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Saturday, March 29, 2008
Charleston, South Carolina

Contact: John R. Polito
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Do Kennedy and Waxman know
about electronic or e-cigarettes?

by John R. Polito

The nicotine gum, patch, pill, spray, inhaler, lozenge, nicotine straws, water, lotions, lip balms, nicotine coffee, chocolates and disintegrating muco-adhesive nicotine film, it is any wonder that Philip Morris USA, America's leading cigarette seller (with a 50.4% U.S. market share in 2007), is on its knees before Congress begging it to pass legislation that guarantees the cigarettes survival, legislation that arguably strips all 50 States of their current power to ban the sale of our nation's #1 killer, the cigarette?

Co-authored by Philip Morris USA, "The Family Smoking Prevention and Tobacco Control Act" seeks to grant the U.S. Food and Drug Administration limited authority to regulate tobacco, extremely limited authority.

Championed by Senator Ted Kennedy in the Senate (S.625) and Representative Henry Waxman in the House (H.R.1108), in regard to government policy, does the proposed legislation effectively grant the cigarette industry an official government license to annually kill hundreds of thousands of Americans?

Is Philip Morris using Senator Kennedy and Representative Waxman to guarantee the cigarette's survival? Spewing forth more than 3,500 chemical particles and 500 gases that could include up to 81 cancer causing chemicals, while annually claiming more than 400,000 U.S. smokers, with a flood of less harmful nicotine delivery devices entering the market, did Philip Morris at some point awaken to the realization that America's dirtiest drug delivery device's days were numbered?

Section 907(b)(3) of the proposed bill reads as follows:

   "(3) POWER RESERVED TO CONGRESS - Because of the importance of a decision of the Secretary to issue a regulation establishing a tobacco product standard --

        (A)  banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll your own tobacco products; or

        (B)   requiring the reduction of nicotine yields of a tobacco product to zero,

        Congress expressly reserves to itself such power."

If enacted, would the above language invoke the Supremacy Clause of the United States Constitution and preempt states and cities from banning the sale of cigarettes?

Would it destroy a state right recognized 108 years ago by the U.S. Supreme Court in Austin v. Tennessee which held, "there is doubtless fair ground for dispute as to whether the use of cigarettes is not hurtful to the community, and therefore it would be competent for a state, with reference to its own people, to declare, under penalties, that cigarettes should not be manufactured within its limits. No one could say that such legislation trenched upon the liberty of the citizen by preventing him from pursuing a lawful business."

Does the bill actually destroy greater health regulatory power than it creates, the power to totally forbid the sale of the most destructive form of nicotine delivery? Some attorneys who've studied the legislation think the "Powers Reserved to Congress" clause may preempt state bans. Others think that Section 917(a)(1), which reserves the state's power to establish the legal smoking age somehow reserves such power to the states, or that Section 907(b)(3) only imposes limits upon the FDA, not the states. If so, why not clearly state that the power to ban cigarette sales is reserved to "Congress or the States"?

But Americans appear disturbed by more fundamental concerns, such as compelling 9,000 FDA employees, watchdogs we want getting excited about any product related death, to accept regulatory responsibility for more than 400,000 annual smoking related deaths, deaths caused by a product that all agree cannot be made safe.

A Zogby poll released on February 26, 2008 found that 82% of Americans fear that "a proposal by some in Congress to mandate FDA regulation of tobacco would interfere with the FDA's core mission of regulating pharmaceutical drugs and the nation's food supply." But the legislation has some rather zealous backers.

According to Tobacco Free Kids, the legislation's most vocal and visible proponent, among other things "these bills would grant the FDA authority to restrict tobacco advertising and promotions, especially to children." Oh, if it were only true.

The legislation does not propose removing even one of the ocean of tobacco advertising signs from any neighborhood convenience store, an end to tobacco advertising in magazines publishers know are destined for schools, libraries or doctors offices, R ratings for movies in which teen idols smoke cigarettes, or forbid the sale of tobacco inside any store which grants access to those under 18 years of age. The only specific "advertising" restrictions revealed in the proposed legislation - if fair to call them restrictions - relate to cigarette pack health warnings. But given that honest advertising of legal products is protected under our Constitution, how could it impose restrictions?

According the U.S. Supreme Court's 2001 decision in Lorillard Tobacco v. Reilly, so long as commercial speech [advertising] involves a lawful activity [the sale of cigarettes] and is not misleading, it falls within the "purview of the First Amendment."

The Court, in striking down a Massachusetts regulation forbidding outdoor advertising of smokeless tobacco or cigars within 1,000 feet of a school or playground stated, "the State's interest in preventing underage tobacco use is substantial, and even compelling, but it is no less true that the sale and use of tobacco products by adults is a legal activity."

Although normal to equate the potential effects of a ban on the sale of cigarettes to what occurred in the U.S. between 1920 and 1933, when the 18th Amendment to the U.S. Constitution prohibited the sale of all "intoxicating liquors," with so many other forms of nicotine delivery available would such comparisons be fair or accurate?

A 2003 study by GlaxoSmithKline consultants found that 37% of all nicotine gum users were then hooked on the cure. U.S. Presidential candidate Senator Barack Obama is among them, having admitted being dependent upon nicotine gum for at least 13 months. But long-term nicotine gum use or using it for nicotine maintenance, not cessation, is in violation of current FDA use guidelines.

In 2002 the FDA declared both the nicotine lollipop and nicotine lip balm as being illegal products on dual fronts, as being either unapproved nicotine cessation products or unapproved nicotine addiction treatment products. Now, the most sophisticated harm reduction device yet, the electronic or "e-cigarette," could itself see increasing FDA scrutiny. Marketed by a Scottsdale, Arizona based company calling itself "NJoy," the e-cigarette is being sold as an "alternative to smoking that offers reduced health risk."

Picture of an electronic or e-cigarette showing three segments, a battery compartment, atomizer and a liquid reservoir cartridge that also serves as a mouth piece.What looks like a plastic cigarette houses a battery, an atomizer to vaporize nicotine into mist form and a liquid reservoir cartridge containing a nicotine solution (which comes in three different strengths) which also serves as a mouth piece.

When the e-cigarette is inhaled, a sensor detects air flow which activates a microprocessor. This in turn activates the atomizer which injects tiny droplets of the nicotine solution into the air flow, producing a vapor mist that's inhaled by the user. Propylene glycol is included in the nicotine solution so as to make the mist resemble normal cigarette smoke. The tip of the e-cigarette is an orange light-emitting diode that's activated during air flow so as simulate a burning cigarette.

Does Congress have an obligation to become informed regarding the current state of nicotine delivery science prior to granting the cigarette an official government birth certificate and guaranteed right to life?

Does the e-cigarette really have potential to replace real cigarettes? Knowing little about the e-cigarette, this week I conducted my first e-cigarette interview with a U.S. e-cigarette user named Andy:

Question: How challenging was it for you to transfer your dependency from tobacco cigarettes to e-cigarettes?

Andy: Not very. The feel is definitely different, but the main thing is just not thinking too hard about it. It took me a few days to become accustomed to how you draw on the e-cigarette. It's more like smoking a cigar than a cigarette, but after that it was fine. Also, your mouth will tend to feel dry for the first few days, but that goes away very quickly. I've been an e-cigarette user for about six months now.

Question: How does it compare to smoking tobacco?

Andy: It's different. The "smoke" has a different feel to it than actual cigarette smoke does. The taste, depending on who you purchase your cartridges/liquid from, is actually considerably better. The tobacco flavored liquid/carts tastes like actual tobacco, rather than cigarette taste. Closer to a cigar. The various flavors that you can get come pretty close to what they're advertised as. The vanilla liquid I'm using currently definitely has a vanilla taste to it.

The biggest difference, really, is that I don't FEEL like a smoker anymore. If you've ever been a smoker yourself, you know how it feels when you go a week without a smoke. You start smelling things again, your sense of taste improves a bit, your lungs feel clearer, etc. Imagine that, except without withdrawal symptoms. That's the difference.

Question: Do you smoke as often as you did cigarettes?

Andy: Sort of, but not really. With regular cigarettes, you tend to light one up, smoke it, and then go a while before you light up another, unless you're a chain smoker. With an e-cigarette you tend to just take a puff occasionally rather than concentrated smoking. On the whole I'd say I actually get about the same amount of nicotine over the course of a day, just more spread out rather than in bursts.

Question: Do you occasionally still find yourself smoking tobacco cigarettes? If so, how often and how much?

Andy: Smoking an actual cigarette basically tastes horrible now. Like I said, in all respects except for still getting nicotine it's very much like quitting smoking entirely.

Question: How do costs compare?

Andy: It is far, far cheaper. I don't use cartridges, personally, I use a technique known as dry-smoking. Basically you put a few drops of the liquid directly into the atomizer chamber. An 8ml bottle of the E-liquid (roughly $5 US) lasts me around a week and a half to two weeks. Even when I did use cartridges, it ended up cutting my cost by about 1/3rd.

Question: Are manufacturer representations regarding the number of e-cigarettes per cartridge accurate?

Andy: Yes and no. It depends largely on who you buy them from. A cartridge from the e-cig site, for instance, only has about as much in it as ten cigarettes or so. The NJoy cartridges, on the other hand, are pretty close to a pack and a half apiece. If you refill them yourself, you can vary how much liquid a cartridge contains as well, just by buying cartridges with a more dense fiber matrix. The actual MODEL of the e-cigarette will vary the amount as well. My e-pipe actually gets roughly two packs per cartridge, when I use a cartridge for it, but it's a considerably larger cartridge size than my e-cigarette.

Andy: Also, some of the claims are definitely true. These things, with the exception of the apple-flavored liquid, are odorless. I've smoked inside my office at work for months now, nobody even notices unless they actually physically see the vapor, and even then they can't smell it. Leaves no lasting odor on clothing, and a very briefly lasting taste in the mouth. My wife says the taste is actually slightly sweet, regardless of which flavor I use, so apparently it's not a bad taste to other people.

An empty bottle of Black Leaf 40, an insecticide one sold in America which was 40% nicotine sulfateIf Andy's above e-cigarette responses are anywhere near normal or average, does it make sense for the United States Congress to enact legislation guaranteeing that the traditional cigarette remains protected as though an endangered species, until such year as 51% of both houses of Congress vote to ban it, as outlined in Section 907(b)(3) above?

But let's not kid ourselves about Andy or Senator Obama's cleaner nicotine feedings. Once sold as Black Leaf 40, an insecticide, nicotine's lethalness (LD50) is 166 times greater than caffeine. We've seen an explosion of disturbing nicotine research, including concern that the super-toxin nicotine may be responsible for eating brain gray matter.

The most horrific nicotine dependency burden may not be the nicotine addict's final illness or how they die, but how they spent an entire life in chemical servitude to nicotine's two-hour half-life inside human blood-serum, bouncing between dopamine generated "aaah" sensations and insula driven urges, craves and anxieties.

Not suprisingly, the NJOY website does not mention chemical addiction as an e-cigarette use risk. Understandably, it also does not want to share known nicotine use health risks but clearly has obligations to do so. A bigger concern is youth access, not just their ability to purchase e-cigarettes via the Internet but the fact that while all states have youth tobacco access laws, few have laws governing youth use or possession of "tech-bacco" or tobacco-free nicotine products.

Still, Congress needs to ask itself, which makes sense, legislatively institutionalizing what's by far the most dangerous form of nicotine delivery or dumping it and immediately passing legislation that motivates transfer to cleaner delivery?

But in doing what's right, why not ban the practice of permitting the marketing and sale of nicotine products inside the neighborhood candy, chip and soda store, stores we each know to be frequented by neighborhood children and teens? Also youth obviously need legislative protection against the newest entry into the nicotine addiction industry, those selling "tech-bacco."

XXX

No Copyright - This Article is Public Domain

Last updated March 31, 2008 at 2109 EST






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Written March 29, 2008 and last updated December 27, 2013 by John R. Polito