FDA Notice Provides a “Backdoor” for Commenting on GRAS Notification Program

The U.S. Food and Drug Administration (FDA) today published a Federal Register Notice soliciting comments on its GRAS Notification (GRASN) Program.  “GRAS” is an acronym for the phrase “generally recognized as safe.”

Under sections 201(s) and 409 of the FD&C Act, any substance that is intentionally added to food is a food additive, which is subject to premarket review and approval by FDA, unless the substance is GRAS by qualified experts.  The voluntary GRASN Program, which is predicated on a 1997 proposed rule, essentially provides industry with an alternative to the mandatory food additive petition program for gaining FDA approval to use a new food ingredient.

Today’s Notice is a routine announcement of an opportunity for public comment on the proposed collection of certain information by FDA under the Paperwork Reduction Act of 1995, and solicits the typical information:

1. Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
2. The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Ways to enhance the quality, utility, and clarity of the information to be collected; and
4. Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

However, in light of the current status of the GRASN Program, it also provides a unique comment opportunity.

In February 2014, the Center for Food Safety (CFS) sued FDA in the U.S. District Court for the District of Columbia, seeking to invalidate the GRASN Program as a violation of the Administrative Procedure Act because it had operated for over 15 years under the provisions of a proposed rule.  (See our report on the lawsuit here.)  However, in October 2014, FDA and CFS settled the lawsuit by filing a consent decree that requires FDA to promulgate a final rule by August 31, 2016.  (See our report on the settlement here.)

With publication of a final rule about the GRASN Program less than a year away (unless extended by engagement of a process in the consent decree), the Notice creates a timely occasion to submit views and suggestions to FDA for consideration.  Any such comments must be submitted by November 16, 2015.