CSPI has been a party in three lawsuits that have been brought to get FDA to do its job: Namely, to rule on the safety of phthalates, ubiquitous and harmful chemicals used in food packaging and processing equipment.
Starting in December 2021 and again in December 2026, CSPI, along with a coalition of health advocacy groups filed three related lawsuits seeking to force FDA to decide whether to ban certain phthalates in food packaging and processing materials. Earthjustice is counsel for the coalition for these cases.
Background on phthalates
Phthalates are a family of chemicals primarily used to make plastics more flexible. For decades, FDA has authorized the use of numerous phthalates in a variety of food packaging and processing materials. From there, phthalates leach into the food and beverages that we eat and drink daily, such as milk, other dairy products, meat, seafood, spices, cooking oils, baked goods, grains, and a variety of packaged and processed foods. As a result, certain phthalates can be found in most foods, making them nearly impossible to avoid.
Phthalates are hormone disruptors—chemicals that can turn on, turn off, or change the signals sent by hormones like estrogen, testosterone, thyroid hormone, and insulin—linked to a variety of health harms, including impairment of fetal genital development, poorer reproductive success, and reduced IQ. Babies and young children, as well as Black, Latino, and low-wealth individuals, face heightened risks of serious health problems from phthalate exposure compared to the general population.
The petitions
The Federal Food, Drug, and Cosmetics Act (FDCA) prohibits the use of unsafe chemicals that contact food. To protect consumers from these ubiquitous and harmful chemicals, in 2016, CSPI and other nonprofit organizations filed two Petitions (i.e., a Food Additive Petition and a Citizen Petition) urging FDA to ban phthalates in food packaging and processing materials, arguing that they were unsafe in violation of the FDCA.
The lawsuits and FDA's subsequent actions
First two lawsuits
After years of inactivity on the Petitions, in 2021, the coalition sued FDA in two related lawsuits to force the agency to respond to our 2016 requests. The suit on the Citizen Petition was filed in the U.S. District Court for the District of Columbia (“District Court Action”). The suit on the Food Additive Petition was filed in the U.S. Court of Appeals for the District of Columbia (“First DC Circuit Action”) because the relevant law required litigation be filed in a federal court of appeals by filing a Petition for Writ of Mandamus. These lawsuits covered 28 phthalates.
On May 19, 2022, FDA responded to both the Citizen and Food Additive Petitions and denied both of them. Also on May 19, FDA granted a separate industry petition requesting that FDA revoke its approval of 23 phthalates that are no longer used as food additives (the “Abandonment Petition”). Because there was only partial overlap between our Petitions and the Abandonment Petition, FDA’s grant of the latter left nine remaining phthalates authorized for use in food contact applications, including some of the most concerning chemicals.
On Jun. 21, 2022, the coalition pursued administrative appeals and filed with FDA a Request for Reconsideration of FDA’s denial of the Citizen Petition and Objections to FDA’s denial of the Food Additive Petition. On Jul. 21, 2023, FDA denied the Request for Reconsideration, and on Oct. 29, 2024, FDA denied the coalition’s Objections, thereby issuing its final decision on the 2016 Petitions.
Based on FDA responses, the coalition voluntarily dismissed without prejudice the First DC Circuit Action on Jun. 24, 2022 and the District Court Action on Jan. 23, 2025.
Third lawsuit
On Dec. 19, 2024, CSPI and the coalition filed another lawsuit in the DC Circuit (“the Second DC Circuit Action”) to challenge FDA’s October 2024 final decision to maintain approval for the use of phthalates as food additives and the agency’s outdated determinations that the use of phthalates as indirect food additives is safe. This lawsuit seeks to get FDA to re-evaluate its decades-old authorizations for the use of multiple phthalates in food packaging and food production materials. Oral argument was held in the Second DC Circuit Action on Feb. 2, 2026.
On May 27, 2026, FDA issued a report analyzing whether eight of the nine phthalates that remain approved for food additive use are “chemically or pharmacologically related” such that FDA should consider their cumulative effects in an updated safety assessment. In the report, FDA reached the conclusion our coalition urged them to reach in our Objections five years ago, namely, that certain phthalates (i.e., DEHP, DCHP, DINP, and DIOP) are related and that FDA must therefore consider their cumulative effects. While this Report may seem like some progress, unfortunately, it has no impact on FDA’s continued authorization for the use of these and other phthalates as food additives. The May Report states plainly that it is merely a preliminary “step that could inform a potential future cumulative risk assessment” for a subset of the phthalate additives. The Report includes neither a safety assessment nor regulatory recommendations, let alone regulatory changes to FDA’s approval of the phthalates.
We continue to await the court’s decision in the Second DC Circuit Action.
