On Friday, the FDA made an unexpected announcement that it was unveiling a “comprehensive regulatory plan” to reduce tobacco-related disease and death. The announcement was surprising in part because the Trump Administration had recently unveiled its Unified Regulatory Agenda, which emphasized deregulation and did not identify any significant planned tobacco-related action. So what does this […]
Eight public health groups, joined by three individual physicians, filed a lawsuit today asking a federal court to order the FDA to implement graphic health warnings for cigarettes. Quick background: The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) instructed to the FDA to promulgate a rule within two years that required graphic health […]
This blog tends to focus on federal regulation or state regulation, but local regulation is also particularly important in some areas of law – particularly public health law, my area of focus. Recently, there have been coordinated efforts to limit local regulation through the use of state-level preemption. Recent examples from my home state of […]
Jonathan Adler (Case Western), Roger Meiners (Texas A&M), Andrew Morriss (UT-Arlington) and Bruce Yandle (Clemson) have co-authored Baptists, Bootleggers & Electronic Cigarettes, which is forthcoming in the Yale Journal on Regulation and has already been previewed online here and elsewhere. As the title suggests, this article applies the “Baptists & Bootleggers” theory of regulation to […]
Along with colleagues at the Public Health Law Center, I published an article this week in the journal Tobacco Control that critically reviews the FDA’s implementation of its authority to regulate the sale of new tobacco products. In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), establishing federal authority to […]
On Wednesday, I spoke on a panel at the Food & Drug Law Institute’s FDA Regulation of Tobacco Products Conference. I provided an update on two pending lawsuits involving industry challenges to FDA’s tobacco-related actions. (My slides, as well as those of the other presenters, can be downloaded from the conference link.) The first case, […]
On Wednesday, I spoke on a panel at the Food & Drug Law Institute’s FDA Regulation of Tobacco Products Conference. I provided an update on two pending lawsuits involving industry challenges to FDA’s tobacco-related actions. (My slides, as well as those of the other presenters, can be downloaded from the conference link.). The first case, […]
The key compromise at the heart of the 2009 Tobacco Control Act was this: Tobacco products that were already on the market would be “grandfathered,” but any new tobacco products would have to undergo premarket review and demonstrate that allowing them to be sold would be “appropriate for the protection of public health”—a tough standard […]
In a surprising ruling, a three-judge panel of the Eleventh Circuit ruled last week in Graham v. R.J. Reynolds Tobacco Company that strict liability claims and negligence claims in the long running Engle-progeny litigation are preempted by federal law. The decision, written by Judge Tjoflat, applied a broad reading of the implied preemption doctrine, concluding that […]
Eric Lindblom, a Senior Scholar at Georgetown Law School’s O’Neill Institute for National & Global Health Law, has published an important new article entitled Effectively Regulating E-Cigarettes and Their Advertising – and the First Amendment in the Food & Drug Law Journal. (Full disclosure: Lindblom was my supervisor when I worked at the FDA Center […]
On November 18, the U.S. House voted (mostly on partly lines) to pass the EPA Science Advisory Board Act of 2014. Although the name of the Act is pretty dull, its impact would be significant. Among other problems, the bill would make the EPA Science Advisory Board (SAB) less scientific, and it would prohibit it […]
I recently returned from the 2014 Public Health Law Conference, a fantastic event held every two years in Atlanta and hosted by the Network for Public Health Law, the American Society of Law, Medicine and Ethics, and the Robert Wood Johnson Foundation. Presentations at the conference covered a wide range of issues from Ebola (the […]
I’m very pleased to be joining this blog as well. I’ll blog about my area of interest – public health – with a focus on regulatory law and policy. My specific area of expertise is tobacco policy, and as the FDA’s Center for Tobacco Products continues its efforts to regulate tobacco (and continues to get […]