Charles H. Manley

In June 2006, Sen. Tom Harkin asked the U.S. Government Accountability Office (GAO) to ”review the policy and actions of the Food and Drug Administration (FDA) with respect to the classification of certain food ingredients as Generally Recognized as Safe (GRAS).” Sen. Harkin’s request resulted in GAO’s report, “FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS),” issued in Feb. 2010.

Upon the release of the GAO report, the media largely reported the perspective stated in its title and on the GAO’s focus on nanotechnology. But the report is much more than a simple criticism of FDA and the GRAS concept. The GAO described the usefulness of the GRAS concept while focusing on the well-recognized weakness in some, but by no means all, GRAS determinations—the issue of the necessary general recognition of safety under the conditions of the intended use of the substance. The vast majority of current GRAS determinations apply the “scientific procedures” mechanism provided by Congress in Section 201(s) of the Federal Food, Drug, and Cosmetic Act.

Because Congress did not explicitly require that FDA be informed of GRAS determinations made by private parties, there have been longstanding concerns that such “private unpublished” GRAS determinations could result in unsafe food ingredients being added to foods through an absence of FDA oversight. However, in the early days of the GRAS concept in the 1960s and 1970s, there was extensive and vigorous examination and enforcement by FDA, resulting in a substantial body of case law that is helpful in interpreting the criteria for valid GRAS determinations. The focus of most of these enforcement actions was the “general recognition” of safety achieved through the application of a scientific analysis. Further, these cases support the conclusions of the GAO that for GRAS determinations to be legitimate and therefore protective from a public health view, they must be fully open and transparent and thus subject to full review by FDA and the public.

Concerns over the adequacy of private unpublished GRAS determinations have been addressed, in part, by FDA establishing a voluntary GRAS notification program in 1997. While the program has not been finalized as a codified regulation, it has fully replaced the agency’s existing regulations on how private parties may obtain an FDA determination that a food ingredient is GRAS. The program allows FDA to be much timelier in its issuance of its opinion on GRAS status and has been popular with food ingredient manufacturers. Since 1998, over 300 food ingredients have been evaluated through the program—with the vast majority receiving positive opinions from FDA. As concerns rise about the safety of food ingredients, the assurance that FDA can provide in its voluntary GRAS notification program has real public health and commercial value.

Over the 50-yr history of GRAS, it is apparent that Congress’ original intent to provide FDA with a way to address food ingredient safety concerns for substances unlikely to pose a risk has been realized, and that FDA’s management of the GRAS concept has been a success. There have been few significant public health issues with GRAS substances.

GAO’s recommendations for improvement center on the concepts that there should be complete transparency of the private GRAS process, and that GRAS evaluations should be performed by legitimate experts with no financial interest in the outcome of the evaluations. While requiring FDA to review all known existing GRAS substances would create a huge burden for the agency, FDA could require that going forward all private GRAS determinations and the data supporting them must be submitted to FDA if the substance is not entered into the FDA’s voluntary GRAS notification program. The GRAS program of the Flavor and Extract Manufacturers Association (FEMA) of the United States has been doing this for nearly 50 years. In fact, the GAO report notes that FEMA’s GRAS program is an excellent example of an independent scientifically based safety assessment program that meets the requirements of FDA’s voluntary notification program.

What is the future of GRAS? We believe that the GRAS concept should, and will, remain an important tool for FDA and the food industry alike. GRAS determinations, made by FDA or industry, allow the agency to use its limited resources to pursue high priority food safety issues such as microbial contamination. Could the existing GRAS process be improved? We agree with the GAO that increasing transparency through a requirement that the FDA be notified of all private GRAS determinations, either through the existing voluntary notification program or by another means, would be a significant improvement. Sen. Harkin and the GAO have provided a valuable contribution to the future of the GRAS concept. The GAO report should be required reading for all those interested in the valuable regulatory concept of GRAS.

John B. Hallagan is the General Counsel for the Flavor and Extract Manufacturers Association ([email protected]). Charles H. Manley, a Professional Member of IFT, is past President of IFT (1999–2000) and past President of FEMA ([email protected]).