In September 2016, the FDA ruled 19 specific active ingredients could no longer be included in consumer antibacterial soap, as they did not meet the Generally Recognized as Safe (GRAS) and Generally Recognized as Effective requirements.
At the time, the agency deferred rulemaking for one year on three additional ingredients— benzalkonium chloride (BAC), benzethonium chloride (BZT), and chloroxylenol (PCMX)—to allow for the development and submission of new safety and effectiveness data for these ingredients.
Eight years later, the deferment is still active, and antibacterial washes with these ingredients are still being sold to consumers.
Now, a letter from the Green Policy Institute—signed by 42 other organizations with expertise in science policy, public health, environmental health and environmental justice—urges a meeting, information and ultimately a decision on the long-deferred ingredients.
Critical review
BAC, BZT and PCMX are all members of a class of chemicals known as quaternary ammonium compounds (QACs).
“Questions about whether BAC, BZT and PCMX provide any antiseptic benefit loom large especially since the other 19 antimicrobials that were part of the 2016 Final Rule were found to be no more effective than non-antimicrobial soap and water. Meanwhile, the evidence of the health hazards linked to QACs, including their possible contribution to antimicrobial resistance, has only gotten stronger,” reads the letter sent to the FDA.
Indeed, a critical review was published in May 2023 by a team of authors from academia, government, and non-profit organizations (including the Green Policy Institute’s Executive Director Arlene Blum). The review evaluates currently available information on the ecological and human health profile of QACs, finding multiple areas of potential concern. Adverse ecological effects include acute and chronic toxicity to aquatic organisms, with concentrations of some QACs approaching levels of concern. Meanwhile, for humans, known adverse health effects include dermal and respiratory effects, developmental and reproductive toxicity, disruption of metabolic function such as lipid homeostasis, and impairment of mitochondrial function. Additionally, QACs’ role in antimicrobial resistance has already been demonstrated.
The study authors also found that QAC use accelerated in the years during and since the COVID-19 pandemic.
2016 to 2024
The 2016 1-year deferral was granted by the FDA with the assumption that the manufacturers would perform the required studies regarding safety and effectiveness, and provide regular progress reports. According to the Green Policy Institute’s letter, based on public records, that has not been the case.
The rulemaking dockets show the last manufacturers’ report to FDA on the progress of their studies was on July 14, 2020. In November of that year, the FDA noted some required studies still had not been performed, and the agency asked for an updated report by Oct. 1, 2021.
The rulemaking docket does include an October 2021 update; however, it is marked “Restricted: Confidential Business Information.” No additional documents have been posted to the docket since then.
“We are concerned that QACs continue to be widely used in over-the-counter consumer antiseptic washes, including by children, despite the absence of data that they are GRAE or GRAS, and in the absence of FDA performing a benefit-to-risk ratio analysis,” reads the letter. “The fact that neither the safety nor the efficacy of the deferred antimicrobials has been established in the 8 years that FDA has already given the manufacturers may be indication that they are neither safe nor effective.”
The Spring 2024 Regulatory Agenda for the U.S. Department of Health and Human Services/Food and Drug Administration makes no reference to a rulemaking on consumer antiseptic washes.