The Food and Drug Administration (FDA) today affirmed its May 2022 decision to allow the ongoing use of phthalates, a class of toxic chemicals, in food packaging and food production equipment. Health and environmental advocates had asked FDA to reconsider that decision based on mounting scientific evidence that phthalates in food cause serious health harm.

Phthalates are chemicals that hurt people’s hormonal systems and are linked to a range of health harms, including preterm birth, birth defects, infertility, miscarriage, breast cancer, diabetes, and asthma. Phthalates also harm the developing brain, leading to reduced IQ and attention and behavior disorders in children. Babies and young children are most vulnerable to harm from phthalates and suffer the greatest exposure.

People of color in all age groups, as well as economically insecure people, also face higher risks of serious health problems from exposure to phthalates compared to the general population. Safer substitutes for these chemicals are readily available.

“There is overwhelming evidence that phthalates in our food cause life-altering damage to people’s health, including the health of babies and young children,” said Earthjustice Attorney Katherine O’Brien. “Rather than fulfill its duty to protect public health from this toxic exposure, FDA has wasted years on delay tactics while both the evidence of phthalates’ toxic effects and the human health toll continue to grow.”

In 2016, a coalition of health and environmental advocates petitioned the FDA to ban companies’ use of phthalates in plastic used to package and produce food. After unlawfully delaying its decision for years while evidence of phthalates’ hazards mounted, FDA denied the petition in May 2022.

On behalf of Alaska Community Action on Toxics, Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Defend Our Health, Environmental Defense Fund, and Learning Disabilities Association of America, Earthjustice formally requested that the agency reconsider its decision denying the petition.

Despite decades of scientific studies linking phthalates to serious and irreversible health harms, FDA has continued to allow the use of phthalates in food packaging and processing materials — including phthalates that were banned years ago from use in children’s products because they are not safe.

Federal law prohibits the use of chemicals in food or food-contact materials unless the scientific evidence before FDA demonstrates they are safe. The FDA must apply this rule by assessing new chemicals before they enter the market and by reviewing whether chemicals approved years ago are, in fact, safe based on current science.

Quotes from clients and partners:

“The continued use of phthalates in food processing and packaging represents an ongoing public health threat with serious implications for babies, young children, and women in particular,” said Dr. Peter G. Lurie, president of the Center for Science in the Public Interest. “The risk of harm outweighs whatever advantages phthalates offer to the food industry. I hope in time, the FDA reverses the ill-considered decision it announced today. And the food industry needn’t wait for the FDA to start eliminating these toxicants on their own.”

“Babies in the U.S. are born pre-polluted with harmful phthalates, and food packaging and processing equipment is one of the largest remaining sources of unnecessary exposure. Prenatal development is a perilous time, and expecting parents should not have to worry about genital malformations, reproductive problems, and adverse neurodevelopment in their children because the FDA failed to act on phthalates,” said Dr. Deborah Bennett, Professor, University of California, Davis. “By refusing to grant the petition FDA is out of step with the Consumer Product Safety Commission, which banned these phthalates from toys to protect children from their harmful effects, and many other countries, who have long ago phased them out of use in food packaging, personal care products, and other common sources.”

“Phthalates are one of the most thoroughly studied classes of chemicals, and the science clearly indicates they pose a substantial and preventable health risk, particularly to children, people of color, and people with low incomes. Harms include genital and other reproductive malformations, preterm birth, and problems with brain development, learning, and attention,” said Dr. Heather Patisaul, Professor and Associate Dean for Research at North Carolina State University. “The FDA is entrusted with keeping food safe for all Americans. By failing to act on phthalates in food contact materials, the FDA is violating that trust.”

“FDA has once again failed the public by ignoring the harmful effects of phthalates on our health,” said Kristina Sinclair, associate attorney at the Center for Food Safety. “The agency’s refusal to listen to the science will have detrimental health effects for years to come.”

“In its decision today, FDA goes to great lengths to avoid a rigorous, affirmative review of the risks posed by ortho-phthalates in food,” said Tom Neltner, Senior Director of Safer Chemicals at the Environmental Defense Fund. “In May, members of Congress called for FDA to hold a public hearing based on previous objections to a related ortho-phthalates petition. FDA’s decision today—its failure to act on those objections and hold a public hearing—erodes the agency’s credibility when it comes to food chemical safety assessments.”

“No child should be exposed to phthalates in their food,” said Tracy Gregoire, director of the Healthy Children Project at the Learning Disabilities Association of America. “These chemicals are linked to lifelong learning challenges, including learning disabilities, ADHD, and cognitive deficits. FDA has the power and the responsibility to protect children’s brain health by taking action on phthalates now.”