Overview
In a somewhat rare occurrence, the US Food and Drug Administration (FDA) published notices in the Federal Register on October 30, 2024, announcing that the agency has denied objections, submitted by a group of Non-Governmental Organizations (NGOs), related to agency rulemaking activities. The objections are specifically tied to agency rulemaking activities involving phthalates used in food-contact applications. Objections of this nature – and agency responses to the same – do not arise with great frequency. Thus, these notices provide an opportunity for the regulated industry to glean insights into FDA’s deliberative processes and application of administrative law principles.
The history of this particular situation dates back to 2016, when FDA filed a Food Additive Petition (FAP) in response to an NGO submission that called on the agency to revoke the clearances for all phthalates that, at the time, were authorized in FDA’s indirect food additive regulations. The NGO submission called on FDA to revoke the clearances on the basis of safety concerns. The FAP impacted more than two dozen phthalates, and a number of individual FDA regulations that authorized their use in food-contact applications. In response to the NGO petition, industry submitted a competing FAP, which FDA filed in 2018. The industry petition called on FDA to revoke the vast majority of the clearances as well, but on the basis of abandonment of use rather than safety.
FDA denied the NGO petition in 2022, and instead acted on the industry petition, issuing a final rule revoking the majority of the relevant phthalate clearances on the basis of abandonment. At the same time, the agency announced a Request for Information (RFI) from industry about the remaining uses of several phthalates that were not abandoned.[1] The NGOs then filed objections to FDA’s denial of their own FAP, as well as another objection to FDA’s final rule acting on the industry FAP.
FDA’s most recent federal register notices summarize the agency’s reasons for denying both of the NGOs’ objections. In denying the NGO objection to FDA acting on the industry petition, FDA stated, in brief, that its actions were reasonable, and that the NGOs had not provided any legitimate basis to overturn the agency’s final rule.
FDA spent more time explaining its basis for denying the NGOs’ objection to the agency’s denial of the original NGO FAP filed in 2016. A summary of the NGOs’ arguments and highlights of FDA’s denial – as well as the agency’s underlying rationale for the same – include the following:
- The NGOs argued that FDA unlawfully placed the burden of proof regarding the safety of the phthalates on the NGOs, asserting that FDA is required to revoke an indirect food additive clearance so long as some evidence is provided that the authorized substance may not be safe. FDA disagreed, noting that “[i]t is fundamental that a food additive petition – whether requesting an authorization, modification, or repeal – must provide sufficient support for its request.” In other words, the evidentiary burden rests with the petitioner to provide adequate support that a substance is either safe or unsafe.
- The NGOs argued that FDA failed to evaluate the safety of the few phthalates still authorized in FDA’s indirect food additive regulations and that were not encompassed in the abandonment petition submitted by industry. FDA responded by noting that the agency did, in fact, consider the safety arguments raised by the NGOs in their original 2016 FAP, and concluded those safety arguments were insufficient to warrant revocation of any of the phthalate clearances. FDA additionally noted that its RFI was intended to further investigate the safety of these remaining authorizations, and that the review process is ongoing.
- The NGOs argued that FDA failed to consider new safety information that has become available since 2016, and which allegedly draws into question the safety of phthalates. FDA noted that “mere citation” of scientific studies, without substantive underlying analysis of the same, does not constitute a justification for action. Rather, substantive analysis of the studies is required by the NGOs for the agency to consider the issue.
- The NGOs argued that FDA misapplied language in Section 409 of the Federal Food, Drug, and Cosmetic Act, requiring the agency to consider the cumulative effects of chemically or pharmacologically related substances. The NGOs specifically took the position in their original 2016 FAP that all phthalates should be grouped into a single class, applying data from any one chemical to the entire set. FDA reiterated that, consistent with its statements in the 2022 Order denying the 2016 NGO FAP, the agency had already concluded that the available information does not support grouping all phthalate chemicals into a single class assessment.
Please contact Steptoe LLP’s Food-Contact Team with any questions regarding this matter, or to further discuss the implications of FDA’s denial of the NGO objections.
Links to some of the key FDA rulemaking activities summarized above follow below.
2022 FDA Final Rule Acting on Industry FAP
2022 FDA Order Denying 2016 NGO FAP
2024 FDA Denial of NGO Objection to 2022 Final Rule
2024 FDA Denial of NGO Objection to Denial of 2016 NGO FAP
[1] These include: diisononyl phthalate (DINP, CAS No. 28553-12-0), diisodecyl phthalate (DIDP, CAS No. 26761-40-0), di(2-ethylhexyl) phthalate (DEHP, CAS No. 117-81-7), dicyclohexyl phthalate (DCHP, CAS No. 84-61-7), butylphthalyl butyl glycolate (BPBG, CAS No. 85-70-1), diethyl phthalate (DEP, CAS No. 84-66-2), ethylphthalyl ethyl glycolate (EPEG, CAS No. 84-72-0) and diisooctyl phthalate (DIOP, CAS No. 27554-26-3).
