FDA Advances Safety Review of Litigated Food Packaging Chemicals: What It Means for Regulatory Compliance

On May 27, 2026, the U.S. Food and Drug Administration (FDA) took a pivotal step in how it evaluates the safety of chemicals used in plastic food packaging. According to a recent report from Bloomberg Law, the agency is seeking public input on a scientific assessment that groups four specific phthalates together for a cumulative risk assessment.

Here is a breakdown of the FDA’s latest action, the litigation that sparked it, and what it means for chemical hazard communication.

A Shift in Regulatory Methodology

Phthalates are widely used as plasticizers to make polyvinyl chloride (PVC) and other plastics soft, flexible, and malleable for use in food packaging and processing equipment.

Historically, the FDA has evaluated the safety of these food-contact substances on a chemical-by-chemical basis. In fact, the agency previously rejected petitions to ban these substances, stating there was insufficient evidence to assess them collectively.

However, FDA scientists have now reversed course, determining that four specific ortho-phthalates share enough similarities in their chemical structures and toxicological profiles (specifically regarding antiandrogenic effects) to be evaluated as a group. The four chemicals are:

• DEHP (Di(2-ethylhexyl) phthalate)

• DCHP (Dicyclohexyl phthalate)

• DIOP (Diisooctyl phthalate)

• DINP (Diisononyl phthalate)

This "Chemically or Pharmacologically Related" (CPR) grouping allows regulators to assess the cumulative dietary exposure to these chemicals, marking a significant methodological pivot for the agency.

The Litigation That Forced the Issue

The FDA's updated stance follows intense legal pressure from consumer health and environmental advocacy groups. In 2023, the FDA denied a petition filed by Earthjustice to ban these substances as a public health risk.

In response, Earthjustice sued the government. In February 2026, they argued before an appellate court that the FDA has a duty under the Federal Food, Drug, and Cosmetic Act to address the severe health risks posed by phthalates, which studies show can leach into packaged foods and disrupt hormone regulation. The current safety review is seen as a direct response to this ongoing litigation and mounting public scrutiny.

Broader Industry Impact

The decision to group these phthalates is a bellwether for the chemical and packaging industries. As Brian Sylvester, a partner at Morrison Foerster, explained to Bloomberg Law, the FDA's move "signals a potentially more integrated approach to post-market review of related food-contact substances rather than evaluating each chemical entirely in isolation."

Furthermore, the FDA is operating under a heightened mandate to scrutinize the food supply. Driven by Acting FDA Commissioner Kyle Diamantas and influenced by federal initiatives like the Make America Healthy Again (MAHA) Commission, post-market reviews of chemicals added to or in contact with food have become a top agency priority.

If the FDA ultimately determines that these grouped phthalates are unsafe, it could declare foods that come into contact with them adulterated—making them illegal to sell or distribute.

Implications for SDS Authoring and Hazard Communication

For clients of SDSWriter.com and professionals managing chemical compliance, this development is a critical reminder to stay proactive. While the FDA’s current review does not immediately ban these substances, the writing is on the wall. A future restriction or a change in hazard classification will have immediate downstream effects on your hazard communication strategy:

• Section 11 (Toxicological Information): Cumulative risk assessments by federal agencies often yield new, formalized data on reproductive toxicity and endocrine disruption. SDS authors must ensure these sections reflect the most current authoritative scientific consensus.

• Section 15 (Regulatory Information): If the FDA revokes food-contact authorizations for these phthalates, SDSs for products sold into the food, beverage, and packaging sectors will require immediate regulatory updates.

• Pivoting to Alternatives: As downstream packagers and food processors anticipate potential bans, chemical suppliers will likely see increased demand for alternative plasticizers. Manufacturers must ensure that the Safety Data Sheets for these substitute chemicals are accurate, fully compliant, and ready for market distribution.

Next Steps

The FDA is accepting public comments on its scientific assessment of these phthalates until June 26, 2026.

Now is the time for manufacturers and suppliers of food-contact materials to audit their product portfolios. If your supply chain relies on DEHP, DCHP, DIOP, or DINP, you should closely monitor the outcome of this assessment and begin preparing your compliance and substitution strategies today.

Need help updating your hazard communication documents to keep pace with changing FDA, OSHA, or EPA regulations? Our experts at SDSWriter are here to ensure your Safety Data Sheets are accurate, up-to-date, and globally compliant.