Petfood Insights
David A. Dzanis, DVM, PhD, DACVN
Get more Read Dr. Dzanis’ previous column on GRAS at www.petfoodindustry.com/ InsightsGRAS.aspx.
FDA lays out options
for new ingredients
AS OF THE time of this writing,
initiation of the US Food and Drug
Administration’s (FDA) pilot program
to accept generally recognized as
safe (GRAS) notifications for animal
feed and petfood ingredients is still
pending. However, in anticipation
of the start of the program later in
2010, several presentations on the
subject were given at the Association
of American Feed Control Officials
(AAFCO) meeting in January. Most
interesting is how GRAS notifications
compare and contrast with the other
primary means to allow for use of
new ingredients.
TABLE 1 SUMMARIZES the main
differences in new ingredient options.
Compared to the legally binding
approval under the food additive peti-
tion (FAP) process through FDA, the
AAFCO animal feed ingredient defi-
nition process consists of an informal FDA review
of the data. Technically, an AAFCO-defined
ingredient is still an unapproved food additive,
but for all practical purposes, feed control officials
How do GRAS
noti;cations
compare with the
other primary means
to allow for use of
new ingredients?
Find more online
For more information, visit http://www.aafco.org/Portals/
IDCIngredientDefinitions/tabid/166/ Default.aspx and click on
these presentations:
Options for Including Ingredients in the Official Publication,
Shannon Jordre, Center for Veterinary Medicine (CVM), FDA;
Process Options for Substances Used in Feed, Mika Alewynse,
CVM, FDA; and
Animal GRAS Feed Notifications, Geoffrey Wong, CVM, FDA.
are extremely unlikely to question the use of the
ingredient in animal feed or petfood (provided it
meets any specified conditions of use) regardless
of the process employed.
While FDA does not make an independent
judgment as to the safety of the subject of a
GRAS notification, it is presumed that feed
control officials will also consider a “no questions” response by FDA as sufficient tacit indication of ingredient acceptability.
An AAFCO definition generally requires less
data than FAP, though the need to demonstrate
safety and utility can still be sizable. Completion of either process can take years. Although
a GRAS notification requires the same data as
FAP, theoretically FDA should be able to respond
to a GRAS notification faster than the other two
options. However, the upfront time it may take
the submitter to compile and evaluate the data
can be longer than the other methods.
ANY OF THE three options can be burdensome
to the submitter in both time and resources
required. In theory, a manufacturer may be able
to bring the ingredient to market quicker through
the GRAS notification process. However, the
requirement for data to be freely accessible to the
public may be difficult, if not wholly infeasible, in
the case of a new ingredient. Also, a determination of GRAS by a firm typically requires that
an expert panel be convened to review the data,
which may add significant resource requirements
compared with the other methods.
If data suggest a potential target animal,
human food or environmental safety issue,
FAP is usually most appropriate. In fact, if FDA
determines existence of a safety risk during an
AAFCO definition review, it most often will
cease further review of the proposed definition
and require the firm to submit an FAP. ■
