January 2012 Integrator Round-up on Natural Products: Harkin and Hatch ask FDI to withdraw New Dietary Ingredient (NDI) draft guidance
A notice from the American Herbal Products Association (AHPA) on January 5, 2012 announced that U.S. Senators Orrin Hatch, R-Utah, and Tom Harkin, D-Iowa have asked the Food and Drug Administration (FDA) to immediately withdraw the agency’s “controversial draft guidance on new dietary ingredients” (NDIs). In a letter to FDA Commissioner Margaret Hamburg, MD, they request “a new draft that will provide needed clarification on what constitutes an NDI, but does not undermine the balance Congress struck in [Dietary Supplement Health and Education Act (DSHEA)] to provide consumers with access to safe, affordable dietary supplement products.” In December, AHPA and other leading natural products industry organizations all called for an overhaul of the guidance document. AHPA president Michael McGuffin states: “This request is in alignment with the position AHPA stated in our comments submitted to the agency in December. We look forward to working with FDA to create new guidance that is consistent with DSHEA and ensures that consumers will continue to have access to safe, affordable dietary supplement products.” Harkin and Hatch are the principal authors of the DSHEA.