All American Pharmaceutical Receives FDA Warning

All American Pharmaceutical Receives FDA Warning

BILLINGS, Mont.The Food andDrug Administration (FDA) in October issued an extensive warning letterfollowing an inspection of the All American Pharmaceuticals and Natural FoodCorp. facility here. FDA noted several violations of the Food, Drug and CosmeticAct (FDC) and the Dietary Supplement Health & Education Act (DSHEA).

The agencys first concern was the continued stocking ofproducts containing androstenedione and additional steroid precursors, which theagency has determined are not lawfully marketed dietary ingredients in theUnited States.FDA acknowledged All Americans claim that the products are forexport; however, the agency said there were several recordkeeping violations aswell as a lack of foreign purchaser specifications.

FDA also took issue with label claims and Web site claims forseveral dietary supplements, including vitamin C for immune function, B complexfor depression, St. Johns wort for depression, wild yam to preventmiscarriage and antioxidants to protect against cancer. FDA contends the claimsare disease claims, positioning the products as unapproved new drugs. Inaddition, FDA questioned the use of a fat blocker claim for a chitosan product,alleging there is no scientific substantiation for the structure/function claim.