Greetings,
As a concerned citizen and former smoker, I have grave concerns regarding this bill, and who it will affect in the long term.
The new "Marlboro Brand Protection Act", as some are calling it, was signed into law by president Obama on June 22nd, 2009. The actual bill is called H.R.1256, The Family Smoking Prevention and Tobacco Control Act and essentially gives the FDA regulatory control over tobacco products. Many argue that the Bill simply maintains the current market share by Philip Morris, who helped craft the Bill, H.R.1256 has the potential to put very tight restrictions on smoking alternatives that could have otherwise had a net positive effect on public health.
The ramifications of this bill are staggering. First off, it places FDA control over a product that is known to kill. This flies in the face of the true nature of the FDA, to safeguard the health of the people by testing products and devices for safety, and food for safety. Cigarettes are far from safe. This will leave the impression that cigarettes are safer now that the FDA has control. Far from the truth. With the FDA seeking to remove many of the known chemicals in cigarettes, this will give the impression of a safer cigarette. The net effect will be more new smokers, who now believe it is OK to smoke because of the reduced risk factor.
The second ramification is nicotine reduction. The basic theory of this is to reduce nicotine content that will keep people from being addicted. This is also far from the truth. Nicotine is one of the most addictive substances known to man, and reducing the content is equivalent to the street corner crack dealer who gives large supplies to new customers to get them hooked, then reducing the quantity and raise the price to keep them hooked. The effect is the same with nicotine reduction. We will see a dramatic increase of smokers purchasing more cigarettes and inhaling the cigarette deeper to compensate for the lowered nicotine content. This in itself will cause millions of American smokers to put themselves in a greater risk of cancer, emphysema, heart disease, and many other health risks of smoking. This will have the net effect of increasing, not decreasing, the number of deaths per year due to tobacco use. This is far from the intended purpose of this Bill.
Third ramification is it places Philip Morris in a large market share with virtually no competition, and they managed to pull this off by manipulating our American Government to become no less than a monopoly. This is serious. In the minds of Americans, this is seen as a corporate takeover of our American Legislature. Philip Morris crafted this bill in such a way that it insured that they hold the over 50% of the market place in cigarette sales despite tight regulations, and using the Tobacco Free Kids group as a front, they came out as a "savior" but in actuality, got exactly what they wanted. This is why many are calling this the "Marlboro Monopoly Act" or the "Philip Morris Protection Bill". And as Marlboro is the cigarette of choice by thousands of High School students and new smokers each and every day, and is predominantly displayed and easily accessable, PM USA virtually assured themselves as being the SOLE supplier of cigarettes in this country, compliments of our American Government
The forth ramification is banning safer alternatives, such as the electronic cigarette (otherwise known as the e-cigarette or e-cig). We will discuss this below.
Whether or not it is a good bill or a bad bill, that seems to be in the hands of the FDA who will create the procedures and regulations to govern this age old industry. It is clear the FDA will have a lot of power in determining who makes money from selling tobacco and tobacco products. What is not so clear is how this “Big Tobacco meets FDA Bill” will effect the electronic cigarette. Below is the definition of a tobacco product according to the Bill:
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) Definition of Tobacco Products- Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:
`(rr)(1) The term `tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).
`(2) The term `tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g).
`(3) The products described in paragraph (2) shall be subject to chapter V of this Act.
`(4) A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).’.
DEFINITION OF AN ELECTRONIC CIGARETTE
Definition:
An electronic cigarette typically consists of a white cylindrical tube which consists of a battery, operation LED, and a microchip to control operation. The ATOMIZER is the element that heats the liquid, turning it into a vapor which is inhaled through the mouthpiece.
Instead of tobacco, however, e-cigarettes are filled with liquid consisting of Propylene Glycol, water, flavorings, and optional nicotine. When smokers draw on the cartridge, the battery activates the atomizer, heats the liquid, which creates a water-based vapor that is inhaled into the lungs. The excess cigarette-like "smoke" vapor is then emitted from the end of the e-cigarette, completing the cigarette smoking illusion.
1- The Electronic Cigarette as a Tobacco Product
I believe we can make a couple assumptions. First, the e-cigarette with zero nicotine would certainly NOT fall into the definition of a tobacco product. In this case, there is no nicotine, no tobacco, no drug…..just propylene glycol or vegetable glycerin, water, and flavoring. Second, the actual electronic cigarette device (battery, atomizer, mouthpiece/cartridge) could not be considered a tobacco product. So, the only thing that could be classified as a tobacco product would be the eliquid. But eliquid can be made with synthetic nicotine or with a compound similar to nicotine or with nicotine from another source other than tobacco. And if it is, then there would be no part of it derived from tobacco. The other argument is that nicotine extracted from a tobacco plant and purified is so far removed from the original plant that it ceases to be a tobacco product. This falls in line with the FDA’s current assertion that the electronic cigarette is a new drug and therefore needs approval.
2- The Electronic Cigarette as a New Drug
First off, it is a stretch to claim nicotine is a “new drug”, when in fact it is one of the oldest drugs used by man. Second, if the definition of a drug must include “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” then the electronic cigarette does not fall into this category. Using the e-cigarette is smoking, it doesn’t cure it (if smoking is even a disease to begin with). Some call it vaping, but it is still the habit of hand to mouth. Drug addiction is considered a disease by the CDC. So does the electronic cigarette diagnose, cure, mitigate, treat, or prevent drug addiction? Since e-smokers continue to get the nicotine, then NO. Users could use the zero nicotine eliquid, but there is no evidence that they will or even if they do, that they will stick with it and not go back to nicotine. If electronic cigarettes treat nicotine addiction then cola treats caffeine addiction.
3 -So What is the Electronic Cigarette?
As many of us in this industry have stated from the beginning, the electronic cigarette is unique. It is a technology that will continue to create ripples well into the future. This doesn’t mean it should be given a free pass and it doesn’t mean it should be pulled off the market. It means we need to have rational and intelligent discussions with regulatory bodies to ensure the industry follows standards and consumers are protected. Instead of these discussions, the e-cigarette industry has been attacked by politicians with local agenda’s, by public health organizations with money ties to the pharmaceutical industry, and the FDA who seems to take orders from the pharmaceutical companies. Considering the size and scope of smoking cessation sales in the US and worldwide, it is not hard to contemplate the drive to protect the market.
The e-cigarette industry has begun the process of legitimizing the industry through the formation of the Electronic Cigarette Association. Although a very young organization with much yet needed to be done, the ECA strives to implement standards and bring trust to this new industry. The ideal situation would be for the FDA to work with the ECA to create standards while using industry money to regulate, rather than tax payer dollars. Prohibition didn’t work. The “quit or die” philosophy doesn’t work. And banning products that have the potential of the electronic cigarette can not possibly be in the best interest of public health.
By allowing the Food and Drug Administration (FDA) power over tobacco products, this will leave people with the very wrong impression that cigarettes are safer now that they are FDA approved.
In conclusion, the Bill, as it stands now, signed by President Obama, will have the effect of removing safer alternatives from the market, increase current smokers risks by smoking more to compensate for the reduced levels of nicotine, cause an increase of deaths of smokers who are put into this situation of increased risk, give the public a false impression that cigarettes are safer because they are FDA "approved", and create a monopoly for Philip Morris.
We, as informed citizens, feel that this move is more to increase tax revenues for the Government due to increased cigarette sales, and not because of concerns of the health and safety of the American Public. We feel, as citizens, that this is a Government For The Money, By The Money. We sincerely hope that we are wrong.
Thank you for your time,
James S. Williams
Warwick, Rhode Island
Email:
xxxxxx@cox.net
