May 7, 2007
Charles O. Holliday, Chairman and CEO
E.I. duPont de Nemours and Company
1700 Market Street
Wilmington, DE 19802-4809
Dear Mr. Holliday:
This letter concerns your firm's labeling and marketing of the products "DuPont RelyOn Antiseptic Spray" and "DuPontRelyOn Antiseptic Hand Wipes." As presently labeled and promoted, these products violate the new drug and misbranding provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described in detail below."..we are not aware of sufficient evidence to show that that they are. generally recognized as safe and effective for these labeled uses. In particular, we are not aware of evidence that these products are safe and effective in preventing.individuals from becoming infected with Hepatitis A, B, and C, HIV-1 (AIDS virus), methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus faecalis (VRE), and the other diseases listed in the product labeling..."
Regarding claims that "DuPont RelyOn Antiseptic Spray" and "DuPont RelyOn Antiseptic Hand Wipes" are acceptable under guidelines issued by the Centers for Disease Control and Prevention (CDC), as reflected by the above statement, we acknowledge the existence of that agency's guideline titled "Guideline for Hand Hygiene in Health-Care Settings." Like many CDC guidelines, this one is intended to assist health-care professionals.
The guideline discusses the possible efficacy of "alcohol hand rubs," but it does not specifically recommend their use in preventing the diseases caused by the specific microorganisms referenced in the labeling and promotion for "DuPont RelyOn Antiseptic Spray" and "DuPont RelyOn Antiseptic Hand Wipes."
Rather, the guideline provides a general recommendation that "alcohol hand rubs" be used, among other things, "to reduce the transmission of pathogenic microorganisms to patients and personnel in health-care settings," and only if hands are not visibly dirty or contaminated with proteinaceous material or soiled with blood or other body fluids.
Further, the guideline acknowledges the need for additional data and study to substantiate specific antimicrobial claims and that differing formulations can affect a product's efficacy. It does not authorize or recommend the inclusion of disease-prevention. claims like the ones described above on product labeling.