Proctor & Gamble Receives Warning from the FDA

Proctor & Gamble has received a warning from The U.S. Food and Drug Administration (FDA) in regard to what the agency says are unlawful claims concerning its product called Vicks Early Defense Foaming Hand Sanitizer (Early Defense) product.

The FDA says the claims made and the directions that are given for the use of the product cause it to be classified as an unapproved new drug under the Federal Food, Drug, and Cosmetic Act. It specifically cited the promotion of Early Defense for use by schoolchildren to prevent colds and its ability to provide antimicrobial activity for up to three hours.

The FDA says that although it is not aware of any significant health risks from the product, they are worried that it has not been proven safe and effective for what they claim it can do.

Under the FDA's Over the Counter monograph system, OTC drugs can be marketed, under certain circumstances, without getting the agencies approval first. In order to qualify, the drugs much comply with the applicable standards that specify conditions regarding the drugs' labeling and formulation. If an OTC drug does not have FDA approval and also does not meet the requirements, it is considered to be an unapproved drug and therefor, it is illegal to market it.

The main ingredient in Early Defense is triclosan, and there is a proposed OTC monograph that covers triclosan. Companies are allowed to market their products under a proposed monograph as long as they comply with the conditions in the proposed monograph. In this case, however, the claims that the product prevents colds and also gives up t three hours of antimicrobial activity are not allowed under the proposed monnograph.

The proposed monograph that covers triclosan dictates that their labeling must tell the customers to rinse with water after they use the product and the label on Early Defense does not have this information. Therefore, Early Defense falls outside of the perimeters of the proposed monograph and is now considered to be an unapproved new drug.