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December 18, 2013

Proposed Regulation Would Require Makers of Antibacterial Soaps to Prove Their Products Are Safe and Effective

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By Richard G. Morgan and Douglas L. Pfeifer

In recent years, there has been a push by some consumer groups to place restrictions on the use of certain chemical antimicrobials used in consumer products. Much of this focus has been on triclosan, a prevalent ingredient in antibacterial soaps that can also be found in clothing, furniture, cosmetics, deodorant, toothpaste, kitchenware, and a variety of other products.

Yielding to pressure from these groups, the U.S. Food and Drug Administration (FDA) issued a proposed rule on December 16, 2013 to establish conditions under which over-the-counter consumer antiseptic products intended for use with water are “generally recognized as safe and effective” (GRAS/GRAE). The proposal covers only consumer antiseptic washes that are intended for use as either a hand or body wash and does not include healthcare antiseptics for use in hospitals or in other specific healthcare situations. The proposed rule also does not apply to hand sanitizer products.

Research, Reformulate or Relabel?
Prior to the finalization of the proposed rule, companies will have to provide the agency with data on the effectiveness and safety of the active ingredient in their products. If they do not, once the rule is effective they will have to reformulate by removing the antibacterial active ingredient or remove the antibacterial claim from the product’s labeling.

Effectiveness. The FDA takes the position that currently available data are not sufficient to show an additional benefit from the use of consumer antiseptic hand or body washes as compared to using non-antibacterial soap and water. The FDA proposes requiring that the use of any active ingredient in a consumer antiseptic wash product be supported by studies that demonstrate a direct clinical benefit. The FDA defines a clinical benefit as a reduction in the number of infections in the population that uses the antiseptic wash and not just a reduction in observed quantities of bacteria.

Safety. The FDA expressed concerns over data suggesting that systemic exposure to the active ingredients in consumer antiseptic hand or body washes is higher than previously thought. The agency also expressed concern that new information suggests that widespread antiseptic use can have an impact on the development of bacterial resistance. As a response to these concerns, the FDA is proposing that safety data be submitted for each consumer antiseptic-wash active ingredient. Three broad categories are proposed for this data: (1) safety-data studies described in current FDA guidance; (2) data to characterize potential hormonal effects; and (3) data to evaluate the development of resistance.

Manufacturers and Distributors at Greater Risk for Product-Related Lawsuits
If companies that market consumer antiseptic hand or body washes are forced to remove the active ingredient in their products or revise claims regarding the products, they can expect increased exposure to potential lawsuits. The most likely lawsuits would be based on promises of product efficacy and could include allegations of consumer fraud and breach of express or implied warranty. Personal injury lawsuits are less likely unless new studies link the active ingredient to quantifiable injuries or health risks. Environmental lawsuits are possible but, like personal injury lawsuits, they will likely need a more concrete scientific basis to prevail.

Companies wishing to bolster their defenses against potential lawsuits will want to examine their products and the testing available, or that can be done, to support GRAS/GRAE status. If that is not possible, the company should reconsider its current formulation or product claims.

Comments to the proposed rule are due by June 16, 2014, and companies have until December 2014 to submit new data and information. The FDA has indicated its goal is to have the final rule in place by September 2016.

The proposed rule may be found at

For More Information:
If you have questions about the proposed rule or have concerns about related litigation, please contact one of the authors listed below.

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