June 11, 2021 Press Release
WASHINGTON – Congressman Ted W. Lieu (D-Los Angeles) and Congresswoman Katie Porter (D-Orange County) led a letter signed by 12 Members of Congress to the Food and Drug Administration (FDA) urging the Acting Commissioner of the Food and Drug Administration to take action on the presence of phthalates in food and cosmetics. Phthalates are a class of toxic endocrine-disrupting chemicals that cause developmental and reproductive harm. Despite evidence demonstrating the danger of these chemicals, the FDA has approved 28 phthalates for use in food packaging and food processing equipment. The presence of phthalates in foods and cosmetics poses serious concerns and warrants the FDA’s immediate consideration.
In the letter, the Members write:
Dear Acting Commissioner Woodcock:
On February 18, 2021, Members of Congress wrote to you about the use of phthalates in medical devices. In that letter, members called on the Food and Drug Administration (FDA) to prioritize reviewing and updating the agency’s 2002 guidelines on the use of phthalates and other endocrine-disrupting chemicals (EDCs) in IV containers and other medical devices. Recent scientific papers and reporting has brought to light the presence of phthalates in food and cosmetics. For the same reasons that this dangerous chemical should be banned from IV containers, we request that the FDA should ban phthalates from food contact materials and cosmetics.
As explained in the February 18 letter to the agency, phthalates are a family of toxic chemicals that can cause reproductive and developmental harm. Despite an abundance of science that makes clear how dangerous these chemicals can be, the Centers for Disease Control and Prevention’s National Biomonitoring Program found that they are present in most Americans’ bodies. Further research conducted by the State of California has found that 100% of children had phthalates in their body. These chemicals disrupt the endocrine system and are known to affect male and female reproduction, breast cancer, malformation of the male genital tract, and other body functions. On March 10, 2021, a group of experts published a peer-reviewed paper in the American Journal of Public Health that concluded that phthalates are toxic to children’s brain development and increase risks for learning, attention, and behavioral disorders, including ADHD in childhood. The article proposes that we should “eliminate ortho-phthalates from products that lead to exposure of pregnant women, women of reproductive age, infants, and children.” This evaluation of evidence of neurotoxicity, the most comprehensive to date, only provides further evidence that we must take quick and aggressive action to protect American consumers.
Every day, American families are exposed to multiple phthalates in their diets regardless of whether they eat at home or at a restaurant. Consumers are also exposed to phthalates in cosmetics absorbed through their skin. These exposures are not uniformly experienced: Black and Latina women have higher exposure to certain phthalates compared with White women and this difference cannot be explained by socioeconomic status. In a nationally representative sample, Black women had higher exposures to a real-world mixture of hormonally active phthalates compared to White women.
Despite mounting evidence over the last few decades, the FDA has approved 28 phthalates for use in food packaging and food processing equipment. They are used as plasticizers, binders, coating agents, defoamers, gasket closures, and slimicide agents and can contaminate food. Their uses are not limited to final food packaging; they contaminate food across the supply chain from farm to fork. Although phthalates are used in other consumer products, food has been identified as a primary source of exposure, especially for children. When examining how children are exposed to phthalates through dietary means, researchers have found them in milk and dairy products due to contact with materials used during the mechanical milking process.
By 1973, the FDA had recognized that different types of phthalates share similar toxicity levels and ability to migrate into food, making them members of the same class of chemicals. Despite this recognition, the agency continued to approve use of new phthalates without considering their cumulative toxic effect by their collective presence in the diet. Although the evidence on the health risks of phthalates has only grown stronger over the years, the FDA has done very little to actually reduce the contamination of the food supply chain with phthalates. It has done nothing to make cosmetics safer from these chemical additives. As a result, even though organizations like the Consumer Protection Safety Commission (CPSC) banned the use of eight phthalates in children’s toys and articles more than four year ago, they remain present in the food that young people eat every day.
The time for action on this health risk to families, especially our children and underserved communities, is long overdue. As you well know, FDA’s mission includes “protect[ing] the public health by ensuring that . . . foods are safe,” and a critical way that FDA protects the public from unsafe food is by ensuring that food additives cannot be used “if a fair evaluation of the data. . . fails to establish that the proposed use of the food additive. . . , will be safe.” FDA’s regulations define safe to mean that “there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.” Both the law and regulations require FDA’s safety determination to include both “safety factors” to account for scientific uncertainty and consideration of the “cumulative effect of [an additive] … taking into account any … related [substances]”—a consideration that is particularly relevant for phthalates because people are exposed to multiple related phthalates from their diets and other products. Given the accumulated evidence linking phthalate exposure with neurodevelopmental and reproductive developmental impairments, FDA can no longer have a “reasonable certainty” that phthalates in food contact substances will not be harmful.
Because of the evidence linking pregnant women’s exposure to phthalates to impaired reproductive development, numerous health and environmental groups submitted a food additive petition to FDA more than five years ago urging it to withdraw its approval of all phthalates as food additives or food contact substances. However, despite the 180-day statutory deadline for FDA to act on food additive petitions, FDA has taken no final action on the phthalates petition. We are deeply concerned about FDA’s lengthy delay in responding to this petition and its inaction on phthalates in cosmetics.
We implore you to take the steps necessary to protect Americans from harmful exposures to toxic phthalates in food and cosmetics. Specifically, we ask the FDA to:
- Grant the pending food additive petition that has been under agency review for five years as there can no longer be “a reasonable certainty in the minds of competent scientists” that phthalates in food contact materials are not harmful, especially given the cumulative effect of exposure to multiple phthalates.
- Evaluate whether cosmetics containing phthalates are adulterated or misbranded, and if so, take corrective action expeditiously.
The presence of phthalates in foods and cosmetics poses serious concerns and warrants the FDA’s immediate consideration. We urge the FDA to institute policies that will protect our families, friends, and children from these harmful substances. Thank you for your attention to this wide scale public health harm.