GAO Recommends FDA Strengthen Its Oversight of GRAS Food Ingredients

On March 5, 2010, the U.S. Government Accountability Office (GAO) released a report entitled Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS). The Federal Food, Drug, and Cosmetic Act (FFDCA) exempts generally recognized as safe (GRAS) substances, which include spices, artificial flavors, emulsifiers and binders, vitamins and minerals, and preservatives, from the general requirement that companies obtain Food and Drug Administration (FDA) approval before marketing food additives. Currently, companies may determine a substance is GRAS without FDA’s approval or knowledge. GAO notes, however, that “a few substances previously considered GRAS have later been banned,” while “concerns have been raised about the safety of other GRAS substances, including those containing engineered nanomaterials, materials manufactured at a tiny scale to take advantage of novel properties.” Congress asked GAO to review the extent to which: (1) FDA’s oversight of new GRAS determinations helps ensure the safety of these substances; (2) FDA ensures the continued safety of current GRAS substances; and (3) FDA’s approach to regulating engineered nanomaterials in GRAS substances helps ensure the safety of the food supply. The report is available online.

What GAO Found

According to GAO, FDA’s oversight process does not ensure the safety of all new GRAS determinations. FDA reviews only the GRAS determinations submitted to its voluntary notification program, and FDA generally does not have information about other GRAS determinations companies have made because companies are not required to inform FDA of them. Furthermore, FDA has not taken steps that could help ensure the safety of GRAS determinations, particularly those about which the agency has not been notified. GAO notes that FDA has not issued guidance to companies on how to document their GRAS determinations, or monitored companies to ensure that they have conducted GRAS determinations appropriately. FDA also has yet to issue a final regulation for its 1997 proposed rule that sets forth the framework and criteria for the voluntary notification program.

FDA is not systematically ensuring the continued safety of current GRAS substances. While, according to FDA regulations, the GRAS status of a substance must be reconsidered as new scientific information emerges, FDA has not systematically reconsidered GRAS substances since the 1980s. According to GAO, “FDA officials said they keep up with new developments in the scientific literature and, on a case-by-case basis, information brought to the agency’s attention could prompt them to reconsider the safety of a GRAS substance.” GAO notes, however, that FDA has largely not responded to concerns about GRAS substances, such as salt and the trans fats in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted between 2004 and 2008. In fact, GAO states, FDA has decided on the validity of these concerns in only one of 11 cases. In addition, FDA does not know to what extent, or even whether, companies track evolving scientific information about their GRAS substances.

According to GAO, FDA’s approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA’s knowledge. While some uses of engineered nanomaterials have the potential to help ensure food safety, GAO states that “uncertainties remain about how to determine their safety in food.” After reviewing the uncertainties associated with the safety of engineered nanomaterials, FDA has decided that it does not need additional authority to regulate products containing such materials. Rather, FDA encourages, but does not require, companies considering using engineered nanomaterials in food to consult with FDA regarding whether such substances might be GRAS. Because GRAS notification is voluntary and companies are not required to identify nanomaterials in their GRAS substances, FDA does not know the full extent to which engineered nanomaterials have entered the U.S. food supply as part of GRAS substances. GAO states: “In contrast to FDA’s approach, all food ingredients that incorporate engineered nanomaterials must be submitted to regulators in Canada and the European Union before they can be marketed.”

Recommendations

GAO offered the following recommendations, all of which are in process:

• To ensure better FDA’s oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to require any company that conducts a GRAS determination to provide FDA with basic information — as defined by FDA to allow for adequate oversight — about this determination, such as the substance’s identity and intended uses, and to incorporate such information into relevant FDA databases and its public website;
   
• To ensure better FDA’s oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to minimize the potential for conflicts of interest in companies’ GRAS determinations, including taking steps such as issuing guidance for companies on conflicts of interest and requiring information in GRAS notices regarding expert panelists’ independence;
   
• To ensure better FDA’s oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to monitor the appropriateness of companies’ GRAS determinations through random audits or some other means, including issuing guidance on how to document GRAS determinations;
   
• To ensure better FDA’s oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to 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 FDA’s timeline for making it final;
   
• To ensure better FDA’s oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to conduct reconsiderations of the safety of GRAS substances in a more systematic manner, including taking steps such as allocating sufficient resources to respond to citizen petitions in a timely manner, developing criteria for the circumstances under which the agency will reconsider the safety of a GRAS substance, and considering how to collect information from companies on their reconsiderations; and
   
• To ensure better FDA’s oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to help ensure the safety of engineered nanomaterials that companies market as GRAS substances without FDA’s knowledge, including taking steps such as issuing guidance recommended by FDA’s nanotechnology taskforce, developing an agency definition of engineered nanomaterials, and requiring companies to inform FDA if their GRAS determinations involve engineered nanomaterials.