FDA Stakeholder Update - November 26, 2019

FDA Announcements

FDA Warns 15 Companies for Illegally Selling Various Products Containing Cannabidiol as Agency Details Safety Concerns FDA issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food. These actions come as the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products, while maintaining the agency’s rigorous public health standards. The FDA plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks. [11/25/2019]

Statement on Efforts to Help Make Development of Biosimilar and Interchangeable Insulin Products More Efficient Access to affordable insulin can be a matter of life and death for Americans with diabetes. If not appropriately treated, diabetes can lead to serious and life-threatening complications, including heart disease, organ failure and blindness. And consistent, lifelong access to insulin is imperative to patient survival and quality of life. However, we are aware that the high cost of insulin raises serious concerns about the ability of many patients to access insulin products. This is an issue the FDA takes very seriously; therefore, today we are announcing new draft guidance that is intended to help facilitate the development of, and improve patient access to, life-saving insulin products. [11/25/2019] Statement on New Steps to Advance Innovation in Medical Device Sterilization with Ethylene Oxide At FDA we continue to closely monitor the supply chain effects of closures and potential closures of specific large-scale sterilization facilities that use a gas called ethylene oxide to sterilize certain medical devices prior to their use. Ethylene oxide is used in the manufacturing processes for a variety of both medical and non-medical products. While potential impacts to the availability of sterile medical devices is a concern given their criticality to our health care system, we also recognize the value in reducing over-reliance on ethylene oxide in commercial operations, including for medical device sterilization. [11/25/2019]