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Unlawful Marketing of Hand Sanitizer for Children

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 says the product's claims and directions for use cause it to be an unapproved new drug under the Federal Food, Drug, and Cosmetic Act.

FDA cited specifically Procter & Gamble promotion of Early Defense for use by schoolchildren 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 about the marketing of this over-the-counter (OTC) drug for use by children and others because it has not been proven safe and effective for these claims.

Under its OTC drug monograph system, FDA allows OTC drugs to be marketed without first obtaining agency approval in certain circumstances. These drugs must comply with applicable standards regarding monographs that specify conditions for the drugs' labeling and formulation. OTC drugs that do not have FDA approval and do not meet these requirements are considered unapproved drugs that are unlawfully marketed.

Outside of Proposed Monograph

There is a proposed OTC monograph that covers triclosan, the active ingredient in Early Defense. FDA allows companies to market their products (which would otherwise be unapproved new drugs) under proposed monographs, as long as the companies comply with the conditions in the proposed monograph. 

• In this case, the product's claims that it prevents colds and provides up to three hours of antimicrobial activity are not allowed under the proposed monograph.
• Under the proposed monograph, when antimicrobial products use triclosan as their active ingredient, their labeling must direct consumers to rinse with water after use and Early Defense does not. 
• Early Defense falls outside the proposed monograph and is considered an unapproved new drug because it lacks these directions and makes these impermissible claims.

For More Information

Warning Letter to Procter and Gamble
http://www.fda.gov/foi/warning_letters/s6508c.htm

FDA's Drug Safety Initiative
http://www.fda.gov/cder/drugSafety.htm

Date Posted: September 26, 2007

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