New Proposal on Antibacterial Soaps

Greetings!

On Tuesday, December 17, 2013, FDA published a proposed amendment to the tentative final monograph for topical antiseptic/antimicrobial products (http://tinyurl.com/qbatlul). The proposed rule addresses the formulation of “consumer antiseptic products intended for use with water” or in laymen’s terms, antibacterial hand and body washes.

Products intended to kill bacteria and other microbes are regulated as drugs by FDA.  Such products sold over the counter (without a prescription) must conform to FDA monographs that detail the ingredients, concentrations and labeling that is to be used on over the counter drug products of a given class.  The process by which a monograph becomes final involves a great deal of data review; proposed rules; public comments and resolution of those comments with FDA’s mission to protect public health.  In the case of topical antimicrobial products the process stalled in 1994 with publication of a so-called “tentative final monograph” (TFM) that questioned the safety and efficacy of a number of common active ingredients in those products.

In April of 2011 we wrote about (http://tinyurl.com/pexls8k) certain regulatory actions FDA took based on the tentative final monograph and noted that a lawsuit had been filed in 2010 that sought to force FDA to finalize the monograph.  The lawsuit was filed by the National Resources Defense Council and less than one month ago FDA entered into a consent decree to finalize the monograph in a timely manner. Tuesday’s proposed rule is a result of this consent decree.

The rule proposes that additional safety data is necessary to support the use of consumer antiseptic wash active ingredients and that the active ingredients must also have data demonstrating a clinical benefit over nonantibacterial soap and water.  The proposed rule states in part,

“Several important scientific developments that affect the safety evaluation of these ingredients have occurred since FDA’s 1994 evaluation of the safety of consumer antiseptic active ingredients under the OTC Drug Review. New data suggest that the systemic exposure to these active ingredients is higher than previously thought, and new information about the potential risks from systemic absorption and long-term exposure have become available. New safety information also suggests that widespread antiseptic use can have an impact on the development of bacterial resistance.”

The document also discusses some of the underlying concerns for these types of products:

“Since the 1994 TFM was published, new data have become available indicating that systemic exposure to topical antiseptic active ingredients may be more than previously thought. Systemic exposure refers to the presence of antiseptic active ingredients inside and throughout the body. For example, triclosan is an antiseptic active ingredient commonly found in consumer antiseptic hand and body wash products. It is absorbed through the skin and has been found in both human breast milk and urine. Further, triclosan has been found at relatively consistent levels in urine samples collected from a representative sample of the U.S. population since sampling began in 2003. We believe that the consequences of this systemic exposure need to be assessed.”

The document goes on to discuss the data gaps for several of the active ingredients; gaps that must be filled in order for the products to remain on the market in the future. Over 20 ingredients that require additional safety and efficacy data are listed.  Some commonly used ingredients included on the list are Benzalkonium chloride, Benzethonium chloride, Triclosan, Triclocarban, Hexylresorcinol, Povidone-iodine Fluorosalan, Hexachlorophene, Methylbenzethonium chloride and Phenol.

So how long does industry have to submit safety and effectiveness data? As outlined in Hyman, Phelps and McNamara’s Law Blog of November 28, 2013 (http://tinyurl.com/owp928g), the consent decree detailed a timeline that stipulates that the final monograph must be published by September 15, 2016. In the proposed rule FDA has stated that the effective date for compliance with what would be the new monograph would be one year after publication of the final rule, which means September 15, 2017 if the timeline is met.

FDA’s proposal will be costly to industry and many in the public will be sorry to see changes to highly favored products.  It will be interesting to see which ingredients pass muster.  In the meantime, Americans can reduce their exposure to the ingredients of concern by following the Center for Disease Controls instructions for hand washing with nonantimicrobial soap: http://www.cdc.gov/features/handwashing/.

As always, the associates of FDALabels.com and Bioscience Translation & Application are ready to assist you with your FDA regulatory questions. Contact us today at info@FDAlabels.com or info@BioTransApp.com. I you find our posts informative, consider visiting http://eepurl.com/Imbjv to subscribe to our occasional email newsletters regarding FDA regulations and other topics of interest to FDA-regulated companies.  We send messages targeted to the dietary supplement, cosmetic, food, OTC drug and medical device industry sectors.  You may subscribe to one or all of the newsletters and you may unsubscribe at any time.

All the best to you and yours as we approach 2014!

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Evelyn & Associates

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Hand Sanitizers and OTC Drug Regulation

In August of last year we sent our cosmetic and OTC drug clients a link to a Hyman, Phelps and McNamara Law Blog Post about a lawsuit against FDA that sought to force the agency to finalize the tentative final monograph on hand sanitizers that has been “tentative” since 1994. This week FDA issued four warning letters to companies promoting hand sanitizers and other products as effective again MRSA (methicillin-resistant Staphylococcus aureus bacteria).  FDA issued a press announcement about these letters due to the concern that the public could be misled and subsequently harmed by the MRSA claims (http://tinyurl.com/4x6j777).  I find the warning letters interesting because of what we can learn about the regulation of over the counter drug products, particularly those under review by FDA or subject to tentative final monographs.

One of these warning letters went to Oh So Clean, Inc, doing business as CleanWell Company, which markets thymol-based hand sanitizers and sanitizing wipes. (Thymol is a constituent in the herb thyme.)  The warning letter demonstrates how FDA can enforce the stipulations of over the counter drug monographs that remain tentative. The warning letter results from FDA inspection of the company in August of 2010.  At that time CleanWell Company received a 483 letter detailing the violations FDA observed during the inspection. The warning letter issued last week notes that the company’s September response to the 483 letter “lacks sufficient corrective actions” and details FDA’s findings that the products are unapproved new drugs.

Based on the product labels and the company’s website, FDA categorizes the CleanWell products as “OTC topical antimicrobials” and cites the tentative final monographs (TFMs) for OTC healthcare antiseptics and OTC first aid antiseptics as the governing regulations for these products.  Interestingly, the response to an inquiry our company made to FDA in 2009 listed only the healthcare TFM as pertaining to hand sanitizers. Nevertheless, both of these monographs are being evaluated under FDA's OTC Drug Review process and the April 18 warning letter notes that “Pending a final monograph, the agency does not object to the marketing of OTC drugs that meet the formulation and labeling requirements described in the TFM.”  Unfortunately, the CleanWell “products’ formulation and labeling are not consistent with any of these TFMs.”  You can review the TFMs at http://tinyurl.com/3pxx464.

So what were the problems with these products?

First, the drug facts boxes identified Thymus vulgaris oil (thymol 0.05%) as the only active ingredient. The pertinent TFMs do not list this as an approved active ingredient but the First Aid Antiseptic TFM lists thymol in combination with eucalyptus, menthol, methyl salicylate and alcohol as an acceptable active ingredient. In addition, the product claims go beyond what is permitted by the tentative final monographs for antiseptic products. In particular, the claims of effectiveness against MRSA are non-monograph. The only way to make claims outside of those detailed in the monographs is to undertake clinical trials in order to gain FDA approval for new over the counter drug claims.

Even if thymol alone were an acceptable active ingredient for this type of OTC product, the company’s own website and other labeling state that active ingredient used in the products is a blend of essential plant oils.  FDA refers to incorrect labeling such as this as “misbranding”.

The warning letter further cites violations of good manufacturing practices, which render the products “adulterated” and orders the company to “cease manufacturing and distributing all your unapproved new drug products” and to take corrective action and respond to the warning letter within 15 working days. This is undoubtedly a real blow to products that were available in several well-known retail outlets.  

Similar problems were noted in the other warning letters about MRSA claims—simple failure to follow the monographs, which detail how to formulate and label over the counter drug products.  It is our view that timely and competent review of the product labels and claims could have helped these companies identify the issues cited by FDA and remain active in the marketplace.  Is your product compliant with applicable FDA regulations or has a slight tweak of the marketing materials skewed your claims beyond those permitted?  Let the Bioscience Translation & Application team help you ensure compliance so your marketing plans are not disrupted by FDA enforcement activities.

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