Antibiotic Resistance

Some antimicrobial chemicals in cleaning products are now banned by the FDA. Dr. Kanthe Shelke discusses ways manufacturers are searching for alternatives.

Dr. Kanthe Shelke
Antibiotic Resistance
October 2017
 
The overuse of antibiotics has been a growing concern for a number of years. This is true not only for the general population, but in the scientific and regulatory communities as well.
 
Antibiotics play an important role in the food and non-food industries. This family of drugs is known to protect consumers against infection… but lately, it seems their application in household products like soaps and detergents – as well as in animal feed – has come with a cost. The more we rely on such drugs, the more likely bacteria are to develop resistance to them.
 
In 2015, the Food and Drug Administration restricted the use of antimicrobials in food-producing animals. This strategy was designed to bring the use of such drugs under veterinary supervision so that they are used only when necessary for assuring animal health.
 
And finally, this past September, FDA tackled the other part of the problem, and banned triclosan and tricocarban… and 17 other chemicals commonly used in over-the-counter, household topical antiseptic products. Topical antiseptic products are antibacterial liquid, foam and gel hand soaps as well as bar soap and body washes.
 
In making the announcement, the agency stated there was insufficient evidence that adding antimicrobial chemical made such products better at preventing illness and the spread of certain infections than just plain soap and water.  Manufacturers were given one year to take these ingredients out of their products. 
 
The ban should not surprise manufacturers. The FDA has been pondering this matter since 2013, after scientific studies suggested that long-term exposure to tricolsan and triclocarban—the more common active ingredients in antibacterial formulations—might cause hormonal effects or bacterial resistance. The agency asked manufacturers for evidence of safety of antibacterial soap ingredients being used today and proof that products containing these chemicals are more effective than simple soap and water. 
 
When FDA found no evidence that these ingredients are more effective than soap and water, it decided to remove them from retail shelves. In rendering its decision, the agency cited evidence suggesting antibacterial ingredients may do more harm than good over the long term and nowrecommends washing your hands with plain soap and water rather than antibacterial products. 
 
Some companies have replaced triclosan with benzalkonium chloride, benzethonium chloride or chloroxylenol (PCMX) in their antibacterial products even as some manufacturers and industry groups (such as the American Cleaning Institute) insist antimicrobial soaps and washes are safe and effective. 
 
To date, however, either no additional data has been submitted or the material submitted is inadequate for the agency to declare that any of these ingredients are Generally Recognized as Safe and Effective. Companies have another year to provide more data on their safety and effectiveness.
 
The ban applies only to antibacterial soaps and washes.  These chemicals are also present in a number of other products including after-shave, cosmetics, deodorant, face cleanser, and even kitchenware like antimicrobial cutting boards. At this time, however, the FDA makes no recommendations against these products. The ban also does not apply to hand sanitizers or wipes, or other antibacterial products used in hospitals and other professional health care settings.
 
The quest is on for safer alternatives while gathering evidence of safety and effectiveness of these chemicals. Failure to meet the agency’s request means a likely ban in the year ahead of other products containing these chemicals.
 
I am Dr. Kantha Shelke for PLMA Live!
 
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