FDA antibacterial review excludes healthcare products

A new U.S. Food and Drug Administration (FDA) effort to review the safety and effectiveness of antibacterial hand soaps and body washes will not include products used in healthcare settings, according to the agency.

Healthcare and consumer antiseptic products will be evaluated separately, the FDA said, because “these categories are distinct based on the proposed use setting, target population, and the fact that each setting presents a different risk for infection.” A previous review in the mid-1990s had included both healthcare and consumer products.

Under the FDA’s recently proposed rule, makers of over-the-counter antibacterial hand soaps and body washes would have to demonstrate that their products are safe for long-term daily use as well as more effective at preventing illness and the spread of certain infections than plain soap and water. Any of the consumer antispetic products not deemed safe and effective would need to be reformulated or relabeled to remain on the market.

The FDA says it issued the proposed rule because "[n]ew information on potential risks posed by the use of certain consumer antiseptic washes has prompted us to reevaluate the data needed for classifying consumer antiseptic wash active ingredients as generally recognized as effective."

The agency’s efforts are part of a larger, ongoing review of antibacterial active ingredients, among them triclosan and triclocarbon. The proposed rule does not apply to hand sanitizers, wipes or antibacterial products used in healthcare settings.

The FDA is accepting comments on the proposed rule for 180 days. Comments can be made online or via mail or delivery service. Companies will have a year (the comment period and about six more months) to submit new data and information, then another, 60-day comment period will begin. For more information and commenting instructions, see the proposed rule.

See other content by this author here.


Topics: Regulatory Compliance