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FDA issues false claims warning to manufacturers of hand sanitizers
FDA recently issued warning letters to companies that manufacture and market over-the-counter products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylocococcus aureus.
FDA recently issued warning letters to companies that manufacture and market over-the-counter products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylocococcus aureus (MRSA).
“MRSA is a serious public health threat,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA cannot allow companies to mislead consumers by making unproven prevention claims.”
Labels for some of the firms’ hand-sanitizing drug products also claim that they help prevent infection from Escherichia coli, H1N1 influenza virus, or both. FDA noted that it does not have sufficient evidence to demonstrate that these products are safe and effective for these purposes.
The FDA warning letters, which inform companies they are violating federal law, were sent to the following:
- Tec Laboratories for Staphaseptic First Aid Antiseptic/Pain Relieving Gel;
- JD Nelson and Associates for Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant;
- Dr. G.H. Tichenor Antiseptic Co. for Dr. Tichenor's Antiseptic Gel;
- Oh So Clean, Inc., dba CleanWell Company. for CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacterial Foaming Handsoap
These companies have 15 days to correct the violations cited in the letters. Failure to do so may result in legal action, including seizure and injunction.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
