A hard look at FDA's review of GRAS notices.
Generally Recognized as Safe (GRAS) substances are exempt from premarket approval; however, the standard of "reasonable certainty of no harm" is the same. In 1997, the voluntary GRAS affirmation process was replaced with the voluntary U.S. Food and Drug Administration (FDA) GRAS notice process. Under the GRAS notice process, pivotal safety data are required to be in the public domain, and consensus of safety among experts is required. FDA issues responses of "FDA has no questions", "Notice does not provide a basis for a GRAS determination", or, "At Notifier's request, FDA ceased to evaluate the notice." Of 528 notices reviewed, there were 393 "no questions letters", 17 "insufficient basis letters", and 84 "cease to evaluate letters". Of those deemed to be insufficient, most failed to meet the general recognition criteria. Only four raised questions about potential safety, of which three received a no questions letter upon providing more data. Of the 84 withdrawn notices, 22 received a no questions letter upon resubmission. In spite of criticisms, the FDA GRAS notice process is clearly defined, efficient, and cost-effective, and there have been no known public health issues following its implementation.
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Ashley
A
Roberts
Intertek Scientific and Regulatory Consultancy, 2233 Argentia Road, Suite 201, Mississauga, ON, L5N 2X7, Canada.
Lois A
LA
Haighton
D000818:Animals; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards; D004305:Dose-Response Relationship, Drug; D005503:Food Additives / Q000009:adverse effects* / Q000592:standards; D019649:Food Industry / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D059022:Food Safety / Q000379:methods*; D033161:Government Regulation; D006291:Health Policy; D006801:Humans; D009753:Nutritive Value; D011050:Policy Making; D015397:Program Evaluation; D064167:Recommended Dietary Allowances; D018570:Risk Assessment; D018675:Toxicity Tests / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
D005503:Food Additives
Critical review; FDA; Food ingredients; GRAS; Notices