Tweaks to GRAS Procedures Expected

LAS VEGASWhile FDA has not finalized the generally recognized as safe (GRAS) notification procedures, major changes in current regulation are not expect, according to Robert S. McQuate, Ph.D., CEO and co-founder, GRAS Associates LLC. At SupplySide West, he said once the GRAS notification procedures are final, the food industry should receive refinements and clarification; and he hopes changes with FDAs decline to file" procedure.

Currently, food ingredients can be self-affirmed GRAS without needing to notify FDA. Companies can, however, submit their GRAS notifications to FDA, which can then issue a non-objection or an objection letter.

In 1997, FDA released a proposed rule regarding administrative procedures governing FDAs voluntary GRAS notification program, which have not been finalized. In early 2010, the Governmental Accountability Office (GAO) published a detailed evaluation of FDAs administration of the GRAS program, and was critical of the fact FDA had not yet issued final regulations.

In response, FDA reopened the comment period to obtain updated feedback. McQuate went over these comments in his talk. He noted a general agreement among industry and regulatory bodies that the self-affirmed process works well, so he doesnt expect big changes if and when FDA does finalize the procedures.

However, the GAO report and comments encouraged FDA to clarify some issues. GAO said FDA should seek to minimize conflicts of interest with individuals undertaking GRAS evaluations. Also, the GAO had concern with FDAs inability to oversee safety of all GRAS determinations, including self-determinations, and said the self-affirmations may be inadequate in depth, scope and rigor.  The report recommended all companies that self-affirm GRAS determinations should provide basic info to FDA so the agency is aware of all the GRAS ingredients on the market.

In response, FDA acknowledged its concern with lack of full awareness of all GRAS determinations; however, the agency declined to implement the GAO recommendation because it said it lacked legislative authority to require such submissions.

McQuate said FDA needs to incentive increased participation in voluntary GRAS notification to FDA. The agency can do this by adding mechanisms to protect confidentiality of company information, which currently may be made public by getting a GRAS no-objection letter.

McQuate said FDA can help encourage submissions by changing its decline to file" procedures. FDA may decline to file a GRAS notification if the agency believes it is similar to another substance that previously received a no-objections letter. However, companies currently do not have guidance on the criteria that makes two substances similar, MeQuate said.

Other comments submitted to the GRAS procedures included information on nanoparticles and scientific substantiation requirements.

GRAS Associates LLC is a consulting firm that focuses on food ingredient safety matters. GRAS Associates conducts GRAS evaluations and assists clients with new dietary ingredient (NDI) and color additive submissions to FDA. McQuate began his regulatory career within FDAs GRAS Review Branch, and previously worked for The Dial Co. and the National Soft Drink Association.