Food processing and packaging can introduce non-food substances, such as those used to greaseproof paper takeout containers, into food. Some of these substances may pose health risks.
FDA reviews information on the safety of such substances before their first use. As new information becomes available that suggests a substance may pose a health risk, FDA will occasionally reevaluate it based on the new information. But, FDA doesn't have specific authority to require companies to provide the information that the agency may need for such reviews—so re-evaluation may not be possible.
We recommended that FDA request this authority from Congress.
What GAO Found
The Department of Health and Human Services' Food and Drug Administration (FDA) has primary responsibility for reviewing the safety of food contact substances before and after they enter the market. These substances come into contact with food during processes such as manufacturing, packaging, and transporting food (see fig.). Such substances may migrate into food, where they could pose a risk to human health. FDA conducts premarket reviews of the safety of substances largely by reviewing companies' submissions of supporting evidence before substances enter the market. FDA bases its postmarket reviews on safety information, including new information published since the substance's initial approval for use.
Since 2000, FDA has helped to stop the use of three types of unsafe substances, such as some per- and polyfluoroalkyl substances (PFAS) that are used to greaseproof food packages. These substances may cause health effects, such as liver damage. However, FDA faces two limitations that impede a risk-informed, postmarket review process for food contact substances:
- FDA does not have specific legal authority to compel companies to provide information and data on substances' safety and extent of use. FDA needs such information to prioritize and conduct postmarket reviews. FDA officials said they have 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. In 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 information and data on food contact substances' safety and use.
- FDA staff can search the agency's information system for each food contact substance and find the date of the last premarket review. However, FDA's system cannot readily identify all substances that, according to their last review dates, may warrant additional review because new safety information may have emerged. Tracking review dates in a way that allows FDA to identify these substances may help address challenges FDA faces in making risk-informed decisions on which substances to prioritize for postmarket review.
Why GAO Did This Study
Thousands of food contact substances are available for use in manufacturing, packaging, and transporting food. These substances are used, for example, in food wrappers and in the lining of metal food cans. Academic, consumer, and other stakeholders have raised concerns that some of the substances may, by themselves or in combination with other substances, contribute to adverse health effects, such as thyroid disease and hormone disruption.
This report (1) identifies the primary means that companies use to bring food contact substances to the market and describes FDA's premarket safety review process and (2) examines FDA's postmarket safety review actions and the limitations of such reviews. To conduct this work, GAO interviewed FDA officials and stakeholders and reviewed, among other things, FDA documents and the agency's website for actions it took from January 2000 to May 2022 to stop the use of potentially unsafe substances.
GAO is making two recommendations to FDA to (1) request from Congress specific legal authority to compel companies to provide the information needed to reassess the safety of substances and (2) track the dates of the last reviews for all food contact substances to allow FDA to readily identify substances that may warrant postmarket review. FDA neither agreed nor disagreed with the first recommendation and agreed with the second recommendation.
Recommendations for Executive Action
|Food and Drug Administration||The Commissioner of FDA should request specific legal authority to compel companies to provide specific information that they have about food contact substances already on the market. FDA could do so when it submits its report to the House Appropriations Committee on options to systematically reassess the safety of food additives and obtain information on their use. (Recommendation 1)||
|Food and Drug Administration||The Commissioner of FDA should direct the agency to track the dates of the last pre- and postmarket reviews for all food contact substances in a way that allows FDA to readily identify substances that may warrant postmarket review. (Recommendation 2)||