FDA Advances Safety Review of Litigated Food Package Chemicals

The FDA on Wednesday sought public input on its scientific assessment of chemicals used in plastic food packaging that represents the agency’s next step toward evaluating whether substances known as phthalates are still safe for consumers.

Scientists at the Food and Drug Administration determined that the safety of four phthalates could be assessed as a group based on similarities between their chemical structure and health effects. That grouping allows regulators to assess cumulative dietary exposure to those chemicals in a future risk assessment, the agency said in a press release.

The finding is a marked shift from the agency’s previous rejections of petitions by consumer health groups to ban those phthalates, decisions which landed the government in court. The FDA in 2023 denied a petition filed by environmental organization Earthjustice to ban phthalates as a risk to public health on the basis that there wasn’t enough evidence to treat the chemicals as a group in a safety evaluation.

Earthjustice sued the government over that decision, and in February argued before an appellate court that the FDA had a duty to address “severe health risks” posed by phthalates under the Federal Food, Drug, and Cosmetic Act. Studies have found the chemicals, which are used to make plastics soft and malleable, can leech into packaged foods and affect brain development or hormone regulation.

The agency’s decision to group the four phthalates for a safety assessment “signals a potentially more integrated approach to post-market review of related food-contact substances rather than evaluating each chemical entirely in isolation,” Brian Sylvester, a partner at Morrison and Foerster and head of the firm’s food regulatory work, said in an email.

The scientific review published Wednesday, described by the agency as informing a forthcoming risk assessment, comes after the agency identified postmarket reviews of chemicals added to or used in contact with food as a top priority in January.

If the FDA found any of the phthalates under review unsafe, it could declare foods that come in contact with plastics using the chemicals adulterated and illegal to sell or distribute.

The focus on chemicals in foods comes as the Trump administration’s Make America Healthy Again Commission raises concerns that chemicals are contributing to developmental issues and chronic disease, particularly in children. Health and Human Services Secretary Robert F. Kennedy Jr., who chairs the commission, has long criticized synthetic chemicals including food dyes and pesticides.

Acting FDA Commissioner Kyle Diamantas, previously the agency’s top food official, has also made chemicals in food a focus during his time at the agency.

Comments on the agency’s assessment of phthalates are due by June 26.