Regulatory History and Attributes
of Consumer Antiseptics
Nonprescription Drugs Advisory
Committee Meeting
Silver Spring, Maryland
October 20, 2005
Colleen Kane Rogers, PhD
Division of Nonprescription Regulation Development
Center for Drug Evaluation and Research
Overview
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The Monograph Process
Defining Consumer Antiseptics
Attributes of Consumer Antiseptics
Concerns Regarding Consumer
Antiseptics
Nonprescription Drugs Advisory Committee
October 20, 2005
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OTC Monograph Process
Advisory Review Panel
• Category I: GRASE (Generally Recognized As
Safe and Effective)
• Category II: not GRASE
• Category III: cannot determine if safe and
effective
Nonprescription Drugs Advisory Committee
October 20, 2005
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OTC Monograph Process
• Category I: GRASE
• Category II: not GRASE
• Category III: cannot determine if safe and
effective
Nonprescription Drugs Advisory Committee
October 20, 2005
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OTC Monograph Process
Comments
Nonprescription Drugs Advisory Committee
October 20, 2005
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OTC Monograph Process
Comments
Data
Nonprescription Drugs Advisory Committee
October 20, 2005
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Antiseptic Monograph
• 1972 – Advisory Review Panel
• 1974 – Advance Notice of Proposed
Rulemaking (ANPR)
• 1978 – Proposed Rule (TFM)
• 1994 – Proposed Rule (Amended TFM)
• Final Rule (FM)
Nonprescription Drugs Advisory Committee
October 20, 2005
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Antiseptic vs. Disinfectant
• Antiseptic
– Antimicrobial used on the skin
– Regulated by FDA
• Disinfectant
– Antimicrobial used on inanimate
objects or surfaces
– Regulated by EPA
Nonprescription Drugs Advisory Committee
October 20, 2005
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Consumer Antiseptics
• Consumer products are currently
marketed as:
– Antibacterial soaps
– Antibacterial wipes
– Antibacterial bodywashes
– Hand sanitizers
Nonprescription Drugs Advisory Committee
October 20, 2005
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Defining Consumer Antiseptics –
FDA
• Panel defined ‘antimicrobial soap’:
– Reduces the microbial flora of the skin
– May reduce residents and transients
• 1978 TFM: intended for the general
public in non-hospital settings
• 1994 TFM: called ‘antiseptic handwash’
Nonprescription Drugs Advisory Committee
October 20, 2005
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Labeling Claims
• 1974 ANPR and 1978 TFM:
– Antimicrobial/ antibacterial soap
– Deodorant soap/ reduces odor
• 1978 TFM:
– Different uses require different labeling
for consumers and healthcare personnel
– Insufficient data to accept claims for
‘prevention of infection’
Nonprescription Drugs Advisory Committee
October 20, 2005
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Labeling Claims
• 1994 TFM:
– Antiseptic/ antiseptic handwash
– For handwashing to decrease bacteria
on the skin
• After changing diapers
• After assisting ill persons
– Recommended for repeated use
• 2003 Citizen Petition (SDA/CTFA):
– Request anti-viral claims
Nonprescription Drugs Advisory Committee
October 20, 2005
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Defining Consumer Antiseptics –
Industry
• 1994 TFM
– 3 healthcare categories
– 1 consumer category
• 1995 Healthcare Continuum Model
– 3 healthcare categories
– 2 consumer categories
– 1 food handler category
Nonprescription Drugs Advisory Committee
October 20, 2005
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Active Ingredients Used in
Consumer Antiseptics
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Ethanol
Triclosan
Triclocarban
Quaternary ammonium compounds
– Benzalkonium chloride
– Benzethonium chloride
Nonprescription Drugs Advisory Committee
October 20, 2005
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Proposed Consumer Antiseptic
“Handwash” Attributes – FDA
• Attributes:
– Broad spectrum
– Fast-acting
– Persistent (if possible)
• Recommended efficacy testing:
– Same as healthcare personnel handwashes
– Specific bacterial reductions after 1st and
10th washes
Nonprescription Drugs Advisory Committee
October 20, 2005
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Proposed Consumer Antiseptic
“Handwash” Attributes – Industry
• Attributes:
– Broad spectrum
– Fast-acting not essential
– Persistent
• Recommended efficacy testing:
– Single wash to demonstrate efficacy
– No cumulative effect
Nonprescription Drugs Advisory Committee
October 20, 2005
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Proposed Consumer Antiseptic
Bodywash Attributes – Industry
• Attributes:
– Limited or broad spectrum
– Fast-acting not essential
– Persistent
• Recommended efficacy testing:
– Significant reduction in resident flora
compared to baseline – OR –
– Significant reduction in transient flora
compared to use of placebo/ bland soap
Nonprescription Drugs Advisory Committee
October 20, 2005
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Potential Hazards from Using
Consumer Antiseptics
• Individual
– Irritation
– Contact dermatitis
– Antibiotic resistance
– Incomplete immune system ‘education’
• Societal
– Antibiotic resistance
– Impact on ecosystems
– Secondary exposure
Nonprescription Drugs Advisory Committee
October 20, 2005
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Concerns Raised by the 1972 Panel
• Routine use of antimicrobials may have a
long-term harmful effect by reducing normal
flora (hypothetical)
• Widespread use of antibiotics, antiseptics,
and hard surface disinfectants may produce
an increase in gram-negative infections
• Exposure of the entire body to antimicrobial
chemicals when alternate methods of odor
control are available
Nonprescription Drugs Advisory Committee
October 20, 2005
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Concerns Raised by FDA
• Proliferation of triclosan-containing products
– In 1994 TFM, based on new information,
concluded that proliferation was not a
concern
• Antibiotic and antiseptic resistance related to
healthcare antiseptics (1997 NDAC)
– Decreased susceptibility to antiseptics was
not a concern at that time
– Recommended surveillance
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October 20, 2005
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Current FDA Concerns
• Antibiotic and antiseptic crossresistance
• Environmental concerns
– Secondary exposure
– Impact on ecosystems
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October 20, 2005
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What Do We Need to Know?
• Finalizing the Monograph
• Need NDAC input to develop some
policies
– What population would benefit from
consumer antiseptics?
– How do we measure the benefit of
these products?
– Which potential hazards, if any, pose
a concern?
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October 20, 2005
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