SDA/CTFA Coalition Petitions FDA to Allow Anti-Viral Labeling on Qualifying OTC Products

January 17, 2003

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WASHINGTON, D.C. -- The Soap and Detergent Association (SDA) and The Cosmetic, Toiletry, and Fragrance Association (CTFA) Topical Antimicrobial Coalition today petitioned the Food and Drug Administration (FDA) to allow eligible topical antibacterial products to make anti-viral claims, based on testing and evidence of efficacy. If FDA agrees with this petition, the FDA’s Final Monograph for Health-Care Antiseptic Drug Products would allow health-care personnel, food handler and consumer hand wash products to include anti-viral indications and labeling for viruses commonly transmitted by the hands.

In its petition, the Coalition made the following supporting comments:

• Product efficacy would be based on the American Society for Testing and Materials’ (ASTM) independent, published testing methods to assess anti-viral activity. The Final Monograph would cross-reference ASTM methods for both anti-viral and antibacterial activity.
  
• ÿ From a public health perspective, consumers, food handlers and health care workers should be able to understand and evaluate the anti-viral benefits of products, which can prevent the spread of respiratory and gastro-intestinal infections caused by viruses.
  
• ÿ Extensive current data show that several active ingredients in topical antibacterial products also are highly effective at inactivating a variety of viruses.
  
• ÿ FDA has recognized the role that topical antibacterial products may have in decreasing the number of viruses on the hands.
  

“As an industry, it is important we share these important product benefits with consumers,” said SDA Director of Human Health and Safety Francis Kruszewski, Ph.D. “This submission to the FDA is the next step toward making it possible.”