FDA Defends Phthalate Food Additive Authorizations in Legal Challenge
FDA acted reasonably when it denied a petition seeking to remove authorization for five phthalate chemicals used as food additives, the FDA told the D.C. Circuit on August 13, 2025.
The case, Alaska Community Action on Toxics v. FDA, No. 24-1382, marks the latest dispute over the safety of chemicals long used in food packaging and processing. It centers on five phthalates—DCHP, DEHP, DINP, DIDP, and DAP—that remain approved for food use after industry voluntarily revoked authorizations for 23 other phthalates. FDA denied the petitioners’ removal request in 2022 and overruled their objections in 2024, prompting the current appeal.
Decades-Old Safety Data
The petitioners argue that FDA’s denial ignores mounting evidence of phthalates’ hazards. “FDA’s authorizations rely on safety assessments conducted at least 40 years ago,” their March 28, 2025, opening brief states. “In the intervening decades, the evidence of phthalates’ serious health risks—including their capacity to harm children’s brain development and cause life-altering changes in cognition and behavior—has expanded substantially.” They contend that FDA “arbitrarily dismissed” evidence of toxicity and unsafe exposure levels.
In its opening brief, FDA contends that the petitioners have not established standing to bring the case. Even the “most specific declaration…fails to provide any objective evidence of imminent harm,” and the petitioners’ brief fails to show “a ‘substantial probability’ their identified members will suffer specific health effects,” FDA states.
Burden of Proof
If the court reaches the merits, a key dispute will be which party bears the burden of proof. The petitioners argue that the Federal Food, Drug, and Cosmetic Act (FFDCA) only requires “evidence that raises ‘significant questions as to the safety of the authorized uses,’” citing FDA’s 2016 revocations of three PFAS additives as precedent. FDA counters that the petitioners are trying to “sidestep” their evidentiary obligations. “Nothing in the statute supports an approach whereby repeal petitions benefit from vastly more lenient burdens than authorization petitions,” the agency’s brief states.
On the factual record, FDA maintains its denial rested on a “fair evaluation” and that its conclusions “about the lack of sufficient scientific data…merit substantial deference.” The agency alleges flaws in the petition, including its “central premise” that phthalates could be treated as a class—but the petitioners argue that issue was mooted when industry revoked most phthalate authorizations.
A final question is whether FDA was required to hold an administrative hearing before overruling the petitioners’ objections to the petition denial.
More on FDA’s 2022 petition denial can be found in a previous post.
