FDA Requires Testing for “Antiseptic” Soap
Health Letter, March 2014
In December 2013, the Food and Drug Administration (FDA) issued a proposed rule that would require manufacturers of antiseptic soaps to demonstrate that these products are more effective than ordinary soap and water at preventing illness. The proposed rule is a good first step in getting many potentially dangerous products off the market.
A number of soaps and body washes are currently marketed with the label “antiseptic,” “antibiotic,” or “antibacterial,” suggesting that the products kill bacteria or other germs and prevent the risk of illness. In fact, experts have found no evidence that antibacterial soap products are any more effective than plain soap, and some ingredients in these products may contribute to health problems, including bacterial resistance and undesired hormonal changes.
The proposed rule applies to soaps and body washes sold to the public, not antiseptics used by doctors or hospitals, or the type of hand sanitizers that are rubbed on without water. Once finalized, it would require manufacturers to demonstrate that adding an antibiotic, or microorganism-killing, active ingredient into soaps or body washes is safe and effective at preventing infection before allowing such products to be marketed.
The proposed rule is not the first time the FDA has asked manufacturers of cleaning products to test the effectiveness of “antiseptic” claims. In 1994, the FDA issued an earlier version of the current proposed rule, which would have required makers of antibiotic soap to demonstrate that the active ingredients were effective.
Although the proposed rule was never finalized, some manufacturers did submit studies to the FDA to demonstrate the effectiveness of certain antibiotic active ingredients used in consumer products. After reviewing the data, the FDA found that most of the studies were unreliable, often because they did not include a control group that washed with ordinary, antibiotic-free soap. More important, none of these studies actually showed that using antiseptic to reduce the bacteria on the skin in everyday consumers actually prevented illness.
In fact, only a few studies even looked at illness rates. Of these, only two were randomized, blinded and adequately controlled. What did these two relatively high-quality studies find? One of the studies did demonstrate that washing regularly with soap and water – regardless of whether the soap contained antibiotics – is effective at reducing illness. Yet neither study showed that washing with antibiotic soap provided any additional benefit over washing with ordinary soap and water.
The proposed rule issued in 2013 would require companies to prove that using an antiseptic soap actually reduces the number of infections for the people who use it. If these studies fail to show a benefit, the FDA will prohibit the active ingredients from being included in the soap and body wash products.
New concerns about antibiotic safety
One of the reasons the FDA is requiring proof of reduced illnesses is due to new concerns that antiseptic products may be riskier than previously thought.
One concern comes from new evidence that the active ingredients in antiseptic soap are sometimes absorbed into the body through the skin and can be distributed throughout the body. For example, triclosan, an antibiotic active ingredient commonly found in antiseptic hand and body wash products, is absorbed through the skin and has been found in both urine and breast milk. Yet little is known about this process, or whether other antibiotic active ingredients also are absorbed in this way. The FDA is asking companies to conduct further studies to address this uncertainty before allowing various active ingredients to be used in consumer soaps.
Another concern for the FDA is that some antibiotics may cause hormonal changes when absorbed into the system. Both triclosan and triclocarban, another commonly used antibiotic, have been shown to cause changes in the thyroid gland, as well as the reproductive, growth and developmental systems of newborn and adolescent animals. Most disturbing, one study showed that the effects of exposure impacted not just the exposed animal, but also that animal’s offspring. Researchers are still not sure what causes these changes.
Finally, the FDA acknowledges the obvious risk that widespread use of antibiotics in soap could contribute to the development of antibiotic-resistant bacteria. Multiple studies conducted in the laboratory have shown that bacteria that have been exposed to low doses of antibiotics adapt to the chemical and become harder to kill over time. Less is known about whether using antibiotics in consumer products will lead to this kind of resistance, and the FDA is asking for high quality studies exploring antibiotic resistance before determining whether consumer use of antibacterial soaps causes harm.
When will the requirement go into effect?
In issuing the proposed rule, the FDA indicated that the requirement of safety and efficacy testing should go into effect no later than one year after issuing a final rule, citing potential safety concerns. Yet this one year clock does not start until the final rule is actually issued, and that process could take years.
For example, the FDA made its first attempt to issue a rule on antiseptic soap in 1994. Now, a decade later, that rule has not been made final, and the FDA is replacing the 1994 proposal with the current proposed rule.
The FDA has given industry and the public six months to comment on its proposed rule and 12 months to submit new data or information. After that, the agency will allow 60 days of additional commenting on the new data before considering the data and then deciding on a final rule.
Comments are already pouring in: More than 30 comments have already been submitted since the proposed rule was published last December, many probably from manufacturers. Ordinary consumers also can submit comments by visiting www.regulations.gov and typing “FDA–1975–N–0012” into the search box.
Protect yourself: Avoid antiseptic soaps
While the FDA ponders comments, consumer soaps and body washes will continue to be marketed with antibiotic active ingredients that have not been proven safe or effective for everyday use. You should take action now to protect your family by avoiding these products. When you purchase a cleaning product, be sure to review the labeling to make sure none of the ingredients are claimed to have “antiseptic,” “anti-biotic” or “anti-bacterial” properties.
To prevent germs and illness, wash regularly with ordinary soap and water. Wet your hands, lather them completely with soap, and rub them together thoroughly before rinsing completely. Experts disagree on how long you should rub before rinsing with soap: Some say 15 seconds is enough, while others recommend 30 or even 45. One tip to make sure you are scrubbing long enough, particularly when teaching children, is to sing the “alphabet song,” which takes about 30 seconds. Make sure to scrub all over your hands, including the area under your nails, which can serve as a reservoir for bacteria.
 Food and Drug Administration. FDA taking closer look at “antibacterial soap.” December 16, 2013. http://www.fda.gov/forconsumers/consumerupdates/ucm378393.htm. Accessed on February 14, 2014.
 78 Fed. Reg. 76444, 76444, December 17, 2013.
 78 Fed. Reg. 76444, 76450, December 17, 2013.
 Ibid at 76452.
 Ibid at 76451.
 Ibid. at 76444.
 Drugs that do not conform to an FDA monograph must undergo new drug approval http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/Over-the-CounterDrugs/default.htm. The monograph must “The monographs establish conditions under which certain OTC drug products are generally recognized as safe and effective.” http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ucm317137.htm. Therefore, unless the manufacturers can prove safety and effectiveness, either through the monograph or NDA process, the product will be banned as an unapproved new drug.
 Ibid at 76454.
 Ibid at 76470.
 Ibid at 76447.
 Food and Drug Administration. Safety and effectiveness of consumer antiseptics; topical antimicrobial drug products for over-the-counter human use; proposed amendment of the tentative final monograph; reopening of administrative record. http://www.regulations.gov/#!documentDetail;D=FDA-1975-N-0012-0317. Accessed February 18, 2014.
 St. Mary Medical Center. Five steps to hand washing. http://www.stmaryhealthcare.org/FiveStepstoHandwashing. Accessed February 18, 2014.
 National Public Radio. Keep flu at bay with a song. http://www.npr.org/templates/story/story.php?storyId=103576804. Accessed February 18, 2014.
 U.S. Department of Agriculture. ABCs of hand washing. http://health.mo.gov/living/families/wic/wiclwp/pdf/R_0995_ABC_of_Hand_Washing.pdf. Accessed February 18, 2014.
 78 Fed. Reg. at 76451.