# Presentation: 347930

## 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

**The Monograph Process**
**Defining Consumer Antiseptics**
**Attributes of Consumer Antiseptics**
**Concerns Regarding Consumer Antiseptics**

## OTC Monograph Process                           

- Category I: GRASE (Generally Recognized As Safe and Effective)
- Category II: not GRASE
- Category III: cannot determine if safe and effective

## OTC Monograph Process

- Category I: GRASE
- Category II: not GRASE
- Category III: cannot determine if safe and effective

## OTC Monograph Process

**Comments**

## OTC Monograph Process

**Comments**

**Data**

## 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)**** **

## Antiseptic vs. Disinfectant

**Antiseptic**
**Antimicrobial used on the skin**
**Regulated by FDA**
**Disinfectant**
**Antimicrobial used on inanimate objects or surfaces**
**Regulated by EPA**

## Consumer Antiseptics

**Consumer products are currently marketed as:**
**Antibacterial soaps**
**Antibacterial wipes**
**Antibacterial bodywashes**
**Hand sanitizers**

## 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’**

## 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’ **

## 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**** **

## 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**

## Active Ingredients Used in Consumer Antiseptics

**Ethanol **
**Triclosan**
**Triclocarban **
**Quaternary ammonium compounds**
**Benzalkonium chloride**
**Benzethonium chloride**

## 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 1****st**** and 10****th**** washes**

## 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**

## 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**

## Potential Hazards from Using Consumer Antiseptics

**Individual **
**Irritation**
**Contact dermatitis**
**Antibiotic resistance**
**Incomplete immune system ‘education’**
**Societal**
**Antibiotic resistance**
**Impact on ecosystems**
**Secondary exposure**

## 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**

## 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**

## Current FDA Concerns 

**Antibiotic and antiseptic cross-resistance**
** **
**Environmental concerns **
**Secondary exposure**
**Impact on ecosystems**

## 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?**