FDA Regulates OTC Antimicrobial Hand Soaps

By Cyndi Root

The Food and Drug Administration (FDA) is moving to regulate antimicrobial hand soaps. The agency questions whether the topical solutions are more effective than regular soap and water for preventing infection and disease. Also of concern to the agency is the inclusion of chemicals in some products. Therefore, the FDA will require manufacturers to put their products through clinical trials just like other over-the-counter (OTC) drugs.

Disease Prevention

The FDA notes that consumers have a high degree of confidence in these products. In a recent press release, Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) said that soaps are widely used. The agency acknowledges the consumer belief that antimicrobial products prevent germs from spreading, but says that no evidence supports these conclusions. With the new regulations, the FDA is forcing manufacturers to supply evidence. Dr. Woodcock said, “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

Chemicals in the Products

Many antimicrobial soaps contain the chemicals triclocarban and triclosan, which could cause hormonal imbalances and bacterial resistance. Some consumer groups consider triclosan dangerous and point out that the FDA has been aware of the danger since 1978. The FDA did not confirm that the chemical was dangerous and left it on the marketplace. Now however, the FDA wants to put the burden of proof on manufacturers. They must prove that these chemicals are safe.

FDA Deputy Director Sandra Kweder said that animal studies have indicated hormonal effects from the chemicals and resistance to antibiotics. She acknowledged that the animal studies do not establish the dangers to humans. Toxicity is often in proportion to exposure and the FDA did not divulge the conditions of the animal studies. The degree of toxicity to humans may relate to the amount of product used and the exposure time.

The new regulations will require manufacturers to prove that triclosan, triclocarban, and other chemicals are safe and the product is effective. If not, they will have to reformulate the products or take them off the market. The new rules only cover products that consumers wash off with water, not creams that remain on the skin or antibacterial wipes. The FDA intends to address these products separately.