FDA Proposes Hand Soap Rule

The FDA has issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.

The new rule will require businesses to provide more benefit-to-risk analysis.  They will have to prove that  the risk from the use of a consumer antiseptic wash drug product must be balanced by a demonstration that it is superior to washing with nonantibacterial soap and water in reducing infection.

They will also have to prove that the product is safe, meaning that long term and widesparead use of anitseptic washes will not have an impact on the development of bacterial resistance.

The FDA will also be taking a closer look at the active ingredients of these products and will require additional safety data, as well as effectiveness data before classifying a product as generally recognized as safe and effective (GRAS/GRAE).

Small business manufacturers of antibacterial hand soaps and body washes may need to reformulate or relabel their products to remain on the market. 

If you oppose this proposed rule there is still time to make your voices heard.  You may make comments on the proposed rule by 16 June 2014.  Visit the comment page to provide your input to this proposed rule.

By Jack Rivers