GRAS affirmation petitions approved during 1987–1996 took an average of 87.2 months to be approved by the FDA, despite manufacturers being allowed to market the substances while awaiting FDA action.
Sources
- Legal Aspects of the Food Additive Approval Process - NCBI (ncbi.nlm.nih.gov)
- https://www.fda.gov/food/generally-recognized-safe-gras/fdas-approach-gras-provision-history-processes (fda.gov)
- https://www.khlaw.com/insights/final-gras-regulation-putting-voluntary-notification-procedure-place (khlaw.com)
- https://downloads.regulations.gov/FDA-1997-N-0020-0141/content.pdf (downloads.regulations.gov)