FDA Issues Final Rule Regarding the Safety & Effectiveness of Consumer Antiseptic Products

September 8, 2016

FDA Issues Final Rule Regarding Safety & Efficacy of Antibacterial Soaps

On December 16, 2013, the FDA released a proposed rule regarding the safety and effectiveness of certain antibacterial soap products.  If finalized, this ruling would require manufacturers of antibacterial soaps to demonstrate that their products are safe for long-term daily use, and that they are more effective in preventing the spread of certain illnesses and infections than plain soap and water.  Any manufacturers that fail to provide FDA with this data would be required to reformulate or relabel their products.  In its press release on the subject, FDA stated that this rule was proposed “after some data suggested that long-term exposure to certain active ingredients used in antibacterial products — for example, triclosan (liquid soaps) and triclocarban (bar soaps) — could pose health risks, such as bacterial resistance or hormonal effects.”

On Friday, September 2nd, the FDA finalized this rule, requiring manufacturers of over-the-counter (OTC) antibacterial hand soaps and body washes to remove triclosan and triclocarban from their products.  This comes after manufacturers failed to demonstrate that they are both safe for long-term daily use and also more effective than using plain soap and water.  As such, companies will no longer be able to market antibacterial washes containing these ingredients.

Since the proposed rule was issued, FDA states that manufacturers have been “phasing out the use of certain active ingredients in antibacterial washes, including triclosan and triclocarban.”  In a recent press release, FDA states that all manufacturers have one year to comply with the final rule by removing products from the market or reformulating the products to remove antibacterial active ingredients.

The ruling applies to “consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban. These products are intended for use with water, and are rinsed off after use.”  FDA also notes that this rule does not apply to hand sanitizers or wipes, or antibacterial products used in health care settings.

For additional details, view FDA’s final rule and the accompanying press release.

Do you manufacture an OTC antibacterial soap product or other FDA-regulated product? We can help ensure that you are in compliance with all FDA regulations and requirements.  For more information on our services and how we can help you, contact us today.


June 9, 2016

FDA Simplifies Process for Requesting Expanded Access to Investigational Drugs

On Thursday, June 2nd FDA released the final Individual Patient Expanded Access Investigational New Drug Application (Form FDA 3926), which is a new form for physicians to use when requesting...

June 6, 2016

FDA Updates Guidelines for Biosimilar Naming Convention

On August 28, 2015, FDA announced the availability of a draft guidance, entitled “Nonproprietary Naming of Biological Products,” which established a naming convention for biological products. The...

June 14, 2016

FDA Clarifies Regulations Regarding How Patients May Be Charged for Investigational Drugs

On Thursday, June 2nd the FDA issued a final guidance, entitled “Charging for Investigational Drugs Under an IND — Questions and Answers.” The guidance provides information concerning the...