No More ‘Antibacterial’ Soap, Says FDA

Antibacterial soaps boast their protective benefits in massive advert campaigns around the globe. This often leaves the general population convinced of the extra protection claimed, without doing any research on their own. However, the FDA has finally stepped in to the matter, and ruled that over the counter antibacterial soaps will not be sold in US.

The FDA has arbitrated a total of 19 antimicrobial agents to be either ineffective or unsafe. All products incorporating these 19 chemicals are to be taken off the shelves within one year. The FDA plans to officially publish this ruling on 6th September, though the decisions in already available in the form of a PDF document on its website.

When explaining the basis of the ruling, the director at Center for Drug Evaluation and Research of FDA, Janet Woodcock, said, “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.” As already noted, this misperceived edge over conventional soaps has always been the selling point for these products.

The second reason for the prohibition on sales was that antimicrobial soaps might actually be harmful for the user. Janet says that ‘some data suggests that antibacterial ingredients may do more harm than good over the long-term’.

Back in 2007, the magazine Scientific America published that the use of antimicrobial soap is akin to using antibiotics in a reckless behavior. The argument goes that both expose microbes to stress, which induces the emergence of resistant strains among them.

Among the chemicals banned two of the most commonly used were triclosan and triclocarban. Triclosan is the active ingredient in antimicrobial bar soaps while triclocarban is added in antimicrobial liquid hand and body washes.

Scientific America stated: “Triclosan has a specific inhibitory target in bacteria similar to some antibiotics.” The two substances are ubiquitous in major brands of antimicrobial soaps like Safeguard.

The decision comes in as a follow-up to the December 2013 proposal ruling which required the makers to submit data proving the safety and superior protection granted by antimicrobial soaps and washes over the regular ones. Since manufacturers failed to provide satisfactory information on these 19 antimicrobial agents, the FDA passed the current ruling.

In the released FDA file, it is elucidated that the measured effectiveness of the antibacterial product had declined recently due to a lack of data proving otherwise. Therefore, they no longer rank the products as generally regarded as effective (GRAE).

The FDA released document further states that due to a lack of studies showing effects of exposure by these 19 antibacterial over long terms, the administration demoted the drugs from antibacterial soaps as generally regarded as safe (GRAS) as well. Apart from a lack of longitudinal study, they also named potential hormonal effects and increase in bacterial resistance as the impetus behind the move.

The following is the complete list of antimicrobials banned by the recent ruling: cloflucarban,  fluorosalan, hexachlorophen, hexylresorcinol, iodophors (iodine-containing ingredients), methylbenzethonium chloride, phenol (greater than 1.5 percent), phenol (less than 1.5 percent), secondary amyltricresols, sodium oxychlorosene, tribromsalan, triclocarban, triclosan and triple dye.

These substances are found in antibacterial substances which should be followed by washing off the substance with water. It should be noted, however, that the FDA has not banned over the counter sale of all products containing these substances, the ruling exclusively applies to “consumer antiseptic wash products”. Even hand sanitizers are not included in the banned category.

For now the FDA suggests that consumers should use usual soaps with plenty of water to clean their hands. In case you don’t remember, rubbing your hand properly after applying soap can significantly sanitize your hands.

Theresa M Michele of the Division of Nonprescription Drug Products (also a part of the FDA) says that: “If you use these products because you think they protect you more than soap and water, that’s not correct. If you use them because of how they feel, there are many other products that have similar formulations but won’t expose your family to unnecessary chemicals. And some manufacturers have begun to revise these products to remove these ingredients.”

In case you’re still looking for a placebo, so as to feel relieved after a quick hand wash, maybe next time not make it so quick and rinse properly in the sink, though this way it won’t be just a placebo.

Leave A Reply

Your email address will not be published.