We, as a society, are past the point of vaping being a new trend. It is now an epidemic for our young people with unfortunately no end in sight if we don’t take action now.
The Reagan-Udall Foundation, a non-profit created to advance the work of the U.S. Food and Drug Administration, held a two-day conference this week on current psychedelic research and clinical study design.
The U.S. Food and Drug Administration (FDA) together with the Reagan-Udall Foundation for the FDA are hosting a virtual public meeting on psychedelic research, Jan. 31 to Feb. 1.
Titled "Advancing Psychedelic Clinical Study Design," the event aims to explore "empiric approaches to address key issues in psychedelic drug development and research."
It is well to be noted that a proposed FDA reorganization might as well have food safety first and foremost; however, stakeholders throughout industries will go on to feel the effects of what Michael Rogers, associate commissioner for regulatory affairs, called the largest reorganization in the history of the FDA.
When the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued marketing denial orders (MDOs) for Suorin and Blu PLUS+ e-cigarette products, Tony Abboud, executive director of the Vapor Technology Association (VTA), said the decision was just the latest installment of the FDA and CTP’s efforts to implement its de-facto ban on e-cigarettes in the U.S.
The FDA’s largest reorganization in history, involving about 8,000 employees, is far more than just “moving some boxes around.” The proposed changes and updates to an FDA-wide reorganization plan have been out for external reviews and clearances since Dec. 13, 2023, and implementation should occur sometime during 2024.
What started as a crisis over the safety and supply of infant formula became a wide-ranging review of FDA’s food programs by the Reagan-Udall Foundation.
The Food and Drug Administration’s Center for Tobacco Products (“CTP”) has released a strategic plan intended to guide the Center’s activity for the next five years. While the strategic plan highlights the laudable goals of regulatory clarity, stronger enforcement against non-compliant actors and more timely and transparent application review, the plan is problematic in that it promotes an agenda of burdensome new regulations and does not provide a clear emphasis on the promotion of less harmful alternatives in the tobacco and nicotine marketplace.
On January 31 and February 1, the Reagan-Udall Foundation for the FDA, will hold a virtual public workshop, “Advancing Psychedelic Clinical Study DesignExternal Link Disclaimer.” This meeting will bring together researchers, regulated industry, and other key stakeholders to discuss scientific issues that arise while working with psychedelics in clinical trials and drug development.
In February of this year, Vapor Voice published my reflections on my past 11 years affiliated with the vapor industry. And while many would say that the vapor industry has been a roller coaster, I remain firm in my belief that a place for vapor products exists in a United States harm reduction strategy. That said, the way things are going at present, it could be years before we see this materialize.
