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)

Saturday, May 11, 2013

Remembering the Bad Old Days of HIV/AIDS Exceptionalism--and How News from Kansas, an HBO Documentary, and Dancing with the Stars Can Teach Students To See it When it Happens Again

 

The  controversy in Kansas over Sub HB 2183, which was passed into law on April 17th, 2013, puts me in mind of how difficult it is to explain the period of time when  "aids specific" laws emerged.  My purpose in highlighting this situation is not to get deeply involved in Kansas law or politics.  It is pull together some material that may be helpful for teaching public health law to students unaware of the lessons we have learned from the laws proposed, and passed, specifically in response to the emergence of HIV/AIDS during the 1980’s. Without an understanding of the fear and panic that accompanied a disease for which there was no test, no treatment, no vaccine and which quickly killed  young, healthy people within months of starting symptoms, it is easy to minimize the risk of such a thing happening today.

What Happened in Kansas

 As I understand it, Sub HB 2183 was presented as a statute similar to those in almost every state intended to protect first responders and others who face occupational exposure to infectious
diseases and pathogens.  It gives the State’s Department of Health the authority to develop a mechanism for mandatory testing or even isolation of the person who is the possible source of infection
if he is unable to give consent or if no surrogate decision maker can be found.  Time is of the essence in these situations and the goal is to provide prophylactic treatment as soon as possible—not to stigmatize the source of infection. 

 One of the effects of Sub HB 2183 was to eliminate a bill passed in 1986 which specifically prohibited the State from quarantining individuals based on a diagnosis of HIV/AIDS.  This led to concerns that people living with HIV/AIDS in Kansas would no longer be protected.   Ann Gotlib explains these concerns, and their historical context, clearly in IJFAB-the International Journal of Feminist Approaches to Bioethics

 In an open letter to concerned citizens, the Secretary of Kansas’ Department of Health & Environment explained that “This bill was never about isolation or quarantine related to persons with HIV infection.”  Instead, the bill “provides the authority for the secretary…to adopt administrative regulations for prevention and control of HIV in addition to the other specified infectious diseases under current law.”    He continues to explain that the Bill reflects an attempt to modernize an old statute from that era, KS 65001, that specifically prohibits the state from quarantining or isolating individuals diagnosed with HIV/AIDS.  

Without getting in to Kansas politics and law any deeper, KS 65001 is indeed is a good example of an “AIDS specific” law of that era in that it prohibits the State from quarantining individuals based on a diagnosis of HIV/AIDS.  Indeed, according to the Kansas Equality Coalition, the Bill passed based on a compromise that involved  creating “a list of diseases ‘not’ subject to quarantine, and to include HIV/AIDS in that list.” 

What Kansas Can Teach
Public Health Students Today

Whatever the motivation for the legislation or its effect on
the citizens of Kansas, the controversy  deserves attention and study just as would thediscovery of a “living fossil.”   It gives us direct access to studying the past.

For anyone else looking for ways to bring that time alive, here are a few words about my experience

Continue reading

May 11, 2013 in AIDS, Health Law, Personal Experience, Policy, Politics, Proposed Legislation, Public Health, Public Opinion | Permalink | Comments (0) | TrackBack (0)