On October 29, 2024, the US Food and Drug Administration (FDA) provided an Update on Phthalates in Food Packaging and Food Contact Applications (the Update), affirming its 2022 Final Rule to remove 25 plasticizers in various food contact applications, as well as its denial of a consumer group petition to amend or revoke regulations for the food contact use of 28 phthalates.

While the current regulations will remain unchanged for the moment, the Agency noted that phthalates are included on the List of Select Chemicals in the Food Supply Under FDA Review. Jim Jones, the Deputy Commissioner for Foods leading the new Human Foods Program, has brought heightened focus on chemical safety since arriving at FDA.

The Update addresses objections to FDA’s issuance of its 2022 Final Rule that amended the food additive regulations to no longer provide for the use of 25 plasticizers in various food contact applications. The 2022 Final Rule granted a petition submitted by the Flexible Vinyl Alliance, which demonstrated that industry had abandoned the food contact use of most previously authorized phthalates. The Environmental Defense Fund, Breast Cancer Prevention Partners, Environmental Protection Network, Environmental Working Group, and Healthy Babies Bright Futures objected to the 2022 Final Rule because it did not cover diallyl phthalate (DAP), thus leaving intact the authorized use of that chemical. FDA’s response explained that the objections did not provide any basis for the Agency to modify the 2022 Final Rule.

In addition, FDA’s Update discusses its response to objections filed by several public interest groups to FDA’s 2022 denial of the interest groups’ 2016 petition to amend or revoke regulations for the food contact use of 28 phthalates. In its original denial of the petition, FDA noted 23 of the 28 substances – those that were abandoned – were revoked by the 2022 Final Rule discussed above. In its response to these objections, FDA concluded that the objectors did not establish a basis for modifying or revoking the denial order. More specifically, the Agency explained that the petition was originally denied because “it did not establish, through data and information, sufficient support to take the requested action of grouping the 28 phthalates as a class and revoking the authorizations for the 28 phthalates on the basis that they were unsafe as a class.” In its Update, FDA reaffirmed its original conclusion that the available data “does not support grouping all 28 phthalate chemicals into a single class assessment.”

FDA’s Update response also addresses the toxicological evidence presented by petitioners to FDA, finding it to be insufficient to support the claim that the use of authorized phthalates in food contact applications is harmful.

Conclusion

While FDA’s announcement preserves the status quo for the moment, phthalates in food contact applications are on FDA’s list for continued assessment. As noted in DLA Piper's brief alert, FDA will be establishing a formal process for the post-market assessment of chemicals in food, including food additives, substances that are generally recognized as safe (GRAS), color additives, food contact substances, and unintentional contaminants (eg, environmental contaminants).

FDA is accepting comments on the proposed factors it will consider to ensure its assessments are fit for purpose. Comments on the proposal are due December 6, 2024.

For any additional information or questions, please reach out to Sharon Mayl or Greg Sperla.