FDA Policy in Conflict with Executive Order 13563?

The attached letter from FDA’s Chief Operating Officer responds to Congressional concerns about agency regulatory actions that could increase the vulnerability of generic pharmaceutical manufacturers to lawsuits. The FDA letter suggests that the agency routinely violates the Public Participation section of President Obama’s Executive Order on regulatory review, 13563. FDA states:

FDA generally declined requests for meetings related to this issue pending publication of the proposed rule. Other than through review of the petition described above and of the comments on the petition and of correspondence from members of Congress and the public, FDA did not consult with outside parties. While FDA generally does not participate in a dialogue during the development of proposed rules, there are occasions when FDA staff will participate in a listen only session with interested parties.

Therapeutic Advances in Chronic Disease Article on Regulating E-Cigarettes

Editor’s Note: The complete study, “Achieving appropriate regulations for electronic cigarettes” by Daniela Saitta, Giancarlo Antonio Ferro, and Riccardo Polosa of the University of Catania, Catania, Italy, is attached here. The article’s conclusion quotes the former director of the UK’s Action on Smoking and Health stating, with respect to e-cigarettes, that “‘there is place for regulation, but it should be to create an ‘enabling framework’ for these new, much less risky, alternatives to smoking to enter the market in a way that gives consumers confidence in switching from smoking’ [Bates, 2012].” The study abstract is reprinted below.

From: Therapeutic Advances in Chronic Disease

E-cigarettes finding a North Jersey fan base in ex-tobacco users

From: NorthJersey.com


As New Jersey mulls an e-cigarette tax and the medical community continues to stress the unknown health implications of so-called electronic vaping devices like e-cigarettes, a passionate community is growing in North Jersey – it’s a group of advocates largely made up of former smokers who say they quit traditional tobacco cigarettes when they started vaping.

“This completely changed my life,” said 28-year-old Adam Jankowski of Garfield, who credits vaping for quitting his six-year cigarette habit in a week last spring.

Are regulations necessary for e-cigarettes?

From: New Hamshire Business Review

Critics of vaping are demanding regulatory action that would go far beyond current efforts to ban e-cig sales to minors under 18

By Michael McCord

One of the more eye-opening national television commercials of late shows a man using an e-cigarette in public and proclaiming his right to exercise his “free will.”

It’s stunning because by law there has been no cigarette advertising on television for more than four decades. But  electronic cigarettes reside in a proverbial Wild West of no regulation and no special taxation because they aren’t cigarettes. They are nicotine delivery devices and they exude water vapor instead of tobacco smoke.

Dems Urge FTC to ‘Protect Children’ From E-Cigs

From: CSPnet.com

Bill would be enforced independent of FDA regulations
By Melissa Vonder Haar, Tobacco Editor

WASHINGTON — Despite admitting that the health implications of electronic cigarettes “are not yet clear,” five Democrats introduced a bill on Wednesday that could limit or outright ban the segments’ ability to market the new products.

U.S. Senators Barbara Boxer (D.-Calif.), Dick Durbin (D.-Ill.), Tom Harkin (D.-Iowa), Richard Blumenthal (D.-Conn.), and Edward Markey (D.-Mass.) proposed the Protecting Children from Electronic Cigarette Advertising Act, which would permit the Federal Trade Commission (FTC) to determine what constitutes marketing e-cigarettes to children, and would allow the FTC to work with states’ attorneys general to enforce the ban.