FDA Calls Bluff on Antibacterial Soap

The Food and Drug Administration warned Procter & Gamble that its Vicks Early Defense Foaming Hand Sanitizer (Early Defense) makes claims that have not been proven safe or effective. The FDA specifically cited the product's use "by schoolchildren to prevent colds and to provide antimicrobial activity for up to three hours." The FDA is not aware of any significant health risks from using the product, but these claims haven't been proven, according to the FDA.

"FDA is concerned with the marketing of this over-the-counter drug for use by school children and others," Dr. Steven K. Galson, the director of FDA's Center for Drug Evaluation and Research, said in a statement made available to the press. "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." FDA rules require certain labeling of over-the-counter drugs, as defined by agency monographs.

In the case of triclosan, the active antibacterial ingredient in the hand sanitizer, the FDA does not permit claiming that the product "prevents colds and provides up to three hours of antimicrobial activity" and it requires products with triclosan to "direct consumers to rinse with water after use" which, according to the FDA, the Procter & Gamble sanitizer does not. Therefore, "Early Defense falls outside the proposed monograph and is considered an unapproved new drug because it lacks these directions and makes these impermissible claims." It is considered an "unlawfully marketed" drug. The warning letter is an early step. If Procter & Gamble does not resolve the alleged violations after receiving the warning letter, the FDA may escalate the confrontation by issuing an injunction or seizing illegal products.

With antibacterial soaps in the news, it's worth it to point out that many experts say antibacterial soap is not necessary -- and may ultimately be harmful. Why? Plain old soap is a simple and effective tool for removing dirt and bacteria: on the molecular level, it binds on one side with water and on the other with grease and dirt, so a good scrub and rinse removes offending particles. It can be bad because some worry that the over-use of antibiotics will lead to the more-rapid evolution strains of harmful bacteria that are resistant to our best drugs. In other words, antibacterial soaps attack bacteria you least need to worry about, at the same time it emboldens the bacteria you most need to worry about.

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