On December 19, 2024, a group of health advocates represented by nonprofit law organization Earthjustice sued the U.S. Food and Drug Administration (FDA) to force the agency to reevaluate its decades-old authorizations for the use of certain phthalates in food contact materials.
The plaintiffs filed the lawsuit because FDA denied their petition requesting the agency revoke the food contact approvals for 28 phthalates. FDA says approvals for the majority of those phthalates have been revoked, and that the remaining phthalates are slated for safety reassessment. Earthjustice filed the lawsuit in the U.S. Court of Appeals for the D.C. Circuit on behalf of Alaska Community Action on Toxics, Breast Cancer Prevention Partners, the Center for Environmental Health, the Center for Food Safety, the Center for Science in the Public Interest (CSPI), Defend Our Health, the Environmental Defense Fund, and the Learning Disabilities Association of Illinois.
The Phthalate Problem
Phthalates are chemicals used to make plastics more flexible, durable, and transparent. At present, nine phthalates are approved by FDA for use in food contact materials. There is evidence linking phthalates to birth defects, infertility, preterm birth, impaired childhood neurodevelopment, and other adverse effects to human health. For example, a 2022 study demonstrated a causal link between di-(2-ethylhexyl) (DEHP), a phthalate still authorized for food contact, and the growth of tumors. phthalates. In January 2024, testing conducted by Consumer Reports found the presence of phthalates in nearly every food that was sampled.
According to FDA, the existing approved food contact uses for phthalates are slated for review—but the agency is not moving quickly enough for consumer advocates and Congress members. Earthjustice says FDA’s authorizations are based on safety assessments that are at least 40 years old. “The harms from phthalates leaching into our foods are serious, and most importantly, they are preventable,” said CSPI President Peter G. Lurie, M.D., M.P.H. “FDA has failed to consider decades of accumulating scientific evidence in the record that the continued use of phthalates is unsafe, and the agency also failed to fully consider the cumulative effects of exposure to multiple phthalates, as the law requires.”Petition to Revoke Food Contact Authorizations for Phthalates Denied; Senators Take Petitioners Side
The Earthjustice lawsuit was filed on behalf of consumer protection groups that submitted a petition (Food Additive Petition 6B4815) to FDA in 2016 requesting the agency amend or revoke specified regulations to no longer provide for the food contact use of 28 ortho-phthalates. According to Earthjustice, FDA did not respond to this petition for six years, until the petitioners forced a response by suing the agency in 2021. FDA then denied the petition in 2022, and upheld the denial decision after pressures to reconsider in October 2024.
The lawsuit filed against FDA is not the only external pressure the agency is facing to revoke authorizations for phthalate uses in food contact materials. On October 3, just weeks prior to FDA’s decision to uphold its denial of Food Additive Petition 6B4815, U.S. Senators Edward Markey (D-MA) and Cory Booker (D-NJ) wrote a letter to FDA Commissioner Robert M. Califf, M.D., urging the agency to revoke its authorization for phthalates in food contact materials. The senators argued that FDA has the legal authority to independently revoke its authorizations for phthalates if the approved food contact uses do not meet the safety standards established by the Food, Drug, and Cosmetic Act, and encouraged FDA to conduct a review of current scientific evidence to make such a determination. The senators also suggested FDA revoke its authorization of phthalates in food contact materials by granting the relief requested in the (then-pending) objections to FDA’s denial of Food Additive Petition 6B4815
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On December 19, 2024, a group of health advocates represented by nonprofit law organization Earthjustice sued the U.S. Food and Drug Administration (FDA) to force the agency to reevaluate its decades-old authorizations for the use of certain phthalates in food contact materials.
The plaintiffs filed the lawsuit because FDA denied their petition requesting the agency revoke the food contact approvals for 28 phthalates. FDA says approvals for the majority of those phthalates have been revoked, and that the remaining phthalates are slated for safety reassessment. Earthjustice filed the lawsuit in the U.S. Court of Appeals for the D.C. Circuit on behalf of Alaska Community Action on Toxics, Breast Cancer Prevention Partners, the Center for Environmental Health, the Center for Food Safety, the Center for Science in the Public Interest (CSPI), Defend Our Health, the Environmental Defense Fund, and the Learning Disabilities Association of Illinois.
The Phthalate Problem Phthalates are chemicals used to make plastics more flexible, durable, and transparent. At present, nine phthalates are approved by FDA for use in food contact materials. There is evidence linking phthalates to birth defects, infertility, preterm birth, impaired childhood neurodevelopment, and other adverse effects to human health. For example, a 2022 study demonstrated a causal link between di-(2-ethylhexyl) (DEHP), a phthalate still authorized for food contact, and the growth of tumors. phthalates. In January 2024, testing conducted by Consumer Reports found the presence of phthalates in nearly every food that was sampled.
According to FDA, the existing approved food contact uses for phthalates are slated for review—but the agency is not moving quickly enough for consumer advocates and Congress members. Earthjustice says FDA’s authorizations are based on safety assessments that are at least 40 years old. “The harms from phthalates leaching into our foods are serious, and most importantly, they are preventable,” said CSPI President Peter G. Lurie, M.D., M.P.H. “FDA has failed to consider decades of accumulating scientific evidence in the record that the continued use of phthalates is unsafe, and the agency also failed to fully consider the cumulative effects of exposure to multiple phthalates, as the law requires.”Petition to Revoke Food Contact Authorizations for Phthalates Denied; Senators Take Petitioners Side The Earthjustice lawsuit was filed on behalf of consumer protection groups that submitted a petition (Food Additive Petition 6B4815) to FDA in 2016 requesting the agency amend or revoke specified regulations to no longer provide for the food contact use of 28 ortho-phthalates. According to Earthjustice, FDA did not respond to this petition for six years, until the petitioners forced a response by suing the agency in 2021. FDA then denied the petition in 2022, and upheld the denial decision after pressures to reconsider in October 2024.
The lawsuit filed against FDA is not the only external pressure the agency is facing to revoke authorizations for phthalate uses in food contact materials. On October 3, just weeks prior to FDA’s decision to uphold its denial of Food Additive Petition 6B4815, U.S. Senators Edward Markey (D-MA) and Cory Booker (D-NJ) wrote a letter to FDA Commissioner Robert M. Califf, M.D., urging the agency to revoke its authorization for phthalates in food contact materials. The senators argued that FDA has the legal authority to independently revoke its authorizations for phthalates if the approved food contact uses do not meet the safety standards established by the Food, Drug, and Cosmetic Act, and encouraged FDA to conduct a review of current scientific evidence to make such a determination. The senators also suggested FDA revoke its authorization of phthalates in food contact materials by granting the relief requested in the (then-pending) objections to FDA’s denial of Food Additive Petition 6B4815
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