Game Changer, California, e-cig explodes, e-cigs harmful?, Future Regulation
September 19, 2013
E-cigs could be a game changer
The tobacco industry has long searched for a holy grail – a product that would give nicotine addicts their fix without also causing disease and death.
The jury is still out on whether e-cigarettes could be that change. Public health groups are highly skeptical, but few doubt that the technology represents a potential sea change.
Some industry observers view e-cigs as potentially the most disruptive force to hit the U.S. tobacco industry since the invention of the cigarette rolling machine.
The market potential for e-cigs has become big enough that major tobacco companies are now entering the category, and even the world’s largest tobacco leaf company has announced plans to become a supplier of nicotine for e-cigs.
While still only a small portion of the overall $80 billion U.S. cigarette market, e-cig sales could surpass traditional cigarette sales within the next decade as cigarette sales continue to decline while e-cig sales grow.
Analysts with Goldman Sachs wrote in late 2012 that if the e-cig market takes off, “there is potential for a big shake-up in the tobacco hierarchy.”
Altria Group consumer research shows that about 50 percent of adult cigarette smokers are interested in alternative products.
California city governments pondering what to do about E-cigs
Seal Beach, Calif., recently passed a 45-day moratorium halting any new e-cigarette and smoke shops from opening in the small beach community.
With fresh memories of how rapidly marijuana dispensaries multiplied and generated controversy, many cities want to slow the spread of electronic cigarette stores until they can figure out the ramifications.
For Jim Basham, Seal Beach's director of community development, the distinguishing line between pot dispensaries and vaping outlets is a bit blurry. He's seen e-cigarette stores evolve into hemp shops — and draw with them a ragtag crowd.
"You have other folks with different intentions," Basham said, "and you can have secondary adverse effects, like crime."
In August, Temple City passed a zoning ordinance that keeps all smoke shops, including those that sell only e-cigarettes, at least 1,000 feet from parks and schools. About a month earlier, Duarte passed an urgency ordinance that temporarily halted any new shops from opening there. And the city of Pico Rivera passed an ordinance that treats the vapor devices like traditional cigarettes.
Some city officials said they want more information about the devices and their health effects.
"I'm not saying you're going to die and go to hell if you use them," said Pico Rivera Councilman Gregory Salcido, who backed the city's decision to treat the devices as regular cigarettes. "But we don't know enough about them, and as a result we're going to cover our bases."
E-cig exploded, Atlanta woman claims
One Atlanta woman claims she's happy to be alive after a very difficult electronic smoking experience.
As WSB-TV reports, Elizabeth Wilkowski is sure that what she experienced was no ordinary event.
"I didn't hear a boom. It wasn't a pop. It was a kaboom!" she said.
Wilkowski claims that she had simply plugged the e-cigarette into her computer's USB port in order to charge it.
This particular e-cigarette was a Seego EHit, manufactured in China.
Are e-cigs harmful? Nobody knows for sure
The jury is still out on whether vaping is dangerous. And there are still plenty of conflicting opinions.
“People are inhaling some type of chemical vaporized compound into their lungs without really knowing what's in it," said Dr. Mike Feinstein, a spokesman for the American Lung Association.
Last year, the American Lung Association issued its own warning about e-cigarettes: “This is a buyer stay-away, a buyer health hazard, potentially."
Dr. Robert Greene, who treats lung cancer patients at Florida’s Palm Beach Cancer Institute, said the product is potentially a health hazard. “There really is no information about whether they're safe or not, and that's part of the problem," said Greene.
He says with no real data on e-cigarettes, the three-year-old tobacco alternative may actually be more harmful that traditional cigarettes.
"The doses of nicotine that you get could conceivably be higher than what you would get in a typical cigarette," said Greene.
According to the Tobacco Vapor Electronic Cigarette Association, e-cigarettes contain just five ingredients, all approved by the FDA. Recently, the FDA announced it will begin to regulate e-cigarettes as a tobacco product.
Future of e-cigs hinges on regulation
There’s been little research done on e-cigarettes, but among those studying the devices is Dr. Greg Connolly, professor of public health at Harvard University.
The future of e-cigarettes, Connolly said, hinges on how the FDA approaches regulation of them.
"This could be a tool — if it's regulated correctly — to help end dependence on cigarettes and nicotine. This is probably the best quitting device known to man," said Connolly, who co-authored an early study on e-cigarettes.
But they just as easily could become a means to hook more people on nicotine, he said.
If the technology continues to develop...they could become even more addictive than the conventional cigarette — that's frightening," Connolly said.
Connolly plans to publish research on a set of habit-forming compounds, or so-called "super juices," that have been in conventional cigarettes like Merit and Marlboro since the late 1970s — and that he has found to be present in some popular e-cigarettes.
These super juices — which aren't present in nicotine gum or patches — could help make e-cigarettes a more effective quitting aid because they would deliver the kick of a regular cigarette, Connolly said. And like the patch, he said, users could wean themselves off nicotine by stepping down the dosage — that is, provided e-cigarettes are regulated such that graduated doses of nicotine are required to be availed.
But Connolly, who has served on FDA's Tobacco Products Scientific Advisory Committee, said the agency does not seem poised to regulate e-cigarettes as a quitting aid. Rather, he said, FDA seems headed toward regulating them as tobacco products, which would leave the companies free to market the highest allowable dosages and essentially assure an ongoing supply of addicts or customers.
"FDA seems to be poised to ban Internet sales, which is exactly what (big tobacco companies) want," Connolly said. "That will only destroy competition and hand the market over to (the big three companies) whose only mission is to make the most addictive product they can."
The three major companies are Lorillard, Philip Morris, and Reynolds American.
The 499-page document places all vapor products under the jurisdiction of the Tobacco Control Act of 2007. Under the changes, vapor products including e-liquid containing no nicotine, will be held to the same requirements.
Numerous vaping advocacy groups have already denounced the regulations. The American VapingAssociation, in a statement, referred to the regulations as “downright prohibition.”
On Twitter this morning, AVA President Greg Conley noted that the regulations effectively freeze the market to new products 90 days after they are published. Any product moving forward that is not already on shelves, would have to go through theprocess immediately, as opposed to being allowed two years for compliance.
SFATA also weighed in on the discussion earlier this morning
“Our industry has a long history of supporting sensible science-based regulations, including license requirements, as well as banning sales to minors and adopting child-resistant packaging,” according to SFATA President and Executive Director, Cynthia Cabrera. “Today’s final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses.”
The regulations include federally requiring age identification, banning of vending machines, free samples and a laundry list of other items. As we at VAPE Magazine are still investigating the documents, more will come in the near future.
Specific warning label instructions are included in the regulations as well, with active manufacturers having 24 months to come into compliance.
In addition, all products — hardware and e-liquid — will have to go through one of two processes to reach the public. The pre-market tobacco application would have to be completed; otherwise manufacturers will be required to show substantial equivalence to a product on the market prior to February 15, 2007.
SFATA is challenging this date with the idea that virtually no products were on the market at that time.
“Although the FDA states it has found a vapor product on the market in 2006, it has yet to be determined whether the far more technologically advanced vapor products on the market today can be considered substantially equivalent to that product,” Cabrera said in a statement. “These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers. It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar job-creating industry, the majority of which are made of small businesses.”
More information, reaction and specific requirements will be posted later today.
Corey Noles is the managing editor of VAPE Magazine. He has worked as a journalist for more than a decade and is the founder, owner of Inked Up E-Liquid Co.
The Smoke-Free Alternatives Trade Association (SFATA), the largest trade association representing and protecting the interests of the vapor industry, today announced it has grown to more than 1,000 business members while establishing 27 local chapters in 25 states throughout the country.
“We are proud to continue to represent the small businesses that primarily make up our industry, which is creating jobs and billions of dollars in revenues and economic activity,” Cynthia Cabrera, president and executive director of SFATA, said in a statement sent to Agent VAPE.
“Advocating with a united and informed voice at the state and federal levels is paramount to the industry’s success, and we are committed to providing the resources to help our organization’s members navigate the increasingly difficult regulatory and legislative environments.”
Founded in 2012 with only a handful of members, SFATA today has grown into the largest vapor trade association, supported by businesses across the entire supply chain, including online retailers, brick and mortar vendors, distributors, manufacturers, professional service providers, importers and wholesalers.
SFATA also maintains committees comprised of members and leading industry thought leaders, including political, regulatory policy advisors, as well as top academics and scientists. The association also retains the foremost legal and public relations firms nationally, and employs top-tier state and federal lobbyists to advocate for the industry and educate legislators, health and regulatory agencies, and media, on vaping products.
“As we fight regressive policies that threaten our industry and the lives of smokers by treating vapor products, which contain no tobacco, more harshly than combustible cigarettes, it is vital now more than ever that the industry come together to fight for the preservation of this category, and not let the FDA hand the industry over to big tobacco,” Cabrera said.
The vaping industry has a long road ahead in the future, now that the Food and Drug Administration has released its regulatory plans. CSPDailyNews.com outlined four major problems that it foresees for the industry.
1. Who Will Survive? Large regulatory fees, including the ban placed on anything after the February, 2007 grandfather date, may cripple small business. Gregory Conley, president of the American Vaping Association, said “It is prohibition that will cost lives, kill jobs and further entrench America’s largest cigarette companies.”
2. Flavors. While flavors aren’t necessarily banned now, that doesn’t mean they won’t be in the near future.
3. Innovation. The FDA has implemented the 2007 grandfather date, pretty much wiping out innovators who can’t afford the hefty approval fees.
4. Black Market. Since only big business will be able to afford to continue, CSP Daily News foresees a large black market for vaping to surface.
A new study, ”Persisting long term benefits of smoking abstinence and reduction in asthmatic smokers who have switched to electronic cigarettes,” has been published in Discovery Medicine. A research group, led by Riccardo Polosa, Ph.D., of the University of Catania, hypothesized that electronic cigarettes could not only assist asthmatic smokers to quit, but they could also contribute to harm reversal of subjective and objective asthma outcomes, according to a story in NicotinePolicy.net.
The researchers looked at changes in health status and respiratory function of 18 smokers who had “mild to moderate asthma who quit smoking by switching to daily electronic cigarette use.”
“Polosa says that switching to daily use of electronic cigarettes may ameliorate clinical, functional and therapeutic outcomes for many asthma patients who smoke and that beneficial effects persist in the long-term. According to the researchers, the use of electronic cigarettes can even reverse the damage caused by tobacco smoke in asthma patients who smoke. Of note, deterioration in methacholine PC20, lung function, ACQ scores and exacerbation rates was noted in the two patients who relapsed to exclusive tobacco smoking,” the story noted.
Lost Art Liquids is the second vaping company to go on record with a lawsuit against the Food and Drug Administration. They filed earlier this week in the Central District of California, challenging the “purported authority to ”deem and regulate e-liquids and other vapor products as ‘tobacco products’ under the Tobacco Control Act and asserts claims against FDA for violations of the Regulatory Flexibility Act, the 1st and 5th Amendments, and the Administrative Procedures Act,” according to a release on PRNewswire.com.
“Lost Art Liquids is and has always been committed to producing the highest quality, safest, and most innovative premium e-liquid products and in serving as a voice for the vapor community. FDA, with its deeming regulation, has ignored our voice and the voices of millions of others, leaving us no choice but to seek judicial relief,” Brian Worthy, CEO of Lost Art Liquids, said in the release. “We are disappointed that the FDA continues to confuse and conflate vapor products with tobacco and chooses to ignore years of well-established research that shows the relative safety of the products compared to combustible cigarettes and the public health benefit they may offer to millions of Americans who use them as an alternative to tobacco.”
Lost Art Liquids argues that the regulation by the FDA is illegal, asserting that vapor products are technology products, not tobacco products.
The Center for Tobacco Products is offering a series of webinars to help the industry understand the finalized rule extending the FDA’s authority to all tobacco products. Under the rule, which is often referred to as the “deeming rule,” the FDA’s authority covers products such as e-cigarettes, cigars, hookah tobacco, and pipe tobacco, among others.
Some of the webinars are designed for specific audiences—tobacco retailers, vape shops, or manufacturers and importers, for example—to help them understand and comply with the new rule. The series includes two live question-and-answer sessions—the first for retailers on May 25, and the second for manufacturers on a date to be announced soon. Members of industry are invited to submit questions for these sessions, either ahead of time by emailing AskCTP@fda.hhs.gov or during the live sessions themselves.
The first six webinars in the series are now available. To receive updates as the presentations on remaining topics become available, sign up here.
FDA offers a wide range of additional resources for industry and anyone interested in learning about the rule and its requirements including:
A compliance chart for industry that clearly sets forth the provisions of the rule along with their compliance dates