Hand soap and alcohol-based sanitizers used by health-care providers should provide regulators with additional safety data in order to stay on the market, the U.S. Food and Drug Administration said Thursday.
Under a proposal released by the FDA, companies that make antibacterial soaps and gels would need to prove that products used by health-care workers don’t cause adverse effects in pregnant users, or aid in the development of antibacterial resistance, according to a statement from the agency.
The move may affect many antiseptic products that contain the antibacterial ingredient triclosan, which the FDA has said may have hormonal effects. The FDA is concerned that triclosan could alter the thyroid and reproductive systems of newborns.
“The FDA recommends that health-care personnel continue to use these products consistent with infection control guidelines while additional data are gathered,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the statement.
In a report ahead of a September 2014 meeting on the topic, FDA staff had also questioned whether chronic use of hand rubs could be the equivalent of drinking a little bit of a beer every day for pregnant health-care providers.
The landscape for health-care antiseptics has changed since the FDA began evaluating them in the 1970s, including the frequency of use of the products and new technology that can detect low levels of antiseptics in the body. Some healthcare providers use the products up to 100 times a day, Theresa Michele, director of the FDA’s division of nonprescription products, said in the agency’s statement.
Purell manufacturer Gojo Industries Inc. and EcoLab Inc., which also makes hand sanitizer products, declined to comment before reading Thursday’s proposal. 3M Co. didn’t immediately reply to a request for comment.
Procter & Gamble Co. and Reckitt Benckiser Group Plc said they don’t make any products that apply to the proposal. Both make consumer antibacterial products, for which the FDA put out a similar proposal in December 2013.
Some companies have been phasing out triclosan. Gojo said it doesn’t use triclosan in Purell because the FDA doesn’t allow the ingredient to be used in leave-on products.
The U.S. soap and cleaning compound market is estimated to total $55.4 billion, and health-care providers account for 14.3 percent of those sales, according to research published by IBIS World in January.
“Hand hygiene is being promoted in health care with clear objectives, strategies and governmental support through policies and resource allocation,” the market analysis said.
The FDA’s proposal has the potential to harm health-care providers’ effort to promote hand hygiene and prevent infections, Russell Olmstead, former president of the Association for Professionals in Infection Control and Epidemiology, said in a telephone interview.
“This entire group of products is key to helping keep patients safe,” said Olmstead, who’s also director of infection prevention and control services for St. Joseph Mercy Health System in Ann Arbor, Michigan.
Alcohol-based hand rubs, particularly, are the fastest and most effective way to prevent infections, he said. Olmstead disagreed with the FDA on the agency’s concern about pregnant women who use the gels and said evidence doesn’t exist that they’re harmful.
The FDA’s proposal is in line with an effort by the FDA to examine the impact of widespread antiseptic use on the development of antimicrobial resistance. The agency released a proposal in 2013 that would require antibacterial soaps that consumers use to meet similar requirements on safety and effectiveness.
At least 2 million Americans become infected with bacteria that’s resistant to antibiotics each year, and 23,000 die as a result of the infections, according to the Centers for Disease Control and Prevention.
The American Cleaning Institute has argued against both proposals, claiming research shows the products are safe and needed to prevent health-care infections.
“Topical antiseptics have a long and safe history of use in health care settings and are a critical component of infection prevention programs worldwide,” the group said in comments for the September meeting the FDA held with advisers on antiseptic products used by health workers.
The proposals came because of a lawsuit by the Natural Resources Defense Council. The environmental advocacy group pushed the FDA to act on triclosan and the FDA decided to evaluate a wider array of chemicals.
The proposal will be available for public comment for 6 months and companies will have a year to submit safety data to the FDA. The FDA will then evaluate the information and make a determination on each active ingredient.