After conducting a study on the U.S. Food and Drug Administration’s (FDA’s) oversight of substances used in food contact materials, the U.S. Government Accountability Office (GAO) recommended that FDA request certain authorities from Congress in order to adequately review the safety of such substances.
At present, FDA does not have the specific authority to require companies to provide the most current information that the agency may need to continually reevaluate the safety of substances used in food manufacturing, packaging, and transportation. In addition to advising FDA to request the authority to compel companies to provide information for safety assessments, GAO also recommends that FDA track the dates of the last reviews for all food contact substances to allow the agency to readily identify substances that may warrant postmarket review. GAO reports that FDA neither agreed nor disagreed with the first recommendation, and agreed with the second recommendation.
GAO conducted the present study of FDA due to academic, consumer, and other stakeholder concerns over the possible harmful health effects, such as thyroid disease and hormone disruption, caused by substances in food contact materials, alone or in combination. Through interviews of FDA officials and stakeholders, as well as a document review, GAO identified the primary means that companies use to bring food contact substances to the market and described FDA's premarket safety review process. GAO also examined FDA's postmarket safety review actions and the limitations of such reviews.
The report states that, since 2000, FDA has helped to stop the use of three types of unsafe substances, including per- and polyfluoroalkyl substances (PFAS) that are used to greaseproof food packages, which may cause health effects, such as liver damage. However, GAO underlined the agency’s limitation in compelling companies to provide information and data on substances' safety and extent of use, and the inability of FDA’s information system to identify all substances that, according to their last review dates, may warrant additional review due to the emergence of new safety information.
FDA informed GAO that the agency has begun to develop options to systematically reassess the safety of food additives, which include food contact substances, in response to a House Appropriations Committee report. Also, FDA has a strategic plan to improve data-driven, postmarket surveillance of substances added to the food supply. GAO stresses that, its report to the committee, FDA could support its strategic plan and have additional options for obtaining information on food contact substances if it requested specific authority to compel companies to provide relevant information.
GAO will provide updated information should FDA take actions in response to GAO’s recommendations.