FDA, please don't overregulate e-cigarettes


We write to comment on the April 25, 2014, proposed regulation issued by the Food and Drug Administration ("FDA"), which would deem certain tobacco products to be covered by the Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act ("Tobacco Control Act"). Our comment focuses on the proposed regulation's treatment of one of those products, electronic cigarettes ("e-cigarettes"). 

E-cigarettes are much safer than cigarettes because they do not have the carcinogenic tars and harmful gases produced by cigarettes. At this time, there is no evidence that e-cigarettes serve as a gateway to cigarettes. Although e-cigarettes are not completely safe and do provide nicotine, the risks are much lower than those from cigarettes. Although further research will be needed on their long-term effects, it is clear that e-cigarettes can play an important harm reduction role. Unfortunately, the proposed regulation threatens to prevent e-cigarettes from playing that role. 

Although the proposed regulation's prohibition on sales to minors and its requirement of a nicotine warning would be beneficial, other provisions would essentially destroy the wide product variety available in today's highly competitive market. The problem is that deeming e-cigarettes to be subject to the Act would automatically subject them to the statutory requirement of premarket review. The FDA's own analysis indicates that the administrative burdens of the review process would drive the overwhelming majority of e-cigarette products out of the market. The dramatically reduced variety and availability of e-cigarettes would undermine efforts to persuade cigarette smokers to switch to e-cigarettes, thereby endangering public health. The proposed regulation is therefore unacceptable in its present form. 

Satel-Viard: FDA, please don't overregulate e-cigarettes

Download PDF

Also Visit
AEIdeas Blog The American Magazine
About the Author




Alan D.

What's new on AEI

Holder will regret his refusal to obey the Constitution
image 'Flood Wall Street' climate protesters take aim at their corporate allies
image 3 opportunities for better US-India defense ties
image Is Nicolás Maduro Latin America's new man at the United Nations?
AEI on Facebook
Events Calendar
  • 29
  • 30
  • 01
  • 02
  • 03
Thursday, October 02, 2014 | 9:00 a.m. – 10:30 a.m.
Campbell Brown talks teacher tenure

We welcome you to join us as Brown shares her perspective on the role of the courts in seeking educational justice and advocating for continued reform.

Event Registration is Closed
Friday, October 03, 2014 | 12:00 p.m. – 1:00 p.m.
Harnessing the power of markets to tackle global poverty: A conversation with Jacqueline Novogratz

AEI welcomes you to this Philanthropic Freedom Project event, in which Novogratz will describe her work investing in early-stage enterprises, what she has learned at the helm of Acumen, and the role entrepreneurship can play in the fight against global poverty.

No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.