HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Friday, April 25, 2014

FDA Regulation of E-Cigarettes—A Gateway to Teaching Administrative Law

 

It’s likely that most readers of this blog already know that the FDA just announced its intent to extend its regulatory powers to E-Cigarettes.   E-Cigarettes have proven to be a "high interest" topic in both my "Constitutional Issues in Health Law" and "Legal Issues in Human Subject Research Classes."  The struggle between the FDA and those it wishes to regulate raise questions about the powers of all three branches of Government.  It can serve as a proxy for all administrative agencies in an Admin Class or as a direct source of study in a public health, environmental or (of course) food & drug law class.

The FDA's current struggles include energy drinks, body building supplements and truth in calorie reporting (no more hiding calories by assuming unrealistic serving sizes).

But back to E-Cigarettes.  

Here is the text of the proposed rule.  And here is the Campaign for Tobacco-Free Kids’ list of reasons why the FDA is justified—and should—be able to do this.

The FDA’s relationship with regulating tobacco products has been a complicated one.  This book review by Margaret Gilhooley can bring you up to date on the history of FDA’s failed attempts to obtain jurisdiction.  It was not until June 22, 2009 that the FDA finally did get regulatory power when President Obama signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA) that the FDA got any authority to regulate tobacco products—and that only through the filter (sorry) of protecting children.   And that still remains the outer limit—protecting children. 

So any regulation of E-Cigarettes has to be along the lines of making them less available to minors.  That’s why what sounds like a relatively weak reason—“even if they are harmless, they are a gateway for children to real cigarettes” is important because that is the statutory basis of the FDA’s power.  It’s not surprising that the FDA’s announcement has been met with immediate protest from Vapers.  New York’s ban (and remember, all the FDA’s done is to announce it intends to assert its authority to look into the product’s safety) has sparked considerable push-back based on issues of “personal liberty.” Apparently this anti-regulation movement is not restricted to the U.S.

   Vapers have had little success persuading cities to exempt e-cigarettes from public spaces, but they have been able to prevent outright bans and to allow the creation of “vaping lounges” –-the English majors among you know these better as modern day equivalent of a legal opium den—perhaps inhabited by today’s Keats, Shelleys and Coleridges.  We even have them in Lubbock.  

The FDA’s goal is to build on the actions of the cities that are equating e-cigarettes with “old style” tobacco to keep e-cigarettes as an “adults only” product.

 

April 25, 2014 in Constitutional, Drug and Device, Environmental Health, FDA, Food, Obama Administration, Policy, Proposed Legislation, Public Health, Public Opinion, State Initiatives | Permalink | Comments (0) | TrackBack (0)

Monday, September 16, 2013

Criminal Charges Sustained Against Chemistry Professor for Death of Assistant in Lab Accident Requires New Focus on Lab Safety Laws

Many of us who teach and write in the area of "research law" area are far more familiar with the regulations protecting human subjects of research than the more general safety of those who conduct research.   We, and our students, need to become familiar with the patchwork of laws and agencies regulating safety in labs and other research settings.   For example, until we had an accident on our own campus, I had never heard of the U.S. Chemical Safety Board which is “an independent federal agency charged with investigating industrial chemical accidents” but whose jurisdiction also extends to colleges and universities.  It's like the NTSB for labs.

We all need to be following the criminal trial of Dr. patrick G. Harran, a professor of chemistry at the University of California, Los Angeles.  The case involves the horrific and tragic death in 2008 of Sheharbano (Sheri) Sangji, a 21 year old college graduate working in Dr. Harran's lab while applying to law school.  In other words, she was not a UCLA student.

Following her death, the University, its Board of Regents and Dr. Harran all faced criminal charges based on violations of the California state labor code.   The charges against the University and the Regents were dropped based on a lab safety agreement between the University and the Los Angeles County District Attorney’s Office, but a California court has rejected Dr. Harran’s motion to dismiss the charges and scheduled a pre-trial hearing for October 3rd

The defendant moved to dismiss, but the court denied his motion.  This case also provides an important link between health law and employment law since it is theCalifornia Labor Code that is the source of the criminal charges against Dr. Harran.  Against his strong protests, the case is going forward on an interpretation of the law finding him, not the university, the employer of his lab assistant.

 Several websites including this one and this one are tracking the case very closely.

This is a video account of the events suitable for use in class.  This is a slightly longer one.  This is a 24 minute version that is also good.

 

For anyone not yet using "Google Alerts" this is a great way to keep track of a story that is not well covered by the national press.

September 16, 2013 in Environmental Health, Research | Permalink | Comments (0) | TrackBack (0)