Antibacterial Soap Health Risks May Outweigh Benefits, FDA Warns

Due to concerns about the potential health risks associated with certain chemical contained in many popular antibacterial soap, federal health regulators are prohibiting the manufacture and sale of antiseptic wash products with these ingredients, indicating that there is no evidence they are better than using plain soap and water.

The U.S. Food and Drug Administration (FDA) issued a final rule on September 2, banning the sale of consumer antiseptic hand and body washes that contain certain ingredients, since the manufacturers have failed to supply scientific evidence that establishes the products are the safe and effective.

The rule was issued roughly two years after the agency first proposed a ban on antibacterial soap ingredients for consumer user in 2013, which set a deadline for this month for final rule making.

During a two year discovery period, the FDA compiled a list of 19 specific active ingredients, including two of the most common liquid soaps, triclosan and triclocarban.

The ban was issued after the FDA requested manufacturers to provide additional data and information that would prove the active ingredients were safe enough to pass the FDA’s Generally Recognized as Safe and Effective standard.

The director of the FDA’s Center for Drug Evaluation and Research (CDER), Janet Woodcock, M.D., indicated in a statement issued late last week that the safety and effectiveness of the products must be verified for consumer use, as many consumers may think antibacterial washes offer additional germ preventions than soap and water, which has yet to be proven.

According to the FDA, the antibacterial soap ban impacts over 2,000 products, which make up nearly 40 percent of products available on the market. The banned products all contain at least one, several, or all of the 19 active ingredients the FDA has now banned from being marketed.

Antibacterial soaps have become increasingly popular over the last several years, with the hand sanitizer market now skyrocketing into a $1 billion-a-year industry. However, side effects to triclosan and triclocarban exposures could be putting consumers at unknown risks.

Several of the major manufacturers of antibacterial soaps, such as Johnson & Johnson and Procter & Gamble, announced their intention to do away with the chemicals prohibited by the FDA’s newly proposed rule prior to the rule’s finalization, said Dr. Theresa Michele, the director of the division of nonprescription drug products at the F.D.A.’s Center for Drug Evaluation and Research.

Emerging research has raised questions about the safety of triclosan and triclocarban, with a recent study finding the antibacterial soap chemicals may disrupt the normal development of the reproductive system and metabolism in animals.

The Natural Resources Defense Council (NRDC) has released several warnings about the risks of overexposure to triclosan and triclocarban, stating the ingredients are endocrine disruptors that interfere with important hormone functions, which can directly affect the brain in addition to human immune and reproductive systems. 

The Centers for Disease Control and Prevention (CDC) suggests that antibacterial soaps should only be used if soap and water are not available and that consumers using hand sanitizers should only use an alcohol-based hand sanitizer that contains 60 percent alcohol.

The rule does not impact consumer hand sanitizers and wipes, or previously approved antibacterial products used in healthcare settings. The rule states manufacturers will have one year to comply with the rulemaking by removing products with any of the 19 prohibited ingredients from the market or reformulating the products.