Triclosan, Other Hand Soap Ingredients, Banned From Over-The-Counter Products

Federal health officials published a final rule this week, banning the use of triclosan and 23 other active ingredients in over-the-counter (OTC) hand soap and similar antiseptic washes and rubs, including hand washes and surgical hand scrubs used in health care settings, due to the potential side effects linked to exposure. 

On December 20, 2017, the FDA published the final rule on hand soap active ingredients in the Federal Register, restricting a total of 24 ingredients, including triclosan, which recent studies have linked to hormone disruption and fetal development interruption.

The rule to ban certain ingredients in OTC antiseptic washes and rubs used in the healthcare setting was first proposed by the FDA in 2015, after studies indicated the side effects of triclosan and several other active ingredients were linked to the disruption of hormone function and the development of antibiotic resistance in bacteria.

The FDA published the rule to help health care professionals and consumers recognize which ingredients are generally recognized as safe and effective enough to pass federal standards. The 24 ingredients banned from antiseptic washes and rubs have not been backed by any evidence or safety assurances that the ingredients do not cause harm to humans.

Triclosan is an antibacterial and antifungal agent that was first introduced to the market in the early 1970’s by the chemical company Ciba as part of a surgical scrub kit. It quickly became a popular antimicrobial agent in everyday products and even in children’s toys, with the goal of making them safer. However, recent research has indicated that exposure to the chemical can cause hormonal and developmental complications.

The risks associated with exposure to antimicrobial chemicals such as triclosan have been widely debated among researchers and the scientific community for years. Until the FDA began performing studies to determine the risks the chemicals pose to humans, triclosan was widely used in hand sanitizer products.

Following growing medical concerns, The National Toxicology Program, at the request of at FDA, looked at the potential for antibacterials to cause cancer through skin exposure to triclosan. Research published in 2014, revealed a link between triclosan and an increased risk of liver disease and development of cancerous tumors.

The FDA’s final rule will remove a total of 24 ingredients from acceptable use in OTC hand washes and sanitizers. Manufacturers will be given one year to remove the ingredients from their products. Manufacturers who intend to use any of the restricted ingredients in future products will be required to submit a new drug application (NDA) to the FDA for approval prior to manufacturing.

In 2016, the FDA instituted a partial ban on triclosan and 19 other antimicrobial ingredients, prohibiting triclosan and triclocarban from use in over-the-counter antibacterial soap, which was a precursor to FDA’s final rule making this month.