British American Tobacco CEO, FD Interviewed On 2016 Half-Year Results

unnamedBAT has unveiled its 2016 half-year results with the company reporting growing volumes and market share gains.

In a video interview, Nicandro Durante, CEO, and Ben Stevens, FD, discuss the company’s strong performance, in spite of adverse currency fluctuations, and the outlook for the full year.

For the video, click on the links:

http://video.merchantcantos.com/companies/b/bat/

http://sites.merchantcantos.com/companies/b/british-american-tobacco/half-year-results-2016/

 

Right to be Smoke-Free Coalition and E-Vapor Industry Trade Associations file Motion for Summary Judgment in Lawsuit Challenging FDA’s Deeming Regulation and the Tobacco Control Act

unnamedToday, 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.
For more information on the lawsuit and updates, visit www.r2bsmokefree.org. To learn more about Keller and Heckman’s e-vapor practice, visit www.khlaw.com/evapor

 

VAPE Magazine to Publish Special Regulatory Issue in September

reguatlion-socialVAPE 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.”

New subscribers will receive a complimentary copy of this issue. SUBSCRIBE HERE for $4.99

For advertising information, email sales@vapemz.com or call (800)958-6427.

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.

For advertising information, contact Jon Laverde at jon@vapemz.com. For news information, contact Managing Editor Corey Noles at corey@vapemz.com.

 

Mistic E-Cigs Introduces Sub-Ohm ‘Pod-Mod’

mistic-e-cig-logoMistic 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.”

 For more information on the company, visit www.misticecigs.com and www.HAUSvape.com, follow on Twitter @MisticEcig and @HAUSpv, watch on YouTube, or like on Facebook at MisticElectronicCigarettes and HAUS.

Indian Government Bans E-Cigarettes

Photo by www.beautifulholidays.com.au

Photo by www.beautifulholidays.com.au

The government of Kerala, India, has banned electronic cigarettes. According to The Indian Express, the reasons cited were “studies claiming that its use can cause various health issues, including cancer and heart ailments.”

The ban went into effect when State Health Minister K K Shylaja directed the additional chief secretary of health to issue an order banning the production, sale and advertisement of e-cigs.

The official release said that media said Kerala e-cig advertisements were targeting youth and children. Additionally, state drug enforcement authorities “had also found that the device is widely used for smoking ganja, hashish and other narcotic substance” according to The Indian Express. E-cigarettes in Kerala are reportedly being marketed through unauthorized courier services and online sites. 

For the full story, visit http://indianexpress.com/article/india/india-news-india/kerala-govt-decides-to-ban-e-cigarettes-2887377/.

SFATA’s Clearing the Haze Episode 7: Former American Cancer Society Director Outlines Areas of Agreement

url-1In this episode of Clearing the Haze, Dr. Thomas Glynn, former director of cancer science and trends for the American Cancer Society, discusses potential areas of agreement between the vaping industry and its opponents, as well as ethics in research, FDA regulations, Royal College of Physicians, and much more.

For the podcast, click here.

V2 Polls 300 Vapers

imagesV2, an electronic cigarette and e-vapor manufacturer, recently completed a poll of 300 consumers of vaping products. The poll, conducted May 11 and 12, showed that two-thirds of vapers are using e-cigs to quit smoking.

CSPDailyNews.com reported other findings as:

  • 62 percent said they do so “to quit or abstain from smoking cigarettes.”
  • 38 percent identified as dual users, vaping e-cigarettes “to obtain nicotine when unable to smoke cigarettes.”
  • 36 percent said they “preferred the flavors and taste over traditional tobacco cigarettes.”
  • 29 percent said they did so because e-cigarettes are more “socially acceptable than smoking cigarettes.”

Adam Kustin, V2’s vice president of marketing, expressed “disappointment” in the U.S. Food and Drug Administration’s (FDA) deeming regulations over electronic cigarettes and vaporizers, especially in the wake of evidence that the products are being used as cessation tools, according to CSPDailyNews.com. He told the site that the ruling is “discouraging” and could “very possibly drive users back to smoking cigarettes.”

For the full story, visit http://www.cspdailynews.com/category-news/tobacco/articles/survey-vapers-are-using-electronic-cigarettes-quit-smoking.

Public Health England Releases ‘E-Cigarettes: A Developing Public Health Consensus’

Screen Shot 2016-07-25 at 9.52.04 AMA joint statement on e-cigarettes by Public Health England and other UK public health organizations was recently released. Here it is in its entirety:

Since 2000, smoking among adults in England has fallen by one third and among children by two thirds. Yet almost one in five adults continue to smoke, with higher rates in the more deprived communities meaning that they bear the majority of the harm caused.

There is a strong public health consensus on tobacco control, embodied in the landmark report Smoking Still Kills. We all agree that e-cigarettes are significantly less harmful than smoking. One in two lifelong smokers dies from their addiction. All the evidence suggests that the health risks posed by e-cigarettes are relatively small by comparison but we must continue to study the long-term effects. And yet, millions of smokers have the impression that e-cigarettes are at least as harmful as tobacco.

Over 1.3 million UK e-cigarette users have completely stopped smoking and almost 1.4 million others continue to smoke. We have a responsibility to provide clear information on the evidence we have, to encourage complete smoking cessation and help prevent relapse to smoking. The public health opportunity is in helping smokers to quit, so we may encourage smokers to try vaping but we certainly encourage vapers to stop smoking tobacco completely.

We know that e-cigarettes are the most popular quitting tool in the country with more than 10 times as many people using them than using local stop smoking services. However, we also know that using local stop smoking services is by far the most effective way to quit. The current national evidence is that in the UK regular e-cigarette among youth use is almost exclusively confined to those young people who have already smoked, and youth smoking prevalence is continuing to fall. This is an area that we will continue to research and keep under closest surveillance.

Since October 2015, regulations to 2 protect children make it an offence to sell e-cigarettes to anyone under 18 or to buy ecigarettes for them and the Tobacco and Related Products Regulations 2016 ban print and broadcast advertising of e-cigarettes as part of an extensive range of regulations. We should not forget what is important here. We know that smoking is the number one killer in England and we have a public health responsibility to provide smokers with the information and the tools to help them quit smoking completely and forever. We share a commitment to provide up-to-date information on the emerging evidence on e-cigarettes, as shown in PHE’s review, which is the third in this area. This commitment drove PHE and Cancer Research UK to set up the UK E-cigarette Research Forum and the Royal College of Physicians to publish Nicotine without smoke, honouring our longstanding promise to monitor and share the evidence, providing clear messages to the public.

There is no circumstance in which it is better for a smoker to continue smoking—a habit that kills one in every two and harms many others, costing the NHS and society billions every year. We will continue to share what we know and address what we don’t yet know, to ensure clear, consistent messages for the public and health professionals.

Public Health England
Action on Smoking and Health
Association of Directors of Public Health
British Lung Foundation
Cancer Research UK
Faculty of Public Health
Fresh North East
Healthier Futures
Public Health Action
Royal College of Physicians
Royal Society for Public Health UK
Centre for Tobacco and Alcohol Studies
UK Health Forum

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