Tag Archives: Tobacco

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 […]

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 […]

Bridging the Gap Between Science and Law

by Micah Berman — Wednesday, Oct. 22, 2014

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 […]

Cost-Benefit Analysis, the FDA, and Tobacco

by Micah Berman — Tuesday, Sept. 16, 2014

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 […]