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

AEI Election Watch 2014: What will happen and why it matters
image A nation divided by marriage
image Teaching reform
image Socialist party pushing $20 minimum wage defends $13-an-hour job listing
AEI on Facebook
Events Calendar
  • 27
  • 28
  • 29
  • 30
  • 31
Monday, October 27, 2014 | 10:00 a.m. – 11:30 a.m.
State income taxes and the Supreme Court: Maryland Comptroller v. Wynne

Please join AEI for a panel discussion exploring these and other questions about this crucial case.

Tuesday, October 28, 2014 | 9:30 a.m. – 12:15 p.m.
For richer, for poorer: How family structures economic success in America

Join Lerman, Wilcox, and a group of distinguished scholars and commentators for the release of Lerman and Wilcox’s report, which examines the relationships among and policy implications of marriage, family structure, and economic success in America.

Tuesday, October 28, 2014 | 5:30 p.m. – 7:00 p.m.
The 7 deadly virtues: 18 conservative writers on why the virtuous life is funny as hell

Please join AEI for a book forum moderated by Last and featuring five of these leading conservative voices. By the time the forum is over, attendees may be on their way to discovering an entirely different — and better — moral universe.

Thursday, October 30, 2014 | 2:00 p.m. – 3:00 p.m.
A nuclear deal with Iran? Weighing the possibilities

Join us, as experts discuss their predictions for whether the United States will strike a nuclear deal with Iran ahead of the November 24 deadline, and the repercussions of the possible outcomes.

Thursday, October 30, 2014 | 5:00 p.m. – 6:15 p.m.
The forgotten depression — 1921: The crash that cured itself

Please join Author James Grant and AEI senior economists for a discussion about Grant's book, "The Forgotten Depression: 1921: The Crash That Cured Itself" (Simon & Schuster, 2014).

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