Packaging Chemicals—After Being OK’d for Use—Get Another Look

By Eric F. Greenberg, Attorney-at-law

FDA will hold a September 25 public meeting about an “enhanced systematic process” for “post-market assessment of chemicals in food.” The agency made clear that food contact substances, such as those from food packaging, are part of the project, as are ingredients considered Generally Recognized As Safe (GRAS), food additives, color additives, and contaminants.

This new FDA effort may end up placing new obligations on packagers, though if your work involves food packaging, you are well familiar with the various efforts you and others already apply to assuring their safety.

Indeed, there’s a little-known community that spends an extraordinary amount of time doing assorted things to check out packaging material safety, including collecting information from suppliers, reviewing documentation and guarantee letters, and commissioning laboratory testing. This community includes regulatory affairs professionals, scientists, engineers, regulators and, of course, lawyers.

I say it’s a ‘little-known’ community because it’s been my perception, based on years practicing in this area, that there are large swaths of the packaging industry—and lawmakers, and the general public—who have no earthly idea that any of this is going on.

But then, awareness is pretty minimal of the engineering genius underlying food packaging materials and structures, and of packaging overall, too. Few average consumers are aware of the reason the plastic used to make a bag of chips is different from that used for a sandwich bag, or understand the complexities of multi-layer, multi-material structures, or are aware of the presence of modified atmospheres within packages.

Here’s what this community spends its days and nights thinking about: The Federal Food, Drug and Cosmetic Act and related regulations require that food packaging materials will not adulterate the food, and therefore that they be safe, and that they will not impart off-odor, taste, or color to the packaged food.

Legally, a substance can’t be in contact with food unless it’s a food additive cleared for that particular use, or unless it’s otherwise exempt because, for example, the exposure involved is GRAS, or you can confirm that the substance won’t get into the food at all.

The foundation of any clearance is a conclusion that the intended use is safe, that is, that there’s a reasonable certainty that no harm will result from the use, taking into consideration an estimate of the amount of the substance that will get into the average American’s diet.

The emphasis has been on establishing in the first instance that exposures to a substance getting into food from its packaging are safe, carefully confirming the substance’s chemical identity, and the safety of substances that are expected to migrate or otherwise come out of the packaging materials and get into food when they are used as intended.

Moreover, the legal obligations don’t stop there. A packager always has an ongoing obligation to assure that the substance used is exactly the one originally evaluated, and that it is behaving as expected in actual use via preventive controls such as Good Manufacturing Practice.

What’s more, the FDA regulations have long included provisions that allow for FDA, or packaging companies, to recognize that their prior safety conclusions might no longer appear to be valid, based on newer or changed toxicological information. In past years, under the current regulatory framework, FDA has withdrawn some existing clearances for substances, such as PFAS, BPA, and some food additives directly added to food.

And yet, for many years, some advocates have raised concerns that the current regulatory framework doesn’t incorporate a thorough enough system for identifying and acting on substances whose past safety profile appears later to be incorrect.

So now, FDA has planned this public meeting to help it develop a more formal program. It notes, “The purpose of this meeting is for FDA to share information about the development of FDA’s enhanced systematic process for post-market assessment of chemicals in food including considerations for identifying and prioritizing food chemicals currently in the market for safety reviews. During the event, there will also be presentations from stakeholders as they share their perspectives on this topic.”

FDA is already active in watching over the safety of chemicals in food. It published a list of chemicals it is keeping an eye on and points to its current activities that include: its ongoing evaluation of safety information about substances authorized for use; monitoring the food supply for contaminants; and research and method development to assure that packagers and the agency can identify, minimize, and estimate levels of exposure to potentially unsafe substances, among others.

The public meeting will address overall principles and steps for a post-market assessment process; prioritizing chemicals for post-market assessment; and engaging stakeholders throughout the process.

The results of FDA’s new efforts are, of course, unknown at this time, but here’s hoping they won’t include new and burdensome obligations on packagers, such as reporting or recordkeeping, above and beyond what’s currently required. Due consideration should be given to the extensive efforts at assuring chemical safety that food packagers, packaging makers, and their suppliers already undertake.

The September 25 meeting will be held at the FDA’s White Oak, Md. campus, and virtual participation will be available. For more information on the public meeting, see pwgo.to/8342.

Also, comments on the overall program will be accepted by FDA until December 6, 2024, so you have time to get your dibs in even if you can’t participate in the September meeting. PW

Eric Greenberg can be reached at [email protected]. Or visit his firm’s website at www.ericfgreenbergpc.com.

INFORMATIONAL ONLY, NOT LEGAL ADVICE.