• Summaries on FDA's Final Rule on GRAS Notices and the Draft Guidance Document on New Dietary Ingredient Issues
  • September 7, 2016 | Authors: Melvin S. Drozen; Leslie T. Krasny; Evangelia C. Pelonis; Natalie E. Rainer; Frederick A. Stearns
  • Law Firms: Keller and Heckman LLP - Washington Office; Keller and Heckman LLP - San Francisco Office; Keller and Heckman LLP - Washington Office; Keller and Heckman LLP - San Francisco Office; Keller and Heckman LLP - Washington Office
  • Final Rule on GRAS Notices

    The GRAS Notice final rule, published on August 17 amends and clarifies the criteria for determining when a substance may be considered "generally recognized as safe" (GRAS) for an intended use in food and, thus, exempt from the premarket approval requirements applicable to "food additives" as defined under Section 201(s) of the Federal Food, Drug, and Cosmetic (FD&C) Act. The final rule does not reflect any meaningful departure from FDA's position on the level of support required to make a GRAS determination (either when making a self-GRAS determination or submitting a GRAS Notice to FDA). However, the final rule details the new format requirements for GRAS Notices submitted to FDA, which will be required to include seven parts.

    We have reviewed and analyzed the Final Rule on GRAS Notices and have prepared a summary for interested parties available here.

    FDA's Draft Guidance Document on New Dietary Ingredient Issues

    Additionally, we have reviewed and analyzed FDA's recently issued draft guidance document titled, "Dietary Supplements: New Dietary Ingredient Notifications and Related Issues" (hereinafter "Revised Draft") which updates the previous version of the guidance document issued in July 2011.

    The Revised Draft provides additional insight into FDA's position on important issues including: (1) when "chemical alteration" of a dietary ingredient or changes to the manufacturing process would cause it to become a new dietary ingredient (NDI); (2) when synthetic versions of botanical and other dietary ingredients would be NDIs; (3) how manufacturers should document that their dietary ingredients were marketed before October 15, 1994; and (4) what safety information should be included in new dietary ingredient notifications (NDINs). However, FDA continues to interpret many statutory provisions very narrowly and in a way that arguably goes against Congress' intention to establish a less-burdensome regulatory framework for dietary supplements. Thus, we expect that the dietary supplement industry will continue to disagree with some of FDA's positions in the Revised Draft. The Agency requests that comments on the Revised Draft be submitted by October 11, 2016 to ensure that they are considered in the develo
    pment of the final version of the guidance.

    We will continue to monitor and report on FDA's activities regarding the implementation of the Final Rule on GRAS Notices and the Draft Guidance Document on New Dietary Ingredient Issues. Please email [email protected] and let us know if you have any questions or if you would like to discuss how the final rule or revised draft will impact your business.

    FDA's recent changes to GRAS Notices and New Dietary Ingredient Issues will be included in the curriculum during Keller and Heckman's upcoming Practical Food Law Seminar being held September 27-29, 2016 in Washington, DC. Join industry experts for a three-day seminar that provides members of the food industry with a comprehensive presentation of the applicable statutory and regulatory framework for foods including dietary supplements. The course will focus on food safety, as well as labeling and advertising.