In a final rule published on Sept. 6, 2016,¹ the U.S. Food and Drug Administration (FDA) reassessed its risk-benefit analysis for consumer antiseptic washes (antibacterial hand and body washes) and found that the evidence in support of their safety and effectiveness was inadequate. As a result, under the rule, 19 active ingredients used in various consumer antibacterial hand and body washes are not generally recognized as safe and effective (GRAS/GRAE) by FDA.

This means that products containing any of those active ingredients are considered mis-branded under section 502 of the Federal Food, Drug and Cosmetic Act (21 USC 352), and cannot be marketed as of the rule’s Sept. 6, 2017 effective date, unless the ingredient is approved through the FDA new drug application process. Absent an approved application, manufacturers of products containing these ingredients must discontinue marketing these products in Sept. 2017. FDA estimates that this change will affect more than 700 products.

In its risk-benefit analysis, FDA determined that manufacturer's provided insufficient evidence that antibacterial soaps and washes had a direct clinical benefit superior to washing with non-antibacterial soap and water for the general population. According to FDA, proof of a reduction in surface skin bacteria did not prove a reduction in infection rate. In addition, in light of new information about potential risks from systemic absorption and long term exposure,² as well as the potential impact such ingredients may have on bacterial resistance and antibiotic resistance, FDA determined that the data available are inadequate to establish safety for long-term, daily repeated exposure to these ingredients.

The final rule does not cover health care antiseptics, consumer antiseptic rubs (such as hand sanitizers or wipes), "first aid" antiseptics or antiseptics used in the food industry. Rather, the rule covers OTC consumer antiseptic washes, such as hand and body washes, that may be used by the general population on a frequent, daily basis.

¹ Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use, 81 FR 61106, https://www.federalregister.gov/articles/2016/09/06/2016-21337/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for

² In its 2013 Consumer Antiseptic Wash Proposed Rule, in addition to evidence regarding bacterial resistance, FDA cited additional data needed to support a GRAS/GRAE finding including pharmokinetic studies, developmental and reproductive toxicity studies, carcinogenicity studies and data to characterize potential hormonal effects.