Senators Tom Harkin (D-IA) and Orrin Hatch (R-UT) have introduced new legislation to provide FDA with additional resources so that it can continue to enforce the existing laws governing dietary supplements. Called the “Dietary Supplement Full Implementation and Enforcement Act of 2010,” it also requires FDA to file annual reports with Congress about how the FDA is regulating dietary supplements.
According to the Salt Lake Tribune
, Senator Hatch is expected to tesify before the Senate special committee on aging about the new legislation.
Offering their support of the bill were the Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN), both based in Washington, D.C.
“While some have called for additional regulations on supplements, Senators Harkin and Hatch understand that the real need is to fully enforce the stringent statutes already on the books, to the full extent of the law,” said NPA executive director and CEO John Gay. “The way to get the bad actors out of the industry is by putting more cops on the street, plain and simple.”
Adding his thoughts, Steve Mister, president and CEO, CRN commented, “CRN is pleased to add its support of the Dietary Supplement Full Implementation and Enforcement Act of 2010. Further, CRN applauds Senators Tom Harkin and Orrin Hatch for their efforts to fully fund, implement and enforce the Dietary Supplement Health and Education Act (DSHEA) of 1994. CRN and its member companies have long advocated for more resources to help FDA better enforce industry regulation, and this bill is a step in the right direction to making that happen.”
The new bill will tighten product-specific enforcement and double funding given to the Office of Dietary Supplements (ODS) to expand research and consumer information about dietary supplements.
The bill would also 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.