Senators Hatch and Harkin urge FDA  to withdraw NDI draft guidance

Senators Hatch and Harkin urge FDA to withdraw NDI draft guidance

Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) sent a letter to the FDA asking for immediate withdrawal of the draft guidance on new dietary ingredients (NDI) that they said undermines DSHEA.

In a letter to Food and Drug Administration Commissioner Margaret Hamburg, M.D., Sens. Orrin Hatch, R-Utah, and Tom Harkin, D-Iowa--the principal authors of the Dietary Supplement Health and Education Act (DSHEA)--asked Hamburg to immediately withdraw the agency's controversial draft guidance on new dietary ingredients (NDI) and begin work on "a new draft that will provide needed clarification on what constitutes an NDI, but does not undermine the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Saying that the draft guidance "serves to undermine DSHEA in a number of important aspects," the senators listed their "significant" concerns with the current draft guidance, including:  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 Hamburg to direct her staff to meet with their staffs in early January to discuss their concerns in more detail.

"AHPA is pleased that Senators Hatch and Harkin have requested that FDA withdraw the draft NDI guidance," said American Herbal Products Association President Michael McGuffin. "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."   

About the American Herbal Products Association

The American Herbal Products Association is the national trade association for and the voice of the herbal products industry. AHPA is comprised of domestic and foreign companies doing business as growers, processors, manufacturers, and marketers of herbs and botanical and herbal products, including foods, dietary supplements, cosmetics, and non-prescription drugs. Founded in 1982, AHPA's mission is to promote the responsible commerce of herbal products.

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