On May 24, 2010, Sens. Tom Harkin of Iowa and Orrin Hatch of Utah introduced the Dietary Supplement Full Implementation and Enforcement Act of 2010 (S 3414), legislation that would ensure that the Dietary Supplement Health and Education Act (DSHEA) and other requirements for dietary supplements are fully implemented and enforced.
The bill would reinforce the authority FDA has to regulate the supplement industry under DSHEA, and ensures the Agency has additional resources to implement that authority more fully. The bill would provide FDA with additional resources over a five year period to accomplish important regulatory mandates set out by DSHEA, such as:
- assuring that manufacturing facilities are GMP compliant through additional facility inspections;
- calling on FDA to issue clear guidance for new dietary ingredients (NDIs) and the submission of these NDI notifications, as well as the criteria for establishing a reasonable expectation of safety for these ingredients;
- implementing an annual registration process for supplement manufacturers, packers and distributors;
- requiring more dialogue between FDA and the Drug Enforcement Administration (DEA) so that anabolic steroids (or their analogues) do not reach consumers as a mislabeled supplement; and
- developing appropriate consumer education initiatives that will create more informed supplement customers.
DSHEA was enacted to ensure consumers have access to beneficial, high quality supplement products. It also provides an important regulatory framework that safeguards the general public from adulterated, mislabeled or harmful products. This legislation will go a long way to demonstrate that DSHEA works and to reinforce the safety, quality and benefit of supplement products to the public.
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