This lawsuit was 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.

In December 2021, CSPI along with a coalition of health advocacy groups filed two, related lawsuits seeking to force FDA to decide whether to ban twenty-eight phthalates in food packaging and processing materials.

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

After years of inactivity on the Petitions, CSPI as part of a coalition of public interest organizations sued FDA to force the agency to respond to our 2016 requests. Specifically, we argued that FDA’s delay violated the FDCA’s requirement that FDA respond to the Food Additive Petition within 180 days and that FDA violated the Administrative Procedure Act by not responding to the Petitions within a reasonable time.

The suit on the Citizen Petition was filed in the U.S. District Court for the District of Columbia. The suit on the Food Additive Petition was filed in the U.S. Court of Appeals for the District of Columbia because the relevant law required litigation be filed in a federal court of appeals by filing a Petition for Writ of Mandamus. On May 19, 2022, FDA responded to both the Citizen and Food Additive Petitions and denied both of them. In its responses, FDA determined that the Petitions, which proposed a cumulative safety assessment of all 28 phthalates, failed to account for differences in the various chemicals’ structures and toxicological effects, undermining the safety analysis. On May 19th, FDA also 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 leaves nine remaining phthalates authorized for use in food contact applications, including some of the most concerning chemicals.

On June 21, 2022, the coalition 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 July 21, 2023, FDA denied the Request for Reconsideration. It has yet to rule on the coalition’s Objections.

Based on FDA responses, the coalition voluntarily dismissed the Court of Appeals action and awaits the FDA’s response to the coalition’s Objections.

The coalition filed an Amended Complaint in the District Court case, challenging the FDA’s denial of its Citizen Petition. The Amended Complaint alleges, among other things, that FDA’s denial was arbitrary and capricious because it applied the wrong legal standard and failed to address substantial evidence demonstrating that phthalates are not safe for food contact use. This District Court case is stayed pending FDA’s responses to the coalition’s Objections.

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