GAO Report Criticizes FDA’s Oversight of GRAS Substances (Including Nanomaterials) and Points to Potential Legislative Fixes

By Nisha P. Shah and Ricardo Carvajal –

The title of a report issued by the U.S. Government Accountability Office (“GAO”) neatly sums up that agency’s perspective: “FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS).”  The report was requested by Tom Harkin, Chair of the Senate Health, Education, Labor, and Pensions Committee, and Rosa DeLauro, Chair of the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Entities of the Committee on Appropriations.

The Food, Drug, and Cosmetic Act exempts GRAS substances from the definition of “food additive” and the corresponding requirement that companies obtain FDA premarket approval.  This exemption permits companies to self-determine whether the intended use of a substance is GRAS.  Under a program established by FDA pursuant to a rule proposed in 1997, companies may voluntarily notify FDA of their GRAS self-determination.  FDA has yet to issue a final rule.

In part, the GAO report concludes:

• FDA lacks information about certain GRAS determinations because of the voluntary nature of the GRAS notification program;

• FDA does not systematically reconsider the safety of GRAS substances as new information or methods become available; 

• Because GRAS notification is voluntary and companies are not required to identify engineered nanomaterials in their GRAS substances, FDA has no way of knowing the extent to which these nanomaterials have entered the food supply.

In part, the GAO report recommends:

• FDA should “develop a strategy to require any company that conducts a GRAS determination to provide FDA with basic information … about this determination, such as the substance’s identity and intended uses, and to incorporate that information into relevant agency databases and its public Web site;” 

• FDA should “finalize the rule that governs the voluntary notification program, including taking into account the experience of the program to date, incorporating input from a new public comment period, and reporting to Congress and the public the agency’s timeline for making it final;”

• FDA should “develop a strategy that ensures the safety of engineered nanomaterials that companies market as GRAS substances without the agency’s knowledge, including taking steps such as issuing guidance recommended by the agency’s nanotechnology taskforce, developing an agency definition of engineered nanomaterials, and requiring companies to inform FDA if their GRAS determinations involve engineered nanomaterials.”

More broadly, the report recommends that, “[i]f FDA determines that it does not have the authority to implement one or more of these recommendations, the agency should seek the authority form Congress.”

In its response to the report, FDA generally agreed with GAO’s findings and recommendations.  Although FDA conceded that certain actions are beyond the scope of its current authority (e.g., collecting information about company reconsiderations of the safety of GRAS substances), FDA sidestepped GAO’s broader recommendation that the agency seek whatever additional authority is necessary to implement the report’s specific recommendations.  However, FDA’s response suggests that FDA is mulling all options:

FDA is actively considering steps it can take under current law to improve both premarket and post-market oversight of all added food substances, whether they enter the market based on a GRAS determination or through a formal FDA approval process.  In particular, FDA believes that its ability to oversee the safety of added food ingredients, including GRAS substances, would be enhanced if the manufacturer were required, prior to marketing any new substance or new use of an existing substance, to notify FDA and submit scientific evidence demonstrating the safety and legality of the intended use.  FDA also agrees with GAO that there is a need for enhancement of post-market oversight, including more effective tools for FDA to obtaining from sponsors new information related to the safety of marketed food ingredients sot that FDA is better able to identify substances meriting a substantive post-market review.  Implementation of these ideas would require additional resources, and some may require new legislation.

The current statutory regime for independent GRAS determinations has been in effect for over 50 years, since the enactment of the Food Additives Amendments of 1958.  Independent GRAS reviews have served as a useful tool to enable food products to enter the market with comprehensive safety reviews, without tying up limited government resources.  The GAO report does not identify a single actual safety problem that has been caused by this regime, but instead raises the specter of nanomaterials as an apparent basis for the conclusion that more regulations, and possibly amendments to the FDC Act, are necessary to protect the public.  At the same time, the GAO report fails to acknowledge the current regime’s important role in fostering innovation – not least in the area of biotechnology. 

For its part, FDA currently seems disinclined to recognize the effectiveness of post-market statutory tools in ensuring the safety of food ingredients.  Even so, the considerable benefits of the current regime are implicitly acknowledged in FDA’s response to GAO: “FDA believes that the GRAS concept has continuing utility as a practical tool for distinguishing between substances and new uses of substances that merit a full pre-market safety evaluation by FDA and those that do not.”  Query whether, in tightening its oversight of GRAS, the agency would only be making safe food more expensive.