Ad Hoc Group on Content Determination (Administration Task Group)
3. Determining whether an expert panel is needed, panel composition.
The regulatory framework for determining whether a substance can be considered
generally recognized as safe (GRAS) in accordance with section 201(s) (21 U.S.C. §
321(s)) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. § 301 et.
Seq.) ("the Act"), is set forth at 21 CFR 170.30, which states:
General recognition of safety may be based only on the view of experts
qualified by scientific training and experience to evaluate the safety of
substances directly or indirectly added to food. The basis of such views
may be either (1) scientific procedures or (2) in the case of a substance used
in food prior to January 1, 1958, through experience based on common use in
food. General recognition of safety requires common knowledge about the
substance throughout the scientific community knowledgeable about the
safety of substances directly or indirectly added to food.
General recognition of safety based upon scientific procedures shall require
the same quantity and quality of scientific evidence as is required to obtain
approval of a food additive regulation for the ingredient. General recognition
of safety through scientific procedures shall ordinarily be based upon
published studies, which may be corroborated by unpublished studies and
other data and information.

In lieu of convening a formal external expert panel, a GRAS determination may
be conducted by company personnel provided they are “qualified “ as defined
above. In that case, the company personnel assume the role of the GRAS expert
panel. Current FDA guidance does not currently specify that an external/outside
panel of experts must be convened.

GRAS expert panels can also be comprised of a combination of internal company
personnel and external experts (consultants, independent experts, academicians)
or of all external/outside experts. In both cases, the expert panel should be
comprised of individuals qualified by scientific training and experience to
evaluate the safety of substances directly or indirectly added to food.

The composition of a GRAS expert panel should encompass experts experienced
in the review of food and food ingredients and their identity, manufacturing,
intake and safety. The actual composition of the expert panel should be tailored
to the specific issues/areas of concern for an individual ingredient and its GRAS
determination. Areas of expertise might include the following: chemistry, food
technology, genetically modified foods/ingredients, human nutrition,
exposure/intake assessment, pediatric nutrition, general toxicology, or a
specialization within toxicology such as developmental/reproductive toxicology,
genotoxicity/carcinogenicity, allergenicity, etc. The nature of each food or food
ingredient and potential safety issues will help determine the makeup of the expert
panel.

While there is no requirement for a specific number of expert panelists, the
traditional GRAS expert panel is comprised of a minimum of three panelists but
has included additional experts when deemed necessary.