P&G gets warning letter from FDA regarding hand sanitizer

Procter & Gamble Co. may need to wash its hands clean of a new sanitizerthat health officials say is hazardous to children.

The Food and Drug Administration on Tuesday released a warning letter it had sent to P&G for “making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer product,” the agency stated. 

The agency reported that the product’s claims and directions for use cause it to be an unapproved new drug under the Federal Food, Drug, and Cosmetic Act, citing specifically P&G 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 because this product has not been proven safe and effective for these claims.

“FDA is concerned with the marketing of this over-the-counter drug for use by school children and others,” stated Steven Galson, director of FDA’s Center for Drug Evaluation and Research. “Over-the-counter drugs are often widely used without supervision by a doctor or other health care professional, so it is essential that manufacturers obtain FDA approval or fully comply with OTC monographs and agency policies.”

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. 

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, the agency stated. 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 claims regarding the prevention of colds.

P&G spokesman David Bernens said on Tuesday that the company would comply with the FDA’s complaints.

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