American Herbal Products Association (AHPA) President Michael McGuffin issued the following statement in response to the New York and Indiana Attorneys General May 26 letter to the Food and Drug Administration (FDA):
"AHPA and its members support the New York and Indiana attorneys general expressed call for more resources to strengthen enforcement of the numerous FDA regulations that govern the dietary supplement marketplace.
"But AHPA does not believe there would be any increased product quality or benefit to consumers to require ingredient companies to comply with the dietary supplement cGMP rule at this late date. AHPA supported FDA in 2003 when it proposed to include ingredient companies in the proposed cGMP rules. FDA then chose not to do so. But it is neither feasible nor necessary to roll back the clock. Since the passage of the Food Safety Modernization Act (FSMA) in early 2011 ingredient suppliers have prepared for the cGMP and Preventive Controls regulations that will be issued later this year to implement this new law, and these regulations - which will apply to all domestic and international suppliers of food and food ingredients - will be more than adequate to ensure the accurate identity and quality of all food ingredients, including those used in supplements.
"AHPA also notes that this letter indicates some misunderstanding of the current responsibilities of all dietary supplement manufacturers. Compliance with the dietary supplement cGMP regulation and with the food allergen law is not voluntary but is compulsory. Compliant companies may not include undeclared or substitute ingredients or contaminants that would adulterate a supplement product, and must meet the same FDA standard for 'gluten-free' and major food allergen labeling as is required for conventional foods.
"Finally, AHPA does not believe that consumers of vanilla extract believe they will find vanilla beans in each 2 ounce bottle, or vanilla flowers in the several prominent national brands that bear pictures of flowers on their labels. Extraction of botanical ingredients is intended, just as with flavor extracts, to provide herbal products in a useful form to consumers."