A New Front in the NGO Assault on GRAS: CFS Seeks a (Temporary?) Return to GRAS Affirmation

By Ricardo Carvajal, Diane B. McColl & JP Ellison –

The Center for Food Safety filed suit in the DC District Court challenging FDA’s allegedly “unlawful action of exempting substances that are [GRAS] from regulation as food additives under a proposed rule for more than fifteen years.”  The complaint asks the court to declare the agency in violation of the Administrative Procedure Act, “vacate” the GRAS notification proposed rule issued in 1997, and “reinstate” the GRAS affirmation regulation until FDA “properly promulgates” a GRAS notification final rule.
 
As noted in the complaint, FDA has operated its GRAS notification program consistent with the terms laid out in the agency’s 1997 proposed rule.  The complaint contends that, in so doing, the agency “exempts substances from food additive regulations despite the fact that they may pose serious risks to human health and welfare.”  The complaint cites several examples of products that allegedly “achieved GRAS status through the proposed rule” and expose “Plaintiff and the public to risky products without adequate procedural due process or meaningful agency oversight.”
 
Until FDA issues a final rule governing the GRAS notification program, Plaintiff seeks a return to GRAS affirmation as a means to “require a thorough, independent review and analysis of all scientific evidence prior to granting GRAS status to any substance” (emphasis added).  The complaint thus fails to recognize that the GRAS affirmation process was also voluntary, and that FDA does not “grant” GRAS status to a substance; rather, the use of a substance either is or is not GRAS based on whether it meets the applicable statutory criteria.  The complaint also fails to recognize that the GRAS affirmation program proved unsustainable because of its drain on the agency’s resources.  Finally, it is unclear how the ultimate relief sought by Plaintiff – issuance of a final rule governing the GRAS notification program – would resolve Plaintiff’s claims about the alleged deficiencies of that program. 
 
Whether the complaint stands any chance of success may be beside the point.  In spreading fear and misinformation about the safety of substances added to food, it can be expected to find a ready audience primed by the PEW-sponsored publications cited in the complaint.  Those publications were authored by staff that have since moved to the Natural Resources Defense Council, where they have been put to work hatching additional efforts to discredit FDA’s administration of the GRAS exception.  Correcting the many errors and distortions in the record piled up in these attacks will take significant time and effort, little of which is likely to come from FDA given the agency’s limited resources.  The task will therefore fall to industry and the community of scientific experts qualified by training and experience to evaluate the safety of food ingredients.  In our view, it’s a worthy undertaking.  The GRAS exception has demonstrated itself to be a positive feature of the U.S. food regulatory system, and it deserves a thorough defense.