Potential risk around food packaging has become a greater focus for both regulators and consumers in recent months. Certainly, there is potential risk from packaging that comes in contact with a food and it may carry the same contamination risk as that of any other food-contact surface. But “FDA does not have specific legal authority to compel companies to provide information and data on substances’ safety and extent of use,” which the Agency needs to prioritize and conduct post-market reviews of food-contact substances. GAO wants to change this.
Non-food substances, such as those used to greaseproof takeout containers, can leach into packaged food. Although FDA reviews substance information before its first use, the science is continually evolving making it important that re-evaluation be conducted when new information suggests a potential health risk. Such risks are important to assess because the mere presence of a hazard does not mean it will pose a public health risk.
To better enable the re-evaluation, GAO has recommended that FDA:
- request from Congress specific legal authority to compel companies to provide the information needed to reassess the safety of substances.
- track the dates of the last reviews for all food contact substances to allow FDA to readily identify substances that may warrant post-market review.
GAO initiated the study in response to Congressional request and concerns raised by academic, consumer, and other stakeholders that some of the substances used in food packaging may contribute to adverse health effects, such as thyroid disease and hormone disruption. The resulting report is based on GAO interviews with FDA officials and stakeholders, analysis of FDA substance-review data, and reviews of an FDA study on food-contact substance notifications and other relevant regulations and guidance.
The study found that FDA-initiated post-market reviews have helped stop the use of three types of substances after identifying safety concerns – long-chain PFAS, short-chain PFAS (which emerged to replace long-chain) and diphenyl ketone. To eliminate these, FDA worked with manufacturers to phase out use and/or revoked the regulation authorizing the use in contact with food.
However, because FDA has limited access to unpublished information and data from companies on the safety of food contact substances and their uses, and the agency’s food-contact substance review date tracking does not readily allow for the summarizing of substances that may warrant additional review, the implementation of a risk-informed post-market review process is impeded.
In response to the report, FDA agreed with the recommendation for better date tracking, with FDA officials stating they have begun to develop options for the systematic reassessment. However, the agency “neither agreed nor disagreed” with the recommendation to request stronger authorities for gaining company information, though it will consider its implementation in its report to the House Appropriations Committee scheduled for March 2023.
What does this mean to the industry? First off, the industry is unlikely to see any immediate impact, given that FDA will not be going before Congress until March 2023. But should new authorities then be granted to FDA, there could be a significant impact not only on packaging companies, but on the manufacturers, processors, retailers, and foodservice establishments that use packaging that is called into question. We doubt that Congress will make sweeping changes, but there is a clear message to industry here that potential and actual risks associated with packaging are clearly on the FDA’s radar and should be part of a food company’s risk-management thinking.
With the report specifically mentioning “greaseproof paper takeout containers,” foodservice companies may want to begin at least researching PFAS-free options to be prepared for the potential banning of current packaging. Along the same lines, all food companies up and down the supply chain need to be aware of the potential banning of currently used packaging, even requesting supplier information on the substances used in their packaging, though they may not be compelled to comply with a customer request any more than with an FDA request. It has been our experience that such requests are not always met with clear risk-based responses. So, working closely with packaging manufacturers to collectively manage the risk is a prudent approach.
While certain chemicals in food can be hazardous at high levels, there is a continual battle between the consumer perception that all chemicals (and unpronounceable ingredients) in foods are bad and the complexity of chasing zero in relation to detectability vs. preventability. It is a challenge we have discussed at length in our food safety articles, and it looks to be one we will continue discussing into the future as perception and science continue to be at odds.