Author Archives: Micah Berman

The FDA’s Big (?) Announcement on Nicotine Regulation

by Micah Berman — Tuesday, Aug. 1, 2017

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 […]

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Public Health Groups Ask Court to Make FDA Do Its Job

by Micah Berman — Wednesday, Oct. 5, 2016

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 […]

State Preemption: Arizona vs. Local Control

by Micah Berman — Monday, Sept. 5, 2016

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 […]

E-Cigarette Regulation: A Response to Adler et al.

by Micah Berman — Tuesday, July 5, 2016

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 […]

Premarket Review of Tobacco Products: The FDA’s Misplaced Priorities

by Micah Berman — Wednesday, Apr. 13, 2016

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 […]

Update on FDA Tobacco Litigation

by Micah Berman — Thursday, Oct. 22, 2015

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, […]

Update on FDA Tobacco Litigation

by Micah Berman — Thursday, Oct. 22, 2015

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, […]

“Substantial Equivalence”: Massive Backlog at the FDA Center for Tobacco Products

by Micah Berman — Wednesday, Sept. 16, 2015

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 […]

Eleventh Circuit finds Tobacco Suits Preempted: Trouble for Future Public Health Regulations?

by Micah Berman — Sunday, Apr. 19, 2015

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 […]

E-Cigarette Marketing and the First Amendment

by Micah Berman — Thursday, Mar. 12, 2015

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 […]