seizure and injunctions.