The Arkansas Department of Health’s Position Statement on Electronic Cigarettes states, “The Arkansas Department of Health (ADH) is committed to disease prevention and control.” In the interests of disease prevention, the Consumer Advocates for Smoke-free Alternatives Association is pleased to provide you with more accurate information about electronic cigarettes (e-cigarettes.) CASAA is a non-profit organization that works to ensure the availability of reduced harm alternatives to smoking and to provide the public with truthful information about such alternatives.
CASAA estimates that over a million former smokers owe their smoke-free status to having switched to electronic cigarettes. All are enjoying the same type of health improvements reported by those who stopped smoking by using any other method. Yet, the Arkansas Department of Health opposes the sale of the products that have saved the health, and perhaps the very lives, of so many.
The inflammatory allegations in the FDA’s press release about their testing of e-cigarettes are not supported by the actual lab report posted on the FDA’s web site. The lab report reveals that the FDA found
tobacco-specific nitrosamines (TSNAs) and
tobacco-specific impurities “at very low levels” in the unvaporized liquid. Not mentioned is the fact that the same TSNAs are present in FDA-approved nicotine products at an equivalent amount (~8 ng). Also not mentioned is the fact that a pack of tobacco cigarettes contains over 100,000 ng of TSNAs. The 0.01 ml of diethylene glycol (DEG), mischaracterized as “antifreeze” in the press release, that the FDA measured in one of the cartridges is thousands of times below the toxic level. The FDA did not find any toxic quantities of chemicals in the vapor.
E-cigarettes are not intended to be a drug that treats nicotine addiction. Instead, they are proving to be an acceptable replacement for smoking on the part of long-term smokers who had almost given up all hope of ever becoming a former smoker. In case you are unfamiliar with the legal status of e-cigarettes in the United States, the U.S. Federal Court system has ruled that, in the absence of health claims, the FDA can only regulate e-cigarettes under the Family Smoking Prevention and Tobacco Control Act (FSPTCA). Because e-cigarettes were marketed prior to February 2007, no FDA approval is required under the law. However, the FDA can certainly work to ensure safety by establishing manufacturing standards and labeling requirements for the products under FSPTCA. The fact that the FDA so far has refused to do so does not change the fact that the products have an excellent safety record.
No product, whether FDA-approved or not, has ever been proven 100% safe. However, lacking the constituents that cause 99% of tobacco-related diseases, e-cigarettes are certainly safer than smoking. The FDA has failed to prove that the products pose “acute health risks.” The “potentially serious symptoms” reported by the FDA for e-cigarettes are no different from the symptoms reported by users of FDA-approved nicotine products such as the patch, gum, and lozenges. There have been no reports of serious injuries from e-cigarettes. In contrast, the FDA-approved smoking-cessation drug, Chantix, logged over 1,000 serious injury reports on MedWatch in one quarter alone. So it appears that FDA-approval under FDCA is no guarantee of product safety.
CASAA supports bans on sales to those under the legal age for smoking. CASAA all supports allowing indoor use of the products because they present no danger whatsoever to bystanders. Seeing them used indoors serves as a powerful incentive for continuing smokers to improve their own health by switching to a much less harmful alternative.
CASAA urges the Arkansas Department of Health to expand its study of e-cigarettes beyond the FDA’s press releases and consider the scientific evidence. The product description provided below is followed by a long list of resources that detail product safety and health effects.
There is no evidence that pubic health would be improved or protected by prohibiting the sale or use of e-cigarettes. All of the available scientific evidence points in the opposite direction.
Sincerely,
Elaine Keller, Vice President
The Consumer Advocates for Smoke-free Alternatives Association
CASAA | The Consumer Advocates for Smoke-Free Alternatives Association
What are Electronic Cigarettes?
E-cigarettes are battery operated devices that vaporize a liquid solution consisting of 89-90% propylene glycol, water, flavoring, and optionally a small amount of nicotine. E-cigarette use mimics smoking; but, there nothing is burned, so the user inhales vapor, not smoke.
What is their purpose?
Even after watching his father die of smoking-related lung cancer, Chinese pharmacist Hon Link was unable to stop smoking because he was dependent on the beneficial effects of nicotine. He knew the tar, carbon monoxide, particulates, and thousands of chemicals in smoke cause 99% of tobacco-related diseases. He invented the electronic cigarette as a safer way of delivering nicotine by eliminating exposure to the harmful elements in smoke. E-cigarettes are a replacement for smoking.
How well do they work?
Surveys show that between 31% and 82% of consumers are using electronic cigarettes as a complete replacement for smoked cigarettes. This compares quite favorably with the average 7% success rate of FDA-approved nicotine products.
Who uses electronic cigarettes?
Concerns that electronic cigarettes are marketed to children have proven unfounded. One survey found that 55% of users were between the ages of 31 and 50, and 32% were older than 50. All were previous smokers. Of the 90% who had tried to stop smoking before, 67% tried more than 4 times and 21% tried 10 times or more.
Why are flavors offered?
Most consumers initially choose a tobacco-like flavor when they first begin using an e-cigarette. However, within a short time, they begin to find the taste of tobacco unpalatable. This factor may explain why so many e-cigarette users report that they have lost all urges to smoke. Only 16.7% of regular users report that they have never tried a fruit, beverage and/or candy flavored liquid. Only 0.1% state they were drawn to e-cigarettes due to the tasty flavors available.
Is there second-hand vapor that might be harmful to bystanders?
The e-cigarette generates no side-stream smoke from its tip. The exhaled vapor of the e-cigarette is composed of propylene glycol, and contains almost no nicotine; and no carbon monoxide. Dr. Murray Laugesen of Health New Zealand tested one brand of e-cigarettes for over 50 smoke toxicants and none were found. Dr. Laugesen stated, “Lacking any active ingredient or any gaseous products of combustion, the PG mist or ‘smoke’ is not harmful to bystanders.”
Are e-cigarettes approved by the FDA?
In April 2009, Smoking Everywhere filed suit against the FDA seeking an injunction against FDA product seizures. Sottera, Inc. (dba NJOY) joined as an intervener plaintiff. In July 2009, the FDA held a press conference to announce results of testing the products of the two plaintiffs. The FDA used partial truths and inflammatory language to falsely portray electronic cigarettes as being more dangerous than tobacco cigarette smoking.
The FDA’s press release stated that the electronic cigarettes it tested contained “carcinogens.” But the FDA did not mention that the 8 nanograms of Tobacco-specific nitrosamines (TSNAs) detected in the “high” cartridges are no more likely to be carcinogenic than the 8 nanograms of TSNAs in an FDA-approved nicotine patch. The FDA also failed to point out that the 0.01 ml of diethylene glycol (DEG) found in one of the 18 cartridges is thousands of times below the toxic level. The FDA’s press release described DEG as “an ingredient in antifreeze,” presumably because antifreeze is more likely to evoke feelings of fear than some of the more common uses of the chemical such as solvent, lubricant, or humectant. No DEG was found in the vapor of the cartridges tested by FDA, and no other lab has ever detected DEG in e-cigarettes.
In the case of Smoking Everywhere and Sottera (dba NJOY) versus the U.S. Food and Drug Administration, both the lower court and the U.S. District Court of Appeals for the District of Columbia have issued opinions that, as long as vendors make no claims that electronic cigarettes can cure or treat a disease, the FDA cannot regulate the products as a drug or drug-delivery device combination under the Food, Drug, and Cosmetics Act.
http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf
http://www.casaa.org/files/ct app opinion on injunction.pdf
Are Electronic Cigarettes Harmful?
The Honorable Richard J. Leon, of the U.S. District Court for the District of Columbia stated that the FDA failed to provide any evidence that the products have harmed anyone. Since that opinion was issued, millions more of the products have been sold; and to date there have been zero reports of any serious adverse event. Side effects reported are no different from those reported with use of FDA-approved nicotine products. Over 90% are reporting health improvements citing improved breathing, less coughing, and better fitness.
Questions have been raised that e-cigarettes might increase nicotine addiction. Dr. Laugesen’s testing determined that each puff of vapor delivers only 10% of the nicotine delivered in a puff of smoke, and this has been verified in clinical trials.
Dr. Michael Siegel Dr. Michael Siegel of Boston University School of Public Health reviewed the available evidence on the safety and effectiveness of e-cigarettes—including the testing conducted by the FDA—and concluded, “A preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products.”
Journal of Public Health Policy - Electronic cigarettes as a harm reduction strategy for tobacco control: A step forward or a repeat of past mistakes[quest]
Additional information
Harm Reduction:
Casaa.org - Harm Reduction
Journal Articles:
CASAA.org
Lab Reports on E-cigarettes:
CASAA.org
Sources
Bullen, C., McRobbie, H., Thornley, S., Glover, M., Lin, R., & Laugesen, M. (2010). Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tobacco Control. 2010 Apr;19(2):98-103.
Effect of an electronic nicotine delivery device (... [Tob Control. 2010] - PubMed result
Cahn, Z., & Siegel, M. (2010). Electronic cigarettes as a harm reduction strategy for tobacco control: A step forward or a repeat of past mistakes? Journal of Public Health Policy 32: 16-31.
Palgrave Macmillan Journals
Consumer Advocates for Smoke-free Alternatives Association (2011) CASAA Position Statement on Electronic Cigarettes.
http://www.casaa.org/files/Casaa Position Statement.pdf
Etter, JF. (2010) Electronic cigarettes: a survey of users. BMC Public Health. 2010; 10: 231.
Electronic cigarettes: a survey of users
Garland, Kavanaugh, & Williams. United States Court of Appeals for the District of Columbia Circuit. Case: 10-5032 Document: 1281606 Filed: 12/07/2010.
http://www.casaa.org/files/ct app opinion on injunction.pdf
Health Canada. (2010). Diethylene glycol; classification with respect to acute toxicity. Date Modified: 2010-09-21.
Diethylene glycol; classification with respect to acute toxicity - Workplace Hazardous Materials Information System - Health Canada
Heavner, K., Dunworth, J., Bergen, P., Nissen ,C., & Phillips, CV. (11/26/2009) Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of e-cigarette users. Tobacco Harm Reduction 2010 Yearbook, Chapter 19.
THR2010. (tobaccoharmreduction.org)
Laugesen, M. (2008). Safety Report on the Ruyan® e-cigarette Cartridge and Inhaled Aerosol. Health New Zealand.
http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
Laugesen, M. (2009). Ruyan® E-cigarette Bench-top tests. Poster 5-11 at Society for Research on Nicotine and Tobacco (SRNT) Dublin, Updated 07 May, 2009.
http://www.healthnz.co.nz/DublinEcigBenchtopHandout.pdf
Leon, RJ. United States District Court for the District of Columbia. Order, Civil Case No. 09-771 (RJL). Filed 01/14/2010.
http://www.casaa.org/files/SE-vs-FDA-Ruling.pdf
Siegel, M. Letter to Members of the Health Committee of the New York State Assembly regarding Assembly Bill A01468 (01/23/2011).
http://www.casaa.org/files/MSietel-NYA01468 letter.doc
Trtchounian A., Williams M., & Talbot, P. (July 19, 2010) Conventional and electronic cigarettes (e-cigarettes) have different smoking characteristics. Nicotine & Tobacco Research Advance Access. Doi:10.1093/ntr/ntq114
U.S. Food and Drug Administration. (5/4//09). Final Report: Evaluation of e-cigarettes.
http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf
. Makes one proud to be associated with them. NOT!!!
