Antibacterial Hand Soap Update
FDA bans the use of 19 ingredients in antibacterial hand soaps (including Triclosan)

On September 2, 2016 the U.S. Food and Drug Administration (FDA) ruled that it was banning the use of 19 active ingredients commonly used in the formulations of antibacterial hand soaps, and as a result all antibacterial hand soaps containing any one of these ingredients will no longer be available for use effective September 2017.

The reasons stated by the FDA for making this decision are twofold: first, there is concern that there is no empirical evidence available to definitively prove that antibacterial hand soaps containing these ingredients are actually any more effective at preventing illness than merely washing with regular hand soap and water; and second, there is concern that antibacterial hand soaps containing these ingredients may pose a long term health risk.

The most commonly used ingredient in antibacterial hand soaps which can be found on this newly banned list is Triclosan, an ingredient which is present in a variety of antibacterial hand soap formulas in both the consumer and institutional markets.

Many companies have already replaced triclosan in their antibacterial hand soaps with one of three other chemicals — benzalkonium chloride, benzethonium chloride or chloroxylenol (PCMX). While there are not any known issues with these ingredients at this time, please note that the FDA has given the companies using them in their formulations another year to provide more data on their safety and effectiveness, and WAXIE will continue to monitor that dialogue in order to keep our customers informed. In the meantime, these ingredients will continue to be the primary chemicals being used in antibacterial soap formulations to replace the outgoing products which contained triclosan.

What is Triclosan? According to the FDA, triclosan is an ingredient added to many consumer products intended to reduce or prevent bacterial contamination. Triclosan has been added to antibacterial hand soaps, but also to body washes, toothpastes, deodorants and other cosmetics which are used by consumers – and all of them are products which will now need to be reformulated or discontinued over the course of the next year in order to comply with the FDA’s ruling. It is worth noting that triclosan may also be found in many other products in a typical household – everything from clothing, kitchenware, furniture and toys – and all of these other products are not regulated by the FDA, and subsequently are not subject to this ban.

So what is wrong with Triclosan? While there are some short-term studies which have found that exposure to high doses of triclosan is associated with a decrease in the levels of some thyroid hormones in animals, it is not known what long term impact this ingredient has on humans, and there have not been any studies which have been completed to find conclusively that there is any long term impacts to human health.

There is also a concern that it is possible that exposure to triclosan makes some bacteria resistant to antibiotics – although again, it isn’t known conclusively whether or not this is the case. There is some cause for concern, however, and therefore the topics of safety for humans as well as antibiotic resistance continues to be researched.

The real issue leading to this ban is that it is not certain whether or not antibacterial hand soaps containing triclosan actually do a better job of preventing illness than just washing with plain old soap and water. Absent any evidence proving the benefits of washing with antibacterial soaps containing triclosan, the FDA has concluded that the potential risks associated with triclosan outweigh any potential benefits of allowing the ingredient to remain in antibacterial hand soap formulations used by the public – and therefore, the FDA recommends that people wash their hands with plain old soap and water.

“Following simple handwashing practices is one of the most effective ways to prevent the spread of many types of infection and illness at home, at school and elsewhere,” says Theresa M. Michele, MD, of the FDA’s Division of Nonprescription Drug Products. “We can’t advise this enough. It’s simple, and it works.”

“There’s no data demonstrating that these drugs provide additional protection from diseases and infections. Using these products might give people a false sense of security,” Michele says. “If you use these products because you think they protect you more than soap and water, that’s not correct. If you use them because of how they feel, there are many other products that have similar formulations but won’t expose your family to unnecessary chemicals. And some manufacturers have begun to revise these products to remove these ingredients.”

FAQ’s:

Q: Does this FDA ruling apply to healthcare?

A: No, this ruling does not affect antibacterial products used in healthcare settings.

Q: Does this FDA ruling apply to hand sanitizers?
A: No, this ruling does not affect consumer hand sanitizers or wipes.

Q: What is WAXIE doing to comply with this FDA ruling?

A: WAXIE has already begun phasing out triclosan from many of its antibacterial hand soaps – and it is anticipated that this transition will be completed for all antibacterial hand soaps well in advance of the required deadline. The plan is to maintain current WAXIE item numbers for the replacement products so that the transition will be a “rolling” change to minimize potential confusion and hardship for customers.

Q: What are the other ingredients which are affected by this ruling?

• Cloflucarban
• Fluorosalan
• Hexachlorophene
• Hexylresorcinol
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer-iodine complex
• Povidone-iodine 5 to 10 percent
• Undecoylium chloride iodine complex
• Methylbenzethonium chloride
• Phenol (greater than 1.5 percent)
• Phenol (less than 1.5 percent) 16
• Secondary amyltricresols
• Sodium oxychlorosene
• Tribromsalan
• Triclocarban
• Triclosan
• Triple dye

FDA Issues Rule on Safety and Effectiveness of Antibacterial Soaps: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517478.htm

FDA Ruling on Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use: https://www.federalregister.gov/documents/2016/09/06/2016-21337/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for

FDA Federal Register 21 CFR Part 310, RIN 0910-AF69: Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use: https://www.gpo.gov/fdsys/pkg/FR-2016-09-06/pdf/2016-21337.pdf

FDA Consumer Update: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378393.htm

FDA webpage – 5 Things To Know About Triclosan: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm205999.htm

Article from Cleanlink: http://www.cleanlink.com/news/article/FDA-Rules-On-Safety-And-Effectiveness-Of-Antibacterial-Soaps--19970

Clean Hands: A Win For Everyone: http://info.waxie.com/hand-hygiene-easy-1-2-3