U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. Reports, Manuals, & Forms
  4. Reports
  5. Economic Impact Analyses of FDA Regulations
  6. Summary: Substances Generally Recognized as Safe (Final Rule)
  1. Economic Impact Analyses of FDA Regulations

Summary: Substances Generally Recognized as Safe (Final Rule)

The Food and Drug Administration (FDA or we) is issuing a final rule to replace the voluntary GRAS (generally recognized as safe) petition process with the voluntary GRAS notification procedure; the final rule will end our Interim Pilot program.  The rule will provide more clarity to firms considering whether a food substance is GRAS under the conditions of its intended use and considering submitting GRAS notices to us.  Our GRAS petition process required notice and comment rulemaking, a time-consuming process that created a disincentive for firms to participate.  We judge that the GRAS notification procedure provides a strong incentive for firms to voluntarily participate in our program, and allows us to respond to GRAS notices in a timely manner.

Regulatory Impact Analysis

Substances Generally Recognized as Safe (Final Rule) (PDF - 175KB)

Federal Register: 81 FR 54959, August 17, 2016

Docket: FDA-1997-N-0020 (formerly 97N-0103)

   
Back to Top