FDA issued draft NDI guidance on July 5, 2011, to fulfill a requirement established by the U.S. Congress with the passage of the Food Safety Modernization Act. Although the supplement industry had requested guidance on this subject for several years, FDA's draft was roundly criticized as a flawed attempt by the agency to reinterpret the NDI section of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Comments filed by the American Herbal Products Association (AHPA) last December called on FDA to withdraw the guidance. In its comments, AHPA stated that the draft, if implemented as written, would "change the rules that have been in place for the last 17 years and significantly increase the burden on the supplement industry far beyond the intent of Congress with no concomitant benefit for consumers."
"It is deeply gratifying to hear that FDA has decided to rethink its approach to good guidance on this important element of DSHEA," said Michael McGuffin, AHPA president. "We look forward to working more closely with the agency in the development of the kind of guidance that is needed by the supplement trade to ensure compliance with this important safety feature of the law."
NDIs are dietary ingredients that were not already marketed in the United States when DSHEA was passed. The manufacturer or distributor of an NDI or a supplement containing an NDI is generally required to submit a notification to FDA 75 days before market introduction, though there are exceptions to this rule.
AHPA was informed that FDA's decision to revise its draft meeting was communicated in a meeting between the offices of Sens. Orrin Hatch, R-Utah, and Tom Harkin, D-Iowa, and senior FDA officials.
"The dietary supplement industry should once again recognize the commitments of Senators Hatch and Harkin to ensure continued access to a broad range of dietary supplements," added Mr. McGuffin.
The Council for Responsible Nutrition (CRN) also commended the FDA. “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CRN credited the industry’s perseverance in communicating to the agency its legitimate concerns about the original draft guidance, issued last July, combined with misgivings voiced from numerous Members of Congress, as contributing to the agency’s decision to reissue the draft guidance.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 said it understood 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,” said Mr. Mister. “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.”
FDA has not at this time indicated a timeline for issuance of revised NDI guidance, however the agency indicated a desire to move quickly.