Press Release


Embargoed Until Contact

July 10, 2014

Sue Ducat
Director of Communications
(301) 841-9962
sducat@projecthope.org

   

E-Cigarettes and Federal Regulation

 

Bethesda, MD -- The latest Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation describes federal policy makers’ recent efforts to propose rules for e-cigarette regulation. E-cigarettes, virtually non-existent ten years ago, have skyrocketed in popularity, including among people who claim to use e-cigarettes as a tool to help them quit smoking altogether. The 2009 Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration (FDA) authority to oversee the manufacture, marketing, distribution, and sale of regulated tobacco products such as cigarettes, tobacco in cigarettes, roll-your-own, and smokeless tobacco. But it left unregulated other tobacco products such as cigars, pipe and hookah tobacco, nicotine gels, and e-cigarettes. However, the law does give the FDA authority to deem other products that meet the statutory definition of tobacco—a product "made or derived from tobacco" and  “intended for human consumption”—as subject to its regulatory oversight. It is under this authority that the FDA recently proposed rules for how it intends to regulate e-cigarettes.

 

Topics covered in this brief include:

 

  • What’s the background, and what’s the policy? As the brief explains, the e-cigarette market is in a state of flux. Beginning in 2008, the FDA tried to regulate e-cigarettes as unapproved drug and device combination products because they were often marketed as tobacco cessation aids. Under that standard, e-cigarette makers had to prove their products were safe and effective as advertised, which could cost hundreds of millions of dollars in clinical trials to prove. The e-cigarette makers then sued the FDA in federal court. In December 2010, the US Court of Appeals for the D.C. Circuit ruled in Sottera, Inc., v. Food and Drug Administration that as long as Sottera’s products were not marketed for therapeutic use, then the FDA could only regulate e-cigarettes as tobacco products, not as smoking cessation devices. 

  • What’s the debate? The brief examines the critics and supporters’ views of e-cigarettes, assessing the question of e-cigarettes’ safety, and whether or not they should be regulated by the FDA as a tobacco product or a medical device. E-cigarettes are widely believed by supporters and critics to be a safer alternative, and a potentially valuable smoking cessation tool. Opponents, however, say there is no evidence that smokers will not simply continue to use both products. There is also concern that e-cigarettes could serve as a "gateway drug" to tobacco cigarettes. The FDA currently does not have sufficient data about e-cigarettes to determine what effect they have on public health.

  • What’s next? With e-cigarettes’ potential health safety in question, on April 25, 2014, the FDA published its proposed rule on how it plans to regulate e-cigarettes. The comment period will extend to August 8, 2014, and already has attracted thousands of formal comments from all sides of the debate. The FDA is also funding more than three dozen studies about e-cigarettes, which cover a variety of behavioral, psychological, and economic topics.   
 
 
About Health Affairs
 

Health Affairs is the leading journal at the intersection of health, health care, and policy. Published by Project HOPE, the peer-reviewed journal appears each month in print, with additional Web First papers published periodically and health policy briefs published twice monthly at www.healthaffairs.org. Read daily perspectives on Health Affairs Blog. Download weekly Narrative Matters podcasts on iTunes.