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  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)

   
 
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