Hand Sanitizers Are Designed to Protect People Navigating This Environment
To avoid the use of Methanol and other harmful impurities, our Wiley Product Regulation Group issued an alert yesterday to provide a one-stop resource on the Food and Drug Administration’s (FDA’s) temporary policy on hand sanitizers. To all of us as we navigate the new environment of COVID-19, this is one consumer product we are thankful to have. We applaud all of the companies, including distilleries like Barr Hill in Vermont (not a firm client), who’ve identified that they have the ability to help avoid shortages of these important products and are carefully following WHO guidelines. We are asking all companies who read this blog and our one-stop resource to stay mindful that these products are supposed to protect people, not hurt them.
Today, FDA issued another warning to consumers and health care professionals about hand sanitizers that have tested postive for methanol, either as an intentional additive or at impurity levels. Methanol is NOT Ethanol. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin as well as life-threatening when ingested. Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic effects. In its notice, FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program. When doing so, they should provide the agency with as much information as possible to identify the product. The attorneys in our Product Regulation group work with companies and technical consultants to assess the safety of consumer products, including assessments of potential impurities and all intentional ingredients. We applaud the companies that are being responsible, and we urge all companies to make sure you have the help you need to sell these products. Stay safe and #WELL.