FDA Food Packaging Regulation Amendments – Jay Lee’s U.S. Report (124)
- nofearljc
- Apr 7
- 2 min read
FDA Revises Food Packaging Regulations – Jay Lee’s U.S. Report (124)
FDA Gains Authority to Revoke FCN-Registered Materials Over Safety Concerns
Updated FCN List – Packaging Exporters Must Pay Attention
Ban on PFAS-Containing Packaging, Including Microwave Popcorn Bags
△ Jongchan Lee, CEO of J&B Food Consulting
The U.S. Food and Drug Administration (FDA) has announced a final rule granting the agency authority to revoke the validity of previously registered food packaging materials under the Food Contact Notification (FCN) program. This rule aims to streamline administrative procedures and enhance chemical safety in food packaging.
Previously, the FDA allowed food contact materials with an estimated daily intake of 0.5 ppb to 1 ppm to be approved within 120 days upon submission of the required FCN documentation.
Under Title 21 of the U.S. Code of Federal Regulations (CFR), food contact substances are regulated under:
Approved Food Additives (Parts 174-179)
Pre-approved Substances (Part 181)
GRAS-Registered Substances (Parts 182-186)
Exempt Substances (Part 170.39)
Now, the FDA has the power to revoke an FCN registration if safety concerns arise. Additionally, manufacturers and suppliers will be notified of the FDA’s decision and given the opportunity to appeal.
The final rule explicitly grants the FDA authority to withdraw approvals if manufacturers fail to provide necessary safety data or address concerns. Even if companies voluntarily withdraw an approved use, the FDA can still revoke approval based on safety concerns.
Decisions regarding revoked FCNs will be published in the Federal Register, and the official revocation date will be the date of publication. Once an FCN is revoked, the specified food contact material can no longer be legally used. The FDA will also update the FCN list on its website, and packaging exporters must review these updates carefully.
Ban on PFAS-Containing Food Packaging
The FDA has also decided to phase out food packaging containing per- and polyfluoroalkyl substances (PFAS), often called ""forever chemicals.""
At the end of February, the FDA banned the use of PFAS in various food packaging materials, including:
Fast food wrappers
Microwave popcorn bags
Takeout containers
Pet food bags
PFAS coatings have been widely used in paper and cardboard packaging to prevent grease leakage and improve water resistance. Commonly found in fast-food wrappers, microwave popcorn bags, takeout containers, and pet food packaging, these materials will no longer be allowed for food contact use in the U.S.
Compliance Risks for Exporters
Companies exporting food to the U.S. must verify whether their packaging contains PFAS. Failure to comply could expose importers to consumer lawsuits in the U.S.
Additionally, California's Proposition 65 already regulates harmful chemicals in packaging, further increasing legal and regulatory risks. While Korea's current testing standards focus mainly on residual organic compounds, PFAS testing must now be added to ensure compliance with U.S. regulations.
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jay@jnbfoodconsulting.com or 714-873-5566
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