On Friday, the Food and Drug Administration announced a final rule establishing over-the-counter consumer antiseptic wash products with one or more of 19 specific active ingredients — including triclosan and triclocarban — can no longer be marketed.
Here are six things to know about the final rule.
1. The ban comes because soap 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," according to an FDA statement.
2. The FDA first issued a proposed rule in 2013 after new data revealed triclosan in liquid soaps and triclocarban in bar soaps could actually pose health risks and propel antibiotic resistance. "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," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research. "In fact, some data suggests that antibacterial ingredients may do more harm than good over the long term."
3. Under the 2013 proposed rule, manufacturers had to give the FDA data on the products' safety and efficacy if they wanted to continue marketing them to the public. This included data from clinical trials concluding that the products were better than non-antibacterial soap in reducing infection and human disease.
4. Manufacturers did not provide necessary data for the following 19 affected ingredients, which are now banned by the final rule:
- Cloflucarban
- Fluorosalan
- Hexachlorophene
- Hexylresorcinol
- Iodophors including
- Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
- Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol
- Nonylphenoxypoly 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
5. The new final rule does not cover three specific active ingredients used in over-the-counter antiseptic products: benzalkonium chloride, benzethonium chloride and chloroxylenol. The FDA is allowing for the development and submission of new data for these ingredients.
6. Since the proposed rule was released in 2013, some manufacturers started taking some products containing those active ingredients off the market. Now, they will have one year to comply with the final rule by reformulating all affected products or removing them from the market.