Legal Angle: U.S. Calls for Changes in Regulation of Food-Contact Materials
A November government oversight report found what it calls deficiencies, and recommends changes, in how the Food and Drug Administration regulates food-contact substances. Plastics are front-and-center in the report, which is titled “Food Safety: FDA Oversight of Substances Used in Manufacturing, Packaging and Transporting Food Could Be Strengthened.”
The report is from the Government Accountability Office and was created with input from stakeholders inside and outside government. It is the latest chapter in a long-running saga, which has seen various activities targeting food-packaging materials, especially plastics. Consumer advocacy groups and internal government watchdogs have complained about FDA’s oversight of food-contact materials, especially substances considered Generally Recognized as Safe (GRAS), in petitions to regulators, an unsuccessful lawsuit and before Congress.
The report emphasizes post-market actions, i.e., revisiting the safety of substances on the market that were previously found to be safe for food contact, but now might be considered safe. It describes three examples of FDA stopping the use of food-contact substances: per- and polyfluoroalkyl substances (PFAS), short-chain PFAS and diphenyl ketone (benzophenone).
The report is focused on the substances FDA has cleared and doesn’t encompass companies’ self-determined GRAS conclusions. Objections relating to such conclusions, including the fact that FDA isn’t aware of them, have been the subject of other proposals to change the law.
For example, there’s a bill under consideration in Congress that would create the “Ensuring Safe and Toxic-Free Foods Act of 2022.” If passed, it would instruct FDA to revise regulations about GRAS substances such that manufacturers would have to give FDA notice of their GRAS conclusions, among other changes. (The bill has been referred to a committee and, if reintroduced when Congress convenes in January, would be renamed to reflect the new year.)
The most significant focus of the new GAO report is the workings of FDA’s Food Contact Notification (FCN) program, analyzing FDA data from 2000 to 2022. It notes that, since 2000, FCNs “represented about 93 percent of FDA’s total reviews resulting in food-contact substances being allowed to enter the market.”
The report points out advantages of FCNs, namely, that the clearance they provide is company-specific, and that they have a four-month FDA review process, which is relatively swift and predictable. (Another advantage is that the law places the burden on FDA to object within that four-month review period, otherwise the FCN becomes effective.)
The report recommends that FDA “… should request [from Congress] 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.” Also, “The Commissioner of FDA should direct the agency to track the dates of the last pre- and post-market reviews for all food-contact substances in a way that allows FDA to readily identify substances.”
The GAO report is another front in the ongoing effort toward making changes in how FDA regulates food-contact substances.
Or, maybe it’s better to describe it as another potential legal burden for plastics in food packaging. Together with recent state government actions against substances found in plastics, notably the model law banning PFAS and phthalates that is in the process of being adopted in multiple states, and California’s onerous law against many single-use plastics, it appears that plastics in food packaging are facing significant headwinds from many sources.
Yet, there’s a logical flaw in some of the long-expressed views of NGOs and others. Their view seems to be that, because there are a few examples of substances whose safety is now in question, the whole system is failing and needs to be changed. While some proposed changes make sense, a full overhaul seems like an overreaction. Thankfully, this report isn’t calling for that.
When governments consider what they want to do on these issues—as is the case with any public policy choice—a balancing of several considerations will have to take place. It will be up to Congress, FDA and industry stakeholders to hash out the correct balance among the need to protect the public health, available funds and available personnel. We hope, they will consider, as well, whether new requirements really achieve better public protection in light of any new burdens they place on industry.
Eric F. Greenberg is Principal Attorney of Eric F. Greenberg, PC, Chicago, with a practice concentrated in food and drug law, packaging law and commercial litigation. Website is www.Ericfgreenbergpc.com.
This column is informational only and not legal advice. A version of this column appeared in the Dec. 22 edition of Packaging World.