When dealing with Congress and Government, we should begin with clearly stating, and having a shared understanding among us, of our objective--what we are requesting.
With my limited participation in this forum, I believe the following is what we are looking for:
We seek the exemption of personal personal vaporization products known as electonic cigarette and the e-liquid, low-concentration nicotine suspended in propylene gylcol or vegetable glycerin with or without favoring, from the Food, Drug, and Cosmetic Act of 1938, Section 505 (21 USC 355).
We request that this exemption is granted to all manufacturers and vendors so that electronic cigarettes and e-liquid are allowed to freely manufactured, marketed, and distributed to consumers in the U.S.
Rationale:
Tabacco smoking is well-known to be a major threat to public health in the U.S. According to Center for Disease Control and Prevention (CDC), over 400,000 Americans die every year from smoking-related diseases such as lung cancer and enphysema. Second-hand smoke alone accounts for 38,000 deaths per year. Including the healthcare costs and lost productivity, smoking costs the U.S. $167 billion every year. Unquestionably, introducing an effective nicotine replacement therapy and smoking cessation product is extremely critical to both enhancing the public health and economic prosperity in the U.S.
Electonic cigarettes, though they are referred to as cigarette, contain no tabacco products of any kind. These devices simply turn the low concentration nicotine solution into vapor--much like the "smoke" machine used in the entertainment industry. Hence, the vapor from electronic cigarettes does not contain any toxic chemicals and known carcinogens such as tar, formaldehyde, and ammonia that comprise a large portion of cigarette and tabacco smoke.
Our rationale for seeking the exemption of electronic cigarette is threefold. First, use of electronic cigarettes, commonly referred to e-smoking, is found to be an extremely effective nicotine replacement therapy. Although the scientific clinical trials of this product, as required by the Food, Drug, and Cosmetic Act, have not been conducted, a large number of the U.S. consumers used this product and stopped smoking. They found that the electronic cigarettes are exceptionally effective nicotine replacement therapy, unparallel to any other methods currently available in the market such as nicotine patches, nicotine gums and nicotine inhalers.
Second, the electronic cigarettes are already widely accepted and used in the U.S. market. This is a unusal circumstance compared to other nicotine replacement and smoking cessation products. None of these other products had garnered such acceptance and use prior to their official introduction. If electronic cigarettes are withdrawn from the market, many people may need to resort back to smoking conventional cigarettes.
Third, the epidemic nature of the public health and economic problems caused by tabacco smoking demand an immediate solution. Withdrawing such effective nicotine replacement therapy, which is already widely used in the U.S. market would lead to catastrophic consequences.
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I personally think that requesting a short-term (say 5 years?) moratorium on the enforcement of section 505 would go much easier than permanent exemption. Five years or so might give manufacturers and vendors to go thru the approval process. Not very likely that Congress and FDA will give permanent exemption.
With my limited participation in this forum, I believe the following is what we are looking for:
We seek the exemption of personal personal vaporization products known as electonic cigarette and the e-liquid, low-concentration nicotine suspended in propylene gylcol or vegetable glycerin with or without favoring, from the Food, Drug, and Cosmetic Act of 1938, Section 505 (21 USC 355).
We request that this exemption is granted to all manufacturers and vendors so that electronic cigarettes and e-liquid are allowed to freely manufactured, marketed, and distributed to consumers in the U.S.
Rationale:
Tabacco smoking is well-known to be a major threat to public health in the U.S. According to Center for Disease Control and Prevention (CDC), over 400,000 Americans die every year from smoking-related diseases such as lung cancer and enphysema. Second-hand smoke alone accounts for 38,000 deaths per year. Including the healthcare costs and lost productivity, smoking costs the U.S. $167 billion every year. Unquestionably, introducing an effective nicotine replacement therapy and smoking cessation product is extremely critical to both enhancing the public health and economic prosperity in the U.S.
Electonic cigarettes, though they are referred to as cigarette, contain no tabacco products of any kind. These devices simply turn the low concentration nicotine solution into vapor--much like the "smoke" machine used in the entertainment industry. Hence, the vapor from electronic cigarettes does not contain any toxic chemicals and known carcinogens such as tar, formaldehyde, and ammonia that comprise a large portion of cigarette and tabacco smoke.
Our rationale for seeking the exemption of electronic cigarette is threefold. First, use of electronic cigarettes, commonly referred to e-smoking, is found to be an extremely effective nicotine replacement therapy. Although the scientific clinical trials of this product, as required by the Food, Drug, and Cosmetic Act, have not been conducted, a large number of the U.S. consumers used this product and stopped smoking. They found that the electronic cigarettes are exceptionally effective nicotine replacement therapy, unparallel to any other methods currently available in the market such as nicotine patches, nicotine gums and nicotine inhalers.
Second, the electronic cigarettes are already widely accepted and used in the U.S. market. This is a unusal circumstance compared to other nicotine replacement and smoking cessation products. None of these other products had garnered such acceptance and use prior to their official introduction. If electronic cigarettes are withdrawn from the market, many people may need to resort back to smoking conventional cigarettes.
Third, the epidemic nature of the public health and economic problems caused by tabacco smoking demand an immediate solution. Withdrawing such effective nicotine replacement therapy, which is already widely used in the U.S. market would lead to catastrophic consequences.
---
I personally think that requesting a short-term (say 5 years?) moratorium on the enforcement of section 505 would go much easier than permanent exemption. Five years or so might give manufacturers and vendors to go thru the approval process. Not very likely that Congress and FDA will give permanent exemption.
