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FDA un-regulates pizza packaging products: A good example or a bad one?

Today’s lesson: What’s true today might not be true tomorrow.

Eric Greenberg
Eric Greenberg

As you probably know, FDA clearances for uses of food-contact substances and other food additives are made on the basis of scientific information about their safety. If the scientific information were to change, the clearance could be invalidated. Same for a company’s conclusion that relevant experts believe their use of a substance is Generally Recognized As Safe—could be true today, but not tomorrow if information changes.

FDA did something in early January that it rarely does: It withdrew, eliminated, deleted, invalidated parts of a regulation that had allowed certain substances, namely some perfluoroalkyl ethyls, to be used as oil and water repellants in paper and paperboard (such as in pizza boxes). FDA said, in announcing the Final Rule making the change, that 21 CFR section 176.170 should be amended to remove “the entries for ‘Diethanolamine salts of mono- and bis,’ ‘Pentanoic acid,’ and ‘Perfluoroalkyl substituted phosphate ester acids.’”

As explained below, this might not be a perfect example of changed safety data leading to a change in the regulations.

FDA took this action in response to petitions filed by the Natural Resources Defense Council, Center for Science in the Public Interest, and several other advocacy groups.

In summary, FDA agreed to the petitions because it agreed the uses of the substances could no longer be said to be “safe.” To understand what they mean, let’s step back a couple of steps and review.

Generally, if your packaging material may reasonably be expected to get into food, it’s considered a “food additive” under the law and needs FDA clearance for your use, unless the use is Generally Recognized As Safe or the subject of a Prior Sanction.

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