M.O.V.E. – Medical Organizations supporting Vaping & Electronic cigarettes

Standard

move-logo-f

CALL FOR DOCTORS, HEALTH CARE PROFESSIONALS AND SCIENTISTS IN SUPPORT OF ELECTRONIC CIGARETTES.
 
As physicians and health professionals we see everyday patients who are severely affected by tobacco smoking, many of whom will eventually die or have their health severely affected despite our help and advice. Tobacco smoking remains the most serious public health issue in the world.
People smoke for the nicotine but die from the chemicals produced when tobacco is burned.i Unfortunately, currently available smoking cessation medications have limited efficacy and acceptability for the majority of smokers. However, we believe that there is a solution: the use of electronic cigarettes clearly has huge potential to help many smokers turn their backs on tobacco.
To this end, we strongly believe that ethically and scientifically speaking it is our responsibility to draw attention to the following:
  • It is the combustion of tobacco and the 4000 chemical substances that are produced when smoking cigarettes that are harmful to health of smokers, not the nicotine.
  • The dangers of electronic cigarettes are considerably lower than those of tobacco. From analysis of the constituents of e-cigarette vapour, e-cigarettes can be expected to be at least 95 to 99% safer than smoking tobacco cigarettes in terms of long-term health risks.ii
  • The vapour exhaled from e-cigarette users is highly unlikely to be harmful to bystanders; nicotine concentrations in exhaled vapour are too low to have pharmacological effects on bystanders.iii
  • Randomised controlled trials show that e-cigarettes are effective in smoking cessationiv and studies of the use of e-cigarettes in real world settings show that they are more effective than other means for stopping smoking including Nicotine Replacement Therapy.v
  • It is estimated that for every one million people who switch from smoking to electronic cigarettes, some 6000 premature deaths a year would be averted.vi
E-cigarettes do not ‘renormalise smoking’ – ‘vaping’ is not smoking.  In many countries the rise in e-cigarette use has been accompanied by a continued decline in tobacco sales and prevalence of smoking.vii
The characteristics of electronic cigarettes should always be compared to those of conventional cigarettes, and discussion about the absolute long-term safety of electronic cigarettes must be contrasted ethically and scientifically with the absolute certainty of the harmfulness of smoked tobacco.
Already estimated 29m consumers in Europe use e-cigarettes.viii But we believe that the individual and public health gains associated with electronic cigarette use are held back by misconceptions about the product.
In light of the numerous studies undertaken to date we – as health professionals – cannot remain passive in the face of the clear public health benefits of electronic cigarettes.
We therefore recommend that our colleagues actively learn more about electronic cigarettes as a new public health tool in the ongoing global health campaign against tobacco-related diseases.
We call on our colleagues to sign this declaration in support of the merits of electronic cigarettes based on scientific evidence and ethical debate.
Yours faithfully,
Group of professionals who support this statement.
If  you  agree  with  the  M.O.V.E  statement  please  click  on  the  image  below  to  add  your  support.

i Russell, M. A. Low-tar medium-nicotine cigarettes: a new approach to safer smoking (1976) BMJ  1 (6023) 1430-1433

ii Farsalinos, K. E., & Polosa, R. (2014). Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review. Therapeutic Advances in Drug Safety, 5(2), 67–86. doi:10.1177/2042098614524430

iii Hajek P, Etter J-F, Benowitz N, McRobbie H (2014) Electronic cigarettes: review of use, content, safety, effects on smokers, and potential for harm and benefit. Addiction.

iv McRobbie, H., Bullen, C., Hartmann-Boyce, J., & Hajek, P. (2014). Electronic cigarettes for smoking cessation and reduction. The Cochrane Database of Systematic Reviews, 12, CD010216. doi:10.1002/14651858.CD010216.pub2

v Brown, J. et al (2014).  Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study. Addiction doi:10.1111/add.12623

vi West, R. B. J. (2014). Electronic cigarettes : fact and fiction. British Journal of General Practice, (September), 442–443.doi:10.3399/bjgp14X681253

vii West R, Brown J, Beard E. Trends in electronic cigarette use in England. Smoking Toolkit Study 140122. 2014.www.smokinginengland.info/latest-statistics

viii Vardavas, C.et al (2014). Determinants and prevalence of e-cigarette use throughout the  European Union: a secondary analysis of 26 566 youth and adults from 27 Countries.  Tobacco Control, 1–7. doi:10.1136/tobaccocontrol-2013-051394

As seen here:

https://sciencecig.wordpress.com/move/

Benefits of E-Cigarettes May Outweigh Harms: Study Findings run counter to recent calls for strict regulation

Standard

By Steven Reinberg

HealthDay Reporter

WEDNESDAY, July 30, 2014 (HealthDay News) — Strict regulation of electronic cigarettes isn’t warranted based on current evidence, a team of researchers says.

On the contrary, allowing e-cigarettes to compete with regular cigarettes might cut tobacco-related deaths and illness, the researchers concluded after reviewing 81 prior studies on the use and safety of the nicotine-emitting devices.

“Current evidence suggests that there is a potential for smokers to reduce their health risks if electronic cigarettes are used in place of tobacco cigarettes and are considered a step toward ending all tobacco and nicotine use,” said study researcher Thomas Eissenberg, co-director of the Center for the Study of Tobacco Products at Virginia Commonwealth University in Richmond.

The study, partly funded by the U.S. National Institutes of Health, was published July 30 in the journal Addiction.

Whether e-cigarettes should be regulated, and how strictly, is being debated by regulatory agencies around the world. Several medical organizations have called for restrictions on use of the increasingly popular devices.

Although long-term risks of e-cigarettes remain unknown, the new study concluded the benefits of e-cigarettes as a no-smoking aid outweigh potential harms.

“If there are any risks, these will be many times lower than the risks of smoking tobacco,” said senior author Dr. Hayden McRobbie, from the Wolfson Institute of Preventive Medicine at Queen Mary University of London.

“We need to think carefully about how these products are regulated,” he said. “What we found is that there is no evidence that these products should be regulated as strictly as tobacco, or even more strictly than tobacco.”

No evidence has shown that the vapor produced by e-cigarettes is harmful to users or bystanders in contrast to cigarette smoke, he added. It’s not the nicotine in cigarettes that kills people, he said. (Nicotine is the addictive agent in cigarettes).

“Use of e-cigarettes by people who don’t smoke is very rare,” McRobbie said. Furthermore, there is no evidence to support arguments that e-cigarettes are a gateway to smoking tobacco, he added.

“There is evidence that e-cigarettes enable some users to quit smoking or reduce their consumption,” McRobbie said. “If there is evidence that e-cigarettes reduce smoking-related harm, then they need to be easily obtainable and not regulated more strongly than tobacco products.”

Dr. Norman Edelman, a senior medical consultant for the American Lung Association, disagrees. The U.S. Food and Drug Administration should have authority over all tobacco products and e-cigarettes, said Edelman, a professor of medicine and physiology and biophysics at the State University of New York at Stony Brook.

“It is imperative that the FDA finalize proposed e-cigarette regulations by the end of 2014,” he said. “The FDA needs to crack down on quit-smoking and other health claims that e-cigarette companies are making,” Edelman said.

Edelman said it’s too soon to know if e-cigarettes will cause long-term damage. “So far there hasn’t been very much chronic use of e-cigarettes. So it’s not possible to say there will be no harm,” he said.

“Since we are talking about a recreational drug — it’s not essential to life, it doesn’t cure any illness — it would only make sense to regulate it rigorously until we find out whether it’s good or bad,” Edelman said.

Earlier this month, the Forum of International Respiratory Societies, which includes more than 70,000 members worldwide, urged governments to ban or limit e-cigarettes until more is known about their health effects.

And this month, the American Medical Association requested tighter restrictions on the sale and marketing of e-cigarettes.

The AMA’s recommendations include a minimum age of purchase; childproof packaging; restrictions on flavors that appeal to young people, and a ban on unsupported claims that the devices help people quit smoking.

Preventing the marketing of e-cigarettes to minors is another priority, the medical association says.

27 Effects of Smoking on the Body…

Standard

The Effects of Smoking on the Body

Tobacco smoke is enormously harmful to your health. There’s no safe way to smoke. Replacing your cigarette with a cigar, pipe, or hookah won’t help you avoid the health risks associated with tobacco products.

Cigarettes contain about 600 ingredients. When they burn, they generate more than 7,000 chemicals, according to the American Lung Association. Many of those chemicals are poisonous and at least 69 of them can cause cancer. Many of the same ingredients are found in cigars and in tobacco used in pipes and hookahs. According to the National Cancer Institute, cigars have a higher level of carcinogens, toxins, and tar than cigarettes.

When using a hookah pipe, you’re likely to inhale more smoke than you would from a cigarette. Hookah smoke has many toxic compounds and exposes you to more carbon monoxide than cigarettes do. Hookahs also produce more secondhand smoke.

In the United States, the mortality rate for smokers is three times that of people who never smoked, according to the Centers for Disease Control and Prevention. It’s one of the leading causes of preventable death.

Central Nervous System

One of the ingredients in tobacco is a mood-altering drug called nicotine. Nicotine reaches your brain in mere seconds. It’s a central nervous system stimulant, so it makes you feel more energized for a little while. As that effect subsides, you feel tired and crave more. Nicotine is habit forming.

Smoking increases risk of macular degeneration, cataracts, and poor eyesight. It can also weaken your sense of taste and sense of smell, so food may become less enjoyable.

Your body has a stress hormone called corticosterone, which lowers the effects of nicotine. If you’re under a lot of stress, you’ll need more nicotine to get the same effect.

Physical withdrawal from smoking can impair your cognitive functioning and make you feel anxious, irritated, and depressed. Withdrawal can also cause headaches and sleep problems.

Respiratory System

When you inhale smoke, you’re taking in substances that can damage your lungs. Over time, your lungs lose their ability to filter harmful chemicals. Coughing can’t clear out the toxins sufficiently, so these toxins get trapped in the lungs. Smokers have a higher risk of respiratory infections, colds, and flu.

In a condition called emphysema, the air sacs in your lungs are destroyed. In chronic bronchitis, the lining of the tubes of the lungs becomes inflamed. Over time, smokers are at increased risk of developing these forms of chronic obstructive pulmonary disease (COPD). Long-term smokers are also at increased risk of lung cancer.

Withdrawal from tobacco products can cause temporary congestion and respiratory pain as your lungs begin to clear out.

Children whose parents smoke are more prone to coughing, wheezing, and asthma attacks than children whose parents don’t. They also tend to have more ear infections. Children of smokers have higher rates of pneumonia and bronchitis.

Cardiovascular System

Smoking damages your entire cardiovascular system. When nicotine hits your body, it gives your blood sugar a boost. After a short time, you’re left feeling tired and craving more. Nicotine causes blood vessels to tighten, which restricts the flow of blood (peripheral artery disease). Smoking lowers good cholesterol levels and raises blood pressure, which can result in stretching of the arteries and a buildup of bad cholesterol (atherosclerosis). Smoking raises the risk of forming blood clots.

Blood clots and weakened blood vessels in the brain increase a smoker’s risk of stroke. Smokers who have heart bypass surgery are at increased risk of recurrent coronary heart disease. In the long term, smokers are at greater risk of blood cancer (leukemia).

There’s a risk to nonsmokers, too. Breathing secondhand smoke has an immediate effect on the cardiovascular system. Exposure to secondhand smoke increases your risk of stroke, heart attack, and coronary heart disease.

Skin, Hair, and Nails (Integumentary System)

Some of the more obvious signs of smoking involve the skin. The substances in tobacco smoke actually change the structure of your skin. Smoking causes skin discoloration, wrinkles, and premature aging. Your fingernails and the skin on your fingers may have yellow staining from holding cigarettes. Smokers usually develop yellow or brown stains on their teeth. Hair holds on to the smell of tobacco long after you put your cigarette out. It even clings to nonsmokers.

Digestive System

Smokers are at great risk of developing oral problems. Tobacco use can cause gum inflammation (gingivitis) or infection (periodontitis). These problems can lead to tooth decay, tooth loss, and bad breath.

Smoking also increases risk of cancer of the mouth, throat, larynx, and esophagus. Smokers have higher rates of kidney cancer and pancreatic cancer. Even cigar smokers who don’t inhale are at increased risk of mouth cancer.

Smoking also has an effect on insulin, making it more likely that you’ll develop insulin resistance. That puts you at increased risk of type 2 diabetes. When it comes to diabetes, smokers tend to develop complications at a faster rate than nonsmokers.

Smoking also depresses appetite, so you may not be getting all the nutrients your body needs. Withdrawal from tobacco products can cause nausea.

Sexuality and Reproductive System

Restricted blood flow can affect a man’s ability to get an erection. Both men and women who smoke may have difficulty achieving orgasm and are at higher risk of infertility. Women who smoke may experience menopause at an earlier age than nonsmoking women. Smoking increases a woman’s risk of cervical cancer.

Smokers experience more complications of pregnancy, including miscarriage, problems with the placenta, and premature delivery.

Pregnant mothers who are exposed to secondhand smoke are also more likely to have a baby with low birth weight. Babies born to mothers who smoke while pregnant are at greater risk of low birth weight, birth defects, and sudden infant death syndrome (SIDS). Newborns who breathe secondhand smoke suffer more ear infections and asthma attacks.

– Interactive Infographic: http://www.healthline.com/health/smoking/effects-on-body

– See more at: http://www.healthline.com/health/smoking/effects-on-body#sthash.8Uc8Bk18.dpuf

World Health Organization needs to see e-cigarettes as part of the solution, not the problem, say leading specialists in nicotine science and public health…

Standard

Over 50 leading scientists from 15 countries have written to Margaret Chan Director-General of the World Health Organization to ask WHO reconsider its intention to classify e-cigarettes the same as regular cigarettes, warning that they risk missing an opportunity to drastically reduce smoking and the illness and death associated with it.

Ahead of the WHO sponsored Framework Convention on Tobacco Control (FCTC) meeting in Moscow this October, the scientists have reacted to a leaked document from a FCTC preparatory meeting indicating that the WHO considers e-cigarettes a “threat” to public health and intends to sideline their use as an accessible alternative to regular tobacco and cigarettes. Snus is already included in the FCTC.

In their letter to WHO Director-General Margaret Chan, the 53 signatories argue that tobacco harm reduction products could play a significant role in meeting the 2025 UN objectives to reduce non-communicable diseases. E-cigarettes and other safer nicotine products are part of the solution, not part of the problem, they say.

At issue is that the FCTC does not differentiate between the risks of different nicotine products. Applying FCTC measures to e-cigarettes would treat them the same as other tobacco products such as tobacco cigarettes and introduce bans on advertising, include them in smoke-free legislation, apply high taxes and large health warnings – all of which will be aimed to reduce their availability, attractiveness and acceptability.

The signatories warn that excessive restrictions on lower risk products will have the unintended consequence of protecting cigarettes from competition from less hazardous alternatives. “If the WHO gets its way and extinguishes e-cigarettes, it will not only have passed up what is clearly one of the biggest public health innovations of the last three decades that could potentially save millions of lives, but it will have abrogated its own responsibility under its own charter to empower consumers to take control of their own health, something which they are already doing themselves in their millions” said Professor Gerry Stimson, Emeritus Professor at the Imperial College in London, a signatory to the letter, and organiser of the upcoming Global Forum on Nicotine.

Globally 1.3 billion people smoke and the WHO estimates that up to one billion tobacco-related premature deaths are possible in the 21st Century – all totally preventable.

Tobacco control policy over the past three decades has successfully communicated the harms associated with smoking, encouraged measures to reduce smoking, and drastically cut smoking in some parts of the world – mainly developed countries (but at the same time that smoking is still increasing in many parts of the developing world).

After a decade of international tobacco control based on restricting and banning products it may be hard for WHO and public health leaders to change their mindsets and see the potential of safer nicotine products to help people shift from smoking: but this is what is needed.

The letter argues that WHO and FCTC must recognise that tobacco products are not all the same with regard to risk. They should recognise the significant reductions in death and disease that are achieved when smokers switch to lower risk nicotine products.

“For the WHO to suggest that e-cigarettes are as risky as other tobacco products would send an erroneous and bleak message to the millions of current e-cigarette users who have used them to quit smoking,” said Robert West, also a signatory to the letter and Professor of Health Psychology and Director of Tobacco Studies at University College in London. “It would discourage smokers from trying them and we would miss out on a major opportunity to reduce smoke related deaths globally.”

Scientists have known for some years that people ‘smoke for the nicotine, but die from the smoke’. The death and disease from smoking arises from the inhalation of tar particles and toxic gases drawn into the lungs.

The signatories to the letter strongly believe that tobacco harm reduction tools such as e-cigarettes, and other less harmful products such as snus, could be the solution. People who currently smoke will do much less harm to their health if they consume nicotine in low-risk, non-combustible form.

“E-cigarette use has been a consumer led revolution and grown as a bottom-up public health initiative that could save millions of lives”, said John Britton, Professor of Epidemiology at the University of Nottingham, UK. “It has moved at a speed that shows just how much smokers want and will choose nicotine products that don’t kill. I hope the WHO and all public health decision makers can recognise and harness the health opportunities that e-cigarettes can provide.”

The signatories argue that the WHO`s targets for reduction of tobacco consumption should be aligned with the ultimate goal of reducing disease and premature death. It is counterproductive to include the reduction of low-risk nicotine products, such as e-cigarettes, within these targets – as WHO has proposed – instead these products should have an important role in meeting the targets.

Links

  1. Letter to Dr Margaret Chan: ‘Reducing the toll of death and disease from tobacco – tobacco harm reduction and the Framework Convention on Tobacco Control’
  2. FCTC Bureau meeting minutes: ‘Draft summary record of the second meeting of the fifth Bureau of the Conference of Parties to the WHO FCTC Geneva, 13-14 November 2013’
  3. Media release: ‘World Health Organization must not extinguish e-cigarettes, say leading scientists’
  4. Commentary on WHO position: http://www.clivebates.com/?p=2011
  5. List of signatories and transparency declarations.

Note

The Framework Convention of Tobacco Control was agreed in 2003 and sets out a framework for controlling and reducing tobacco consumption. With the notable exception of the United States, most countries (178) are parties to the convention. The sixth session of the Conference of the Parties is due to be held in Moscow from 13-18 October http://www.who.int/fctc/en/

 

As seen on; http://nicotinepolicy.net/n-s-p/1753-who-needs-to-see-ecigs-as-part-of-a-solution

SUPPORT YOUR COMMUNITY!! Three Reasons Main Street Independent Businesses are the Backbone of your Community…

Standard

As part of the month-long celebration of  National Preservation Month and its theme  “New Age of Preservation: Embark, Inspire, Engage,” it’s important to take a look and the role and impact of independent businesses in preserving the places that house the vast majority of historic buildings:  our downtowns, village centers, and neighborhood commercial corridors.

To put it simply:  Independent businesses have been and are the backbone of historic communities and downtowns, thereby preserving the buildings, character, culture, and fabric of the community.  There are three main reasons why:

1) They are the trailblazers:  Our indies are typically the first ones to go into a historic mixed-use commercial district, supplying rent to the property owner, a reason to go to that district to the public, and ultimately taxes to the local community.  By running businesses in historic buildings, indies give economic value to that property, enabling it to be maintained for the present and future generations.

2) They are part of the story:   Independents bring authenticity to the community table.  They may be quirky, crabby, creative and/or chaotic, but they are real.  Indies foster a unique vibe for the community they inhabit; they are run by characters that add character to their place.  These businesses, already invested in and committed to that place, are also the first to support local causes and events, giving of themselves while enriching the community at large.

3) RecycleRe-use. Repeat. Local independent businesses cycle so much more of their income in the community where they are located.  They are more likely to source locally and work together within their district.  There is plenty of researched data on this (for example – herehere, and here.)  But then there are the stories – about the business owner in a small Kentucky community who paid his employees with $2 bills one payday, and still found them circulating around town months after the fact.  Keeping money local longer is a crucial benefit that strengthens our communities.

Westfield, NJ Main Street

Anna Mastroianni, owner of the SOLE shoe store in Westfield, NJ, a Great American Main Street Award winner (2004) notes that as an independent business owner “you get to know and be part of the character of the town and bring to it what you know it will appreciate. To us it’s like having the opportunity to take care of our family, which the Main Street community has become.”  And by running a successful business at 201 East Broad Street, SOLE has supported the upkeep and vitality of the landmark historic building where it is located.

In Main Street New Jersey lingo, independents are crucial to growing a community’s economic, physical, social, and civic value.  They are what makes a place be not just any place, and by doing so have, either knowingly or unknowingly, saved countless historic buildings.  Moving forward, we could just as well say:  Preserve historic buildings – Support independent businesses!

About the Author

Jef Buehler has been with Main Street New Jersey and Improvement District Programs since 1996.  He created the NJ350 Pop-Up Store Program, a first-of-its kind statewide temporary retail outlet program that covers 12 months and over 1,000 miles across NJ. He’s considered an entrepreneurial thought leader in the downtown revitalization and management field, but more importantly, he gets things done in support of authentic place-based economic growth, one community at a time.

The FDA and Electronic Cigarettes, a Timeline… by Steve k.

Standard

ImageThe Food and Drug Administration and electronic cigarettes have a pretty long and storied history.  I’ve commented about the FDA and its attempts to ban and demonize ecigs pretty extensively.  I’ve realized perhaps not everyone is intimate with the rocky road we’ve been down. I thought perhaps a little perspective on how things have progressed so far might shed some light and provide a little context for many of the things discussed in the community.

To that end, I’ve put together a little timeline of how things have progressed with the FDA up to this point.

2007

Electronic cigarettes begin to make their way to the United States after experiencing some popularity in Europe.

2008

August 2008 GreenCig, a Chinese manufacturer registers their product with the FDA.  According to this post on the ECF, the company classified their device as a nasal inhaler. There was a great deal of debate on the forum as what that meant, and even what types of nicotine was FDA Approved.

September 2008 The World Health Organization issues a press release for e-cigarette companies to stop making health claims about e-cigarettes being an effective smoking cessation therapy.  The WHO states that “WHO has no scientific evidence to confirm the product’s safety and efficacy.”  The release also notes that some marketers claimed the devices had the approval of the organization.

November 2008 GreenCig’s application for approval of its electronic cigarette is rejected by the FDA. The FDA cited the application as a new drug submitted without study data.

2009

Early 2009 FDA begins seizing electronic cigarette shipments as they enter the country via China.  The agency cites the Food Drug and Cosmetics Act as grounds for seizing the devices as incorrectly labeled medication and delivery devices.

March 2009 A group of Senators headed by Senator Lautenberg of New Jersey urge the FDA to crack down on electronic cigarettes (despite the fact that the FDA was already seizing shipments by this point). Several bloggers pointed out that the senator received significant funding from the pharmaceutical industry.

April 2009 e-Cigarette Company Smoking Everywhere files a lawsuit in federal court to stop the FDA seizure of electronic cigarettes. The company’s primary argument is that electronic cigarettes are a cigarette product and not medical devices.

April 2009 The FDA releases its lab report on electronic cigarettes.  This report will be the basis for the future FDA press release attacking electronic cigarettes.

May 2009 nJoy joins Smoking Everywhere’s suit against the FDA.  nJoy made no health claims in its marketing material, which appeared to be the FDA’s basis for seizing shipments.

June 2009 President Obama signs the Family Smoking Prevention and Tobacco Control Act into law. The law gives the FDA jurisdiction over tobacco products. See the FDA’s Infographic for more detail on what the act entails.

July 2009 The FDA releases their infamous press release making a number of negative claims about electronic cigarettes based on limited testing of cartridges from Smoking Everywhere and nJoy (the two companies suing the agency). The claims included:

  • e-Cigarettes were marketed directly to young people
  • diethylene glycol (used in antifreeze) found in one cartridge
  • Samples contained carcinogens
  • Samples contained toxic chemicals
  • The original press release didn’t mention varying nicotine levels, that appears to have come later

July 2009 NJoy publishes an analysis of the FDA’s lab report (edit: original link is dead, here is a copy of a cached version) citing a number of deficiencies in the report. Among the findings:

  • Lack of standard protocols
  • No comparison to nitrosamines in nicotine replacement products
  • Many substances mentioned were below normally detectable quantities
  • Many impurities were present but less than found in the Nicotrol inhaler
  • Nicotine levels in the control device (inhaler) were not published
  • No study of the vapor was conducted.

August 2009 Tobacco Control advocacy group Action on Smoking and Health (ASH) files an Amicus brief in the Smoking Everywhere lawsuit in support of the FDA.

September 2009 An ad-hoc group of e-cigarette proponents, the Alliance of Electronic Smokers filed an Amicus brief in favor of the e-cigarette companies and disputing the ASH brief.

2010

January 2010 The FDA is ordered to stop blocking imports of electronic cigarettes by Federal District Judge Richard Leon. Judge Leon noted that the FDA could use its newly granted tobacco regulation powers to deal with electronic cigarettes according to an article in the New York Times.

February 2010 The FDA wins a temporary stay of the injunction issued in January pending a review by the appeals board. The FDA is free to continue blocking shipments.

April 2010 A group of of public health organizations including he American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Legacy Foundation, the American Lung Association, the American Medical Association, the Campaign for Tobacco-Free Kids, and Public Citizen file an Amicus brief in support of the FDA’s actions.

June 2010 Smoking Everywhere drops out of the court case. At the time, there were questions surrounding the company’s ability to survive amidst the legal fees and impact to its business caused by the seizures.

June 2010 nJoy files a brief appealing the stay on the basis of adverse impact on its ability to conduct business in addition to the FDA’s inability to demonstrate harm from electronic cigarettes.

July 2010 Another Amicus brief is filed in support of the FDA by health advocacy groups.

September 2010 The FDA sends a warning letter to five e-cigarette companies: E-CigaretteDirect (not the UK vendor), Ruyan, Gamucci, E-Cig Technology and Johnson Creek.  The letter states that the agency intended to regulate the products under the Federal Food, Drug and Cosmetic Act and their products were not in compliance.

September 2010 The Federal Appeals Court hears arguments concerning the stay of the injunction in the nJoy V FDA case.

September 2010 (Side Note) The New York Times publishes a piece that the FDA caved to political pressure from Senator Lautenberg and others to approve a knee replacement device that the agency had previously denied approval.  Clearly not e-cigarette related, but I thought I would just leave that here.

December 2010 The Federal Appeals court rules in favor of nJoy and reinstates the injunction against electronic cigarette seizures. Judge Leon advises the agency to use the Tobacco Control act to regulate e-cigarettes. The FDA must decide if it wishes to take its case to the Supreme Court.

2011

Janurary – March 2011 Various vendors report in online forums and blogs that the FDA is continuing to stop electronic cigarette shipments into the country in defiance of the court order from December, 2010.

February 2011 Totally Wicked sues the FDA over shipment seizures in the wake of the previous court ruling.

April 2011 The FDA announces it will not appeal the decision in the nJoy case. The FDA finally stops intercepting e-cigarette shipments. The agency announces it will pursue e-cigarette regulation under the Tobacco Control Act. In its letter, the FDA announces that intends to leverage the following steps to regulate the devices under the Act:

  • The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act.   The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
  • The Sottera decision states that products made or derived from tobacco  can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices.  The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.
  • Section 201(rr)(4) of the Tobacco Control Act prohibits the marketing of “tobacco products” in combination with other FDA-regulated products. As mentioned, FDA has already issued a draft guidance on this provision, which it intends to finalize.
  • “Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.”  A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent.   FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”

May 2011 Totally Wicked voluntarily drops its suit against the FDA in light of the announcement and the FDA’s stopping seizures.

July 2011 The FDA announces its intent to have draft regulations concerning other tobacco products (including e-cigarettes) by October.

October 2011 A group of Senators led again by Senator Lautenberg send a letter to the FDA urging the agency to “move swiftly” to begin regulation of electronic cigarettes.

December 2011 The FDA announces a comment period for regulation of non-face-to-face sales of electronic cigarettes, leading to speculation that the FDA may severely limit online and mailorder sales of electronic cigarettes.

2012

May 2012 After several quiet months from the FDA, lets slip via a sources sought request that it intended to have draft regulations of e-cigarettes in place by Summer 2012. The request was for technology to identify online and offline advertising for tobacco products.

August 2012 The FDA releases a report on “adverse events” reported from e-cigarette use. The report showed some 100 adverse effects were reported.  Analysis of the report on the ECF noted that there are millions of users of the system, and a number of individuals thinking they were being helpful submitted adverse impact reports for things like “being able to breathe easier” which likely artificially inflated the number of adverse impacts, which likely are just a handful of things.

Today

Summer has passed, and no draft regulations have been put forth by the FDA. Speculation among the cigar industry is that the agency likely won’t propose anything until the election is over. There is further speculation that the exact steps the FDA takes will depend on the political landscape after November.  This is perhaps true, but it seems to me that the train has already left the station and the FDA will roll something out in the future.

How oppressive it will be, nobody knows.  Speculation ranges from simple quality control over e-liquid on the low-end to very strict regulation allowing only pre-filled cartridges with either tobacco or menthol flavoring (along with online sales and advertising bans) on the extreme end of the spectrum.

Thank you for sticking with me through this massive undertaking.  I hope I gave you a little more perspective on how the FDA exists within our vaping culture. I’d love to hear what you think about the FDA and any potential regulations in the comments!

September 26, 2012 – Steve K. – http://stevevape.com/