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August 23, 2011
On July 1, FDA published a Federal Register notice on a Draft Guidance for Industry on Dietary Supplement New Dietary Ingredient Notifications and Related Issues. This draft guidance came about because of a provision in the 2011 Food Safety Modernization Act in which Congress instructed FDA to issue, within 180 days after the enactment of the Act, guidance to clarify the agency’s policies regarding new dietary ingredients (NDIs). The fact that FDA issued this 50+ page draft guidance on time suggests the importance with which the agency views compliance with Section 413 of the Food Drug & Cosmetic Act.
So what comes next? FDA is obligated to follow its Good Guidance Practices (GGP) (OMB Bulletin for Agency Good Guidance Practices, and 21 CFR 10.115). At this step, FDA has only announced that the draft guidance is available for public comment; the draft guidance has not been implemented. FDA proposed a 90 day period for public comment. After reviewing comments received, the agency must prepare a robust response-to-comments document and make it publicly available. The OMB GGP Bulletin notes that the agency should (emphasis added) incorporate changes suggested in comments, when appropriate, into the final version of the guidance document. FDA may decide after reviewing comments that it is appropriate to issue another draft of the guidance document rather than a final guidance. FDA is not likely to make any changes in NDI notification compliance enforcement until after the final guidance is issued.
Although there are marked differences of opinion between the dietary supplement industry and the FDA on the policies discussed in the draft guidance, all parties should recognize the need for clear guidance from FDA on how the statutory requirement for NDI safety determinations and notifications are to be enforced. A lack of clear guidelines for NDI safety notifications, FDA’s stringent review of the notifications and the agency’s low “no objection” rate, and lax enforcement of the premarket NDI notification requirement, has resulted in a situation where a substantial portion of NDIs are marketed without submission of a NDI safety notification. Responsible firms who commit the resources to conduct thorough safety evaluations and submit a NDI safety evaluation are put at a disadvantage by a system that allows others to ignore the rules. The current system has allowed too many dietary ingredients that have been introduced in the U.S. since DSHEA to avoid submitting NDI safety notification and thus avoid any oversight that these dietary ingredients will indeed be reasonably be expected to be safe.
FDA has a good track record with a successful, voluntary GRAS premarket notification program for conventional food ingredients that works well for both the industry and the agency. It is possible for FDA to also create a fair premarket notification program for dietary supplement NDIs. The Good Guidance Practices are there to ensure transparency and public input in development of significant guidance documents. Your comments on the draft guidance are an important factor in FDA developing fair and effective NDI safety notification policies. Comments on the draft guidance may be submitted electronically to http://www.regulations.gov, or in writing to the Division of Dockets Management (HFA_305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md 20852, by October 3, 2011. Comments should reference Docket No. FDA-2011-D-0379.
James Hoadley, Ph.D. is an independent consultant with EAS Consulting Group. He had a 20-year career at FDA where he participated in the development of NLEA-implementing nutrition labeling and health claim regulations. As a Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) Dr. Hoadley’s primary responsibilities were in food label claim regulations. In this role, he conducted scientific and regulatory reviews of petitions for new health claims and nutrient content claims. EAS Consulting Group specializes in FDA regulatory matters with a prime focus of assisting domestic and foreign dietary supplement, food pharmaceutical, medical device, tobacco and cosmetics firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives and is assisted by an extensive network of independent consultants with many years of FDA and industry experience.
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