03.01.10
The Council for Responsible Nutrition (CRN), Washington, D.C., has sent a letter to Sen. John McCain (R-AZ) regarding the recently introduced Dietary Supplement Safety Act of 2010.
In his letter, Steve Mister, president and CEO of CRN, said the association is “concerned about some of the mischaracterizations of the dietary supplement industry.”
“Dietary supplements are already required by the Federal, Food, Drug and Cosmetic Act (FDCA) to ensure that the claims they make about their products are truthful, and not misleading, and that the manufacturer has adequate substantiation to support these claims. Current federal law also 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. 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.”
In a statement on the Senate floor, Sen. McCain said the legislation would require dietary supplements to list all ingredients on packaging, mandate all supplement manufacturers to register with FDA to ensure the agency knows what is being sold and provides FDA with mandatory recall authority.
CRN’s letter states: “We respectfully disagree that your legislation, as introduced, would not ‘seek to limit consumers’ ability to purchase dietary supplements,’ and that it would not establish ‘a new regulatory structure for dietary supplements’ at FDA. S 3002 would replace the existing New Dietary Ingredient provisions of the FDCA with a list of ‘Accepted Dietary Ingredients’ to be created by FDA; it would be illegal to market a supplement containing an ingredient that is not on the list. Accordingly, dietary ingredients with a long history of safe use and wide consumer acceptance would have to petition FDA to get on the list…”
“Moreover, the legislation would create civil liability for any retailer that sells dietary supplements if it fails to obtain certification from its suppliers or manufacturers that the products it sells have met all the upstream regulatory requirements, such as being on the list of ‘Accepted Dietary Ingredients.’”
While Mr. Mister noted there are parts of the legislation it can agree on, “there are onerous provisions in the bill that do, in fact, fundamentally alter the regulatory structure and limit consumer access.”
In his letter, Steve Mister, president and CEO of CRN, said the association is “concerned about some of the mischaracterizations of the dietary supplement industry.”
“Dietary supplements are already required by the Federal, Food, Drug and Cosmetic Act (FDCA) to ensure that the claims they make about their products are truthful, and not misleading, and that the manufacturer has adequate substantiation to support these claims. Current federal law also 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. 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.”
In a statement on the Senate floor, Sen. McCain said the legislation would require dietary supplements to list all ingredients on packaging, mandate all supplement manufacturers to register with FDA to ensure the agency knows what is being sold and provides FDA with mandatory recall authority.
CRN’s letter states: “We respectfully disagree that your legislation, as introduced, would not ‘seek to limit consumers’ ability to purchase dietary supplements,’ and that it would not establish ‘a new regulatory structure for dietary supplements’ at FDA. S 3002 would replace the existing New Dietary Ingredient provisions of the FDCA with a list of ‘Accepted Dietary Ingredients’ to be created by FDA; it would be illegal to market a supplement containing an ingredient that is not on the list. Accordingly, dietary ingredients with a long history of safe use and wide consumer acceptance would have to petition FDA to get on the list…”
“Moreover, the legislation would create civil liability for any retailer that sells dietary supplements if it fails to obtain certification from its suppliers or manufacturers that the products it sells have met all the upstream regulatory requirements, such as being on the list of ‘Accepted Dietary Ingredients.’”
While Mr. Mister noted there are parts of the legislation it can agree on, “there are onerous provisions in the bill that do, in fact, fundamentally alter the regulatory structure and limit consumer access.”