The ubiquitous antibacterial soaps found in most bathrooms and lavatories are now under scrutiny to determine if these products are really effective in killing germs and safe for people to use. The U.S. Food and Drug Administration (FDA) recently announced its intention to modify a 1994 review on the effectiveness and safety of antibacterial soaps currently sold in the market. The FDA added that long-term use of these products could potentially lead to the creation of bacteria that are resistant to antibiotics as well as pose danger to human health by affecting the hormones of people.
The FDA said that there is currently no evidence that using antibacterial soaps as against using plain soap and water is more effective in killing germs and preventing illness. To be subjected to further study and testing are the ingredients triclosan usually found in liquid soaps and triclocarban, a similar chemical found in hard bath soaps. There are about 2,000 individual products that contain these chemicals.
Dr. Sandra Kweder, the deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research said that companies manufacturing these products which contain triclosan and triclocarban and claiming its antibacterial properties must show data behind the claim. Because if companies do not comply, the products will need to be reformulated or rebranded in order for it to be allowed to remain in the market.
In 1994, the FDA proposed removing triclosan from certain products but because the FDA did not take any final and specific action, such ingredients are still found in soaps sold to this day. And in 2010, the Natural Resources Defense Council (NRDC), an organization actively involved in the promotion of a healthy environment by seeking sustainable policies from the government and private companies sued the FDA to force it issue a new rule with regard to the said ingredients.
The suit was recently settled with the condition that starting January 2014 there must be a 180 days devoted to public comment on the proposed rule and companies will be given a one year period or until December 2014 to require them to submit additional data and new information on their products. And by September 2016 the FDA should be able to finalize the rules and determine if these products are really safe and effective to use.
According to Mae Wu, an attorney for NRDC, “This is a good step toward getting unsafe triclosan off the market.” She added that even without triclosan in soaps cleaning ones hands with just plain soap and water is more effective and can carry no potential health risks.
The FDA has already accumulated enough scientific data to question the effectiveness and safety of antibacterial soaps. The agency is now in the process of determining whether the widespread use of such products contributes in the creation of drug-resistant bacteria. Much like how penicillin acts but by a different mechanism, triclosan targets a specific enzyme called the enoyl-acyl carrier protein reductase (ENR). The ENR is essential to cell-wall synthesis but the problem with ENR according to experts is that the bacteria can develop versions with amino changes that make the enzyme resistant to drugs. The new mutant ENR enzyme is now harder to kill.
Triclosan as a compound can also be absorbed into the blood even if this is just applied externally according to the FDA. Triclosan resembles other drugs known as endocrine disrupters and these chemicals can enhance or inhibit the normal effects of hormones like estrogen, testosterone and thyroid hormone among others. Fortunately, the effects are reversible.
This recent action of the FDA does not affect alcohol-based hand sanitizers, wipes and other antibacterial products utilized in health care set-ups. Most of the hand sanitizers sold in the market have 60% alcohol or ethanol content and are considered safe in cleaning when water and soap are not available, added Dr. Kweder.
Many have lauded the FDA for this recent move. The question that antibacterial soaps are really effective and safe is now being taken more seriously. Whether or not these products are really effective must just be secondary to the real concern if these products can potentially affect peoples’ health in a negative manner.
By Roberto I. Belda