P&G Should Clean Up Vicks Early Defense Hand Sanitizer Claims, Labels – FDA

Product claims and labeling for Procter & Gamble's Vicks Early Defense Foaming Hand Sanitizer are not permitted under FDA's tentative final monographs for OTC health care and first-aid antiseptics, according to the agency.

In a Sept. 14 warning letter to the Cincinnati-based firm, FDA says the claims cause the product to be considered an unapproved new drug under the Food, Drug and Cosmetic Act.

"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 states in a release.

Officials at the Cincinnati District Office of FDA's Public Health Service highlight claims on Vicks' Web site indicating that Vicks Early Defense is effective in fighting "germs" that cause colds.

"We are not aware of sufficient evidence to show that the product is generally recognized as safe and effective in preventing individuals from becoming infected with colds, a condition caused by viruses," the warning letter explains.

FDA specifically notes its concern about the promotion of Early Defense for use by schoolchildren.

Nonprescription 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," Dr. Steve Galson, director of FDA's Center for Drug Evaluation and Research, says in a release.

According to the product's usage directions, Vicks Early Defense is to be applied to hands and allowed to dry without wiping, FDA observes.

Under the OTC Drug Review - the agency's process for updating monographs - the active ingredient in the product, 0.1 percent triclosan, is recognized for use as "an antimicrobial hand cleanser, followed by a water rinse," but not as a "leave-on liquid form for use without rinsing," according to the letter.

CDER's Office of Nonprescription Products aims to submit the final monograph for OTC health care and first-aid antiseptics, as well as other pending final monographs, for FDA clearance by 2010.

David Bernens, a P&G associate director for external relations, says that before Vicks Early Defense launched in August, the firm developed its labeling language according to the monographs and substantiated the claims with research.

"When we launched it we believed we were within the FDA's regulations under the monograph," Bernens said, adding, "We have a very robust system for making sure that we believe we're within that monograph."

That system did not anticipate controversy relating to the no-rinse directions on Vicks Early Defense's label, he said. "I don't think that anyone saw anything to do with rinsing or not rinsing as an area of concern - that that was something the FDA would take exception to."

"That's new to us. Triclosan has been around for 30 years; it's been proven safe and effective," Bernens said.

He noted that FDA's warning letter cites language from different parts of the product's Web site but does not address print or broadcast ads for the product.

"We're looking at our Web site to make sure that we don't think there's anything wrong with it."

"We will be responding to the FDA and working with them on giving them additional information, whatever they need to become comfortable with what we're doing," Bernens said. "I'm sure there'll be a language discussion as to, 'Are you inferring this or are you not inferring this?' Something to that extent."

P&G markets Vicks Early Defense Foaming Hand Sanitizer in 47 ml containers with a suggested retail price of $2.99; a 150 ml version costs $5.75.

FDA says it would not object to marketing a triclosan-containing OTC antiseptic hand-wash formulated and labeled in accordance with its OTC Drug Review.

However, the agency advises P&G that such marketing would be "subject to the risk that a final monograph or rule may require" reformulation, re-labeling or FDA approval through a new drug application.

- Malcolm Spicer ([email protected])