Sunday, December 30, 2012
Thursday, December 20, 2012
|Dr. Konstantinos Farsalinos|
Dr. Konstantinos Farsalinos, research fellow at the Onassis Cardiac Surgery Center and his colleague, Dr. Giorgio Romagna, have prepared an extensive questionnaire for electronic cigarette users. The goal is to make the biggest ever survey on electronic cigarette users - more than 10,000 people - that will be published in a medical-epidemiological journal. The survey will cover major aspects on electronic cigarette use, address many of the common arguments made by those against e-cigs and could positively influence public health authorities.
The questionnaire will be released using Survey Monkey and be available in English, Greek, Italian and possibly French. The cost of the survey and data manipulation is expected to be approximately 15,000-20,000 euros (approx. $20,000 - $27,000), depending on the number of participants. CASAA will publish a link to the survey when it becomes available.
Additionally, Dr. Farsalinos recently announced that a case report he submitted for publication - of a patient with a rare clinical condition that was relieved by smoking cessation with the use of e-cigarettes - has been accepted for publication. Dr. Farsalinos wrote that the main conclusion of this case study is that, "despite the daily use of e-cig, you still obtain the health benefits of smoking cessation."
Those following electronic cigarette research may recall that Dr. Farsalinos and his team recently published the first clinical study of the acute effects of electronic cigarettes on cardiac function. They decided to compare their results with the acute effects of regular cigarettes on cardiac function since electronic cigarettes are marketed to smokers only, as an alternative habit. Researchers found that e-cigarettes appeared to cause no acute adverse effects on cardiac function during the study.
Tuesday, December 18, 2012
Silver Spring, MD, December 17, 2012 --
Yesterday, the FDA held a public hearing to obtain input on certain questions related to the implementation of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA). CASAA President Elaine Keller spoke on behalf of the organization. Also presenting before the FDA panel* as private citizens or as representatives of other organizations were CASAA's Legal Policy Director Gregory Conley, CASAA's Scientific Director Carl V Phillips, and CASAA advisor Bill Godshall.
|Dr. Carl Phillips, CASAA Science Director|
speaking at FDA hearing
While electronic cigarettes and low-risk, smoke-free tobacco products were not being considered at this hearing, CASAA supports the consideration of NRT for long-term use as a form of tobacco harm reduction (THR) for smokers who cannot or will not quit, rather than requiring the products to be used solely as tools for complete nicotine abstinence. It is CASAA's opinion that this could open the door for products such as electronic cigarettes and low-risk, smoke-free tobacco products to also be considered as THR products. Therefore, CASAA's presence at the hearing was to speak on behalf of tobacco harm reduction policies.
The topic of electronic cigarettes did arise several times and some known opponents of electronic cigarettes admitted that testimony given by electronic cigarette consumers was compelling and warranted future study. Surprisingly, most of the anti-tobacco speakers at the hearing seemed to agree with THR advocates that smoking cessation is a far more urgent goal than total nicotine abstinence.
"Risk needs to be assessed not in comparison to abstinence but in comparison to a percentage scale of harm impact," CASAA's Dr. Phillips told members of the FDA panel. "Smoke-free alternatives are far healthier. A lifetime of [smoke-free nicotine/tobacco] use is less harmful than a couple months of relapse smoking."
Written public comments will be accepted until January 16, 2013. If you would like to submit comments supporting tobacco harm reduction policies, you may find information on how to submit and what to say here: CASAA Call to Awareness - FDA Public Hearing on Nicotine Reduction Therapy Products
Recordings of yesterday's hearing may be watched using these links:
CASAA Media Contact
Elaine Keller, President
*FDA Panel: Grail Sipes, JD Senior Regulatory Counsel, Office of Regulatory Policy Center for Drug Evaluation and Research; Sandra Kweder, M.D., Deputy Director of FDA Office of New Drugs, Center for Drug Evaluation and Research; Christine Win, Acting Deputy Director of FDA Office of New Drugs, Center for Drug Evaluation and Research; Bob A. Rappaport, M.D., Director Division of Analgesics, Anesthetics, and Rheumatology Products, FDA’s Center for Drug Evaluation and Research; Dr. Celia Winchell, Team Leader with the Division of Anesthesia, Analgesia and Rheumatology; Andrea Leonard-Segal, M.D., Director, Division of Nonprescription Clinical Evaluation, Center for Drug Evaluation and Research; Corinne Huston, MSPH, M.D., Senior Medical Advisor in the Office of the Director, Center for Tobacco Products; and Eric Lindblom, J.D., Director, Office of Policy, FDA Center for Tobacco Products.
Wednesday, December 5, 2012
COVINGTON -- Commissioners on Tuesday unanimously approved a ban on use of all tobacco products in county parks, effective April 1.
#Recreation Commission Director Tommy Hailey said the purpose of the ban is to discourage youths from using tobacco and teach them the disadvantages of using.
#Attorneys with the state Department of Health have reviewed the ordinance and given their approval, Hailey said, meaning the county qualifies to apply for grants to fund signs and brochures to notify and educate the public on the ban.
During citizens' comments at the end of the meeting, which followed commissioners' vote, Julie Anderson, a member of CASAA, The Consumer Advocates for Smoke-free Alternatives Association, said it doesn't make sense to include smokeless tobacco and smoke-free products in the ordinance. Electronic cigarettes have not been shown to be a danger as far as secondhand smoke, she said. Anderson said she smoked two packs a day for 35 years and, "If it weren't for these I'd still be smoking, so it's important to get people to quit, but taking away an alternative for them that's not harmful for bystanders is sometimes, I think, shortsighted."
Read full story >
The Rest of the Story: Tobacco News Analysis and Commentary
by Dr. Michael Siegel, Boston University
|Dr. Michael Siegel|
(See: Cheah NP, et al. Electronic nicotine delivery systems: Regulatory and safety challenges: Singapore perspective. Tobacco Control 2012; doi: 10.1136/tobaccocontrol-2012-050483.)
The study examined 20 brands of electronic cigarettes, and analyzed the contents of their cartridges for nicotine, propylene glycol, glycerin, polycyclic aromatic hydrocarbons, and tobacco-specific nitrosamines.
The results were reported in the study abstract as follows: "Varying nicotine amounts were found in ENDS cartridges which were labelled with the same concentration. Chemicals such as PPG and glycerol were found to be present in the nicotine-containing liquid of the cartridges. ENDS varied in their contents and packaging information. Limited information was available on the contents of nicotine and other chemicals present in a variety of ENDS sampled."
The paper concludes as follows:
"While the current attention on traditional tobacco products is important, it is also necessary to focus on novelty products like ENDS, which may encourage maintenance of tobacco usage behaviour and slow down the impact of national smoking control programmes. Tobacco control policy makers and professionals are seriously urged to find ways to address the gap in the scientific understanding and the legal framework of such products, as this gap may impede efforts at curbing tobacco use."
The Rest of the Story
If you read the introduction, methods, and results of this study, and then proceed to the discussion, you will be shocked and you might think you are reading the discussion to a different study. This is because the discussion has very little relevance to the actual findings in the paper....READ MORE >>
Government funded anti tobacco extremists falsely claim products are target marketed to youth.
Please note that the groups lobbying for this law are funded by the Colorado Department of Public Health and Environment, which last year demonized and called for a ban on the sale of dissolvable smokefree tobacco products to adults (which they also falsely accused of being target marketed to children).
Most local tobacco retailer licensing laws/regulations require all tobacco products to be kept behind the counter, and some tobacco retail licensing laws prohibit use of the products in retail locations (not good news for an e-cig vendor).
And while I've advocated annual tobacco retailer license fees of $100-250 per licensee (to cover costs of enforcement), during the past several years some state/local tobacco retail licensing laws have imposed punitively high annual license fees because the politicians need government revenue and because they dislike tobacco products, companies and/or users (e.g. New York increased its annual tobacco retailer fee to several thousand dollars several years ago based upon overall store revenue, and then reduced it after many retailers justifiably protested).
Also, some recently enacted tobacco retailer licensing laws ban flavored tobacco products (Providence RI), have banned pharmacies from selling tobacco (e.g. Boston and many towns in MA), have limited the number of licenses (preventing new retailers from obtaining a license), prohbited licensees from being within several thousand feet from a school or playground, etc.
The article didn't indicate if Pueblo's health department wants to license e-cigarette vendors under an existing tobacco retailer licensing system or if they were planning a new licensing system just for e-cig vendors (which is much more problematic)
~ Bill Godshall, CASAA Advisor
Tuesday, December 4, 2012
To submit a comment electronically, on the page http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1148-0001, click the “Comment Now” button. Electronic or written comments will be accepted after the public hearing
If members plan to attend in person, CASAA requests that you first email your proposed presentation to firstname.lastname@example.org, so we may assist in the talking points and avoid duplication of our efforts. Once the FDA notifies registered presenters of their scheduled times, the FDA will require an electronic copy of your presentation be submitted by December 10, 2012.
- Did you ever try the nicotine patch, gum, lozenges, or inhalers?
- How did they work for you? Were you able to completely quit smoking, just to reduce how much you smoke, or did they not help at all?
- What do you see as some of the shortcomings of the products and how do you think the NRT products could be improved?
- What other ways did you try to control your smoking in the past?
- If you have quit smoking, what product made this possible? (Perhaps e-cigarettes?) What does this product (or the combination of products that you use) provide that NRTs did not?
- Providing smokers with low-risk alternative sources of nicotine works much better than requiring nicotine abstinence.
- Recommend removing barriers to using the products such as time limits on how long to use them, warnings about using more than one product at a time, and warnings against smoking while using an NRT.
- Point out that reducing the number of cigarettes smoked each day can be a stepping stone to quitting altogether.
- Point out that achieving freedom from inhaling smoke is much more important for health than concerns about addiction to nicotine.
- Recommend that the FDA educate the public about the relative safety of nicotine that comes from sources other than smoking.
- Recommend that the FDA consider promoting other innovative products that have helped smokers reduce their consumption of cigarettes and eventually stop smoking altogether.