The FDA ruling is specific to OTC rinse-off hand and body soaps; it does not pertain to hand sanitizer products, wipes, or similar anti-bacterial products made for the health care industry.
Essentially, the Administration has determined that nearly 20 ingredients commonly used in these soaps do not provide the claimed anti-bacterial benefits: “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), says in the Administration’s statement on the ruling.
“In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term,” adds Woodcock.
Do not use list
The administration is giving personal care manufacturers 12 months to reformulate anti-bacterial soaps. Once that deadline passes, these ingredients will no longer be allowed in OTC anti-bacterial soaps:
- 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)
- Secondary amyltricresols
- Sodium oxychlorosene
- Tribromsalan
- Triclocarban
- Triclosan
- Triple dye
Time to reformulate?
Depending on your view of the industry, there is either a lot of work to be done or nothing to worry about.
Covering the announcement on its Focus site, The Regulatory Affairs Professional Society quoted FDA spokesperson Andrea Fischer as saying, “this final rule affects a majority of the consumer antiseptic hand and body [washes on the] market, which the FDA currently estimates at about 2,100 products,” adding that “most of the products containing ingredients affected by this proposed rule will require reformulation for continued marketing, which we understand has already begun.”
By contrast, the American Cleaning Institute or ACI (whose membership includes soap manufacturing companies) asserts that the soaps are effective as is: “Consumer antibacterial soaps and washes continue to be safe and effective products for millions of people every single day,” the group claims in its public response to the ruling.
And, the ACI goes on to suggest that with further evidence the ruling won’t stand: ”The FDA already has in its hands data that shows the safety and effectiveness of antibacterial soaps….In the coming year, ACI and its member companies will submit additional safety and effectiveness data on the key ingredients in use in consumer antibacterial soaps today: benzalkonium chloride, benzethonium chloride and chloroxylenol.”
Those particular ingredients were not a part of this ruling, and the FDA itself granted the industry an additional year to submit scientific evidence on their effectiveness.
Early response
Select multinationals, like J&J and P&G, and numerous indie brands are already phasing out or formulating anti-bacterial washes without select ingredients on the FDA’s list of banned ingredients.
And when the ruling came out last Friday, the EWG chimed in quickly. In a press release entitled, FDA Finally Bans Toxic Triclosan From Antibacterial Hand Soaps, that organization’s president Ken Cook claimed “this decision by the FDA” as “a huge victory on behalf of human health and the environment.”