CRN: FDA plans to reissue revised New Dietary Ingredient Notification draft guidance


WASHINGTON — The Council for Responsible Nutrition on Wednesday commended the Food and Drug Administration for its plans to reissue a revised New Dietary Ingredient Notification Draft Guidance. The FDA’s announcement to revisit the draft guidance came following a meeting with agency officials including FDA commissioner Margaret Hamburg and deputy commissioner Mike Taylor and Sens. Orrin Hatch, R-Utah, and Tom Harkin, D-Iowa.

“We are grateful to FDA for its willingness to have an open and ongoing dialogue with our industry," CRN president and CEO Steve Mister said. "We understand the complexities involved for FDA in developing practical and workable regulation, and we remain willing to work cooperatively to help ensure the guidance will be manageable for industry and enforceable for FDA, and will ultimately benefit consumers.”

CRN credits the industry’s perseverance in communicating to the agency its legitimate concerns about the original draft guidance, issued last July, combined with misgivings voiced from numerous members of Congress. According to CRN, the agency will revisit the five specific areas of concern that CRN and other industry trade associations highlighted as particularly problematic for the industry, including:

  • Industry responsibility for proving grandfathered status of particular ingredients;

  • The permissibility of using synthetic versions of botanical components in supplements;

  • The definition of the term “chemically altered”;

  • NDI submissions for an ingredient versus finished products; and

  • The level of data necessary to demonstrate the safety of NDIs.

“We pledge to continue to help educate the industry about the statutory requirements for NDI notifications, even as we engage in dialogue with the agency about specifics of FDA’s interpretation of the law," Mister said.

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