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US FDA finalizes hand sanitizer rule Agency seeks additional data on 3 active ingredients, bans 28 others
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Manufacturers can no longer use 28 active ingredients, including triclosan and benzethonium chloride, in over-thecounter hand sanitizers sold in the US, under a rule finalized by the US Food and Drug Administration on April 11. Millions of consumers rely on hand sanitizers to reduce bacteria on their hands when soap and water are not available.
Hand sanitizers that contain ethyl alcohol can stay on the US market while the FDA seeks additional safety and efficacy data. The FDA stopped short, however, of banning the use of three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—in hand sanitizer products. Instead, the agency will continue to seek additional safety and effectiveness data for those three chemicals to determine whether they are generally recognized as safe and effective for use in consumer hand sanitizers. “We believe industry has made good progress toward providing data and we
will continue to provide updates to the public about the progress of collecting this data,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement, referring to the three chemicals that the FDA deferred from further regulation. The FDA proposed the rule in 2016 and requested data on the three ingredients at that time. Manufacturers are welcoming the additional time to generate the data. “Consumers can continue to use hand sanitizer products with confidence as this regulatory process moves forward. We will work to ensure that these products remain available,” Richard Sedlak, executive vice president of technical and international affairs at the American Cleaning Institute, which represents the US cleaning products industry, said in a statement. Most consumer hand sanitizers sold in the US contain ethyl alcohol, according to the FDA. Consequently, the FDA predicts that banning the 28 chemicals will affect less than 3% of the US hand sanitizer market. Retailers have stopped selling hand sanitizers that contain triclosan, and a small number of products still contain benzethonium chloride, the agency says. Manufacturers who wish to continue using any of the 28 chemicals in hand sanitizers will need to have their products approved as new drugs by the FDA to be legally sold in the US.—BRITT
ERICKSON
C R E D I T: S H UT T E RSTO CK ( A LL )
BY THE NUMBERS
55% Percentage of Nature journal article reviewers who agreed to be acknowledged by name in the published paper during a 3-year trial. 26% of referees opted out and 19% did not respond.
US EPA to restrict reintroduction of asbestos products The use of asbestos-containing products that are discontinued in the US, such as building materials reinforced with the mineral, will be more difficult under a new Environmental Protection Agency rule. The action, announced April 17, does not affect ongoing uses of the carcinogenic material, including asbestos diaphragms installed and periodically replaced in some US chlor-alkali manufacturing plants. The rule also falls far short of health
Asbestos-cement pipes are among the products that EPA will restrict. and environmental activists’ call for the EPA to ban all asbestos products. Instead, the new rule requires any company that wants to reintroduce a discontinued asbestos product to the US market to notify the EPA. The agency will then evaluate the planned uses of the product to determine whether they are safe for human health and the environment. As needed, the EPA will prohibit the products or place restrictions on them before approving their use. The rule will “close the door on certain asbestos products to prevent them from returning to the marketplace without EPA’s review,” says Alexandra Dapolito Dunn, head of the EPA’s Office of Chemical Safety and Pollution Prevention. But Linda Reinstein of the Asbestos Disease Awareness Organization calls the rule “toothless” because it leaves the door open for companies to resurrect obsolete uses of asbestos in the US.—CHERYL HOGUE
Source: “Recognising the contribution of Nature Research journal referees,” nature.com blogs, April 16. APRIL 22, 2019 | CEN.ACS.ORG | C&EN
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