Senators Urge FDA to Revoke Authorizations for Phthalates in Food Contact Materials
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U.S. Senators Edward Markey (D-Massachusetts) and Cory Booker (D-New Jersey) recently wrote a letter to U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf, M.D. urging the agency to revoke its authorization for phthalates in food contact materials (FCMs).
Phthalates are chemicals used to make plastics more flexible, durable, and transparent. At present, nine phthalates are approved for use in FCMs.
In their letter, the senators point to evidence of harm to human health from exposure to phthalates, especially to the neurodevelopmental health of infants and children. They also cite evidence that shows pregnant women’s exposure to phthalates causes preterm labor and complications, and impairs their unborn babies’ brain development and function.
For example, a 2022 study from Northwestern Medicine demonstrated a causal link between di-(2-ethylhexyl) (DEHP), a phthalate commonly used in food packaging, and the growth of uterine fibrioids—tumors that can lead to uncontrolled bleeding, anemia, miscarriages, and infertility.
Additionally, the letter mentions that the Environmental Protection Agency (EPA) has already highlighted health concerns with phthalates, designating several phthalates as high-priority substances for risk evaluation under the Toxic Substances Control Act and as toxic pollutants under the Clean Water Act. Under the Consumer Product Safety Improvement Act of 2008, the Consumer Product Safety Commission (CPSC) also banned certain phthalates in children’s toys due to toxicity concerns.
CPSC and EPA have both concluded that diet is the primary source of exposure to FDA-approved phthalates among women, infants, toddlers, and children. In January 2024, testing conducted by Consumer Reports found the presence of phthalates in nearly every food that was sampled.
The senators argue that FDA has holds the legal authority to independently revoke its authorizations for phthalates in FCMs if the approved phthalates do not meet the safety standards established by the Food, Drug, and Cosmetic Act, as FDA as a statutory responsibility to ensure that packaging and production materials that come into contact with food do not contain toxic chemicals that can harm consumers. The letter encourages FDA to conduct a review of current scientific evidence to make such a determination.
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Another way in which FDA could revoke its authorization for phthalates in FCMs is by granting the relief requested in the pending objections to FDA’s denial of the 2016 food additive petition submitted by Earthjustice and other stakeholders, and by reconsidering its denial of the 2016 citizen petition, which asked that FDA revoke food-additive authorizations and prior-sanctioned uses of certain phthalates in FCMs.
In the absence of federal action, the letter says, several states have chosen to take matters into their own hands. California, Maine, and Vermont have enacted their own regulations banning, controlling, or limiting the use of phthalates in FCMs and other materials, and similar legislation was introduced in Michigan’s legislature in 2023.
