February 3, 2010
WASHINGTONSen. John McCain (R-Ariz.) has introduced the Dietary Supplement Safety Act of 2010, which would amend Federal Food, Drug and Cosmetic Act (FFDCA) and threaten parts of the Dietary Supplement Health and Education Act of 1994 (DSHEA), such as new dietary Ingredients (NDIs). Co-sponsored by Sen. Byron Dorgan (D-N.D.) and backed by the U.S. Anti-Doping Agency (USADA) and several pro and amateur sports bodies, the bill aims to more effectively regulate dietary supplements that may pose safety risks unknown to consumers.
Specifically, the bill calls for dietary supplement facilities to not only register its name and address, but also all trade names and a list of all dietary supplements manufactured, packaged, held, distributed, labeled, or licensed by the facility. Further, all ingredients contained in each supplement must also be disclosed in this registration, which is to be updated annuallyany reformulations or new ingredients would be noted in such an update.
On new dietary ingredients, the 75-notificaiton would say the same under the McCain bill, but ingredients marketed in the United States prior to Oct. 15, 1994 would no longer be automatically excluded from NDI requirements, but the Secretary would maintain a list of Accepted Dietary Ingredients. The bill also contains substantiation filing and evidence of compliance requirements, as well as monetary penalties for non-compliance.
In addition to these changes, the McCain bill would change existing mandatory serious adverse event reporting (SAER) regulations to require minor averse events also be mandatorily reported.
Given steroids in sports nutrition products has been the driver of this type of legislative effort, the bill expectedly outlines FDAs recall authority, including a hearing process, for any supplement that poses a serious health risk to consumers.
While USADA and its Supplement Safety Now members back the bill and showed support for it at its unveiling in Washington, numerous supplement industry groups have reacted strongly against most of the provisions in this bill.
Our industry has long supported efforts to remove the relatively few bad actors who market adulterated products, said the Natural Products Association (NPA), in a public statement. We have advocated for additional enforcement funds for regulators, and for giving regulators additional authority to act. What we cannot support is wholesale changes to a regulatory structure that is working, and could work better if the measures we have supported were adopted. NPA further argued a series of new laws for criminals to ignore is not the answer. Some seek to paint with an awfully broad brush, it said, noting the idea that the 150 million Americans who use dietary supplements are gambling with their health by shopping at mainstream stores just doesnt stand up to scrutiny Hyperbole does not lead to sound policy.
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), further detailed the industry efforts: Over the past several years, CRN has successfully lobbied to increase the regulation under which the supplement industry operates, working to ensure that dietary supplement manufacturers are required to report serious adverse events to FDA; to get FDA to issue and implement supplement-specific good manufacturing practices; to remove anabolic steroids from the supplement market; and to increase funding for FDAs enforcement efforts. CRN also has publicly supported most of the recommendations from the GAO report, including the recommendation for an annual registration of dietary supplement facilities as well as mandatory recall authority for FDAboth of these provisions are included in the Senate Food and Drug Administration Food Safety and Modernization Act legislation, S.510, that CRN supports and hopes to see pass this year.
Specifying parts of the bill, Mister argued requiring manufacturers to report all adverse eventsnot just serious adverse eventswould not protect consumers, but would instead stretch FDA beyond its limits. FDA itself has stated that this would overburden the Agency and would not help protect consumers, Mister noted. The best way to help consumers is through collaborative efforts with industry, government and other stakeholders, such as USADA, to implement the current laws, to provide more resources and funding to FDA, and to pass the food safety bill, which already includes many of these provisions. He vowed CRN would strive to find common ground with the sponsors and supporters of this legislation. Where specific provisions are extensions of positions we have already supported and lobbied for, we applaud more voices joining with ours, he said. But where the legislation would deter retailers from offering a wide variety of legitimate supplements to consumers or would overburden manufacturers, we will seek alternate solutions.
Michael McGuffin, president of the American Herbal Products Association (AHPA), reported the new bill appeared to new burdens on dietary supplements that are not required for any other class of food. 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, he noted.
McGuffin also pointed out the changes to NDI regulations would mean even ingredients that are presently used in food and would be used for the first time in dietary supplements are subject to notification.
And at least in the case of the proposed policing responsibility for retailers, it appears to be more stringent than retailer requirements under current drug laws, he said, noting the bill contains 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 that all NDI notification obligations have been met. All received evidence of such compliance would be subject to FDA review and inspection.
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