FDA Reaffirms Final Rule on Phthalates and Denies Request for Public Hearing

On October 29, 2024, the U.S. Food and Drug Administration (FDA) responded to objections raised by the Environmental Defense Fund and other non-government organizations (NGOs) regarding a 2022 final rule that removed the clearances for 25 ortho-phthalates due to industry abandonment. FDA announced that it evaluated the objections and concluded that they did not provide a basis for modifying the final rule. (The Federal Register announcement on the decision can be found at 89 Fed. Reg. 86,239 (Oct. 30, 2024).)

At the same time, in 2022, FDA denied a separate Food Additive Petition (FAP) submitted by a group of NGOs requesting that the Agency remove authorization for 28 phthalates for safety reasons. In its denial of the NGOs’ FAP, FDA explained that the petition neither supported grouping the 28 phthalates into a single class nor demonstrated that the proposed class of phthalates was no longer safe for the approved food additive uses. (For more details on the 2022 decisions, see the packaginglaw.com article, FDA Issues Decisions on Phthalates Petitions.)

The NGOs objected to FDA’s denial of their FAP and requested a hearing in response to the denial order. Their submission included eight objections, some with multiple parts. However, after evaluating the objections, FDA concluded that the submission does not provide a basis to support modifying or revoking the denial. (FDA’s response to the objections can be found at 89 Fed. Reg. 86,290-86,305 (Oct. 30, 2024).)

In the October 29th announcement, FDA stated that it is working on an updated safety assessment of the remaining authorized uses of phthalates. As part of that assessment, FDA is reviewing the information it received through a request for information issued in 2022 regarding food‑contact uses of ortho-phthalates. The Agency also pointed out that 23 of the 28 phthalates that are the subject of the NGOs’ petition are no longer in use.