That is how many Warning Letters the agency sent out last Friday to manufacturers and distributors of dietary supplements. The specific focus of the letters was products that were being marketed containing dimethylamylamine, also known as DMAA, sold as a “natural stimulant”.
The specific violation cited in the letters was that current law states that when supplements contain dietary ingredients not marketed before October 15, 1994, manufacturers must submit the new ingredient for use as a New Dietary Ingredient, notifying FDA of evidence that supports a conclusion that use is safe. The agency said in the letters that this requirement had not been met.
Further the agency stated that the synthetic DMAA could not be a “dietary ingredient” under Dietary Supplement Health and Education Act of 1994 (DSHEA) which defines a dietary ingredient as a “vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, a metabolite, constituent, extract or combination of these substances.”
FDA has been known in the past to send out a flock of letters at once to stake out a policy decision.
The action appears some time in coming. DMAA has been marketed as a supplement appealing to fitness buffs seeking extra energy. The Army Times reported in December 2011 that the Department of Defense was pulling DMAA containing products from on-base sales pending a review of side effects after some the experiences of some soldiers.
More information on how the agency regulates dietary supplement is contained on an overview page at the FDA site.