On July 21, 2023, the US Food and Drug Administration (FDA) issued a letter denying a request that it reconsider its decision from May 2022 that it would not prohibit the use of eight phthalates as food-contact substances. At the same time, the Agency also reaffirmed that it will continue to allow five other phthalates that were previously prior sanctioned for similar uses.

Read the FDA’s letter here.

Background

Phthalates (more properly, ortho-phthalates) are organic chemicals widely used as plasticizers – substances added to rigid plastics, primarily polyvinyl chloride (PVC or “vinyl”) – to make them more supple and less brittle. As such, they are used extensively in food-contact packaging and other food-contact materials, as well as in many other consumer goods.

On April 12, 2016, several public interest groups including Breast Cancer Prevention Partners, the Environmental Defense Fund, and the Natural Resources Defense Council submitted to FDA a food additive petition (FAP) requesting that FDA (1) revoke and/or amend certain food additive and prior-sanctioned regulations so as to no longer allow for the food-contact use of 30[1] individual phthalates; and (2) specifically prohibit the use of eight phthalates.

FDA agreed to file the first portion of the petition but declined to file the second part. As a result, on April 19, 2016, the same groups submitted a Citizen Petition again requesting that FDA prohibit the use of the same eight phthalates as food-contact substances under 21 CFR Part 189. The eight phthalates are the following:

• Diisobutyl phthalate (DIBP);
• Di-n-butyl phthalate (DBP);
• Butyl benzyl phthalate (BBP);
• Dicyclohexyl phthalate (DCHP);
• Di-n-hexyl phthalate (DnHP)[or simply dihexyl phthalate];
• Diisooctyl phthalate (DIOP);
• Di(2-ethylhexyl) phthalate (DEHP); and
• Diisononyl phthalate (DINP).

In addition, the Petitioners asked that FDA remove the following five phthalates from its list of substances prior-sanctioned as food ingredients, and specifically as plasticizers migrating from food-packaging material (40 CFR §181.27):

• Butylphthalyl butyl glycolate (BPBG);
• Diethyl phthalate (DEP);
• Ethylphthalyl ethyl glycolate (EPEG);
• Di-(2-ethylhexyl) phthalate (DEHP) (use on foods of high water content only); and
• Diisooctyl phthalate (DIOP) (use on foods of high water content only).

The Petitioners used as the basis for their request a report on phthalates issued by a Chronic Health Advisory Panel (CHAP) established by the Consumer Product Safety Commission (CPSC), which had concluded that the eight phthalates are “unsafe or that the evidence indicates developmental health effects are likely.” For the five prior-sanctioned ingredients, the Petitioners alleged that these phthalates “no longer meet the reasonable certainty of no harm safety standard.”

FDA’s Original May 2022 Denial

In a letter dated May 12, 2022, FDA denied both parts of the Citizen Petition and also denied the FAP in a Federal Register announcement dated May 20, 1922. With respect to the CHAP’s conclusions, FDA noted that CHAP’s scientific evaluation was primarily conducted for the purpose of evaluating the safety of phthalates for use in children’s toys and child-care articles (e.g., pacifiers, teething rings), and such assessments did not necessarily apply to the safety of food contact uses due to the different conditions of use. FDA found that the Petition had not provided an explanation for why the CHAP’s assessments of phthalates in children’s toys and child-care articles should apply to the safety of phthalates for food contact uses. FDA noted the FAP had cited two publications (including the CHAP report) that referred to scientific studies showing all eight phthalates could be administered at levels that do not cause toxic effects, and even cited no-observed-adverse-effect-levels (NOAELs) from the CHAP report.

With respect to the five prior-sanctioned ingredients, FDA stated that the FAP had attempted to treat 28 diverse phthalates as a single class for purposes of a safety assessment, apply a proposed Acceptable Daily Intake (ADI) value that had been established for just one of the phthalates to every phthalate in the purported class, and then compare the exposure of all these phthalates against that single ADI. FDA found this to be a flawed approach. Moreover, the Citizen Petition did not provide any additional evidence beyond what was submitted in the FAP. Therefore, FDA concluded that the Petitioners had not shown that any of the five prior-sanctioned phthalates might render food injurious to health (and thus considered adulterated) at the levels specified by the prior-sanctioned use, or indeed at any level of exposure,

In a related move, the FDA addressed another FAP that had been filed in July 2018 from an industry group, the Flexible Vinyl Alliance. This other FAP requested that FDA remove authorizations for the food-contact uses for 23 phthalates since such uses had already been abandoned. FDA complied with this request by issuing a Final Rule, also on May 20, 2022, revoking the authorizations for the food-contact use of these 23 phthalates, all of which had been on the list of 28 phthalates targeted in the earlier FAP. As a result, authorizations remained for food contact use of just eight phthalates, specifically as plasticizers.

The Petition for Reconsideration

One month later, on June 21, 2022, most of the same public interest groups (plus some additional ones) filed a Petition for Reconsideration of FDA’s denial of the Citizen Petition claiming that the Agency had failed to consider relevant information and views contained in the administrative record, namely:

• That FDA had not considered and applied the correct legal standard.
• That FDA had failed to adequately consider hazard and exposure information in the administrative record indicating that the eight phthalates are not safe for food-contact use.
• The FDA had failed to consider the cumulative effects of related phthalates.

The new petition, which requested the same actions from FDA as the original Petition, cited a variety of scientific reports in support of its claims of multiple adverse effects from exposure to phthalates.

FDA’s July 21, 2023 Response

FDA responded to this Petition for Reconsideration by denying all of the Petitioners’ requests. In a lengthy and detailed response, the Agency examined and refuted each of the petitioners’ assertions that it had not adequately considered a number of scientific issues and reports in the administrative record, including: CPSC’s CHAP report on phthalates in children’s toys and child-care articles; declarations of two individual scientists; a 2022 Toxicological Profile for one phthalate (DEHP) published by the Agency for Toxic Substances and Disease Registry (ATSDR); a “wealth of additional hazard information in the record concerning the human health effects”; various epidemiological studies; studies on dietary exposure outside the US; biomonitoring data; and the possible cumulative effect of different phthalates. As such, FDA found that the petitioners had failed to demonstrate that relevant information or views contained in the administrative record were not previously or not adequately considered.

The result of the denial of the Petition for Reconsideration is that the eight specific phthalates and the five prior-sanctioned phthalates can continue to be used as food-contact substances.

[1] FDA later reduced the list to 28 phthalates at the request of Petitioners.