CRN calls into question McCain's dietary supplement safety bill

WASHINGTON The Council for Responsible Nutrition on Thursday penned a letter to Sen. John McCain, R-Ariz., addressing industry concerns around McCain’s recently introduced dietary supplement bill, the Dietary Supplement Safety Act of 2010 (S 3002).

“CRN has been a strong proponent of reasonable regulation of dietary supplements, but we are concerned about some of the mischaracterizations of the dietary supplement industry contained within your remarks on the Senate floor as well as your description of your own bill,” wrote Steve Mister, CRN president and CEO.

For starters, CRN opposes provisions in the bill that would replace the existing New Dietary Ingredient provisions of the Federal Food, Drug, and Cosmetic Act with a list of “Accepted Dietary Ingredients” to be created by FDA, making it illegal to market a supplement containing an ingredient that is not on the list.

“Accordingly, [companies selling] dietary ingredients with a long history of safe use and wide consumer acceptance would have to petition FDA to get on the list, and unless and until FDA grants that approval, these products would be withdrawn from the market,” Mister noted. “That regulatory regime would turn a basic tenet of the Dietary Supplement Health and Education Act — namely, that dietary supplements with a history of safe use should be accessible to consumers unless FDA determines that they are not safe — on its head.”

McCain had suggested that his dietary supplement bill “would simply require dietary supplements to list all ingredients on the packaging, mandate that all dietary [supplement] manufacturers register with the Food and Drug Administration to ensure the FDA knows what is being sold and provide the FDA mandatory recall authority of any dietary supplement if the FDA finds the supplement to be hazardous to one’s health.”

“Current federal law requires dietary supplements to have a standard Supplement Facts box on the label that describes the suggested use, serving size, amount per serving, percentage of the daily value and list of ingredients,” Mister noted, addressing McCain’s suggestion that there exists supplement manufacturers legally operating outside of FDA purview. “If the label does not provide this information along with the identity and quantity of ingredients, then the product is misbranded and its manufacturer is subject to both civil and criminal penalties.”

CRN does support two of the tenets of the legislation, however — annual registration of dietary supplement facilities with FDA and granting FDA mandatory recall authority over all regulated products.