In response to the recent FDA report that found Diethylene Glycol in cartridges from our competitiors. We are pleased to announce that a recent third party analysis of the eSmoke cartridges was found to be free of DEG.

The FDA's report also backed up it's initial statement that e-cigarettes are no safer than real ones in an attempt to scare electronic cigarette users into returning to real cigarettes by alarming them about the carcinogens detected in the product, without telling them that that the levels were no higher than in nicotine replacement products and that they are 1400 times lower than in Marlboros.

Dr. Michael Siegel, a professor in the Social and Behavioral Sciences Department, Boston University School of Public Health with over 20 years of experience in tobacco control, primarily as a researcher stated in his blog titled "The Rest of the Story: Tobacco News Analysis and Commentary" the levels of carcinogens found in the Electronic Cigarette compared to traditional FDA approved NRTs and real cigarettes. His numbers based on scientific findings showed the following:

You can read the full article by Dr. Michael Siegel by clicking here

In another recent article in the Washington Times by Dr. Elizabeth Whelan who is the president of the American Council on Science and Health, Dr Whelan bashes the FDA's scare tactics about the electronic cigarette, stating it to be a very viable option for addicted smokers. You can read the full article on the Washington Times website by clicking here.

To view the lab results of the eSmoke Electronic Cigarette Cartridge click here.

By Dr. Elizabeth M. Whelan | Thursday, August 6, 2009

At a time when the government is ostensibly trying to cut health costs, why is it trying to ban something that might help people quit smoking tobacco, perhaps the most devastating health problem in the U.S.?

The Food and Drug Administration (FDA) held a press conference late last month to scare Americans about the so-called "e-cigarette" -- claiming it was loaded with harmful "toxins" and "carcinogens." The agency was implicitly saying: Stay away from these newfangled, untested cigarette substitutes -- better to stick with the real ones, the ones that we are more familiar with, the ones that cause over 450,000 deaths annually in the U.S.

In making its distorted, incomplete and misleading statement, FDA was violating its long-cherished tradition of sticking to sound science as the basis for its policies. And in doing so, it is putting the lives and health of millions of Americans at risk.

Read the full article at http://www.washingtontimes.com/news/2009/aug/06/fda-smoke-screen-on-e-cigarettes/

"I've probably been a smoker since my late teens," said Charles Jay.

When the Hollywood resident heard about electronic cigarettes, or e-cigarettes, he was intrigued by the convenience.

"I could basically do it anywhere because you weren't leaving an odor behind or leaving any smoke behind," said Jay.

Read the full article @ http://cbs4.com/local/Electronic.Cigarettes.Text.2.1008425.html

“The message that is being sent by the FDA to those who cannot stop smoking, or who do not wish to stop smoking, is that it is better to keep smoking tobacco, which kills more than 400,000 people in the US per year, is the leading cause of preventable death in our country and results in more death than AIDS, drugs, homicides, fires and auto accidents combined,” said Matt Salmon, former US Congressman and President of the ECA. “It is time to stop misinformation, to put the needs of consumers ahead of special interests, to put public health ahead of stifling process, and to embrace the first true innovation in a centuries-old space.”

Matt Salmon

Please visit the ECA website here for additional and  important information that affects you!

Thank You. 

1940

http://history.amedd.army.mil/booksdocs/historiesofcomsn/section2.htm

CLAYTON LOOSLI, M.D.

Dr. Clayton Loosh was an Idahoan who attended the University of Chicago. He worked closely with Dr. O. H. Robertson. He was particularly helpful to the Commission in developing effective means of delivering virus in suspension for experimental challenges in human beings. He was also instrumental in developing the "glycolizers" that were used to create suspension of propylene glycol in the air. These were widely used at Camp Detrick for the protection of the staff who were working with particularly lethal agents. Later, after he became Dean of the School of Medicine at the University of Southern California, he continued to be an active participant in the affairs of the Commission. He worked with mice, trying to produce a controlled antigenic change in the virus. He also obtained interesting, and somewhat surprising, data on the effect of Los Angeles smog on mice infected with influenza virus. At one point, it appeared that the smog actually helped the animals, rather than hurt them. He was a very friendly person with broad interests who was exceptionally well qualified to be dean of a medical school.

1944

http://www.theatlantic.com/doc/194403/hill

The possibility of stopping the viruses in mid-air is of great interest. On this side of the Atlantic we have little concept of the importance of such a control, say in air-raid shelters where thousands of people have had to sleep night after night. In the British shelters the emphasis has been mainly on the control of cross-infections in operating rooms and in hospital wards. It has been found that small droplets such as are expelled in coughing can float in the air for many hours, even days. Arthur T. Edwards recently found that 10 percent of an original amount of influenza virus can remain alive on blankets for days or weeks. It is difficult to know whether the persistence of influenza in certain households is due to this domestication of the virus or to its constant introduction as active members of the family carry home the infection from outside contacts. It is the killing of these droplets that is urgently important. For this, two promising methods have been found: the use of ultraviolet light and of germicidal mists or aerosols.

The theory of their action is simply that a small amount of a chemical which is known to be germicidal be finely dispersed into the atmosphere. Water was not a satisfactory solvent, partly because of its rapid evaporation, and for that reason propylene glycol, a pretty name with which everyone will probably soon be familiar, was used to carry a number of germicides, including Dakin's solution. The English, hard-pressed to improve conditions in their air-raid shelters, which sometimes, as in Bristol, were in deep caves or old tunnels, used aerosols with evident success.

By the crab-like motion which characterizes so many scientific advances, it was then found that propylene glycol alone was highly effective. As little as one part of this substance, in the form of an aerosol, was active in at least several million volumes of air. Its effectiveness against both bacteria and viruses was established in this country by Oswald II. Robertson and his associates at the University of Chicago and later confirmed in England.

1942

http://www.time.com/time/magazine/article/0,9171,932876,00.html

How did it work? Respiratory disease bacteria float about in tiny droplets of water breathed, sneezed and coughed from human beings. The germicidal glycol also floats in infinitesimally small particles. Calculations showed that if droplet had to hit droplet, it would take two to 200 hours for sterilization of sprayed air to take place. Since sterilization took place in seconds, Dr. Robertson concluded that the glycol droplets must give off gas molecules which dissolve in the water droplets and kill the germs within them.

www.healthnz.co.nz

Murray Laugesen

Public health physician  

History 

That propylene glycol (PG) may protect users of the e-cigarette from airborne bacterial and viruses dates back to World War II. ‘Air Germicide’, a story in Time magazine Nov 16, 1942, reported the research of Dr. Oswald Hope Robertson at Chicago's BillingsHospital. He showed that half a part per million of PG in air could kill bacteria and viruses in that air within seconds. He found PG could protect mice from influenza virus, and that monkeys could well tolerate living in air containing PG. On the face of it, e-cigarette users might indeed be better off....actually confers immediate short term positive benefits, by reducing the risk of its users inhaling live viruses and bacteria from room air. This is mind-blowing enough, but could its possible benefits also protect others close by? Is the e-cigarette more than a tool for reducing harm? Is it also potentially a talisman to ward off infection? 

Protecting air travelers 

Air travel is a weak point in defending ourselves internationally from fatal respiratory infections. Bird flu and pandemic influenza can spread globally at the speed of jet travel, as one infected person can infect many others through air-conditioned, re-circulated air. Governments are spending millions on how to contain or just even slow the spread of such epidemics. Perhaps PG should be seriously considered. 

http://en.wikipedia.org/wiki/Propylene_glycol

Studies completed by Dr. Oswald Hope Robertson of University of Chicago's Billings Hospital have shown propylene glycol inhalation may prevent pneumonia, influenza and other respiratory diseases. Time Magazine - Air Germicide

Cases of propylene glycol poisoning are related to either inappropriate intravenous use or accidental ingestion by children.[6&91; The oral toxicity of propylene glycol is very low. In one study, rats were provided with feed containing as much as 5% PG over a period of 104 weeks and they showed no apparent ill effects.[7&91; Because of its low chronic oral toxicity, propylene glycol is generally recognized as safe (GRAS) for use as a direct food additive.

Serious toxicity will occur only at extremely high intakes over a relatively short period of time that result in plasma concentrations of over 4 g/L.[8&91; Such levels of ingestion would not be possible when consuming reasonable amounts of a food product or dietary supplements containing at most 1 g/kg propylene glycol.

http://www.pbs.org/wnet/redgold/innovators/bio_robertson2.html

Dr. Robertson's laboratory then undertook a double program of field studies in hospitals, army barracks, and industrial installations and laboratory experiments in an effort to develop methods of combating the spread of air-borne infections, which had become an exceedingly important source of attrition of human effectiveness during the war. Studies were carried out on the physical chemistry of aerosols containing viable infectious agents. Effects of various parameters on the viability of these agents were studied and the mechanism of air sterilization by chemical agents was worked out in detail. Such studies showed that the previously held theory that bactericidal action was exerted through collision of aerosol particles of germicide with aerosol particles of the infectious agent was erroneous, and that the actual mechanism of action required action of the bactericidal agent through the vapor phase. New agents were developed which were enormously more effective than previous materials, and which were shown to be without toxic effects to human populations. The physical chemistry of aerosol vapor interactions was studied, and a number of fundamental papers were published in this field. While the use of chemical air sterilization was developed to the point where it became a practical measure, it never proved possible to obtain clear-cut epidemiological data demonstrating beyond any question that these measures would reduce respiratory disease in ordinary situations of human habitation. Nevertheless, the fundamental advances obtained in the course of these studies have been useful in a variety of ways, in both pure and applied science.

Congratulations to Bill Godshall and to Dave Sweanor for being willing to publicly put the protection of the health of smokers above the knee-jerk, ideological opposition to a smoking device that we have unfortunately seen far too much within the tobacco control movement. Congratulations to Bill also for his efforts to persuade the FDA to allow e-cigarettes to be legally sold in the United States.

This is an important effort that could result in saving countless lives.

I find it interesting and quite informative that while anti-smoking groups are promoting nicotine replacement therapy via pharmaceutical products - which have dismal efficacy - they are seeking a ban on nicotine replacement therapy via e-cigarettes, which appear to actually be reasonably effective.

What is informative about the inconsistent treatment of these different products by the anti-smoking groups is that there does not seem to be a primary concern for the public's health. Instead, the primary concern appears to be either for the financial well-being of the pharmaceutical companies or for the ideological notion that the act of using a cigarette-like device is to be scorned.

It is absurd to argue that e-cigarettes must be banned because they have not been sufficiently tested for safety. Regular cigarettes have been sufficiently tested for safety and they have been found to be unsafe. But they are still on the market. So why all the concern about testing e-cigarettes for safety? Since they deliver nicotine but not the tar, we know that they are going to be safer than conventional cigarettes. I maintain that it isn't truly safety and health concerns that are leading the anti-smoking groups to call on an e-cigarette ban. I think it is a combination of the financial influence of the pharmaceutical companies on tobacco control and the ideological resistance to the idea that any act of smoking could be tolerated.

Name: Michael Siegel

Location: Boston, Massachusetts

I am a physician who specialized in preventive medicine and public health. I am now a professor in the Social and Behavioral Sciences Department, Boston University School of Public Health. I have 20 years of experience in tobacco control, primarily as a researcher. My areas of research interest include the health effects of secondhand smoke, policy aspects of regulating smoking in public places, effects of cigarette marketing on youth smoking behavior, and the evaluation of tobacco control program and policy interventions.

Electronic Cigarettes probably carry less than one percent of the risk of regular cigarettes and they could carry as little as one tenth of one percent of the risk of smoking. Yet despite their potential to save almost 400,000 lives a year the devices are likely to be banned by a tobacco bill being pushed through the Senate by Philip Morris.

This was the view of one expert we interviewed on the safety of the electronic cigarette, Dr Joel Nitzkin, Chair of the Tobacco Control Task Force for the American Association of Public Health Physicians and a prominent tobacco harm reduction spokesman.

Dr Nitzkin did agree there was a need for improved quality control of the devices, which are manufactured in China.

However, he also stated that even in the worst case scenario of the e-cigarettes carrying one percent of the risks of regular cigarettes the device has a huge potential to save lives.

Dr Nitzkin estimated that if every smoker in the US smoked electronic cigarettes the resulting death toll would be between 400 and 4000 a year.

The compares to the 400,000 estimated deaths caused by smoking regular cigarettes.

When we asked why a tobacco bill sponsored by America's largest tobacco company and which removed safe alternatives while endorsing regular cigarettes was likely to be passed, Dr Nitzkin explained that inaccurate and misleading information was being used to promote the bill:

"This piece of legislation has been sold to health organisations to endorse and to congressmen here in the United States to sponsor using a summary in the description of the bill which is extremely inaccurate and which does not reflect the actual impact the bill will have if passed."

Deadly new flu strain breaks out in Mexico, U.S.

Maybe they should try spraying with Propylene Glycol... one of the key ingredients in eSmoke cartridges, we're not kidding.

Check this article out for the studies mentioned.

Propylene glycol is harmless to man when swallowed or injected into the veins...

it should be most valuable in such crowded places as schools and theaters, where most respiratory diseases are picked up.

Link here...

It’s not too often a product comes along with so much potential. A product with so much pent up demand. A product that is significantly cheaper than alternatives. A product that sells so extremely well right out of the gate the potential to turn a very small speculation into a big score is obvious.

That’s what we’re facing here. The market potential is hundreds of billions. Every retailer who carries it has trouble keeping it in stock. It’s the same type of popularity which turned Crocs (CROX) into a shooting star, made Healys (HLYS), and pushed sales of Snuggies past the four million mark.

Sounds like it has some potential right?

Well, it does have a lot of potential. That is of course, if the World Health Organization (WHO), the FDA, Big Pharma, Big Tobacco, and a U.S. Senator don’t get it completely outlawed.

Disrupting Smokers

I’m talking about the latest nicotine replacement therapy (NRT), electronic cigarettes, or e-cigarettes.

An e-cigarette is a battery powered device that looks like a cigarette. It has a small vaporizer which turns a nicotine cartridge into a breathable vapor. It’s an alternative delivery form of nicotine which, according to many of the e-cigarette retailers, provides the nicotine of a cigarette without a lot of the other contaminants in a regular cigarette (e-cigarette description and pictures).

There’s just so much potential growth. A recent smoking cessation report from consultancy firm Visiongain says, “E-Cigarettes will revolutionize the face of tobacco smoking and could pose a threat to the smoking cessation market.”

As you might expect, a product like this will be in very high demand.

Another Boom Emerges

Jason Cropper, manager of the Electronic Cigarette Company in the U.K., in an interview with Reuters stated, “We can’t keep up with demand. The demand is phenomenal. I’ve got a website run by a lady in Florida and she’s totally out of stock.”

If you go a bit further, it’s easy to see how well these are selling. At the time of this writing, two out of three e-cigarettes at zerotar.net were sold out. Specialty Retailer magazine reports mall kiosks selling e-cigarettes generate about $50,000 in sales per month. There’s not much data out there, but it’s easy to see sales of e-cigarettes are soaring.

From a cost perspective, e-cigarettes are tough to beat. The initial start-up cost of around $100 for charger, battery, vaporizer, etc. The ongoing costs (buying more nicotine cartridges) are around 50 cents to $1 a day (to get the same amount of nicotine as one pack of cigarettes per day).

When you compare that to the cost of $150 to $250 per month (depending on which state you’re in) though, it’s easy to see e-cigarettes are a much cheaper alternative. As an alternative to gum, patches, sprays, lozenges, and inhalers, e-cigarettes are much cheaper as well. And from a health perspective…I think the answer is pretty clear.

From an investment perspective, this is the kind of “disruptive technology” which has changed the face of industry and created fortunes for early investors. Just think of a product, if successful, reaches just 10% of the 500 million+ smokers around the world. That’s the kind of potential we’re looking at here.

Best of all there is one publicly traded company leading the way in the e-cigarette revolution. More on that in moment. First, there’s a big back story here with a lot of pitfalls. It’s a complicated situation with politics set to play a big role in the near future.

Another Competitor Stifled?

What may surprise you is e-cigarettes may not stay on the market much longer even though they’re still relatively new.

It’s no secret how much Big Pharma and Big Tobacco companies spend on lobbying. We watched the impact yet again this past week as the federal government upped the tobacco tax and the House of Representatives passed the Family Smoking Prevention and Tobacco Control Act.

Of course, the bill had the support of Altria (MO), the operator of Philip Morris and owner of the world’s best-selling cigarette brand, Marlboro. The act limited advertising (read: protected market share changes for current competitors) and would give the FDA all sorts of new regulatory powers.

And with a name like “Family Smoking Prevention and Tobacco Control Act,” what politician would want to vote against it?

Big Tobacco would naturally be against the e-cigarette’s success. It’s a direct competitor. In this case, it’s more than just Big Tobacco. Big Pharma has a big stake in this battle as well.

The $3 billion nicotine replacement industry has become a cash cow for pharmaceutical companies. All of those patches and gum sales are easy profits and they’re mostly backed by Big Pharma. Nicoderm is owned by ALZA, wholly owned subsidiary of Johnson & Johnson (JNJ). Nicorette and the prescription drugs Wellbutrin and Zyban are marketed by GlaxoSmithKline (GSK). And one of the latest entrants, Chantix, is marketed by Pfizer (PFE). Of course there are many more but you get the point.

They’ve all seen the early success of e-cigarettes. They see the potential impact to their bottom lines. And they are making the moves necessary to stifle the competition.

Unsafe Until Proven Safe

Recently, New Jersey Senator Jim Lauterman tried to put an end to e-cigarette sales in the U.S. According to his press office:

Sen. Frank R. Lautenberg (D-NJ) today urged the Food and Drug Administration (FDA) to take electronic cigarettes, or “e-cigarettes,” off the market until they are proven safe by the federal agency. 

Electronic cigarettes, alternatives to cigarettes and other tobacco products, are battery-powered devices that use a vapor to deliver nicotine to smokers. When the smoker inhales through the device, air flow is detected by a sensor, which activates a heating element that vaporizes a nicotine solution stored in the mouthpiece. 

Manufacturers and retailers of these products claim that electronic cigarettes are safe, and even that these products can help smokers quit traditional cigarettes. However, no clinical studies have proven these products are effective in helping smokers quit smoking, nor have any studies considered the safety of these products’ long-term health effects. While the FDA has indicated it will evaluate electronic cigarettes on a case-by-case basis, it has not taken any enforcement action against these products, which are currently being sold in mall kiosks across the country and on the Internet. 

Sen. Lautenberg is one of the Senate’s leaders in protecting Americans from the dangers of smoking. Sen. Lautenberg wrote the law banning smoking on airplanes, which helped trigger a broader smoke-free revolution. Sen. Lautenberg is also the author of a law banning smoking in buildings that house federally-funded facilities that serve children.

This would subject them to FDA approval. The costs of which would stifle the small upstart companies who make e-cigarettes and delay their access to the open market.

Lauterman, who is an active anti-tobacco advocate and the recipient of$128,250 in campaign contributions from Pharmaceuticals/Health Products companies, is not alone here though. According to WTBW out of South Carolina:

the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association and the Campaign for Tobacco-Free Kids applaud Senator Frank Lautenberg of New Jersey’s call for the Food and Drug Administration to exert its authority and immediately remove e-cigarettes from the market.

The Tide is Turning

Despite the past effectiveness of embedding legislation which benefits the current leaders of industry in otherwise popular legislation, this one could face some hurdles.

For instance, David Sweanor, who has worked with many health regulators including the WHO, said in a recent interview, “If there is anyone who believes cigarettes are no more hazardous than e-cigarettes I'd recommend a remedial course in basic sciences.”

And then there’s Dr. Joel Nitzkin. He is the Chair of the Tobacco Control Task Force for the American Association of Public Health Physicians, recently sent a letter to Senator Lautenberg. In it Nitzkin states, “As best we can tell, on the basis of currently available research data, these products [including but not limited to electronic cigarettes&91; promise a risk of illness and death well under 1% of the risk posed by cigarettes.”

So there is some support for the e-cigarettes to be allowed to be sold. For the time being, this is still a risky place to invest in due primarily to the potential government regulation.

The only thing that somewhat resembles a pure-play on e-cigarettes I’ve been able to find is Ruyan Group (HK:0329). This is the company which has been making e-cigarettes in China and owns most of the patents for e-cigarettes. It also licenses them to international manufacturers. It recently inked a deal with a media company in China to help get the word out to some of China’s 350 million smokers.

On the bad side, it’s a highly illiquid penny stock traded in Hong Kong (it last traded for HKD 0.187). It hasn’t been immune from the economic downturn either. It expects to post a loss when its next report is filed with regulators.

Also, there are dozens of smaller private competitors which have popped up all around the world (and will likely continue to do so). And it has other businesses so it’s not a 100% pure play on the growth of e-cigarettes. So, at this point in time even without the political risks involved, it’s a heck of a risky position to take.

In the end, this is the perfect situation of how a new technology could revolutionize an entire industry.

The established firms are going to pull what strings they can to prevent competition, but they’ll only be able to hold out so long. People want to quit smoking and in countries where e-cigarettes have been outlawed (e.g. Canada) that hasn’t stopped folks from buying them. Change will likely come regardless of the regulation. The regulators just determine who the winners will be and determine when change will be “approved”.

The opportunity in e-cigarettes is astounding (although, I’m holding off a bit to see how the politics plays out a bit further) opportunity to invest in a new cost-saving technology which is sure to be in very high demand.

It’s the perfect example of how change brings great opportunity. At the Prosperity Dispatch we’ve been focusing on emerging technologies like this for a while. Everything from stem cells to human genome applications to viable alternative energy technologies and everything else which have years and years of growth ahead of them as they change the entire landscape of their industries. Now we can add e-cigarettes to the list of “disruptive technologies” to keep an eye on.

Good investing.

Andrew Mickey
Disclosure: Author has no position in any of the stocks mentioned

Statement on Nicotine-Containing Cigarettes
by
David A. Kessler, M.D.
Commissioner of Food and Drugs
House Subcommittee on Health and the Environment
March 25, 1994

Consider these facts:

• Two-thirds of adults who smoke say they wish they could quit.
• Seventeen million try to quit each year, but fewer than one out of ten succeed. For every smoker who quits, nine try and fail.
• Three out of four adult smokers say that they are addicted. By some estimates, as many as 74 to 90 percent are addicted.
• Eight out of ten smokers say they wish they had never started smoking.

That is the issue I am here to address. Whether it is a choice by cigarette companies to maintain addictive levels of nicotine in their cigarettes, rather than a choice by consumers to continue smoking, that in the end is driving the demand for cigarettes in this country.

Although FDA has long recognized that the nicotine in tobacco produces drug-like effects, we never stepped in to regulate most tobacco products as drugs. One of the obstacles has been a legal one. A product is subject to regulation as a drug based primarily on its intended use. Generally, there must be an intent that the product be used either in relation to a disease or to affect the structure or function of the body. With certain exceptions, we have not had sufficient evidence of such intent with regard to nicotine in tobacco products. Most people assume that the nicotine in cigarettes is present solely because it is a natural and unavoidable component of tobacco.

Mr. Chairman, we now have cause to reconsider this historical view. The question now before us all is whether nicotine-containing cigarettes should be regulated as drugs. We seek guidance from the Congress on the public health and social issues that arise once the question is posed. This question arises today because of an accumulation of information in recent months and years. In my testimony today, I will describe some of that information.

The first body of information concerns the highly addictive nature of nicotine. The second body of information I will be talking about -- in some detail -- concerns the apparent ability of cigarette companies to control nicotine levels in cigarettes. We have information strongly suggesting that the amount of nicotine in a cigarette is there by design. Cigarette companies must answer the question: what is the real intent of this design?

I. NICOTINE IS A HIGHLY ADDICTIVE SUBSTANCE

Let me turn then to my first point about the addictive nature of nicotine.

The nicotine delivered by tobacco products is highly addictive. This was carefully documented in the 1988 Surgeon General's report. You can find nicotine's addictive properties described in numerous scientific papers.

As with any addictive substance, some people can break their addiction to nicotine. But I doubt there is a person in this room who hasn't either gone to great pains to quit smoking, or watched a friend or relative struggle to extricate himself or herself from a dependence on cigarettes.

Remarkably, we see the grip of nicotine even among patients for whom the dangers of smoking could not be starker. After surgery for lung cancer, almost half of smokers resume smoking Among smokers who suffer a heart attack, 38 percent resume smoking while they are still in the hospital. Even when a smoker has his or her larynx removed, 40 percent try smoking again.

When a smoker sleeps, blood levels of nicotine decrease significantly. But the smoker doesn't need to be an expert on the concept of nicotine blood levels to know full well what that means. More than one-third of smokers reach for their first cigarette within 10 minutes of awakening; nearly two-thirds smoke within the first half hour. Experts in the field tell us that smoking the first cigarette of the day within 30 minutes of waking is a meaningful measure of addiction.

I am struck especially by the statistics about our young people. A majority of adult smokers begin smoking as teenagers. Unfortunately, 70 percent of young people ages 12-18 who smoke say that they believe that they are already dependent on cigarettes. About 40 percent of high school seniors who smoke regularly have tried to quit and failed.

It is fair to argue that the decision to start smoking may be a matter of choice. But once they have started smoking regularly, most smokers are in effect deprived of the choice to stop smoking. Recall one of the statistics I recited earlier. Seventeen million Americans try to quit smoking each year. But more than 15,000,000 individuals are unable to exercise that choice because they cannot break their addiction to cigarettes. My concern is that the choice that they are making at a young age quickly becomes little or no choice at all and will be very difficult to undo for the rest of their lives.

Mr. Chairman, nicotine is recognized as an addictive substance by such major medical organizations as the Office of U.S. Surgeon General, the World Health Organization, the American Medical Association, the American Psychiatric Association, the American Psychological Association, the American Society of Addiction Medicine, and the Medical Research Council in the United Kingdom. All of these organizations acknowledge tobacco use as a form of drug dependence or addiction with severe adverse health consequences.

Definitions of an addictive substance may vary slightly, but they all embody some key criteria: first, compulsive use, often despite knowing the substance is harmful; second, a psychoactive effect -- that is, a direct chemical effect in the brain; third, what researchers call reinforcing behavior that conditions continued use. (Chart A) In addition, withdrawal symptoms occur with many drugs and occur in many cigarette smokers who try to quit. These are hallmarks of an addictive substance and nicotine meets them all.

When a smoker inhales, once absorbed in the bloodstream, nicotine is carried to the brain in only 7-9 seconds, setting off a biological chain reaction that is critical in establishing and reinforcing addiction.

Over the past few years, scientists have generated a tremendous amount of information on the similarities among different addictive substances. Some crucial information has come from the fact that, in a laboratory setting, animals will self-administer addictive substances. This self-administration may involve the animal pushing a lever or engaging in other actions to get repeated doses of the addictive substance. With very few exceptions, animals will self-administer those drugs that are considered highly addictive in humans, including morphine and cocaine, and will not self-administer those drugs that are not considered addictive.

Understanding that animals will self-administer addictive substances has fundamentally changed the way that scientists view addiction in humans. It has turned attention away from the concept of an "addictive personality" to a realization that addictive drugs share common chemical effects in the brain.

Despite the wide chemical diversity among different addictive substances, a propert that most of them share is the ability to affect the regulation of a chemical called dopamine in parts of the brain that are important to emotion and motivation. It is now believed that it is the effect of addictive substances on dopamine that is responsible for driving animals to self- administer these substances and for causing humans to develop addictions.

Regulation of dopamine, rewards the activity, and causes the animal or person to repeat the activity that produced that reward The process by which the regulation of dopamine leads an animal or a human to repeat the behavior is known as "reinforcement." Drugs that have the ability to directly modify dopamine levels can produce powerfully ingrained addictive behavior."

One of the ways that researchers now test the addictive properties of drugs is to determine whether animals will self- administer that substance and then to determine whether the animals will stop self-administering if the chemical action of the substance is blocked by the simultaneous administration of another drug that prevents the first substance from acting in the brain. Data gathered over the past 15 years have documented that laboratory animals will voluntarily self-administer nicotine, that nicotine does stimulate the release of dopamine; and that laboratory animals will decrease self-administration of nicotine if the action of nicotine, or the release of dopamine, in the brain is blocked.

A number of top tobacco industry officials have stated that they do not believe that tobacco is addictive. They may tell you that smokers smoke for "pleasure," not to satisfy a nicotine craving. Experts tell us that their patients report that only a small minority of the cigarettes they smoke in a day are highly pleasurable. Experts believe that the remainder are smoked to primarily sustain nicotine blood levels and to avoid withdrawal symptoms.

The industry couches nicotine's effects in euphemisms such as "satisfaction" or "impact" or "strength." Listen to what they say in one company's patent:

It also has been generally recognized that the smoker's perception of the "strength" of the cigarette is directly related to the amount of nicotine contained in the cigarette smoke during each puff.

-patent no. 4,595,024 C1:33-36

But these terms only sidestep the fact that the companies are marketing a powerfully addictive agent. Despite the buzzwords used by industry, what smokers are addicted to is not "rich aroma" or "pleasure" or "satisfaction." What they are addicted to is nicotine, pure and simple, because of its psychoactive effects and its drug dependence qualities.

To smokers who know that they are addicted, to those who have buried a loved one who was addicted, it is simply no longer credible to deny the highly addictive nature of nicotine.

II. CONTROLLING THE LEVEL OF NICOTINE IN CIGARETTES

My second point today involves a growing body of information about the control of nicotine levels exercised by the tobacco industry. Mr. Chairman, I do not have all the facts or all the answers today. The picture is still incomplete. But from a number of pieces of information, from a number of sources, a picture of tobacco company practices is beginning to emerge.

The public thinks of cigarettes as simply blended tobacco rolled in paper. But they are much more than that. Some of today's cigarettes may, in fact, qualify as high technology nicotine delivery systems that deliver nicotine in precisely calculated quantities -- quantities that are more than sufficient to create and to sustain addiction in the vast majority of individuals who smoke regularly.

But you don't have to take it from me. Consider how people in the tobacco industry itself view cigarettes.

Just take a moment to look at the excerpts from an internal memorandum written by a supervisor of research that circulated in the Philip Morris Company in 1972:

Think of the cigarette pack as a storage container for a day's supply of nicotine. . . . Think of the cigarette as a dispenser for a dose unit of nicotine. . . . Think of a puff of smoke as the vehicle for nicotine. . . . Smoke is beyond question the most optimized vehicle of nicotine and the cigarette the most optimized dispenser of smoke.

"Dispensers of smoke . . . which is a vehicle for delivering nicotine." This quote is a revealing self-portrait. Or listen to the words in one tobacco company patent: Medical research has established that nicotine is the active ingredient in tobacco. Small doses of nicotine provide the user with certain pleasurable effects resulting in the desire for additional doses.

-patent no. 4,676,259 C1:21-24

The Design of Cigarettes

How does this industry design cigarettes?

The history of the tobacco industry is a story of how a product that may at one time have been a simple agricultural commodity appears to have become a nicotine delivery system. Prior to the 1940's, the waste products from cigarettes -- the stems, the scraps, and the dust -- were discarded. The tobacco industry had identified no use for these materials in the cigarette manufacturing process.

Then, in the 1940s and '50s, the industry created reconstituted tobacco from the previously unusable tobacco stems, scraps, and dust. This gave cigarette makers the ability to reduce the cost of producing cigarettes by using fewer tobacco leaves and making up the difference by using reconstituted tobacco. While the motive appeared to be purely economic, the reconstitution process was nevertheless a critical development that started the industry down the path toward controlling and manipulating nicotine levels. The ability to control and manipulate nicotine levels becomes important in light of another key realization. Industry patents show that the industry recognized that nicotine is the active ingredient in tobacco smoke. It is what produces the psychoactive effects that lead smokers to crave cigarettes.

Numerous patents illustrate how the industry has been working to sustain the psychoactive effects of nicotine in cigarettes. These charts show samples from several categories of patents: eight patents to increase nicotine content by adding nicotine to the tobacco rod (Chart B); five patents to increase nicotine content by adding nicotine to filters, wrappers and other parts of the cigarette (Chart C); three patents that use advanced technology to manipulate the levels of nicotine in tobacco (Chart D); eight patents on extraction of nicotine from tobacco (Chart E); and nine patents to develop new chemical variants of nicotine (Chart F).

Patents not only describe a specific invention. They also speak to the industry's capabilities, to its research, and provide insight into what it may be attempting to achieve with its products.

It is prudent to keep in mind that patents do not necessarily tell us what processes are currently being used in manufacturing cigarettes. Nevertheless, the number and pattern of these patents leaves little doubt that the cigarette industry has developed enormously sophisticated methods for manipulating nicotine levels in cigarettes. Today, a cigarette company can add or subtract nicotine from tobacco. It can set nicotine levels. In many cigarettes today, the amount of nicotine present is a result of choice, not chance.

Let me show you the language in some of these patents. This is in the industry's own words.

Listen to what industry says it wants to be able to do with nicotine.

First, the industry wants precise control of the amount of nicotine in cigarettes to provide desired physiological effects:

Maintaining the nicotine content at a
sufficiently high level to provide the
desired physiological activity, taste, and
odor...can thus be seen to be a significant
problem in the tobacco art.
-patent no. 3,280,823 C1:43-48

Second, the industry wants to increase the amount of nicotine in some cigarettes.

...the perceived taste or strength of the cigarettes classified as having lower levels of "tar" and nicotine are progressively less than that of the cigarettes which are classified as approaching the characteristics of the "full flavor" cigarettes. It has been proposed to add nicotine and other flavorants to the cut filler of the lower "tar" cigarettes to enhance the taste, strength, and satisfaction of such cigarettes.
-patent no. 4,830,028 C1:40-47

This invention...concerns the problem of maintaining or increasing the nicotine content of the smoke whilst avoiding an undesirable level of particulate matter in the smoke....
-patent no. 3,861,400 C1:1-10

Now listen to what the industry says it can do, right now, at least for patent purposes, with the nicotine in cigarettes:

It can precisely manipulate nicotine levels in cigarettes:

This invention permits the release into tobacco smoke, in controlled amounts, of desirable flavorants, as well as the release, in controlled amounts and when desired, of nicotine into tobacco smoke.
-patent no. 3,280,823 C2:37-40

It is another object of the invention to provide an agent for the treatment of tobacco smoke whereby nicotine is easily released thereinto in controlled amounts.
-patent no. 3,584,630 C2:69-71

[I&91;t can be seen that the process...enables the manipulation of the nicotine content of tobacco material, such as cut leaf and reconstituted leaf, by removal of nicotine from a suitable nicotine tobacco source or by the addition of nicotine to a low nicotine tobacco material.
-patent no. 4,215,706 C3:61-66

...processed tobaccos can be manufactured under conditions suitable to provide products having various nicotine levels.
-patent no. 5,031,646 C5:63-65

Examples of suitable tobacco materials include...processed tobacco materials such as expanded tobaccos, processed tobacco stems, reconstituted tobacco materials or reconstituted tobacco materials having varying levels of endogenous and exogenous nicotine....
-patent no. 5,031,646 C5:21-27

...the present invention...is particularly useful for the maintenance of the proper amount of nicotine in tobacco smoke.

...previous efforts have been made to add nicotine to tobacco products wherein the nicotine level in the tobacco was undesirably low.
-patent no. 3,584,630 C2:5-15

It can precisely manipulate the rate at which the nicotine is delivered in the cigarette:

It is a further object of this invention to provide a cigarette which delivers a larger amount of nicotine in the first few puffs of the cigarette than in the last few puffs.
-patent no. 4,595,024 C2:23-26

It can transfer nicotine from one material to another at will:

Moreover, the process is useful for transferring naturally occurring nicotine from tobacco having a generally high nicotine content to a nicotine deficient tobacco, tobacco filler materials, or RL (reconstituted leaf) which are used in the production of cigarettes and other smoking products... [A&91; low nicotine tobacco ...can also be used as the nicotine donor...
-patent no. 4,215,706 C1:40-48

It is another object of this invention to provide a process for the migration of nicotine from one tobacco substrate (leaf material or reconstituted leaf) to a second tobacco substrate (leaf material, reconstituted leaf material or tobacco stems) or to a non-tobacco substrate.
-patent no. 5,018,540 C2:39-43

It can increase the amount of nicotine in cigarettes:

If desired, nicotine can be incorporated into the expansion solvents used to provide a volume expanded processed tobacco material having a high nicotine content.
-patent no. 5,031,646 C5:65-68

The present invention provides a nicotine-enhanced smoking device with a high nicotine release efficiency....Thus, the smoker is provided with more nicotine from the nicotine-enhanced device than from a similar smoking device which does not contain the nicotine solution or from a comparable cigarette.
-patent no. 4,676,259 C2:30-33, 53-56

The present invention is concerned with the application of additives, such as... physiologically active agents such as nicotine components to the smoking rod, in order to improve or help to improve the satisfaction provided to the smoker.
-patent no. 4,236,532 C1:35-40

It can add nicotine to any part of the cigarette:

The salts [nicotine levulinate&91; can be incorporated into the smoking article in a variety of places or sites. For example, the salt can be applied to the filler material, incorporated within some or all of the filler material, applied to the wrapper of the tobacco rod, applied within the glue line of the wrapper of the tobacco rod, applied within a region (e.g., a cavity)....
-patent no. 4,830,028 C5:59-65

It can use a variety of methods to add nicotine to tobacco:

...[T&91;he additive [nicotine levulinate&91; can be applied using syringes or techniques such as spraying, electrostatic deposition, impregnation, garniture injection, spray drying, inclusion and encapsulation technologies, and the like.
-patent no. 4,830,028 C6:-7

Let me describe in some detail how some of the technologies can be used to increase or control the nicotine level of tobacco.

The industry had to tackle a new problem beginning in the 1960s as public concern about the health consequences of smoking intensified. The industry began to market cigarettes it described as low yield. It faced a major challenge, however, because in the words of patent no. 4,830,028, "the perceived taste or strength of the cigarettes classified as having lower levels of 'tar' and nicotine are progressively less than that of the cigarettes which are classified as approaching the characteristics of the "full flavor" cigarettes."

The patent then describes a way to add nicotine to the "low yield" cigarettes. If nicotine alone is sprayed on a blend of tobacco, the patent states that the smoke that results will be unacceptably harsh or irritating to the user. So, instead of just spraying nicotine on the tobacco blend, the patent combines nicotine with another compound, an organic acid called levulinic acid, to form a salt that masks the irritating qualities of nicotine. (Chart G and H) The patent demonstrates that different percentages of the nicotine salt can be added to blends of tobacco to produce different nicotine concentrations. The control cigarette, the one without any added nicotine, contains l.66 percent nicotine. Adding one percent nicotine salt results in a cigarette with 2.05 percent nicotine. As one increases the amount of nicotine salt sprayed on the tobacco blend, the nicotine content of the tobacco increases.

In this process, great care is paid to the pH of the smoke because pH affects the bioavailability of nicotine -- that is, how much the body absorbs. The patent demonstrates the technology to increase nicotine content in tobacco by up to 76 percent.

U.S. patent no. 5,065,775 (Chart I) describes another technology that can control the nicotine content of tobacco filler. This involves a process for "modifying the alkaloid content of a tobacco material and, in particular, for providing a processed tobacco material having a controlled nicotine content." (C2:57-60) In the words of the patent "[t&91;he process of the present invention provides a skilled artisan with an efficient and effective method for changing the character of a tobacco material (e.g., rearranging components of a tobacco material or altering the chemical nature or composition of a tobacco material) in a controlled manner. That is, the process...can be employed in a way such that changes in the chemical composition of tobacco can be monitored as to occur to a desired degree." (C3:55-63)

The patent allows for the removal of selected substances from tobacco, and incorporating controlled amounts of substances into tobacco. Example 4 within this patent shows how a tobacco blend that starts off with a 2.3 percent nicotine content can end up with a 5.2 percent nicotine content. A highly concentrated nicotine solution is created by subjecting a tobacco blend to a series of chemical steps, including adding water, removing solids, increasing the pH, and mixing this substance with chlorofluorocarbon (CFC) 11 and then evaporating off that CFC 11. This concentrate is then added to water-washed tobacco to increase its nicotine content. This patent demonstrates the technology to increase the nicotine content in tobacco by more than 100 percent .

A third example of sophisticated technology involves the direct transfer of nicotine from one type of tobacco to another type of tobacco. (Chart J) U.S. patent no. 4,898,188 utilizes supercritical fluid extraction. In example 2 in the patent, liquid carbon dioxide is used to transfer nicotine from Burley cut tobacco filler to flue-cured cut tobacco. The flue-cured cut filler starts off with a nicotine content of 2.59 percent and ends up with a nicotine content of 4.83 percent. The Burley cut filler starts off with a nicotine content of 3.56 percent and ends with a nicotine content of 0.88 percent. This patent demonstrates that nicotine can be transferred in significant amounts from one type of tobacco filler to another.

Additional information about the ability to set nicotine content at varying levels comes from the following ad, headlined "More Nicotine or Less," which appeared in an international tobacco trade publication: (Chart K)

Nicotine levels are becoming a growing concern to the designers of modern cigarettes, particularly those with lower "tar" deliveries. The Kimberly-Clark tobacco reconstitution process used by LTR INDUSTRIES permits adjustments of nicotine to your exact requirements. These adjustments will not affect the other important properties of customized reconstituted tobacco produced at LTR Industries: low tar delivery, high filling power, high yield, and the flexibility to convey organoleptic modifications. We can help you control your tobacco.

In fact the process described in this advertisement can raise the level of nicotine beyond what is naturally found in tobacco materials, especially the stems and scraps. A 1985 tobacco journal article describing the LTR process states

Though standard reconstituted tobacco products contain 0.7 - 1.0 percent nicotine, LTR Industries offers the possibility of increasing the nicotine content of the final sheet to a maximum of 3.5 percent...

A dramatic increase in tobacco taste and smoke body is noted in the nicotine-fortified reconstituted tobacco.

All of this apparent technology for manipulating nicotine in tobacco products raises the question of how the industry determines how much nicotine should be in various products. More importantly, since the technology apparently exists to reduce nicotine in cigarettes to insignificant levels, why, one is led to ask, does the industry keep nicotine in cigarettes at all?

The tobacco industry would like you to believe that all it is doing is returning the nicotine that is removed during the process of producing reconstituted tobacco. It should be clear from what I have described thus far that the technology the industry may have available goes beyond such modest efforts.

The industry may also tell you that it is adjusting nicotine levels to be consistent with established "FTC yields" -- these are the amounts of tar, nicotine, and carbon monoxide that are measured for each cigarette product by smoking machines, and disclosed under a voluntary agreement with the Federal Trade Commission. In fact, the control of nicotine levels in cigarettes, dating back at least to patents granted in 1966 for adjusting nicotine levels, preceded the first rules adopted by the FTC on disclosing tar and nicotine yields. Moreover, there is nothing about the FTC yields that would require tobacco companies to increase nicotine in low tar cigarettes, as the industry patents suggest they do. There are no FTC restrictions on nicotine levels, and the FTC guidelines take into account crop variability by sampling completed cigarettes from 50 retail outlets across the country. Indeed, there is no FTC restriction that would prevent the industry from reducing nicotine below addicting levels or eliminating it altogether.

In fact, the technology reflected in the cigarette industry's patents appears to be intended to allow the industry to set the nicotine content of tobacco products at defined levels that have little to do with either the amount of nicotine that was removed during the processing of the tobacco, or with the simple goal of maintaining consistency with established FTC yields. The technology may exist to allow the industry to set nicotine levels wherever it want, or, in fact to remove nicotine entirely. With all the apparent advances in technology, why do the nicotine levels found in the vast majority of cigarettes remain at addictive levels?

Nicotine levels may be dictated in part by marketing strategies and demographics. A blatant example comes from information on the marketing of smokeless tobacco. There is evidence that smokeless tobacco products with lower amounts of nicotine are marketed as "starter" products for new users, and that advertising is used to encourage users to "graduate" to products with higher levels of nicotine. (Chart L) The evidence was developed in lawsuits brought against one manufacturer of smokeless tobacco.

The tobacco industry may tell you that nicotine is important in cigarettes solely for "flavor." There is a great deal of information that suggests otherwise. Some of the patents specifically distinguish nicotine from flavorants. An RJR book on flavoring tobacco, while listing around a thousand flavorants, fails to list nicotine as a flavoring agent. Even research scientists from the same company acknowledge that the nicotine in cigarettes provides pharmacological and psychological effects to smokers in addition to any mere sensory effects.

Moreover, the available information shows that the industry has gone to significant lengths to develop technologies to mask the flavor of increased levels in cigarettes. As I have already noted, the industry's own patents reveal that increasing nicotine in fact usually produces an unacceptably harsh and irritating product, and that the industry has had to take special steps to mask the flavor of increased nicotine in low tar cigarettes.

This should not come as a surprise. The Merck Index, the authoritative encyclopedia of chemicals, describes nicotine as having "an acrid, burning taste." Webster's 7th New Collegiate Dictionary defines acrid as "sharp and harsh or unpleasantly pungent in taste or odor; irritating, corrosive." In fact, U.S. patent 4,620,554 uses the word "hazardous" to describe the taste of nicotine.

What appears to be true is that smokers become accustomed to, and associate, the sensory impact of nicotine (burning in the throat) with the resulting psychoactive effects of nicotine, and thus look for those sensory signals in a cigarette; this is called "conditioned reinforcement."

Moreover, if nicotine is just another flavorant in tobacco, why not use a substitute ingredient with comparable flavor, but without the addictive potential? For example, it has been repeatedly shown that substitute ingredients, such as hot pepper (capsaicin) and citric acid, have similar irritating sensory effects.

Similarities to the Pharmaceutical Industry

Mr. Chairman, this kind of sophistication in setting levels of a physiologically active substance suggests that what we are seeing in the cigarette industry more and more resembles the actions of a pharmaceutical manufacturer. Besides controlling the amount of a physiologically active ingredient, there are a number of other similarities.

One similarity between the cigarette industry and the pharmaceutical industry is the focus on bioavailability. Bioavailability is the rate and extent that pharmacologically active substances get into the bloodstream. For example, the pH of tobacco smoke affects the bioavailability of nicotine. The tobacco industry has conducted research on the pH of smoke and has undertaken to control the pH in tobacco smoke. In patent examples, chemicals have been added to tobacco to affect the pH of tobacco smoke. The industry has even performed bioavailability and pharmacokinetic studies on conventional and novel cigarettes.

The cigarette industry has undertaken research to look at the specific activity of added versus naturally occurring nicotine. Additional research looked at the differences between spiking, spraying and blending compounds into cigarettes.

Development of an "express" cigarette, a shorter, faster burning cigarette with the same amount of tar and nicotine, has been reported in the lay press recently. This is another example of how cigarette companies appear to be controlling the amounts of nicotine to deliver set levels.

The cigarette industry has also undertaken a significant amount of research looking at the potential "beneficial" effects of nicotine. It has studied the effects of nicotine on anxiety, heart rate, electroencephalographs (EEG's), and behavioral performance tasks. Such research on the physiological effects of an active ingredient is a common part of pharmaceutical drug development.

Perhaps the most striking aspect of the research undertaken by the tobacco industry is its search for, and its patenting of, new nicotine-like chemicals that exhibit pharmacological properties which, in their own words, "are indicated for utility as potential psychotherapeutic agents." One patent describes nicotine-like chemicals which

exhibit tranquilizing and muscle-relaxing properties when administered to mammals. The nicotine analogs do not exhibit nicotine-like properties, such as tachycardia, hypertension, gastrointestinal effects, emesis in dogs, and the like.
Example XXIX in the patent

illustrates the pharmacological properties of nicotine analogs....

The tranquilizing effects of invention nicotine compounds are measured after intraperitoneal (IP) and intraventricular (IVC) administration in the form of hydrochloride salts.

Sedation is determined by measuring locomotion in an open field maze, and the response to noxious (air blast) stimuli. Body tone is estimated by handling rats and by the ability to hang from a rotating rod.

Tranquilization after intraventricular (IVC injection) is estimated from muscle weakness in all four limbs, body tone and general activity.

Chart M illustrates the results.

The Problem of the Low-yield Cigarette

We, at the Food and Drug Administration, are concerned not only about the control over nicotine levels exercised by the cigarette industry, we are also concerned that the problems associated with nicotine are aggravated by significant limitations in consumer's ability to reduce their exposure to nicotine by selecting "low" nicotine cigarettes.

Most people who smoke low yield or "light" cigarettes believe that they are getting less nicotine and tar by smoking these cigarettes. For the last 25 years the American public has relied on FTC ratings of tar and nicotine in advertising to tell them what they will be consuming. The "FTC method" utilizes a machine that tests cigarettes in a process involving a two- second, 35 milliliter puff each minute until a predetermined butt length is reached.

Most people don't realize that low yield cigarettes, as determined by the FTC method, do not usually result in proportionally less nicotine being absorbed when compared to high yield cigarettes. Furthermore, there is little correlation between low yield FTC ratings and the total amount of nicotine in cigarettes.

It is a myth that people who smoke low nicotine cigarettes are necessarily going to get less nicotine than people who smoke high nicotine cigarettes. There are several reasons for this. One reason is that there are differences between the smoking habits of a machine and a human. The way in which a cigarette is smoked is probably the most important determinant of how much tar and nicotine is inhaled. Humans can compensate -- and do compensate -- when smoking low yield cigarettes, by altering puff volume, puff duration, inhalation frequency, depth of inhalation, and the number of cigarettes smoked. As a result of these compensatory mechanisms, a low yield cigarette can actually result in a relatively high intake of nicotine.

Beyond the human compensatory mechanisms, several other factors under manufacturers' control contribute to a lowering of machine ratings. These factors include the positioning of ventilation holes, how fast the cigarette paper burns, and the length of the filter paper overwrap.

To understand how the position of ventilation holes in a cigarette can confound the FTC ratings, it is important to recognize that the main determinants of whether a cigarette has a high or low yield in machine testing are the cigarette's ventilation and burning characteristics. Most low yield cigarettes achieve their low ratings because of filter characteristics and also because the smoke is diluted with air. The air dilution is accomplished in part by placing ventilation holes in the filter. What scientists have demonstrated is that "although smoking machines which measure tar and nicotine do not occlude the perforations," 32-69 percent of low tar smokers have blocked the holes with their fingers or lips, resulting in larger nicotine yields. The ventilation holes are sometimes laser generated and can be hard for the smoker to see. Not all smokers are aware of the existence of these holes or that the smoker may be blocking them. (Chart N)

Two other factors that are under manufacturers' control can also confound the usefulness of the FTC ratings. The FTC method smokes a cigarette down to within 3 millimeters of the tipping paper overwrap. According to one study, "between 1967 and 1978, 18 brands of filter cigarettes underwent increases in overwrap width that reduced the amount of tobacco smoked in the cigarettes on the machine, even though the remaining tobacco is still smokeable." (Chart O) Another way that the FTC numbers can be confounded is by "increasing the rate at which cigarettes burn." A faster burning cigarette lowers the puff count. Manufacturers can increase the rate at which a cigarette burns by controlling the porosity of the cigarette paper. The machine takes a puff every minute, but humans can adjust their smoking rate.

Because of all these confounding factors we are concerned that consumers may assume that low yield cigarettes in fact deliver low tar and nicotine when in reality they do not.

Actual Nicotine Levels in Cigarettes

To assess the levels of nicotine in cigarettes, we did two things. First, FDA laboratories measured the amount of nicotine actually in several types of cigarettes. We analyzed three varieties of one brand family of cigarettes; one that is regular, one that is low tar, and one that is ultra low. What surprised us was that the variety advertised as having the lowest yield in fact had the highest concentration of nicotine in the cigarette. (Chart P)

Second, we formally requested from our colleagues at the Federal Trade Commission summary information derived from their data base on the levels of nicotine in cigarettes. What we found was that since 1982 (the earliest year for which the computer data base is available), the sales weighted levels of FTC nicotine in cigarettes appear to increase. (Charts Q,R,S, and T) What was equally striking was that when we segmented sales into high tar, low tar, and ultra low tar cigarettes, the nicotine/tar ratio was higher in the ultra low tar group. (Chart U) We would not have expected to see these differences because high tar has usually been associated with high nicotine, low tar has usually been associated with low nicotine. It has often been said that tar and nicotine travel together in the cigarette smoke. The disparities in the nicotine/tar ratios among these varieties raise the question as to how this can occur.

III. FDA REGULATION OF NICOTINE IN CIGARETTES

The next task facing the FDA is to determine whether nicotine-containing cigarettes are "drugs" within the meaning of the Federal Food, Drug, and Cosmetic Act.

Our inquiry is necessarily shaped by the definition of "drug" in the Act. It is a definition that focuses on "vendor intent." More specifically, it focuses primarily on whether the vendor intends the product to, "affect the structure or any function of the body."

Mr. Chairman, the evidence we have presented today suggests that cigarette manufacturers may intend that most smokers buy cigarettes to satisfy their nicotine addiction.

We do not yet have all the evidence necessary to establish cigarette manufacturers' intent. It should be clear, however, that in determining intent what cigarette manufacturers say can be less important than what they do. The fact that the technology may be available to reduce the nicotine to less than addictive levels is relevant in determining manufacturer intent.

It is important to note that the possibility of FDA exerting jurisdiction over cigarettes raises many broader public health and social issues for Congress to contemplate. There is the possibility that regulation of the nicotine in cigarettes as drugs would result in the removal of nicotine-containing cigarettes from the market, limiting the amount of nicotine in cigarettes to levels that are not addictive, or otherwise restricting access to them, unless the industry could show that nicotine containing cigarettes are safe and effective. If nicotine were removed, the nation would face a host of issues involving the withdrawal from addiction that would be experienced by millions of Americans who smoke.

There is, of course, the issue of black market cigarettes. With nicotine, as with other powerfully addicting substances, a black market could develop.

In these issues, we seek guidance from Congress.

The one thing that I think is certain is that it is time for all of us -- for the FDA, for the Congress, for the American public -- to learn more about the way cigarettes are designed today and the results of the tobacco industry's own research on the addictive properties of nicotine.

Thank you.

The rush to ban electronic cigarettes is hazardous to smokers' health.

Excerpted from Jacob Sullum | reasononline | April 8, 2009

"Last week the House of Representatives approved a bill that authorizes the Food and Drug Administration to regulate tobacco products. Lest anyone think that cigarettes will be safer as a result, the bill prohibits manufacturers from mentioning FDA regulation, saying "consumers are likely to be confused and misled" if they know about it.

Meanwhile, supporters of the bill, which the Senate will consider later this year, are demanding that the FDA ban e-cigarettes, a potentially life-saving alternative for smokers, as unauthorized drug delivery devices. Last month Sen. Frank Lautenberg (D-N.J.), who brags that he is "one of the Senate's leaders in protecting Americans from the dangers of smoking," urged the FDA to take e-cigarettes off the market "until they are proven safe." The next day, the American Cancer Society, the American Heart Association, the American Lung Association, and the Campaign for Tobacco-Free Kids applauded Lautenberg's position.

Michael Siegel, a professor at the Boston University School of Public Health, did not. "This is about as idiotic and irrational an approach as I have ever seen in my 22 years in tobacco control and public health," he wrote on his blog. "A public policy maker who touts himself as being a champion of the public's health as well as some of the leading national health advocacy organizations are demanding that we ban what is clearly a much safer cigarette than those on the market, but that we allow, protect, approve, and institutionalize the really toxic ones."

Introduced by the Chinese company Ruyan in 2004, e-cigarettes produce water vapor containing nicotine and the food additive propylene glycol. The tip of the battery-powered "cigarette" lights up when a user sucks on it, and the vapor looks like smoke, but it dissipates immediately and contains none of the toxins and carcinogens that are generated when tobacco burns.

Given the enormous differences between this vapor and tobacco smoke, the companies that sell e-cigarettes online and from shopping mall kiosks are on firm ground in advertising them as safer alternatives to conventional cigarettes that can be used in places where smoking is banned. The arguments of e-cigarette opponents, by contrast, reek of red herrings.

The critics warn that nicotine is addictive, that it may contribute to cardiovascular problems, and that smokers may use e-cigarettes as way of coping with smoking bans, continuing their habits instead of quitting. All of these objections also apply to the nicotine gum, patches, sprays, and inhalers the FDA has approved as safe and effective smoking cessation tools.

E-cigarettes are less expensive than those products and may be more appealing to smokers looking for an experience that's closer to the real thing. Although they have not been subject to the sort of rigorous testing the FDA demands for new drugs, the drug they contain is not new. It's the same one delivered, in a much dirtier manner, by the cigarettes that the government says kill 400,000 Americans every year.

"The standard for lower-risk products for use by current smokers," argues the American Association of Public Health Physicians, "should be the hazard posed by cigarettes, not a pharmaceutical safety standard." Telling smokers they may not use e-cigarettes until they're approved by the FDA is like telling a floundering swimmer not to climb aboard a raft because it might have a leak.

Jacob Sullum is a senior editor at Reason and a nationally syndicated columnist.

LETTER ON THE ON THE TOBACCO BILL AND ALTERNATIVE SMOKING PRODUCTS TO US HOUSE OF REPRESENTATIVES

Bill Godshall
1926 Monongahela Avenue 
Pittsburgh, PA 15218 
smokefree@compuserve.com
PH 412-351-5880
FAX 412-351-5881

April 1, 2009

The Honorable U.S. House of Representatives Washington, D.C. 20515

RE: Tobacco Regulatory Legislation (HR 1256 & HR 1261)

Dear Representative

Smokefree Pennsylvania urges you to oppose Rep. Waxman's FDA tobacco bill (HR 1256) and to also oppose Rep. Buyer's substitute tobacco bill (HR 1261) because both bills contain outrageous clauses that protect future cigarette markets at the expense of public health.

We oppose Rep. Waxman's legislation, a deal negotiated by Philip Morris and the Campaign for Tobacco Free Kids in 2004, because it protects the most hazardous tobacco product (cigarettes) from market competition by the least hazardous (smokefree) tobacco products, as it:

• bans all new and recently introduced smokefree products, while keeping cigarettes on the market.
• deceives consumers to believe that smokefree tobacco products are just as hazardous as cigarettes
• prohibits industry from telling smokers that smokefree products are less hazardous than cigarettes

Sound product regulations truthfully inform consumers (and the public) about risks of different products, and encourage industry to make lower risk products. Cigarettes are 100 times deadlier than smokefree tobacco products, but 85% of smokers incorrectly believe that smokefree tobacco products are just as hazardous as cigarettes. By switching to smokefree tobacco/nicotine products, smokers reduce their health risks by nearly as much as by quitting all tobacco/nicotine, and millions have already done so. Public health agencies have an ethical duty to inform smokers that smokefree tobacco/nicotine products are less hazardous alternatives to cigarettes, and smokers have a human right to this important information. I coauthored a report "Tobacco harm reduction: an alternative cessation strategy for addicted smokers" at http://www.harmreductionjournal.com/content/3/1/37

While Smokefree Pennsylvania supports the harm reduction provisions in Rep. Buyer's substitute (HR 1261), we oppose the bill since it contains clauses that would increase cigarette sales to minors.

Since 1990, Smokefree Pennsylvania has advocated policies to protect people from tobacco smoke pollution, increase cigarette taxes, reduce tobacco marketing to youth, preserve civil justice remedies for tobacco victims, expand smoking cessation services, and inform smokers that smokefree tobacco/nicotine products are less hazardous alternatives to cigarettes.

Thank you for your consideration, and feel free to contact me anytime.

Sincerely,

William T. Godshall, MPH Executive Director

David Sweanor has worked with numerous companies and organisations, including the International Union Against Cancer, World Health Organization, World Bank and the Pan American Health Organization, on the issue of tobacco harm reduction. He has received both international recognition and prestigious prizes for his work.

How did you get interested in the issue of Tobacco Harm Reduction? 

1) Measures to prevent people from ever engaging in a risky behaviour
2) measures to get those engaging in the behaviour to cease engaging in it
3) efforts to prevent injury to third parties as a result of the behaviour
4) efforts to reduce the risks to those who will continue the behaviour.

By the early 1990s there was no doubt that the vast majority of the harm caused by smoking was from the method of nicotine delivery rather than from the nicotine itself. There would be a parallel problem if people got caffeine from smoking tea leaves rather than making an infusion of these leaves in hot water. At the same time the projections of future smoking rates was for increasing consumption despite global anti-tobacco policies, and there was increasing scientific understanding of the reasons people use nicotine. An ‘abstinence-only’ policy aimed at a nicotine-free world was simply unrealistic.

So certainly by the 1990’s, and much earlier in the case of far-sighted researchers such as Michael Russell, it was clear that there were huge gains to be made from dealing with the delivery system. Oddly, though there had by that time been much focus on issues such as where the product could be used, how it was taxed, limits on advertising, controls on places of sale, packaging requirements, etc., there was little to nothing being done about the product itself.

What progress has been made since you got involved?

Short answer: Not enough.

Longer answer: There is now a much greater awareness that there is a very pronounced continuum of risk depending upon how nicotine is delivered. We are also seeing greater (though still poor) availability of medicinal forms of nicotine and a proliferation of new nicotine products. There is also no longer any scientific doubt that combustion-based products are massively more hazardous than non-combustion products such as Swedish snus. My experience is that as soon as someone grasps the concept of the continuum of risk and recognizes that all nicotine use is not going to end anytime soon, the pieces start coming together. This comes at a time that many countries are moving toward regulating tobacco products and discussing the need for some form of comprehensive regulatory oversight of the full range of nicotine products. Clearly, any rational health-focused regulation will demand that we deal with issues of differential risks.

I know that you don't necessarily agree with our theory that there is a conspiracy against alternative forms of smoking. Yet you have said Snus is a far safer alternative to smoking than cigarettes. How do you explain the reasons for illogical bans against alternative forms of tobacco such as in the European Union, where Snus has been banned but both cigarettes and more dangerous forms of chewing tobacco remain legal?

I think cigarettes have dominated the marketplace of most countries for so long that people have trouble even thinking of alternatives. Many of those who seek restrictions on non-combustion products, and certainly some of the companies selling them, see them as a way to perpetuate rather than replace cigarette smoking. When snus was positioned as a potential additional problem, rather than as a potential partial solution to a much bigger health problem, efforts to keep it off the market seemed logical.

We also have an issue with the tendency of our species to do something ‘because we can’ rather than to look at issues in a more comprehensive way that will better meet long term goals. It was possible to get laws banning a tobacco product that was not yet on the market, just as today it is possible to enforce existing drug laws to ban new recreational nicotine products. Had there been greater awareness of relative risks and a less risk-averse mentality snus could have been seen the way auto safety advocates saw Volvos – an agent of change for the marketplace.

What damage has been caused by the Snus ban?

I think the key thing is that we have lost a great chance to effectively show ‘proof of concept’ for the provision of less toxic alternatives to cigarettes. As soon as there is recognition that consumers can access nicotine without repetitious inhalation of tobacco smoke, and that some portion of current smokers find this to be an acceptable (even preferable) alternative to smoking, it causes a paradigm shift. If we get to the point of no longer seeing cigarettes as a ‘nicotine maintenance monopoly’ we could change the face of public health. If we recognize that the needs of smokers can be met in a way that does not necessarily result in the untimely death of roughly half of long term users maybe we can move society conceptually to the point that nicotine delivery can go through the same metamorphosis as we’ve seen with auto safety, telecommunications, sanitation, pharmaceuticals, food preparation standards, alcoholic beverages and a myriad of other goods and services. The market could be transformed (assuming an appropriate regulatory system) through a virtuous circle of increasing consumer awareness and ever-less-hazardous alternatives to cigarettes.

In addition the ban on products such as snus causes significant ethical and human rights problems. The idea of simply denying access to such a product to millions of smokers – people who are thus left using a massively more hazardous product – should be a great cause of concern. Misleading statements about the risks of products such as snus, especially those from major health organizations and government health departments, also run the risk of eroding consumer trust in public health authorities – a problem that ultimately impacts far more than issues of nicotine.

Do you see any parallels between Snus and the Electronic Cigarette, and the opposition against both of them?

Some part of the opposition to nicotine products comes from the same moral absolutism that we see in other abstinence-only efforts on issues concerning such things as alcohol and sexual activity. Actually, on a very wide range of issues there is a tension between those on a moralist/absolutist quest (usually tied to ideas on the perfectibility of mankind) and those on a pragmatic public health mission. It would wrong to characterize those on a moral quest as being public health advocates, and this is true whether looking at abstinence-only campaigns on sex, on alcohol, on illicit drugs or on nicotine. Campaigns based on making better people rather than making people better are driven by moral concerns rather than public health concerns.

You've stated that electronic cigarettes are not safe, but that they are a lot better than cigarettes. Just how unsafe are they? 

After many tens of thousands of research papers we know what causes the illnesses associated with smoking. In short, ‘it’s the smoke, stupid’. Non-combustion products will vary in their risks, but everything we can see about the sort of product sold in the West (whether smokeless tobacco, electronic cigarettes or medicinal nicotine) tells us that cigarettes are orders of magnitude more hazardous.

As to ‘not safe’, we perhaps need elaboration. The point I try to make when faced with the ‘it’s not safe’ canard is that nothing meets the criteria of being absolutely ‘safe’. Everything has risks, so simply pointing out that something is ‘not safe’ shows a person to be either ignorant or disingenuous. The key issue in looking at safety is that it is a relative concept; we need to look at safety of any activity compared to some alternative. Rather than the unattainable standard of ‘safe’ we should be thinking in terms of ‘safer’. Despite the risks associated with soccer, I would, for instance, prefer my children play soccer rather than play with live hand grenades.

You are a supporter of the electronic cigarette? Can you tell us why?

I am a supporter of less toxic alternative for smokers. Nicotine use should not come with a death sentence.

Ideally we need a nicotine regulatory authority that can facilitate efforts to get alternative products to smokers, accurately inform them of relative risks and move them as far as possible down the continuum of risk.

The nicotine market needs to experience a shake-up and the entrepreneurs who appear to be behind the e-cigarettes might be sufficiently risk-tolerant to cause it to happen. The issue needs to get on the public and political agenda, and we will not get the needed re-thinking of the whole nicotine market until this happens.

Opponents of the electronic cigarette have said that it could stop smokers from giving up, that is untested and untried and that claims that the electronic cigarette are healthier than normal cigarettes are unproven. How would you respond to these allegations?

There is no innovation that I am aware of that did not cause detractors to list various potential negative consequences were the product to be made available – even safety bicycles in the 1890s! But when the status quo is one that will, according to the WHO, result in a billion deaths this century surely we need more than a fear ‘something bad might possibly happen’ to reject an alternative to that status quo.

The obvious solution is to have a regulatory agency that facilitates getting the least hazardous products to consumers, with post-marketing surveillance to control any unintended negative consequences. It certainly would make much more sense than the current state of affairs where government agencies are banning products like snus and e-cigarettes, greatly constraining the potential market for medicinal nicotine, and thus protecting the cigarette cartel rather than the health of citizens.

If there is anyone who believes cigarettes are no more hazardous than e-cigarettes I’d recommend a remedial course in basic sciences. For anti-nicotine campaigners who say we need to wait for more research I would point out the way they are proving Nietzsche correct – we take on the attributes of our enemies. Cigarette companies spent decades making spurious claims that we need ‘more research’ before we could move on policy measures, despite the already-existing basis for informed policy measures. They provide very poor role models.

One criticism that has been levelled at the electronic cigarette is that we don't know the effect of heating up a nicotine vapour and inhaling it into the lungs. Is this a valid criticism?

We certainly know that inhaling a heated nicotine vapour into the lungs is one heck of a lot less hazardous than inhaling the same vapour along with the thousands of chemicals and dozens of known carcinogens that are inhaled when that vapour is delivered by smoking a cigarette. An investigation to determine if the non-smoke vapour is, say, 1/100 or 1/1,000 the risk of cigarette smoking might be a good thing. But if someone thinks cigarettes should not be challenged in the marketplace until we have such results I think they need to try thinking a little more deeply. They should also question whether they have undergone a Nietzsche-like transformation that is causing them to be sounding like a 1970s cigarette company executive.

How do you feel about the public health campaigners, via their campaign to ban electronic cigarettes, attempting to limit the choice of addicted smokers unable or unwilling to quit smoking to cigarettes and cigarettes alone?

I don’t think public health campaigners do this. I think some people on a moralistic abstinence-only agenda take this position, just as some take the position that consumers of alcohol should have no alternative to products like Jamaican Jake or that no one should have access to birth control, or that heroin addicts should not be given clean needles. But those people are not public health campaigners.

At the same time, I think there are people who are legitimate public health campaigners who oppose products like e-cigarettes. This can be because they want all such products to come within a comprehensive regulatory framework for all medicinal and recreational nicotine products; one designed to help move smokers away from cigarettes. They fear that unregulated products could proliferate and create a huge ‘snake oil’ business. But I also think it is incumbent upon such people to be advocating for such a regulatory framework rather than just inadvertently protecting the cigarette business.

The issue of electronic cigarettes is up in the air at the moment. How do you see the future - will it follow Snus into oblivion or will it become the smoking method of the future?

I think we are in the early stages of a revolution on recreational nicotine delivery. Just as with the telecommunications revolution it is likely impossible at an early stage to know how it will change. But it is a safe bet that consumer interests and entrepreneurship will combine to cause fundamental change, as we are already seeing with the rapid growth of non-combustion tobacco products in places such as Norway and the United States and the much greater use of medicinal nicotine products for purposes other than near-immediate nicotine cessation. The winning products in this market transformation will likely be of a wide variety, given differing consumer preferences and the nature of dynamic markets. I personally think that some of the most successful products will likely help consumers wean themselves off nicotine over time. But hundreds of millions of smoking-caused deaths will be averted by greater consumer choice and a proliferation of products, untold billions of dollars will be made by the owners of the successful products, and innumerable jobs will be created as this market transforms. Seldom is there an offer to become a billionaire while saving millions of lives. I think there will be takers.

Link back...

FDA Regulation Threatens Cigarette Alternatives

Jacob Sullum | April 1, 2009, 1:14pm | reason.com

March 27, 2009

• To: All Concerned

• From: Joel L. Nitzkin, MD, MPH; Chair AAPHP Tobacco Control Task Force

• Subject: Tobacco Control Legislation: H.R.1256 and H.R.1261

There are currently two bills before the House dealing with Tobacco and Health. One is Waxman’s FDA/Tobacco bill – H.R. 1256. The other is Buyer’ Tobacco Harm Reduction Act, H.R.1261. Both are so severely flawed that, if passed as currently proposed, they would be worse than no bill at all, from a public health perspective.

The public health perspective that we used as a yardstick with which to estimate the likely impact of each of these bills is the anticipated impact of the legislation on future tobacco-related illness and death. 

Our surprising conclusions are based on analyses and extensive research done by our Tobacco Control Task Force of the American Association of Public Health Physicians. Our findings and conclusions are presented in detail in a series of documents on the tobacco issues page of our www.aaphp.org web site.

Waxman’s bill, as negotiated on his behalf by Campaign for Tobacco Free Kids (CTFK) and Altria/Philip Morris, so limits the authority of the FDA that Altria/Philip Morris could easily block any proposed regulation not to their liking. Even worse, however, is the fact that the bill would grant at least interim FDA approval to currently marketed cigarettes, while placing impossibly stringent barriers against the introduction of near-zero-risk tobacco and tobacco-related products. 

If the summary of this bill used by CTFK and friends to recruit co-sponsors and endorsing organizations accurately reflected the content of the bill, we would enthusiastically endorse it. Unfortunately . . . 
For our analysis of this bill, please see the tobacco issues page at www.aaphp.org. 

Buyer’s bill (H.R.1261), while appropriately regulating lower risk tobacco products, is fatally flawed in not imposing adequate restrictions on tobacco marketing.

AAPHP therefore recommends a set of amendments to the Waxman bill that will 1) enable and encourage current smokers who are unable or unwilling to quit to switch to near-zero-risk nicotine-delivery products; 2) strengthen the regulatory authority of the federal regulatory agency; 3) provide for needed health education, surveillance and research; and 4) Reconsider FDA as the federal regulatory agency. In addition, we recommend simultaneous passage of legislation that will restrict and punish manufacture and marketing of illicit, counterfeit and otherwise contraband tobacco and tobacco-related products. The details are spelled out in the Amendments document on the tobacco issues page at www.aaphp.org.


The facts are these:

1. Conventional cigarettes kill about 400,000 adult American Smokers each year from cigarette-related illness. Over the next 20 years this will total 8 million deaths among current adult smokers, most of which are now over 35 years of age.
2. These deaths are all due to cigarettes, with death rates from all other tobacco products too few for such ready tabulation. The problem is not tobacco. The problem is cigarettes.
3. Smokers smoke because they are addicted to nicotine. The illness and deaths, however, are not due to the nicotine. They are due to unrelated products of combustion, and, to a much lesser degree, toxins inherent in tobacco leaf.
4. Smoking cessation rates among smokers are abysmal –about 3% per year. Pharmaceutical products with counseling, quit lines, etc, are little better – resulting in quit rates no greater than 5% (as measured at 12 months post-intervention) among those willing to try these modalities. In other words, current approaches fail 95% of smokers using them. The only feasible way to reduce illness and death in this 95% of current adult smokers will be to enable and encourage them to switch from cigarettes to near-zero-risk nicotine delivery products
5. Adult American smokers are health conscious, as evidenced by the fact that about half use light and low-tar cigarettes, most believing (incorrectly) that they pose less health risk.
6. Substantial research has already been done and published to demonstrate the comparative risk of cigarettes and a variety of other tobacco products – at least one of which (snus) is near-zero-risk. (see Harm Reduction Paper on tobacco issues page, www.aaphp.org)
7. A variety of non-pharmaceutical alternative nicotine delivery products are already on the market or in various stages of development and market testing. These include sticks, strips, orbs, lozenges and e-cigarettes. The information available suggests risk and benefit profiles similar to widely accepted pharmaceutical nicotine replacement products.
8. Holding the snus and alternative nicotine delivery to the research standards of pharmaceutical products would cost the manufacturers millions of dollars per product and would deny current smokers the benefits of these products for a decade or more. Furthermore, such studies probably could not be conducted at current American academic centers because Institutional Review Board (IRB) guidelines would likely prohibit case/control studies on products with no therapeutic benefit. Thus, the seemingly reasonable research standards in the Waxman bill would likely result in a de-facto ban on all such products. AAPHP therefore favors the research guidelines from the Buyer bill.
9. Since both the Waxman and the Buyer bills would approve currently marketed cigarettes – the most hazardous of all tobacco products, the standard for lower risk products for use by current smokers should be the hazard posed by cigarettes, not a pharmaceutical safety standard.

Given these facts, the legislative challenge then becomes how to encourage and enable current smokers to switch to near-zero-risk products without increasing the numbers of teens who initiate tobacco use. AAPHP believes this can be done by imposing a marketing restriction beyond those included in the Waxman bill, as described in our Amendments document on the tobacco issues page at www.aaphp.org.