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
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All the best to you and yours as we approach 2014!
Sincerely,
Evelyn & Associates
Bioscience Translation & Application
www.BioTransApp.com
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