September 27, 2021

Volume XI, Number 270


September 24, 2021

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Summaries on FDA's Final Rule on GRAS Notices and the Draft Guidance Document on New Dietary Ingredient Issues

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. Click here to view the final rule.

FDA's Draft Guidance Document on New Dietary Ingredient Issues

Additionally, we have reviewed and analyzed FDA's recently issued draft guidance document titled, "Dietary Supplements: New Dietary Ingredient Notifications and Related Issues" (hereinafter "Revised Draft") which updates the previous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

© 2021 Keller and Heckman LLPNational Law Review, Volume VI, Number 243

About this Author

Melvin S. Drozen, FDA, regulatory lawyer, Keller Heckman, law firm

Melvin S. Drozen joined Keller and Heckman in 1987.

Mr. Drozen advises clients on a broad spectrum of FDA, FTC, USDA and EPA (pesticides) regulatory matters, ranging from premarket approval requirements for food additives, dietary supplement ingredients, drugs, and medical devices to advertising and labeling provisions applicable to all of these products. Prior to joining Keller and Heckman, he was an Assistant District Attorney in Brooklyn, N.Y., and then an attorney in the General Counsel's Office of the Food and Drug Administration for seven...

 Leslie T. Krasny, Keller Heckman, Administrative Law Matters lawyer, Food Supplement Regulation Attorney
Senior Counsel

Leslie Krasny joined Keller and Heckman in June 2001 and was instrumental in opening Keller and Heckman's San Francisco office. Ms. Krasny practices in the areas of regulatory and administrative law, primarily focusing on food/dietary supplement and consumer product industry matters, including safety and labeling, recalls, ingredient evaluations/GRAS opinions, health-related claim substantiation, organic requirements, green/sustainability claims, advertising, California's Proposition 65, recall insurance policies, continuing product guarantees, international trade and...

Evangelia C. Pelonis, food and drug regulatory lawyer, Keller Heckman law firm

Evangelia C. Pelonis joined Keller and Heckman in 2003 as a Food and Drug Associate. Ms. Pelonis' practice focuses on all regulatory and compliance matters of the U.S. Food and Drug Administration and the U.S. Department of Agriculture relating to human food, animal feed, food additives and ingredients, and dietary supplements. Ms. Pelonis' works with clients to achieve their marketing goals within the applicable legal frameworks. She counsels clients in all aspects of food development and marketing, from product formulation and manufacturing considerations to food...

Frederick Stearns Attorney Keller Heckman

Frederick Stearns' practice involves a wide range of issues affecting manufacturing of prescription and over-the-counter drugs, medical devices, dietary supplements, and cosmetics.

Mr. Stearns helps product manufacturers evaluate the need for marketing approval from FDA, to pursue appropriate clearance when necessary, and address regulatory compliance issues with marketed products (including OTC drug monographs, product labeling and promotion, and current good manufacturing practices). He also works with clients to respond to FDA enforcement...

Natalie E. Rainer, Keller Heckman, US Regulatory Compliance Attorney, Environmental Torts Lawyer,

Natalie Rainer joined Keller and Heckman in 2007. She practices in the area of food and drug law.

Ms. Rainer advises corporate clients regarding regulatory compliance in North America, Latin America, Europe, and Asia. During graduate school, Ms. Rainer worked at the U.S. Department of Justice, Civil Division as an intern in the Environmental Torts Section. In this position she participated in the defense of the federal government in multi-million dollar environmental lawsuits and wrote a successful U.S. Court of Appeals brief defending the...