By: Christopher A. Parrella, Esq., CPC, CHC, CPCO Parrella Health Law, Boston, Ma. A Health Care Provider Defense and Compliance Firm

The FDA’s recent decision to remove 25 ortho-phthalate plasticizers from food additive regulations underscores its commitment to updating safety standards for food-contact materials. This move reflects an evolving approach to chemical safety assessments, particularly in response to shifting toxicology concerns and industry feedback.

Background on the FDA’s Decision

In October 2024, the FDA reaffirmed its May 2022 Final Rule amending food additive regulations to eliminate 25 ortho-phthalates from 21 C.F.R. Parts 175, 176, 177, and 178. These changes were spurred by a petition from the Flexible Vinyl Alliance and aimed to address safety concerns associated with phthalates used in food-contact applications. Although objections were raised by several non-governmental organizations (NGOs), the FDA maintained that the objections failed to provide sufficient grounds to alter the Final Rule.

The FDA clarified that:

23 of the 25 plasticizers were no longer in use.

A grouping of all phthalates into a single-class assessment, as proposed by the NGOs, lacked scientific support.

The agency would continue evaluating the remaining authorized uses of phthalates through updated safety assessments.

Implications for Specialty Chemical Companies

For manufacturers and stakeholders, the removal of these plasticizers is a clear signal to monitor regulatory developments closely. As the FDA begins post-market assessments of other food-contact materials, companies should prepare for similar scrutiny of longstanding chemical clearances. The FDA’s methodology, as outlined in its recent public meeting on post-market chemical assessments, is likely to set a precedent for future evaluations.

What’s Next?

The FDA’s focus now shifts to the remaining phthalates authorized for food-contact uses. Stakeholders can expect:

Enhanced systematic post-market assessments of food-contact chemicals.

Opportunities for public comment, with the current comment period on FDA’s assessment proposal open until December 6, 2024.

Potential regulatory actions based on the outcomes of ongoing safety evaluations.

Key Takeaways for Compliance

Monitor Regulatory Updates: Companies should stay informed about the FDA’s evolving requirements for food-contact materials.

Prepare for Post-Market Assessments: Proactively review the safety and compliance of authorized substances in food-contact applications.

Engage in Public Comment Opportunities: Provide industry insights during comment periods to help shape regulatory outcomes.

The FDA’s actions highlight the importance of aligning chemical use with current safety standards to maintain compliance and consumer trust.

Navigating Regulatory Changes? We Can Help. Parrella Health Law specializes in compliance guidance for the food, pharmaceutical, and healthcare industries. If your organization is affected by these regulatory changes or anticipates similar reviews, our team can assist in ensuring compliance and minimizing risk.

For questions or assistance, contact Parrella Health Law at 857-328-0382 or email Chris directly at cparrella@parrellahealthlaw.com. Let us help you stay ahead of regulatory shifts.