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.
Today, Agent VAPE received this client alert e-mail from Keller and Heckman:
On July 25, 2016, Keller and Heckman LLP, on behalf of the Right to be Smoke Free Coalition and ten national and state e-vapor industry trade associations (the “E-Vapor Coalition”), filed a Motion for Summary Judgement in a lawsuit challenging parts of the Tobacco Control Act (TCA) and the Food and Drug Administration’s (FDA’s) recently published “Deeming Rule” which, effective August 8, 2016, captures most e-vapor products as regulated tobacco products under the TCA. To review the motion and supporting brief, click here.
The named Plaintiffs in the E-Vapor Coalition lawsuit are the Right to be Smoke Free Coalition, the American E-Liquid Manufacturing Standards Association (AEMSA), the American Vaping Association (AVA), the Electronic Vaping Coalition of America (EVCA), the Georgia Smoke Free Association (GSFA), the Kentucky Smoke Free Association (KFSA), the Louisiana Vaping Association (LAVA), Maryland Vape Professionals (MVP), the Ohio Vapor Trade Association (OHVTA), the New Jersey Vapor Retailers Coalition (NJVRC) and the Tennessee Smoke Free Association (TSFA). Also supporting the lawsuit are the Shenzhen E-Vapor Industry Association-USA (SEVIA-USA), the Smoke-Free Alternatives Trade Association (SFATA), the Consumer Advocates for Smoke-Free Alternatives Association (CASAA) and NOT Blowing Smoke (NBS).
The E-Vapor Coalition lawsuit, which was filed on June 20, 2016 in the U.S. District Court for the District of Columbia, was consolidated with the lawsuit filed earlier in the same court, Nicopure Labs v. FDA, No.1:16-cv-878 (D.D.C. 2016), on June 28, 2016. Following consolidation, the parties agreed to a briefing schedule that allowed Nicopure Labs to file its Motion for Summary Judgment on July 8, 2016, and the E-Vapor Coalition to file a separate summary judgment motion on its unique counts on July 25, 2016 (while incorporating by reference all of Nicopure Labs’ arguments). FDA has until August 16, 2016 - eight days after the Deeming Regulation becomes effective – to respond to both motions. All briefing will be completed by September 8, 2016, and oral arguments have been scheduled for October 19, 2016 at 10:00 AM ET in Washington, D.C.
In its Motion for Summary Judgment, the E-Vapor Coalition argues that FDA’s authority over tobacco products is not unfettered, but circumscribed by the statute’s underlying purposes – which strike a careful balance between various policy issues. Specifically, the statute provides that adults must have continued access to tobacco products (i.e., FDA cannot ban or virtually eliminate such products from the marketplace), while at the same time prohibiting access to such products by underage consumers. Along similar lines, the TCA requires FDA to regulate in a flexible manner so that relatively safer products can be developed and commercialized while more dangerous ones are kept off the market. Any effort by FDA to deem additional tobacco products under the TCA must reflect these compromises.
During the rulemaking, FDA repeatedly acknowledged that using e-vapor products likely presents far less risk than smoking cigarettes, and that individuals switching from combusted tobacco products to e-vapor products may significantly reduce their harm. The agency also recognized that the availability of e-vapor products could potentially lead to increased smoking cessation rates in this country and ultimately reduce tobacco-related disease and death – another one of the primary purposes of the TCA. These conclusions are consistent with scientific research, both in the United States and abroad, finding that e-vapor products are substantially less risky than combustible tobacco products. See, for example, Public Health England’s recent report finding that e-vapor products are 95% less harmful than traditional cigarettes, which was followed by the Royal College of Physicians’ ground breaking report lauding the public health benefits of e-vapor products.
Nevertheless, FDA chose to regulate e-vapor products in a manner that is even more stringent than its regulation of cigarettes. Resulting in what will be a virtual ban on many (if not all) vaping product categories is FDA’s decision to force vaping product manufacturers into a Pre-Market Tobacco Application (“PMTA”) process that was actually designed to prevent the introduction of relatively more harmful tobacco products to the market. Accordingly, PMTAs require, inter alia, long-term clinical studies which, as FDA concedes, do not yet exist. These longitudinal studies must focus on population-level effects, such as the impact of each e-liquid or vaping device on overall smoking initiation or cessation rates.
FDA’s approach also effectively writes out of the TCA one of the pre-market authorization pathways – the Substantial Equivalence (“SE”) Report – that Congress intended for FDA to use in a more flexible exercise of enforcement authority so that relatively less risky products, like e-vapor products, remain on the market and are available to adult consumers so long as they do not raise different questions of public health compared to a predicate (grandfathered) product. The SE Report pathway, while also imposing substantial informational requirements on manufacturers, does not necessarily require long-term clinical studies and, as such, is not as burdensome in terms of time and financial resources as PMTAs. However, without any grandfathered products available for use as predicates, all e-vapor products introduced after February 15, 2007 are forced to go through the PMTA process, which the agency admits will eliminate, at a minimum, 97% of the industry.
With no way to avail themselves of the SE Report pathway, for each vaping product on the market onAugust 8, 2016, manufacturers will have to file a PMTA within a two-year compliance period (i.e., by August 2018). Vaping product manufacturers will not have sufficient time over the next two years to conduct such long-term clinical studies or have the financial resources to meet other PMTA informational requirements that, according to the agency, will likely reach into the millions of dollars for each product application. Moreover, any new e-vapor products intended to be introduced after the effective date of the rule will have to first obtain PMTA authorization – essentially freezing the market on August 8, 2016.
Thus, instead of tailoring the pre-market process based on the type of tobacco product involved, the agency unlawfully adopted a “one-size-fits-all” pre-market regime that ignores e-vapor products’ overall lower risk profile. The E-Vapor Coalition’s motion highlights several of the Deeming Rule’s short-comings, specifically:
FDA has applied a statutory February 15, 2007 grandfather date to e-vapor products that was intended for traditional tobacco products, like cigarettes. FDA was required under the statute to set a new grandfather date which would allow e-vapor products to take advantage of the more flexible SE pathway.
FDA did not consider, as required under the Regulatory Flexibility Act (“RFA”), 5 U.S.C. §§ 601, et seq., any significant alternatives that, in the absence of a new grandfather date, would have allowed vaping product manufacturers sufficient time to develop the extensive information, including long-term clinical studies, necessary to successfully navigate the more stringent PMTA process. As it stands now, such data cannot be generated by the PMTA deadline of August 2018.
Even if FDA is correct in that it must apply the February 15, 2007 grandfather date to e-vapor products, this means that the TCA itself violates substantive due process and is unconstitutional. Under this scenario, there would be no rational relationship between the TCA’s underlying purposes and the means chosen by Congress to accomplish such goals. Indeed, as FDA conceded during the rulemaking, virtually all manufacturers will exit the vaping market, thus depriving adults of a relatively safer tobacco product and a chance to reduce or, better yet, quit their smoking habits.
Accordingly, the E-Vapor Coalition has requested the court grant it summary judgment and: (1) declare that the Deeming Rule exceeds FDA’s statutory authority, is arbitrary and capricious, or an abuse of discretion under the Administrative Procedure Act with respect to FDA’s failure to either establish a new grandfather date for all deemed e-vapor products or exercise its enforcement discretion in this regard; (2) set aside the Deeming Rule to the extent that FDA has applied the February 15, 2007 grandfather date to e-vapor products, and remand the rule to FDA so that the agency can set a new grandfather date for all deemed e-vapor products consistent with the Court’s decision; (3) remand the rule to FDA so that the agency can conduct a proper regulatory impact analysis that addresses the lack of long-term clinical data for e-vapor products; and/or (4) declare the rule unconstitutional to the extent that it applies the February 15, 2007 grandfather date to e-vapor products.
VAPE Magazine, the vapor industry’s original publication, announced this week it will be publishing a regulatory focused issue. The special issue, which will hit newsstands in September, will be focused on the regulatory environment the industry is now facing. A portion of all advertising proceeds from the issue will be donated to the Right to be Smoke Free Coalition lawsuit, which was joined by the industry’s top trade and consumer advocacy organizations.
The edition will feature a wide range of regulatory topics including a story about the market being flooded with new products ahead of the Aug. 8 deadline; a story on the new vapor tax in Pennsylvania and potential repercussions; a story on the potential birth of a vapor black market; and many more stories aimed to educate the public.
“We hope this will be an issue that retailers, manufacturers and distributors will keep at their desk for years to come,” said Managing Editor Corey Noles. “While we don’t usually publish in September, at the rate with which information is being released, we believe it is our job to give the industry a trusted news voice. Sometimes, that means changing our plans.”
“We appreciate our readers and advertisers who have supported us over the years, and we feel a responsibility to them as our industry navigates what will undoubtedly be remembered as it’s fight to stay alive,” Noles said. “Education is the first step to winning the war.”
VAPE Magazine is the industry’s premier publication, with more than 60,000 in readership each bi-monthly edition. The magazine can be found in nearly every vape shop in the United States, UK and other countries around the globe. Visit the magazine online at vapemz.com.
Mistic E-Cigs introduces the Mistic 2.0 POD-MOD, a sleek and powerful closed-ended personal vaporizer that enables consumers to quickly and easily change flavor tanks using the company’s pre-filled pod technology.
Selling for $39.99 at drug, mass and convenience retailers nationwide, Mistic’s new pre-filled vape system starter kit comes in two color options (matte black and matte white), each packaged with two free (a $40 retail value) pre-filled 10 mL flavor pods (matte black: tobacco/strawberry and matte white: menthol/cherry).
“This product simplifies the vaping experience covering the full spectrum of vape consumers,” said John Wiesehan Jr., CEO of Mistic. “It gives the experience, flavor profiles, and vapor production that mod users are accustomed to and also provides ease of use to cig-alike users who haven’t upgraded because they didn’t want to deal with the hassle of bottles and tanks. With a simple pick, click and vape, users can experience different flavors at a moment’s notice.”
Available in a compact, hand form-fitting rechargeable 30-watt unit with an automatic shut-off feature, Mistic 2.0 delivers a robust and satisfying vape from a 1700 mAh battery with the convenience and no-hassle of a cigalike. The battery also has an on-off option as well as stand-by mode to help conserve power.
Offered in 10 mL child-resistant, tamper-proof pre-filled pods, Mistic 2.0 high-end e-liquids (80 VG/20 PG ratio) are made in the USA and available in 4 mg nicotine strengths (4 percent by volume) and 10 flavors: cherry, coconut cream, creamy cantaloupe, fruit mix, java, mango, menthol, strawberry, tobacco and watermelon.
Selling for $17.99-$19.99, each Mistic 2.0 pre-filled pod has its own built-in coil that provides 0.3 Ohms of resistance for maximum sub-ohm vapor production. Each self-contained pod is easily interchangeable for vapers on the go or those wanting to effortlessly experience various flavor profiles.
The company is offering a free Mistic 2.0 POD-MOD starter kit when users spend $30 or more in its online store. Adult consumers can watch a short video about the new product on Mistic’s Facebook page (https://www.facebook.com/MisticElectronicCigarettes) to obtain a special coupon code.
Today’s announcement comes two weeks before the U.S. Food & Drug Administration’s (FDA) final rule on the manufacturing and marketing of newly deemed vapor products go into effect on Aug. 8. Products shipped after this date will not be allowed on the market until the FDA approves a marketing order.
“Innovation is key to our industry’s survival and it was important for us to bring our game-changing vaping technology to adult vapers and smokers before the FDA’s deeming rule goes into effect and stifles future modernization,” added Wiesehan. “While the FDA pathway for vapor products is still relatively unclear and already there are legal challenges to the final regulations, as well as pending legislation to move the February 15, 2007 predicate date, we are taking steps to ensure that our products remain on the market and will proceed with the pathway process for our new Mistic 2.0 line and other company vapor products.”