In response to the introduction of the Dietary Supplement Full Implementation and Enforcement Act of 2010, the Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement industry, issued the following statement.
Statement by Steve Mister, President and CEO, CRN
“CRN is pleased to add its support of the Dietary Supplement Full Implementation and Enforcement Act of 2010. Further, CRN applauds Senators Tom Harkin (D-Iowa) and Orrin Hatch (R-Utah) 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 the Food and Drug Administration (FDA) better enforce industry regulation, and this bill is a step in the right direction to making that happen.
This legislation reinforces 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. Many of the challenges our industry continues to face can be attributed to the lack of enforcement of these basic tenets of DSHEA. CRN believes 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. We strongly support this bill and are eager to work with Congress to ensure its passage.”
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement manufacturers and ingredient suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements in the areas of manufacturing, marketing, quality control and safety, our 70+ manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as CRN’s Code of Ethics. Visit www.crnusa.org.