With regard to the Generally Recognized as Safe (GRAS) assessment of a food ingredient, an Expert Panel is a group of participants who—through appropriate scientific training and experience—are qualified to independently evaluate scientific data, information, methods, and other relevant factors to determine whether or not a substance is safe under intended conditions of use.
Food and Drug Administration’s (FDA’s) Final GRAS Rule doesn’t stipulate that an Expert Panel must be convened in order for the requirement for “general recognition of safety” to be met; however, the practice of convening an Expert Panel has been adopted by many as a means of addressing the Final GRAS Rule criteria that “general recognition of safety requires common knowledge, throughout the expert scientific community knowledgeable about the safety of substances directly or indirectly added to food, that there is a reasonable certainty that the substances is not harmful under the conditions of its intended use.”
In 2017, Hanlon et al. published a review of FDA’s GRAS Notice program, evaluating a number of parameters including the use and makeup of GRAS Expert Panels. Based on the data they compiled at the time, it was reported that two-thirds of GRAS Notices included an Expert Panel conclusion, often called an Expert Panel Report. On average, each Panel had approximately 3 members.
Also in 2017, FDA published a draft guidance document titled “Best Practices for Convening a GRAS Panel: Guidance for Industry.” The draft guidance, which has not been implemented, addresses possible or perceived conflicts of interest when convening an Expert Panel. Certain aspects included in the discussion are balance of expertise, bias, and the amount of non-public information available to the Panel during their review.
Expert Panels can be convened for a single evaluation or they can be a standing panel of experts, as is the case for The Flavor and Extract Manufacturers Association of the United States (FEMA) GRAS Panel. Often, the quantity and expertise of members on a “single-use” Expert Panel will vary based on the substance being evaluated. Typically, a Panel will contain at least one chemist and one toxicologist. If an intended use of the ingredient is in infant formula, it may be desirable to have a pediatrician serve as an Expert Panelist. If the substance is manufactured through a fermentation or bioconversion process, a microbiologist might serve as an Expert Panelist.
Expert Panels independently review a GRAS dossier specifically prepared for a substance, and each member is expected to carefully weigh the presented data as it pertains to safety-in-use. The Panel then convenes to discuss the composite information and determine whether or not a GRAS consensus has been achieved. The Expert Panel typically prepares a report highlighting the key information that supports a GRAS conclusion, which often accompanies a GRAS Assessment in an appendix, both for Independent GRAS Assessments and GRAS Notices.
Convening an Expert Panel is often the recommended and preferred practice in the industry; however, there are a few instances for which it may be unwarranted to convene an Expert Panel:
The substance is “substantially similar” to a substance which was previously described in a GRAS Notice and which received a “no questions” letter from FDA; or
The substance has been evaluated and deemed safe for use in foods by a well-respected panel of experts [for example, The Joint FAO/WHO Expert Committee on Food Additives (JECFA)];
Assembling and convening an Expert Panel is substance- and situation-dependent, so many companies choose to retain consultants with experience in such matters. Other companies opt to forego an Expert Panel altogether. Of note, Hanlon et al. (2017) reported that 200 of the first 600 GRAS Notices submitted to FDA did not include Expert Panel conclusions. Of these, 82% (n=163) subsequently received a “no questions” letter from FDA.
If you aren’t sure how to assemble and convene an Expert Panel, or if you’re looking for some help with navigating the GRAS process in general, please feel free to reach out directly.
The next blog will cover the FDA GRAS notification process and possible outcomes.
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Hanlon, P.R., Frestedt, J., Magurany, K. (2017) GRAS from the ground up: review of the Interim Pilot Program for GRAS notification. Food Chem. Toxicol. 105, 140-150.