FDA WARNING_LETTER - Grato, Inc. - March 25, 2011

On March 14-25, 2011, the FDA inspected Grato, Inc.'s pharmaceutical manufacturing facility, Apotheca, Inc., and other subsidiaries in Woodbine, Iowa. The inspection and website review revealed the firm was manufacturing/marketing unapproved new drugs and misbranded drugs, violating sections 301, 502, 503, and 505 of the Federal Food, Drug, and Cosmetic Act (Act). Significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Parts 210 and 211) were also identified.

Products like "Vital Male Sexual Energy," "Vital HGH Skin Hair Nails," "Vital HGH Immune Booster," "Vital HGH," and "AR Arthritis" were deemed unapproved new drugs because their labeling claims indicate they are intended to treat diseases or affect body functions, making them "drugs" under the Act. Despite being labeled homeopathic, their active ingredients (e.g., Testosterone 30X, Human growth hormone 30C) are not recognized in the Homeopathic Pharmacopeia of the United States (HPUS), thus not qualifying for FDA's homeopathic marketing enforcement policies.

Additionally, "Vital Male Sexual Energy," "Vital HGH Skin Hair Nails," "Vital HGH Immune Booster," "TinnitusDX," "Fibro Relief," and "AR Arthritis" were misbranded as prescription drugs lacking the "Rx only"