Antibacterial soaps sold over the counter that contain at least one of 19 active ingredients can no longer be sold in the U.S. because there is “no scientific evidence they work better than plain soap and water,” and “in fact, … may do more harm than good over the long-term,” the Food and Drug Administration (FDA) announced.
The final rule comes following an FDA review of chemicals in OTC consumer antiseptic wash products such as antibacterial hand soap, during which the agency said it did not find concrete evidence that the chemicals promoted to protect against illness and infection actually prevented the spread of germs.
The FDA issued a proposed rule in 2013 after some data suggested that long-term exposure to certain active ingredients in antibacterial products could pose health risks, such as bacterial resistance or hormonal effects. Under that rule, manufacturers who used at least one of the 19 active ingredients listed who wanted to continue to sell their products in the U.S. needed to provide the FDA with additional data on the safety and effectiveness of their products. This included data from clinical studies demonstrating that the products were better than non-antibacterial washes in preventing human illness or reducing infection.
Manufacturers of antibacterial hand and body washes did not provide the information requested to establish the safety and effectiveness for the 19 active ingredients addressed in the final rule. Thus, the final rule will go into effect. Some manufacturers have already started removing the ingredients from their products.
The final rule includes antiseptic hand and body washes that contain one or more of the 19 active ingredients specified by the FDA. It does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.
Sources: Righting Injustice and the FDA
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.