Last month, the FDA issued a final ruling on antibacterial soaps. No longer can manufacturers say these soaps are more effective than regular soap. Under the new rule, antibacterial soaps and body washes that contain certain chemicals cannot be marketed as such, simply because those ingredients didn’t prove to be both safe and effective for long-term daily use.
The rule applies to soap and body wash products that contain either one or more of 19 active ingredients, including:
• Iodophors (Iodine-containing ingredients), including:
o Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
o Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
o Nonylphenoxypoly (ethyleneoxy) ethanoliodine
o Poloxamer–iodine complex
o Povidone-iodine 5 to 10 percent
o Undecoylium chloride iodine complex
• Methylbenzethonium chloride
• Phenol (greater than 1.5 percent)
• Phenol (less than 1.5 percent)
• Secondary amyltricresols
• Sodium oxychlorosene
• Triple dye
Triclosan is commonly used in liquid soaps, whereas triclocarban is commonly used in bar soaps.
This rule, however, does not apply to hand sanitizers or antibacterial wipes.
The ruling is a result of a lack of scientific evidence to support the fact that antibacterial soaps and washes don’t provide results better than using plain soap and water. Some data the FDA reviewed suggested that long-term use of these antibacterial soaps and body washes could do more harm than good in the end.
Under the new ruling, companies have one year to either remove the appropriate ingredients from their formulas, or to stop marketing them as such, before the final rule goes into effect. Some manufacturers have already started removing those active ingredients from their products. If manufacturers want to continue using those ingredients in their formula, and still have the right to market them as antibacterial, they must provide the evidence to support them as safe and effective compared to regular soap and water. Three of the banned chemicals are deferred to three years before the formulas must be changed or marketing must be stopped.
This comes as a result of an FDA-proposed rule issued in 2013. The rule required antibacterial soap and body wash manufacturers to prove their products were more effective than soap and water. When the manufacturers did not provide the necessary information required to establish safety and effectiveness, the FDA took action and issued this new final rule. Physicians, pharmacists, and nurses should relay this information to patients to protect themselves and
A 2007 paper published in the Journal of Clinical Infectious Diseases found that consumer soaps that contained triclosan and other antibacterial chemicals could be a link the in the growth of dangerous drug resistant bacterial. There is also fear that it could cause hormonal effects.