Three Cheers for the FDA and e-Cig Regulations!

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Hello and welcome. I am Dr. George Lundberg, and this is At Large at Medscape.

I doubt that I would get much disagreement with my belief that President Obama has the world's most difficult job. But who has the second hardest? Vladimir Putin? Angela Merkel? John Boehner? Pope Francis? Mary Barra? Justice Antonin Scalia? Oklahoma executioners?

My vote is for Dr. Margaret Hamburg, Commissioner of the US Food and Drug Administration (FDA). No matter what she does, it affects the lives and fortunes of millions, and many will disagree with every FDA decision.

I have known Peggy Hamburg personally for decades. I even know her famous father, David (former President of the Institute of Medicine, National Academy of Sciences, and of the American Association for the Advancement of Science). I knew former FDA commissioner Frank Young. His tenure included the early AIDS epidemic; you probably saw his TV clips in Dallas Buyers Club. I was privileged to coauthor some JAMA editorials with former FDA commissioner David Kessler. I was especially pleased when David told me that President Bill Clinton was so impressed by one of our JAMA theme issues on tobacco[1] -- the one with the Brown and Williamson papers -- that he told Kessler, "We'll regulate the blankety blanks." And Peggy Hamburg is trying to do just that with e-cigarettes. Tough job.

The FDA just issued draft regulations[2] calling for comments ending on July 9, 2014. Most of my old buddies in the antitobacco zealotry hate e-cigarettes. Some states and many cities have announced plans to be far more restrictive. Dealing with addicting drugs is always difficult.

I support these FDA draft regulations as timely, middle-road, and sensible. The end game should be to ban all tobacco products intended for smoking as fatally dangerous. But many tightly hooked addicts need replacement drugs. E-cigarettes provide that replacement nicotine on the way to tobacco abstinence, or at least to far fewer inhalations of burned tobacco. That is undeniably a good thing.

Regulation Essentials

These are the essentials of e-cigarette regulations:

Maximize availability and minimize cost for any/all persons of any age who are already addicted to nicotine and are currently satisfying the addiction by inhaling tobacco smoke.

Minimize availability and maximize cost for people not yet addicted to nicotine, scaling impediments to access by age, with access by younger people being the more difficult, up to perhaps age 25 years (because the younger the age, the faster the addiction).

Require registration for manufacturers who would be expected to maintain good manufacturing practices, including assurance of no carcinogens in the vapors.

Ignore indoor-outdoor use differences, because there is no side-stream smoke.

Concurrently ramp up regulation of actual tobacco products, making them increasingly more expensive, hard to get, inconvenient to use, and ever less satisfying as the nicotine levels are gradually diminished to zero.

Inform changes in future regulations by the best scientific evidence as it evolves.

Do not trust the big tobacco companies to do anything but make money, any way they can.

The public health and public policy goal is to use e-cigarettes as one more tool to apply on the way to a tobacco-free society, while killing ever fewer tobacco addicts.

A perfect world would have no nicotine in any form. We are far from perfect. The FDA has done a nice balancing act, and I say, three cheers!

That's my opinion. I am Dr. George Lundberg, At Large at Medscape.


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