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May 23, 2003 12:15 PM

Coalition Provides FDA with Additional Data in Support of Consumer Antibacterial Products

WASHINGTON, D.C., May 23, 2003 - The Food and Drug Administration's review of comprehensive rules governing topical antimicrobial drug products should include new data affirming the benefits of antibacterial consumer and food handler products, according to a Citizen Petition filed with the agency.

The Soap and Detergent Association (SDA) and The Cosmetic, Toiletry, and Fragrance Association (CTFA) are urging that the FDA's Final Monograph for Over the Counter (OTC) Health-Care Antiseptic Drug Products encompass all topical antimicrobial categories, including consumer and food handler products.

The SDA/CTFA Coalition's petition provides a literature review and research results supporting the extension of the TFM to include food handler, consumer hand and consumer body products. This submission supplements the Coalition's 2001 petition that supported traditional professional healthcare categories.

In the filing, the Coalition made the following supporting comments:

  • Risk of infection occurs in the workplace, at home, in schools and other public places, due to the transmission of bacteria, foodborne pathogens and other microorganisms.
  • Health-care is not limited to clinical settings; it extends into the workplace and home where similar bacteria may lurk. Control of microorganisms found on the skin is important to public health.
  • A number of studies have demonstrated the ability of topical consumer products to reduce bacteria on the hands and the body, as well as the risk of infection.
  • The use of topical antimicrobial products plays a critical role in infection control. Consequently, there should not be an artificial division of the products into "professional healthcare products" and "consumer products".

"We want to ensure that the FDA has the most current scientific data from which to base its decisions," the Coalition said.

You can view more detailed information on the safety and effectiveness of antibacterial products on ACI’s Antibacterial Information page, at