FDA warns P&G about unlawful marketing of Vicks Early Defense

September 20, 2007

Although FDA is not aware of significant health risks, the agency is concerned about some of the product's claims.

The FDA has sent a warning letter to Procter & Gamble for making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer (Early Defense) product. The agency said the product's claims and directions for use cause it to be an unapproved new drug under the Federal Food, Drug & Cosmetic Act. It cited specifically a Procter & Gamble promotion of Early Defense for use by school children to prevent colds and to provide antimicrobial activity for up to three hours. Although FDA is not aware of significant health risks associated with Early Defense, the agency is concerned because this product has not been proven safe and effective for these claims. For a copy of the warning letter, visit