On December 19, 2024, a group of health advocates represented by nonprofit law organization Earthjustice sued the U.S. Food and Drug Administration (FDA) to force the agency to reevaluate its decades-old authorizations for the use of certain phthalates in food contact materials.
The plaintiffs filed the lawsuit because FDA denied their petition requesting the agency revoke the food contact approvals for 28 phthalates. FDA says approvals for the majority of those phthalates have been revoked, and that the remaining phthalates are slated for safety reassessment.
Earthjustice filed the lawsuit in the U.S. Court of Appeals for the D.C. Circuit on behalf of Alaska Community Action on Toxics, Breast Cancer Prevention Partners, the Center for Environmental Health, the Center for Food Safety, the Center for Science in the Public Interest (CSPI), Defend Our Health, the Environmental Defense Fund, and the Learning Disabilities Association of Illinois.
The Phthalate Problem
Phthalates are chemicals used to make plastics more flexible, durable, and transparent. At present, nine phthalates are approved by FDA for use in food contact materials. There is evidence linking phthalates to birth defects, infertility, preterm birth, impaired childhood neurodevelopment, and other adverse effects to human health. For example, a 2022 study demonstrated a causal link between di-(2-ethylhexyl) (DEHP), a phthalate still authorized for food contact, and the growth of tumors.
Food is a major route of exposure to phthalates. In January 2024, testing conducted by Consumer Reports found the presence of phthalates in nearly every food that was sampled.
According to FDA, the existing approved food contact uses for phthalates are slated for review—but the agency is not moving quickly enough for consumer advocates and Congress members. Earthjustice says FDA’s authorizations are based on safety assessments that are at least 40 years old. “The harms from phthalates leaching into our foods are serious, and most importantly, they are preventable,” said CSPI President Peter G. Lurie, M.D., M.P.H. “FDA has failed to consider decades of accumulating scientific evidence in the record that the continued use of phthalates is unsafe, and the agency also failed to fully consider the cumulative effects of exposure to multiple phthalates, as the law requires.”
Petition to Revoke Food Contact Authorizations for Phthalates Denied; Senators Take Petitioners Side
The Earthjustice lawsuit was filed on behalf of consumer protection groups that submitted a petition (Food Additive Petition 6B4815) to FDA in 2016 requesting the agency amend or revoke specified regulations to no longer provide for the food contact use of 28 ortho-phthalates. According to Earthjustice, FDA did not respond to this petition for six years, until the petitioners forced a response by suing the agency in 2021. FDA then denied the petition in 2022, and upheld the denial decision after pressures to reconsider in October 2024.
The lawsuit filed against FDA is not the only external pressure the agency is facing to revoke authorizations for phthalate uses in food contact materials. On October 3, just weeks prior to FDA’s decision to uphold its denial of Food Additive Petition 6B4815, U.S. Senators Edward Markey (D-MA) and Cory Booker (D-NJ) wrote a letter to FDA Commissioner Robert M. Califf, M.D., urging the agency to revoke its authorization for phthalates in food contact materials. The senators argued that FDA has the legal authority to independently revoke its authorizations for phthalates if the approved food contact uses do not meet the safety standards established by the Food, Drug, and Cosmetic Act, and encouraged FDA to conduct a review of current scientific evidence to make such a determination. The senators also suggested FDA revoke its authorization of phthalates in food contact materials by granting the relief requested in the (then-pending) objections to FDA’s denial of Food Additive Petition 6B4815.
FDA’s Story: Approvals for Some Phthalates Requested by Petitioners Have Been Revoked; the Rest are Under Review
Alongside its denial of the petition in 2022, FDA did revoke authorizations for the food contact use of 23 phthalates (which were named in Food Additive Petition 6B4815) and two other substances based on a separate petition filed by the Flexible Vinyl Alliance in 2018 (Food Additive Petition 8B4820) that demonstrated the use of these substances had been abandoned by industry. The action removed the phthalates from the list of substances authorized by FDA in the Code of Federal Regulations Title 21, Parts 175–178, effectively limiting the use of phthalates in food contact applications to nine chemicals (eight used as plasticizers and one used as a monomer). At the same time, FDA also requested information on the current specific food contact uses, use levels, dietary exposure, and safety data for the eight phthalates authorized for use as plasticizers, which the agency said it may use to update dietary exposure estimates and safety assessments.
In October 2024, after receiving objections to the final rule amending the authorizations for phthalates, FDA doubled down on its decision. The agency said that the groups that filed Food Additive Petition 6B4815 did not establish a basis for modifying or revoking FDA’s denial order as requested in the objections. FDA said one of the reasons it denied the petition is because the petition did not provide sufficient evidence to support the requested action of grouping the 28 phthalates as a class or revoking the authorizations for the 28 phthalates on the basis that they were unsafe as a class. FDA said that it found the available information does not support grouping all 28 phthalate chemicals into a single class assessment, which was the basis of the petition.
FDA also noted that 23 of the 28 phthalates named in the consumer advocates’ petition 6B4815 were no longer in use, and were revoked in the 2022 final rule issued in response to the Flexible Vinyl Alliance’s petition 8B4820. In its denial letter, FDA said that approvals remain for only three of the substances named in petition 6B4815—DEHP, dicyclohexyl phthalate (DCHP), and diisononyl phthalate (DINP).
The agency also expressed that it is currently conducting an updated safety assessment of the remaining authorized uses of phthalates, which are included in FDA’s list of select chemicals under FDA review, and pointed at its request for information on the remaining approved phthalates.
