The U.S. Government Accountability Office (GAO) has issued a report critiquing the premarket authorization programs handled by the U.S. Food and Drug Administration (FDA). The report, Food Safety: FDA Oversight of Substances Used in Manufacturing, Packaging, and Transporting Food Could Be Strengthened, GAO-23-104434, makes two recommendations to FDA for its consideration. These are:
- Request from Congress specific legal authority to compel companies to provide the information needed to reassess the safety of substances already on the market; and
- Track the dates of the last pre- and postmarket reviews for all food-contact substances to allow FDA to readily identify substances that may warrant postmarket review.
The report, which GAO published on November 8, 2022, identifies the primary means that companies use to bring food-contact substances (FCSs) to the market and describes FDA's premarket safety review process. It also examines FDA's postmarket safety review actions, along with the limitations of those reviews. Concerning the first recommendation, the report points out that FDA does not have legal authority to compel companies to provide information and data on substances’ safety and extent of use, yet this information is needed to prioritize and conduct postmarket reviews.
With respect to the second recommendation, the report states that while FDA can search its information system for each FCS and find the date of the last premarket review, the system cannot readily identify all substances that may warrant additional review based on their last review date.
The report notes that FDA neither agreed nor disagreed with the first recommendation and agreed with the second recommendation, which, the Agency has indicated, it has begun to implement.
In preparing the report, 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. FDA noted in particular that advancements in toxicological science may raise new questions not addressed in FDA’s premarket review.
*The Food Contact Notification program became effective in January 2000. For more information on that program, see the Packaginglaw.com article, What is the Best Approach to Obtain FDA Clearance for Food Contact Substances?