AAPHP Petitions to FDA on E-Cigarettes

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.

University Health Coordinator Prefers Tobacco Cigarettes

Jennifer Gacutan-Galang, wellness and health promotion coordinator at the Health Center of San Jose State University, implies that tobacco cigarettes may not be as harmful and life-threatening as previously thought, because they deliver a predictable amount of nicotine. Spartan Daily, 2/23/10

Some students who are trying to quit smoking have switched to an electronic cigarette and have reduced their smoking from 1 pack a day to 1/2 pack. She said that, unlike tobacco cigarettes, the products are not FDA approved and might deliver more nicotine than traditional ones.

Actually, Health New Zealand researchers found that, per puff, electronic cigarettes deliver about 1/10 the amount of nicotine delivered by a tobacco cigarette. Recently, researchers at Virginia Commonwealth University tested levels of nicotine after 10 puffs on one of two brands of elecronic cigarettes and found no more nicotine than when subjects puffed on an unlit cigarette.

So Ms. Gacutan-Galang's fears of nicotine overdose are totally unfounded, not supported by any of the known facts.

At least she understands that there is no danger from second-hand smoke. "You're not burning them, so there is no secondhand smoke and this is what people get offended by," she said. "But they are still harming themselves."

In what way might students be harming themselves with nicotine? Tobacco smoke contains tar, carbon monoxide, particles of tobacco and paper ash, hundreds of carcinogens, and thousands of toxins. These products of tobacco combustion are known to cause lung disease, heart attacks, strokes, and many types of cancer.

Nicotine does not cause any of the "smoking-related" diseases. It raises heart rate temporarily--as does exercise. Nicotine does not impair judgment or performance.

How does nicotine affect health? It enhance the user's alertness, ability to concentrate, and short-term memory. Nicotine also can relieve depression and anxiety. Why would a university student consider these effects undesirable, much less unhealthy?

The most dangerous threat to the health of students at San Jose State University is getting bad advice from poorly informed health "experts."

Dr. Michael Siegel has commented on this situation in his blog: The Rest of the Story