Food Safety:

FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS)

GAO-10-246: Published: Feb 3, 2010. Publicly Released: Mar 5, 2010.

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The Food and Drug Administration (FDA), which is responsible for ensuring the safety of most of the U.S. food supply, is not required to review substances, such as spices and preservatives, added to food that are generally recognized as safe (GRAS) for their intended use. Currently, companies may determine a substance is GRAS without FDA's approval or knowledge. However, a few substances previously considered GRAS have later been banned; and 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. GAO was asked 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. GAO reviewed FDA data on GRAS substances and interviewed a range of stakeholders, among other things.

FDA's oversight process does not help ensure the safety of all new GRAS determinations. FDA only reviews those GRAS determinations that companies submit to the agency's voluntary notification program--the agency 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 certain steps that could help ensure the safety of GRAS determinations, particularly those about which the agency has not been notified. 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. Lastly, FDA has yet to issue a final regulation for its 1997 proposed rule that sets forth the framework and criteria for the voluntary notification program, potentially detracting from the program's credibility. 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, the agency has not systematically reconsidered GRAS substances since the 1980s. 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. However, 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 to the agency between 2004 and 2008. In fact, FDA has decided on the validity of these concerns in only 1 of 11 cases. In addition, FDA does not know to what extent, or even whether, companies track evolving scientific information about their GRAS substances. 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, 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 the agency 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 has no way of knowing the full extent to which engineered nanomaterials have entered the U.S. food supply as part of GRAS substances. 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.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: To better ensure 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.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

    Status: Open

    Comments: As of May 30, 2012, FDA indicated that it continues to strive to use its resources as efficiently and effectively as possible in conducting certain post-market reviews, including citizen petition reviews, in order to best serve public health interests. The agency also said that established criteria will help guide it in conducting efficient and effective post-market reviews of substances added to marketed foods and that such reviews serve the best interest of public health. However, FDA noted that existing resources are insufficient to conduct a comprehensive post-market review of all food ingredients. In addition, the agency stated that there continues to be no statutory requirement for companies to provide FDA with information about all GRAS re-determinations. Since FDA has not taken specific actions to address this recommendation, the recommendation remains open.

    Recommendation: To better ensure 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 the agency's timeline for making it final.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

    Status: Open

    Comments: On December 28, 2010, FDA published a proposed rule reopening the comment period on the GRAS proposal (75 FR 81536). According to FDA, this is the first step of its strategy to issue a final rule. In addition, as part of this action, FDA requested comments on several of GAO's other recommendations. The comment period closed on March 28, 2011. As of May 30, 2012, FDA indicated that it was still reviewing comments received. The agency also stated it expects to complete its analysis of comments in 2012 and will consider the time frame to issue a final rule in light of its limited resources and competing priorities. Since the agency has not yet issued a final rule, this recommendation remains open.

    Recommendation: To better ensure 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.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

    Status: Open

    Comments: On December 28, 2010, FDA published a proposed rule reopening the comment period on the GRAS proposal (75 FR 81536). The comment period closed on March 28, 2011. As of May 30, 2012, FDA indicated that it was still reviewing comments received, including comments related to FDA-issued guidance on how to document GRAS determinations (issue 16 in the proposed rule). Since the agency has not decided what, if any, actions it will take to monitor the appropriateness of companies' GRAS determinations, including the issuance of guidance on how to document these determinations, this recommendation remains open.

    Recommendation: To better ensure 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 conflict of interest and requiring information in GRAS notices regarding expert panelists' independence.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

    Status: Open

    Comments: On December 28, 2010, FDA published a proposed rule reopening the comment period on the GRAS proposal (75 FR 81536). The comment period closed on March 28, 2011. As of May 30, 2012, FDA indicated that it was still reviewing comments received, including comments related to FDA's possible role in minimizing the potential for conflict of interest (issue 15 in the proposed rule). Since the agency has not decided what, if any, actions it will take to minimize the potential for conflicts of interest, this recommendation remains open.

    Recommendation: To better ensure 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 the agency to allow for adequate oversight--about this determination, such as the substance's identity and intended uses, and to incorporate such information into relevant agency databases and its public Web site.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

    Status: Open

    Comments: For purposes of transparency, FDA stated that it continues to post GRAS notices voluntarily provided by companies on its Web site. The agency also cited its continued work on a long-term project to develop a system for data retrieval and evaluation, i.e., the Chemical Evaluation and Risk Estimation System (CERES), stating that this effort is on track. However, as of May 30, 2012, FDA indicated there continues to be no regulatory framework to make GRAS notifications mandatory. Therefore this recommendation remains open.

    Recommendation: To better ensure 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 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.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

    Status: Open

    Comments: On December 28, 2010, FDA published a proposed rule reopening the comment period on the GRAS proposal (75 FR 81536). The comment period closed on March 28, 2011. As of May 30, 2012, FDA indicated that it was still reviewing comments received on the proposed rule, including comments related to the use of engineered nanomaterials (issue 10(c) in the proposed rule). In addition, on April 20, 2012, FDA issued for public comment a draft guidance on assessing the effects of significant manufacturing changes, including where such changes involve nanotechnology, on the identity, safety, or regulatory status of food substances. As of May 30, 2012, the receipt and analysis of comments on this guidance were pending. Since the agency has not decided what, if any, actions it will take to ensure the safety of engineered nanomaterials in food, this recommendation remains open.

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