FDA Allows Hormone-Disrupting Phthalates in Food Packaging

The Food and Drug Administration (FDA) today denied petitions submitted by health and environmental advocates in 2016 to ban phthalates from food packaging and food production equipment. Studies show that these toxic petrochemicals leach into food and drinks, causing serious harm to human health. Today's decision allows for phthalate contamination of food and drinks--ranging from infant formula to meat, milk, spices, and cooking oils--to continue, despite the fact that Congress determined more than a decade ago that several of these chemicals are too dangerous to use in children's toys. At the same time, FDA acknowledged that its safety assessment for food-contact uses of phthalates is out of date and requested new information from the public.

Phthalates interfere with hormone-regulated processes in the body and are linked to a range of health harms including 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.

"FDA's decision recklessly green-lights ongoing contamination of our food with phthalates, putting another generation of children at risk of life-altering harm and exacerbating health inequities experienced by Black and Latina women," said Earthjustice attorney Katherine O'Brien. "FDA's announcement that it will now start reviewing new data on phthalate safety--six years after advocates sounded the alarm--is outrageous and seeks to sidestep FDA's legal duty."

Federal law prohibits the use of chemical additives in food or food-contact materials, unless the available scientific evidence establishes that the additives are safe, taking into account the cumulative effect of all related chemicals in the diet. FDA is charged with implementing this mandate by evaluating new food additives and reviewing the safety of additives already on the market when new evidence shows that they are not safe.

Given the well-established--and growing--body of studies linking phthalate exposure through food and drinks to serious health harms, a coalition of advocacy groups submitted two related petitions asking FDA to ban phthalates as food additives in March 2016. Despite a legal mandate to make a final decision on the principal petition within 180 days, FDA sat on the petition for years. Advocates sued FDA in federal court in December 2021, forcing the agency to finally make a decision.

FDA today also granted a plastics industry petition to revoke federal approval for multiple phthalates added to food packaging and processing equipment based on industry assertions that those uses have been abandoned. But FDA's decisions leave multiple phthalates--including substances with the most well-developed body of scientific evidence demonstrating their toxic effects--on the market. In addition to food and drinks, phthalates can be found in personal care products, cosmetics, pharmaceuticals, cleaning products, building materials, and other consumer products. The cumulative exposure that people experience to multiple phthalates from numerous sources increases their risk of health harms.

The 2016 petitions were submitted by Earthjustice, Environmental Defense Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Improving Kids' Environment, Learning Disabilities Association of America, Breast Cancer Prevention Partners, and Natural Resources Defense Council. Defend Our Health and Alaska Community Action on Toxics joined the litigation to force FDA action on the petitions after years of delay.

Quotes from our clients:

"We submitted these petitions in 2016. The law required a decision several years ago. FDA's failure to act until they were sued is consistent with its broader failings laid bare by Politico last month," said Tom Neltner, Senior Director, Safer Chemicals for the Environmental Defense Fund. "Despite the extra time, FDA has continued to ignore the widespread contamination of food by ortho-phthalates and related chemicals in our food and the cumulative effect these chemicals have on children's health. It's outrageous that FDA decided chemicals banned from children's toys should remain in the food we eat. Families deserve better from FDA."

"Phthalates which put children at risk for lifelong learning challenges, ADHD and lower IQ don't belong in our food supply," said Tracy Gregoire, Director of the Healthy Children Project at the Learning Disabilities Association of America. "FDA has the power and the responsibility to protect children's brain health but is once again failing to protect our children."

"For too long, the FDA has largely remained on the sidelines as concerns have mounted over phthalates in food, exposing all of us to unnecessary risk, especially infants, young children, and Black and Latina women," said Dr. Peter G. Lurie, president of Center for Science in the Public Interest (CSPI). "With today's decision, the FDA is signaling its intent to remain planted on the sidelines, prolonging an already protracted and profound environmental injustice. I fear it's a decision the agency will come to regret as we learn even more about the adverse health impacts of these discredited chemicals on vulnerable members of our society."

"FDA has failed the public by ignoring the growing evidence of phthalates' harmful effects on our health," said Kristina Sinclair, associate attorney at Center for Food Safety. "The agency's refusal to listen to the science and ban phthalates from our food supply will have significant, detrimental health effects on women, children, and other vulnerable populations for years to come."

"We are deeply disappointed with this decision and FDA's continued failure to safeguard public health," said Sue Chiang, Food Program Director at the Center for Environmental Health. "For years we have asked the FDA to ban phthalates in food packaging and food-production materials. We know phthalates migrate into food, and we are particularly concerned about their harmful effects on vulnerable populations like babies and children."

"For far too long, the FDA has failed to protect American families from toxic chemicals in our food; and this decision is yet another example of that failure. As 1 in 8 women are diagnosed with breast cancer in their lifetime (causing over 44,000 U.S. deaths per year), the FDA must do better to keep breast-cancer linked, toxic ingredients like phthalates out of our food," said Lisette van Vliet, Senior Policy Manager for Breast Cancer Prevention Partners.

"It's inexcusable that the FDA is continuing to allow some of the same chemicals prohibited for use in children's toys over a decade ago to still be in direct contact with our families' food," said Patrick MacRoy, Deputy Director of Defend Our Health. "Fortunately, states, including Maine and Vermont, along with many leading food manufacturers, have already taken action to start reducing our exposure to phthalates in packaging. The fact that the FDA will not just demonstrates how incredibly broken chemical regulation at the agency is."

"The decision of FDA to deny the petitions is unconscionable and flies in the face of the Administration's commitment to environmental justice and science. We know that these chemicals can harm our children and future generations and that our Indigenous Peoples face a disproportionate burden. Environmental justice demands that federal agencies end the cumulative impacts of toxic chemical exposures in our communities." said Margaret Yellow Wolf Tarrant, environmental justice organizer with Alaska Community Action on Toxics.