Something extraordinary happened in early September - after more than 35 years of evaluating the issue, the US Food and Drug Administration (FDA) announced it was finally prohibiting controversial chemicals in products used by Americans every day. The controversial chemicals include triclosan, triclocarban, and 17 other chemical ingredients, ones used in everything from hand soaps to toothpaste. The FDA rule applies to “consumer antiseptic wash products,” and does not affect consumer hand “sanitizers” or wipes, toothpaste, or antibacterial products used in health care settings. Consumer pressure and a court order as a result of a lawsuit forced the release of the rule.

Still, the decision was stunning. According to the FDA, “companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Some manufacturers have already started removing these ingredients from their products.”

While the FDA decision does not affect products used in healthcare, the sector is a major consumer of formulations that contain these compounds. The FDA has announced a proposed rule for health care uses of antimicrobials. Comments were due by October 2015, but the FDA has yet to indicate a timeline for a decision and it is unclear if pressure will also be necessary to see the release of this rule.

Long before the FDA’s action on consumer products, important health care professional associations recommended a move away from triclosan in the health care setting. The Association for Professionals in Infection Control and Epidemiology (APIC), the leading professional association for infection preventionists, joined forces with the Society for Healthcare Epidemiology of America (SHEA) in 2014 and issued a Compendium on Hand Hygiene. The Compendium advised against the use of triclosan-containing soap in health care facilities 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.” APIC and SHEA have not yet weighed in on the FDA rule, nor have they indicated whether their organizations will revisit their Compendium in light of the new data on the additional chemicals prohibited by the FDA.

APIC did weigh in during the public comment period on the use of triclosan in consumer products. Their comments noted the need for additional research but also warned of industry-sponsored marketing efforts that:

“suggest the unproven effect of consumer antiseptic products on preventing infections. We base this concern on a recent systematic review of the efficacy of antimicrobial (i.e., triclosan) soaps compared to plain soaps. The study found that antimicrobial soaps were no more effective at preventing infectious illness symptoms or reducing bacterial levels on hands than plain soap. In conclusion, APIC does not advocate the use of antiseptic products which are marketed with the implication of preventing infections without clear data to demonstrate clinical benefit.”

The American Academy of Pediatrics also submitted comments noting the unique vulnerability of children, the hormonal effects of triclosan, and concerns about the development of antibiotic resistance as a result of widespread use of these chemicals.

Triclosan and triclocarban are by far the most commonly used antimicrobials in consumer products. For many years, triclosan has been added to various kinds of hand soaps and gels, toothpaste, mouthwashes, touch surfaces, lunch boxes, kitchen items, toys, plastics, and clothing. Triclosan acts by inhibiting an enzyme necessary for synthesizing fatty acids, which are necessary for building cell membranes and for cell division. Studies show that bacteria can have both natural and acquired mechanisms of resistance to triclosan. Some studies show that bacteria that become resistant to triclosan can also become resistant to other antibiotics.

Exposures to triclosan are widespread in the general population and are measureable in adult and infant urine, breast milk, and meconium. Using triclosan-containing toothpaste or hand soaps can increase urinary triclosan levels. A US Centers for Disease Control study found triclosan present in the urine of 75% of people tested. 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.

Triclocarban is also widely used, environmentally persistent, detectable in many rivers and streams, and tends to bioaccumulate in many invertebrates. Triclocarban shares a number of toxic properties with triclosan, including hormonal effects. Practice Greenhealth has long urged hospitals to move away from triclosan and triclocarban in the health care setting because of the APIC/SHEA Compendium recommendation, as well as concerns about the health and environmental impacts of these chemicals, including concerns about the development of antibiotic resistance.

For more specific information on the FDA’s decision, please see the final rule on consumer antiseptic washes and the proposed rules on health care antiseptics and consumer antiseptic rubs.