FDA Releases Guidance on Best Practices for Convening GRAS Panels

Dec 13, 2017

In a move that some critics of the GRAS system hail as much needed, FDA has issued a draft guidance outlining best practices for putting together an expert panel for evaluating whether or not a substance is Generally Recognized as SAFE (GRAS) for its intended use. The draft guidance is open for public comment until May 15, 2018.

The Federal Food, Drug, and Cosmetic Act waives premarket review and FDA approval for substances deemed GRAS as food additives. But for a substance to qualify as GRAS either via self-affirmation or FDA review, a body of qualified experts must broadly recognize its safe use in food.

In its draft guidance, FDA recommends best practices including identifying GRAS panel members with appropriate and balanced expertise; reducing the risk of bias or the appearance thereof by assessing potential manners for potential or even perceived conflicts of interest; and limiting the data and information provided to the panel to what is also available to the rest of the public.

The draft guidance also reminds interested parties that use of a GRAS panel does not necessarily guarantee that GRAS criteria have been met. It reiterates that for a substance to be GRAS under its intended use conditions, that use must meet the same safety standard as for a food additive—that is, there must be reasonable certainty of no harm under the intended use conditions. Further, the substance’s use must meet the general recognition standard: the substance’s intended food use must be recognized as safe by qualified experts based on publicly available scientific information.