The Council for Responsible Nutrition (CRN), the dietary supplement industry's leading trade association, commends the Food and Drug Administration (FDA) for its plans to reissue a revised New Dietary Ingredient (NDI) Notification Draft Guidance. While FDA has not committed to a timeline for its new draft guidance, the agency has indicated its desire to move quickly.
"We are grateful to FDA for its willingness to have an open and ongoing dialogue with our industry. 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," said Steve Mister, president and CEO, CRN.
CRN credits the industry's perseverance in communicating to the agency its legitimate concerns about the original draft guidance, issued last July, combined with misgivings voiced from numerous Members of Congress, as contributing to the agency's decision to reissue the draft guidance. FDA's announcement to revisit the draft guidance came following a meeting with top agency officials including FDA Commissioner Margaret Hamburg and Deputy Commissioner Mike Taylor and Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa).
CRN understands that the agency will revisit the five specific areas of concern that CRN and other industry trade associations highlighted as particularly problematic for the industry. These include:
- 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. CRN looks forward to the continued support from FDA, particularly Dr. Daniel Fabricant, whose willingness to participate in industry conferences, webinars and other educational efforts has been so important for keeping the lines of communication open and helping the industry understand FDA's expectations for NDI submissions," said Mr. Mister.