FDA restricts health care hand soap chemicals

Triclosan restricted in health care, but others still allowed

In an announcement with implications for all health care facilities, the U.S. Food and Drug Administration (FDA) restricted the use of triclosan and 23 other ingredients in antiseptic washes and rubs effective December 2018, citing a “lack of sufficient safety and efficacy data.”

The agency deferred rulemaking on six other active ingredients – those most commonly used in health care – to give manufacturers more time to provide safety information. A similar 2016 FDA announcement prohibiting triclosan and other chemicals in consumer products was the result of legal action to force the FDA to issue the final rule.

Long before the FDA’s action, infection prevention professional associations advised against the use of triclosan-containing soap in health care because of a “lack of evidence of superior clinical effectiveness compared to other products, concern about promoting antibiotic resistance, widespread human exposures, and potential adverse health effects.”

Leading health care systems have been moving away from triclosan for years, and in 2017, Health Care Without Harm and Practice Greenhealth announced a new goal and guidance to eliminate triclosan in hand hygiene products in health care. Practice Greenhealth members can access a guide, case studies, and a webinar to help remove triclosan from your system.   

Exposures to triclosan are widespread in the general population. The Centers for Disease Control found triclosan present in 75 percent of people tested. Triclosan is measurable in urine, breast milk, and meconium. Using triclosan-containing toothpaste or hand soaps can increase triclosan levels in the body. Once discharged to wastewater, triclosan can persist in the environment and contaminate fish and even food grown in sludge-amended soil.

Triclosan has effects on the thyroid, estrogen, and testosterone systems in mammals. These effects are of particular concern when exposures occur during developmental windows of susceptibility. Triclosan exposure can also impair muscle function in animal models and has been associated with hay fever or allergies in humans. Studies show bacteria can have both natural and acquired mechanisms of resistance to triclosan. Some studies show bacteria that become resistant to triclosan can also become resistant to other antibiotics.

The FDA deferred a decision on six hand hygiene ingredients giving manufacturers more time to provide data to the agency although the agency has been considering the issue for years, and the data request  to manufacturers ended in 2015. The Natural Resources Defense Council (NRDC), which sued the FDA for failing to finalize their draft assessment after many years, has raised concerns about quaternary ammonium compounds included in the deferral because data suggests these chemicals may cause health problems. Hand sanitizers containing these chemicals are marketed as alcohol-free and are widely used in schools as well as in health care settings, according to NRDC.

This rule finalizes the 1994 tentative final monograph for over-the-counter health care antiseptic drug products, including washes and rubs, published in the Federal Register that year. Compounds cannot be used as health care antiseptics after December 2018 without new safety information and approval, according to the new rule. The FDA deferred final rulemaking for one year, subject to renewal, on six other active ingredients most commonly used in health care antiseptic products at manufacturer request to provide manufacturers more time to complete scientific studies. The six compounds are  alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX).