May 25, 2010 – Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA) today introduced the “Dietary Supplement Full Implementation and Enforcement Act of 2010,” which calls for the Food and Drug Administration (FDA) to implement and enforce regulatory requirements established by the Dietary Supplement Health and Education Act of 1994 (DSHEA) and requires not less than $20 million of funds appropriated to FDA in 2010 be allocated for this purpose.

“AHPA recognizes that this bill will protect consumer access to dietary supplements by providing FDA with better resources to enforce the many regulations that govern this class of goods, and thanks Senators Hatch and Harkin for introducing this important piece of legislation,” said McGuffin.

The bill also establishes additional requirements, such as mandating FDA provide industry with guidance on existing rules that apply to new ingredients. AHPA has long supported full implementation of DSHEA’s NDI provisions, and the association will be actively engaged in commenting on any proposed guidance.

Additionally, the bill requires FDA to submit to Congress an annual accountability report including information on the number of dietary supplement manufacturers inspected under FDA’s Good Manufacturing Practice (GMP) regulation, the number of new dietary ingredient (NDI) notifications reviewed, a brief summary of all enforcement actions taken in relation to dietary supplements, and other specific data related to the agency’s regulation of dietary supplements.

“Such an annual accountability report to Congress will provide a written record of FDA’s continuing regulation of dietary supplements,” said AHPA President Michael McGuffin. “Building a collection of facts and figures related to FDA’s enforcement of DSHEA is key to setting the record straight when it comes to the regulation of this class of goods.”