After Years of Delay, FDA Releases Proposed Rule to Better Regulate OTC Antiseptics and Hand Soaps

| 16 December 2013 |  By 

In a long-awaited and legally mandated decision, the US Food and Drug Administration (FDA) today announced that it has filed a tentative final monograph that would more strictly regulate how over-the-counter (OTC) antiseptic products used with water, such as hand soaps, are formulated.


The original monograph for OTC antiseptic drug products was released in 1994, and allowed for some products now thought to be unsafe, most notably triclosan. Triclosan, an antiseptic, is used in many soaps, body washes and even some toothpastes. Though FDA has maintained that it is not hazardous to human health, it has agreed that its use merits "further review" since some animal studies have indicated the ingredient disrupts hormone regulation.

While FDA indicated that it would release the results of that review in 2012, it has remained unpublished.

In November 2013, the National Resource Defense Council (NRDC), which had been engaged in extensive litigation with FDA over how the ingredient is regulated, successfully pressured FDA into agreeing to take action to regulate triclosan.

"It's outrageous that FDA has waited 35 years to protect the public from this harmful chemical. This final rule should prohibit triclosan from use in soaps," said Mae Wu, an attorney in NRDC's health program, in a November 2013 statement. "Washing your hands with soap containing triclosan doesn't make them cleaner than using regular soap and water. In fact, not only do soaps containing triclosan fail to provide benefits consumers might expect, they carry potential health risks."

Proposed Rule: The Basics

Now, as a result of that settlement, FDA is taking new action to more strictly regulate triclosan and other OTC antiseptic products.

"[In] light of more recent scientific developments and changes in the use patterns of these products we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for this use," FDA explains in its Federal Register posting on 16 December 2013.

In addition, those products falling under the monograph will have to exhibit a clinical benefit compared to the use of non-antibacterial soap and water, FDA said.

However, FDA has not yet fully decided how companies will be able to show that their products are generally regarded as safe (GRAS) and effective (GRASE)-only that they will be required to generate clinical study data showing as much.

FDA said efficacy data should show a reduction in infections, not just bacteria. "Data from these clinical outcome studies will help assure that any potential risk from consumer antiseptic wash products is balanced by a demonstrated clinical benefit," it explained. Factors to take into account in efficacy studies, such as the number and length of hand washes, are listed in the proposed rule.

Safety data will also be a key focus of the monograph, FDA said. "We are now proposing that additional safety data will need to be submitted to the administrative record for each consumer antiseptic wash active ingredient to support a GRAS classification," it wrote.

"Because consumer antiseptic washes are chronic use products and are used by sensitive populations such as children and pregnant women, evaluation of the potential for chronic toxicity and effects on reproduction and development should be included in the safety assessment," FDA added.

Affected ingredients will, in addition to triclosan, include triclocarban and at least eight other ingredients which will require safety and efficacy data if they are to remain on the market.

When will we See the Rule?

But even as the rule promises to overhaul many of the products consumers use on a daily basis to wash their hands, they shouldn't expect the rule to impact things too quickly. The proposed rule has a 180-day comment period, and FDA often takes months-even years-to issue a final rule after the comment period ends. FDA also said that it would accept data for 12 months, indicating that it will be at least a year before the final rule is published.

And one other mitigating factor to consider may well be the ultimate cost to consumers. With FDA requesting considerably more data to show evidence of safety and efficacy, consumers may need to be prepared to see much higher prices for the products they purchase, or have fewer options if companies decide the costs aren't worth it to market the product.

FDA said at least 707 establishments would be affected, with compliance costs averaging out to $100,000 to $330,000 per company.

This could result in political pressure from Congress, further delaying the publication of a final monograph. And, as an economically significant rule, it would also be subject to a review by the Office of Management and Budget (OMB), which has been the source of some lengthy delays of FDA rules in the past as well.

The proposed rule does not, as far as Regulatory Focus could tell, indicate when FDA would remove products from the market that do not meet the standards of the rule.

OTC Antiseptic Rule


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