In a letter to FDA Commissioner Margaret Hamburg, MD, Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa)—the principal authors of the Dietary Supplement Health and Education Act (DSHEA)—asked Dr. Hamburg to withdraw the agency’s controversial draft guidance on new dietary ingredients (NDI) and begin work on “a new draft that will provide needed clarification on what constitutes an NDI, but does not undermine the balance Congress struck in DSHEA to provide consumers with access to safe, affordable dietary supplement products.”

Saying that the draft guidance “serves to undermine DSHEA in a number of important aspects,” the senators listed their “significant” concerns with the current draft guidance, including: 

• The requirement that manufacturers submit an NDI notification for every dietary supplement containing an NDI;

• The contention that synthetic copies of botanicals can never be dietary ingredients;

• The limit on the types of physical modifications that do not result in “chemically altering” a dietary supplement by “incorrectly construing the list in DSHEA legislative history as an exclusive rather than illustrative list.”

• The limit on physical modifications diverges from Congressional intent by “including only ingredients that were marketed before enactment of DSHEA in the form of dietary supplements as ‘old dietary ingredients.'” 

Because of these and “other concerns,” the senators asked Dr. Hamburg to direct her staff to meet with their staffs in early January to discuss their concerns in more detail.

Michael McGuffin, president of the American Herbal Products Association (AHPA), Silver Spring, MD, said he is pleased by the Senators’ call to action. “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.”