February 4, 2010 — Senator John McCain (R-AZ) held a press conference to announce his intention to introduce legislation that would amend the Federal Food, Drug and Cosmetic Act (FFDCA) in several areas that would affect dietary supplements. The legislation will be co-sponsored by Senator Byron Dorgan (D-ND).
The bill would make the following amendments to the FFDCA’s current governance of dietary supplements:
• New facility registration requirements to identify all brands, products, and ingredients;
• A revised definition of new dietary ingredients (NDIs) that would rely on an FDA-generated positive list of allowed ingredients;
• Extension of existing adverse event report (AER) requirements, such that even minor AERs would need to be submitted to FDA annually;
• Policing and record maintenance obligations for downstream manufactures and retailers, who will be obliged to obtain written confirmation, from ingredient suppliers or from supplement brand marketers, respectively, of compliance with facility registration and product notification and rules; and
• Obligations and authority for FDA with regard to removing products that present the risk of serious adverse health consequences or death, or are adulterated or misbranded.
More specifically, the bill’s new registration requirements on dietary supplement facilities would establish that these companies disclose “all trade names under which the dietary supplement registrant conducts business [and] a list of all dietary supplements manufactured, packaged, held, distributed, labeled, or licensed by the facility.”
Dietary supplement facilities would also need to identify all product ingredients and to submit all product labels, and all required information would be required to be updated annually.
While all food facilities are now required to be registered with FDA, there is no current requirement for disclosure of products, brands and ingredients, or for supplying labels, and the bill would not extend such new obligations to any other foods.
The bill would also replace the definition of “new dietary ingredients.” Under the Dietary Supplement Health and Education Act (DSHEA), these are defined as any ingredient that “was not marketed in the United States before Oct. 15, 1994 and does not include any dietary ingredient which was marketed in the United States before Oct. 15, 1994.’’
The bill would replace this definition by creating a list of “‘Accepted Dietary Ingredients,’ to be prepared, published, and maintained by the secretary,” and define a new dietary ingredient as any ingredient not included on such list.
Revisions would also be made to the current new dietary ingredient notification process, such that even ingredients that are presently used in food and would be used for the first time in dietary supplements are subject to notification.
With regard to both facility registration and compliance with NDI regulations, the bill would establish a requirement for dietary supplement companies and retailers of supplements to “obtain adequate written evidence from the preceding responsible entity in the chain of commerce” that supplements they receive are registered as required under the facility registration rules, and that all NDI notification obligations have been met. All received evidence of such compliance would be subject to FDA review and inspection.
The draft legislation also addresses adverse event reporting. Dietary supplement marketers are currently required to submit serious adverse event reports to FDA within 15 days of receipt. The McCain legislation would also require annual submission of a compilation report of all adverse event reports. This would establish a requirement that is similar to the current law for prescription drugs. Marketers of conventional foods have no adverse event reporting requirements, even for serious adverse events.
Finally, the bill would create a new responsibility for FDA to issue orders for a supplement company to cease distribution of any product for which FDA determines a “reasonable probability that a dietary supplement or a product marketed or sold as a dietary supplement would cause serious, adverse health consequences or death, or is adulterated or misbranded.” The agency would also be given mandatory recall authority. This new agency responsibility and authority now exists only for certain medical devices.
The draft bill is available here.
Source: American Herbal Products Association, www.ahpa.org