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The American Association of Public Health Physicians (AAPHP) has submitted two tobacco-related petitions to FDA. The first requested that FDA reclassify electronic cigarettes from a drug to a tobacco product. The second requested a follow-up press conference to correct errors and misinterpretations in their July 22, 2009 press conference. That press conference left many with the erroneous impressions that E-cigarettes might be more harmful than conventional cigarettes, that they are being marketed to teens, and that there is no information available to address these issues.
Dr. Joel L. Nitzkin, Chair of the AAPHP Tobacco Control Task Force, who has no financial relations ship with any tobacco-related or pharmaceutical enterprise, has addressed this issue because “the possibility exists to save the lives of 4 million of the 8 million adult American smokers who will otherwise die of a tobacco related illness over the next 20 years.”
As Dr. Nitzkin explains it, “Per our analysis, the only way we can achieve this huge public health benefit will be through addition of a harm reduction initiative to current tobacco control programming by which current smokers are informed of the differences in risk profile presented by different types of tobacco products. In that context, e-cigarettes appear to be the very-low-risk product likely to be acceptable to most current smokers. With strict FDA regulation of manufacturing and marketing -- it should be possible to achieve this public health benefit without increasing the numbers of teens initiating tobacco use. FDA regulation of this product as a drug would mean a de-facto ban until clinical trials not required of other tobacco products can be completed.”
The AAPHP notes that the provisions of the newly adopted FDA/Tobacco law will require that FDA grant full FDA approval to currently marketed conventional cigarettes, and that the Supreme Court is virtually sure to rule that FDA cannot prevent the cigarette manufacturers from informing smokers of the FDA approval. “Thus, the standard for comparison regarding the safety of alternate nicotine delivery products should not be the usual drug safety standards -- it should be in comparison with conventional cigarettes.”
The two petitions (about 20 pages each) plus a common set of attachments (303 pages) are posted on the tobacco issues page of our www.aaphp.org web site. The petitions, but not the attachments are accessible and available for comment on the www.regulations.gov web site. To access the petitions there, go to www.regulations.gov and type in the docket number in the Keyword field. The docket number for the petition to reclassify is FDA-2010-P-0095-0001. The docket number for the petition regarding the press conference is FDA-2010-P-0093-0001.
I urge readers of this blog to follow the directions in the paragraph above and leave positive comments for both petitions. Lives are at stake.
Thursday, March 4, 2010
Wednesday, March 3, 2010
NRT versus Smoking Substitute
In response to pressure from many groups, the FDA wants to regulate electronic cigarettes as a drug-delivery device. This approach would remove the products from the market until (if ever) clinical trials proved them to be “safe and effective.”
In the FDA world, the disease being treated is nicotine dependence (305.1). One approach to treating that diagnosis is "nicotine reduction therapy" (NRT). The "R" is supposed to stand for "replacement", but there really is no intention of replacing the nicotine in sufficient quantities long-term in the same way that thyroxin or estrogen is replaced, so "reduction" is a more accurate word to use in the acronym NRT.
Currently available NRT products have worked for a number of people; but in the long-term, they don't work for 9 out of 10 people. It’s a positive thing that researchers are interested in studying the "e-cigarette" as a potential NRT. Quite a few e-cigarette users have reported that they have been able to titrate down to "no-nic" liquid with a great deal of ease. So perhaps the e-cigarette will prove to be as effective, or more effective, than other forms of NRT. But if e-cigarettes are required to parallel the design of other NRTs, the nicotine dosage would be reduced to well below the amount delivered by smoking. The products would also need to be accompanied by directions for reducing the amount used over time to zero.
That takes care of the smokers who want to be free of nicotine. But a goodly percentage of smokers are unable or unwilling to stop using nicotine, because nicotine is helping them to control cognitive deficits, mood impairments, chronic pain (e.g. fibromyalgia), chronic fatigue, and/or side effects of other medications. And until recently, the most effective way to take in sufficient nicotine to control these problems was by inhaling tobacco smoke.
What if it were possible to convince a large percentage of this latter group to substitute inhaling vaporized nicotine for inhaling combusted tobacco smoke? In this case we would not be "treating" the nicotine addiction, but rather would be removing several devastatingly harmful ingredients from the inhaled substance (i.e., tar, CO, particulates, heavy metals, thousands of toxins, and hundreds of carcinogens.) We would be allowing the product's users to regain or preserve their physical health without requiring them to sacrifice their cognitive and/or emotional health.
Well, it is possible. It is happening. Thousands of e-cigarette users are reporting improvements in their lung health and markers of cardiovascular health. Why in the world would anyone want to tell these former smokers: "Go back to smoking -- or switch to the NRT products that didn’t work for you before"?
The FDA does not need to be "in a pickle" about regulating e-cigarettes for safety or efficacy. If they don't work as substitute for smoking, consumers will just not use them. It's that simple. Efficacy problem solved.
The FDA already has the power to regulate e-cigarettes for safety. Judge Leon has ruled that e-cigarettes are a tobacco product. The law permits the FDA to regulate tobacco products. The FDA can require that labs that produce e-cigarette liquid conduct regular testing and post the results for public viewing. The FDA can specify the maximum allowable amounts of TSNAs. The FDA can require child-proof packaging. The FDA can require labels that provide complete information about ingredients and quantities.
In the FDA world, the disease being treated is nicotine dependence (305.1). One approach to treating that diagnosis is "nicotine reduction therapy" (NRT). The "R" is supposed to stand for "replacement", but there really is no intention of replacing the nicotine in sufficient quantities long-term in the same way that thyroxin or estrogen is replaced, so "reduction" is a more accurate word to use in the acronym NRT.
Currently available NRT products have worked for a number of people; but in the long-term, they don't work for 9 out of 10 people. It’s a positive thing that researchers are interested in studying the "e-cigarette" as a potential NRT. Quite a few e-cigarette users have reported that they have been able to titrate down to "no-nic" liquid with a great deal of ease. So perhaps the e-cigarette will prove to be as effective, or more effective, than other forms of NRT. But if e-cigarettes are required to parallel the design of other NRTs, the nicotine dosage would be reduced to well below the amount delivered by smoking. The products would also need to be accompanied by directions for reducing the amount used over time to zero.
That takes care of the smokers who want to be free of nicotine. But a goodly percentage of smokers are unable or unwilling to stop using nicotine, because nicotine is helping them to control cognitive deficits, mood impairments, chronic pain (e.g. fibromyalgia), chronic fatigue, and/or side effects of other medications. And until recently, the most effective way to take in sufficient nicotine to control these problems was by inhaling tobacco smoke.
What if it were possible to convince a large percentage of this latter group to substitute inhaling vaporized nicotine for inhaling combusted tobacco smoke? In this case we would not be "treating" the nicotine addiction, but rather would be removing several devastatingly harmful ingredients from the inhaled substance (i.e., tar, CO, particulates, heavy metals, thousands of toxins, and hundreds of carcinogens.) We would be allowing the product's users to regain or preserve their physical health without requiring them to sacrifice their cognitive and/or emotional health.
Well, it is possible. It is happening. Thousands of e-cigarette users are reporting improvements in their lung health and markers of cardiovascular health. Why in the world would anyone want to tell these former smokers: "Go back to smoking -- or switch to the NRT products that didn’t work for you before"?
The FDA does not need to be "in a pickle" about regulating e-cigarettes for safety or efficacy. If they don't work as substitute for smoking, consumers will just not use them. It's that simple. Efficacy problem solved.
The FDA already has the power to regulate e-cigarettes for safety. Judge Leon has ruled that e-cigarettes are a tobacco product. The law permits the FDA to regulate tobacco products. The FDA can require that labs that produce e-cigarette liquid conduct regular testing and post the results for public viewing. The FDA can specify the maximum allowable amounts of TSNAs. The FDA can require child-proof packaging. The FDA can require labels that provide complete information about ingredients and quantities.
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