Hand sanitizers USA

Hand Sanitizers: From Stockpiling to FDA Warnings

Consumers have shifted to hand sanitizers in the last few months as an adequate substitute for handwashing to protect themselves against COVID-19. Due to the unprecedented surge in demand, heritage players like Purell and Bath & Body Works are facing outofstock issues, while a new wave of products has emerged courtesy of beauty companies large and small, including LVMH and Tan-Luxe.  Continue reading

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Will the FDA’s OTC Monograph Reform Foster Innovation Including Increased Rx-to-OTC Switch Activity?

After years of the OTC industry and the Consumer Healthcare Products Association working with the FDA to pass long-overdue OTC monograph reform and regulatory modernization, long-sought-after reform is now a reality thanks to the CARES (Coronavirus Aid, Relief, and Economic Security) Act.  The act, which was passed by the U.S. Congress and signed into law by President Donald Trump on March 27, 2020, provides more than $110 million over five years for the FDA to significantly increase capacity and expertise in the Office of Nonprescription Drug Products. Continue reading

To ban or not to ban triclosan? That is the question.

To ban or not to ban triclosan? That is the question.

On December 16, 2013, the Food and Drug Administration (FDA) issued a proposed rule that would require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. The FDA is specifically targeting triclosan, a chemical proven to have some adverse effects on animals and humans alike because it is absorbed through the skin. The chemicals originally used by surgeons to wash their hands before operations in recent decades were added by manufacturers to a variety of products, including mouthwash, laundry detergent, fabrics, and even baby pacifiers. Interestingly, according to the Centers for Disease Control and Prevention, one of the antibacterial active ingredients, triclosan, is present in the urine of 75% of Americans over the age of 5. The New York Times had reported on this back in late summer 2011, bringing to light this very issue – the safety as well as the efficacy – of triclosan. The chemical has been in use in consumer products since 1972 at a use level of 0.10 – 1.0%.Continue reading

FDA Initiative Forms Basis for Healthy Rx-to-OTC Switch Opportunities

FDA Initiative Forms Basis for Healthy Rx-to-OTC Switch Opportunities

In the not so distant past, the U.S. FDA has taken a rather conservative stance concerning Rx-to-OTC switches. Many potential categories have been discounted as not safe and/or effective without a physician’s prescription. This has compelled drug manufacturers to judiciously consider which drugs, if any, they would seek to switch given the necessary multi-million dollar expenditure on prerequisite clinical trials including self-selection, actual-use, and label-comprehension studies with consumers before the application and approval process with the FDA can even begin.  With its recent NSURE (Nonprescription Safe Use Regulatory Expansion) initiative, there are encouraging indications that FDA is becoming more receptive to allowing greater Rx-to-OTC switches.Continue reading