On September 14, 2007, the United States Food and Drug Administration (FDA) issued a warning letter to Proctor and Gamble over concerns about the company’s labeling and marketing of Vicks Early Defense Foaming Hand Sanitizer.

The FDA claims Proctor and Gamble instructs users to use the product in a manner that is inconsistent with FDA’s Over-the-Counter Drug Review. Vicks Early Defense Foaming Hand Sanitizer label lists 0.1 percent triclosan as an active ingredient, an acceptable ingredient for a topical antimicrobial product. However, Vicks’ claims that an antimicrobial effect will still be achieved by leaving hand sanitizer on hands without wiping or using water is not approved by the FDA.

The warning letter further questions the product’s claim to be effective in fighting the “germs” that cause colds. The FDA said it was not aware of sufficient evidence to show support of the product’s claim to preventing users from becoming infected with colds.

Proctor & Gamble has 15 days from the issue of the warning letter to devise a plan to correct the violation.

The FDA is currently reviewing other manufactures of over-the-counter antiseptics.

Sources: U.S. Food and Drug Administration, Warning Letter to Proctor and Gamble No. CIN-WL-07-34157-1 9, September 14, 2007;“F.D.A. Warns Proctor on Hand Sanitizer Advertising” Bloomberg News, September 19, 2007.