WASHINGTON Sens. Tom Harkin, D-Iowa, and Orrin Hatch, R-Utah, on Tuesday introduced the Dietary Supplement Full Implementation and Enforcement Act of 2010, a piece of legislation designed to provide the Food and Drug Administration with additional enforcement resources.
Each of the leading trade associations representing the supplement industry issued their support behind the bill.
“[The Council for Responsible Nutrition] applauds Sens. Tom Harkin and Orrin Hatch for their efforts to fully fund, implement and enforce the Dietary Supplement Health and Education Act of 1994,” stated Steve Mister, CRN president and CEO. “CRN and its member companies have long advocated for more resources to help the FDA better enforce industry regulation, and this bill is a step in the right direction to making that happen.”
John Gay, executive director and CEO of the Natural Products Association added, “While some have called for additional regulations on supplements, Sens. 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. The way to get the bad actors out of the industry is by putting more cops on the street, plain and simple.”
This legislation reinforces the authority FDA has to regulate the supplement industry under DSHEA, and ensures the agency has additional resources to more fully implement that authority. The bill would provide FDA with additional resources over a five-year period to accomplish important regulatory mandates set out by DSHEA, including:
- Assuring that manufacturing facilities are GMP compliant through additional facility inspections;
- Calling on FDA to issue clear guidance for new dietary ingredients 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 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.