FDA Warns Procter & Gamble about Unlawful Marketing of Product for School Children

The U.S. Food and Drug Administration (FDA)The U.S. Food and Drug Administration (FDA) sent a warning letter to Procter & Gamble for making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer (Early Defense) product. The agency says the product's claims and directions for use cause it to be an unapproved new drug under the Federal Food, Drug, and Cosmetic Act. It cited specifically Procter & Gamble 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," said Steven K. Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. "Over-the-counter (OTC) 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. 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 these impermissible claims.

FDA regards compliance with its approval and monograph requirements to be integral to drug safety. Without the foundation of compliance, it is not possible to ensure that consumers and the health care community are provided with established and emerging drug safety information so that they can make the best possible medical decisions about the safe and effective use of drugs.

Companies that do not resolve violations in FDA warning letters risk enforcement actions, such as injunctions against continuing violations and seizure of illegal products.For a copy of the warning letter, visit: http://www.fda.gov/foi/warning_letters/s6508c.htm.

For more information on FDA's Drug Safety Initiative, visit:
http://www.fda.gov/cder/drugSafety.htm

Most Popular Now

AstraZeneca divests rights for Losec to Cheplaphar…

AstraZeneca has agreed to sell the global commercial rights, excluding China, Japan, the US and Mexico, for Losec (omeprazole) and associated brands to Cheplapharm Arznei...

Bayer, Brigham and Women’s Hospital, and Massachus…

Bayer and Partners HealthCare's founding members Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH) today announced the launch of a joint lab to ...

Amgen announces positive results from two Phase 3 …

Amgen (NASDAQ:AMGN) today announced that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter Phase 3 trial (2012021...

Cause of antibiotic resistance identified

Scientists have confirmed for the first time that bacteria can change form to avoid being detected by antibiotics in the human body. Studying samples from elderly patient...

Brilinta monotherapy in high-bleeding risk patient…

New data from TWILIGHT, a Phase IV independent trial (funded by AstraZeneca), showed that in patients at high-bleeding risk who underwent PCI and completed 3 months of du...

Novartis and Microsoft announce collaboration to t…

Novartis announced an important step in reimagining medicine by founding the Novartis AI innovation lab and by selecting Microsoft as its strategic AI and data-science pa...

Bayer inks deals with eleven startups under G4A Di…

Bayer announced today that the company has signed collaboration agreements with eleven digital health startups. As part of the program, Bayer will support these startup c...

Pharmacists provide patient value in team-based ca…

With inhaler in hand, Dr. Cheng Yuet went over every detail to make sure the patient understood how the drug would control their COPD symptoms. Dr. Yuet is proving what a...

Ian Read to retire as Executive Chairman of Pfizer…

Following its regularly scheduled meeting, the Board of Directors of Pfizer Inc. (NYSE:PFE) today announced that Executive Chairman of the Board Ian C. Read has chosen to...

AI and big data predict which research will influe…

An artificial intelligence/machine learning model to predict which scientific advances are likely to eventually translate to the clinic has been developed by Ian Hutchins...

Discovery of new source of cancer antigens may exp…

For more than a decade, scientist Stephen Albert Johnston and his team at Arizona State University's Biodesign Institute have pooled their energies into an often scoffed-...

Chinese activists protest the use of traditional t…

In the West, the number of people challenging scientific authority has been growing in past decades. This has, among other things, led to a decline in the support for mas...