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An Email from Dr Joel Nitzkin

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An Email from Dr Joel Nitzkin

We contacted Dr Joel Nitzkin asking for a quote on his reaction to the tobacco bill for an article for Associated Content. Dr Nitzkin kindly provided us with far more information than we asked for, explaining the bill and its potential consequences for the Electronic Cigarette and other alternatives for smoking in America.

The American Tobacco Bill and Alternative Smoking Aids

There are two bills that will be considered by the Senate that relate to electronic cigarettes. One, already submitted by Burr, S. 579, with one co-sponsor, and the other, to be submitted by Kennedy, co-sponsored by half the Senate. The Kennedy bill, which we have not yet seen, will be a modified version of Waxman’s H.R.1256, as passed by the House about two weeks ago.

There are significant ambiguities in both bills with regard to alternative nicotine delivery products (referred to “nicotine-containing products in the Burr bill) — products that contain nicotine (which may or may not have been derived from tobacco), but no tobacco. The question is whether such products will be considered “tobacco products” or “drugs.”

“These trials, which would then take more than a decade to complete, and would cost in the millions of dollars per product tested if they could be done — cannot be done.”

My impression of the Waxman/Kennedy bill — since it makes no direct reference to such products — is that, if that bill becomes law in its current form — electronic cigarettes will be considered drug-delivery devices, regulated as a pharmaceutical product, and, by that means, banned. Even though the pharmacology and toxicology of nicotine has been known for many decades, my impression is that electronic cigarettes, along with the newly marketed nicotine strips, sticks, etc, will be required to randomized clinical trials comparing them to cigarettes. These trials, which would then take more than a decade to complete, and would cost in the millions of dollars per product tested if they could be done — cannot be done. The reason they cannot be done is because there is no Institutional Review Board that would permit their academic center to participate in a trial in which one or more wings of the trial would require participants to consume a product known to be hazardous to their health (the cigarette wing). Again — the result will be a de-facto ban.

While the Burr bill is not totally clear on this point, my impression is that their intention is for the “nicotine-containing products” to be regulated as tobacco products. This would, in fact, make them safer by requiring inspection and quality control of the manufacturing process to assure accurate dosage and freedom from bacterial, heavy metal and other contaminants. Curiously, however, the Burr bill restricts tobacco product sales for persons under 18 years of age, but places no such restriction on what they call “nicotine-containing products.”

“The safety standard should be comparison to the risk of cigarettes — not the standard used for approval of pharmaceutical products.”

As best I can tell, the Burr bill has zero chance of becoming law, and some version of the Kennedy/Waxman bill will become law. If your intent is to see electronic cigarettes continue to be available in the United States, then, as I see it, one needs to amend the Kennedy bill to assure that the alternative nicotine delivery products are regulated as “tobacco” products whether or not the nicotine is from tobacco, and the criteria by which their safety is ascertained is based on the best available current research and quality manufacturing standards.

The safety standard should be comparison to the risk of cigarettes — not the standard used for approval of pharmaceutical products. The currently available wording that comes closest to meeting these qualifications can be found in the Buyer tobacco bill (H.R.1261) which never made it out of House Committee.

“Their stance … is not opposed by Altria/Philip Morris …because access to such products would cut into cigarette sales.”

Please note that Campaign for Tobacco Free Kids, the organization that drafted the current wording of the Waxman bill in collaboration with Altria/Philip Morris, is totally against the introduction of any new (ie after February 2007) reduced risk tobacco or tobacco-like products because their goal is prevent teens from becoming addicted to nicotine, and they see the only purpose of any such products as addicting more teens to tobacco products. This unshakable anti-harm-reduction stance on their part is with no consideration of the potential benefits of such products for current adult smokers. Their stance against such products is not opposed by Altria/Philip Morris (or at least it wasn’t in 2007 prior to PM acquisition of UST) because access to such products would cut into cigarette sales.

If you have not already done so, you may wish to review some of the documents we have posted on the tobacco issues page of our www.aaphp.org web site. The document of most interest to you is the most recent, addressing amendments proposed for H.R.1256 and H.R.1261 (H.R. 1256 was rammed through the House with no amendments; and H.R.1261 never made it out of committee).

A huge thank you to Dr. Joel Nitzkin for this insight. Readers may also be interested in our interview with him, where he shares his expert opinion on e-cigarettes.


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