JTI Acquires “Ploom” Intellectual Property Rights from Ploom, Inc.

SAN FRANCISCO–(BUSINESS WIRE)–Ploom, Inc. announced today that JTI will acquire Ploom’s modelTwo and pods product line – including the “Ploom” trademark – and general intellectual property related to modelTwo and pods. Concurrent with the transaction, Ploom, Inc. will buy back JTI’s minority stake in order to focus on Ploom’s successful PAX business and an expanding product portfolio.

Ploom’s new corporate name will be PAX Labs, Inc.

Financial details of the transaction were not released. The transaction is expected to close during the first quarter of 2015.

“This partnership has afforded both parties many mutual benefits, and we are proud of our success with the pods product line,” says James Monsees, PAX Labs founder and CEO. “Both companies will profit from this fresh approach. Operating as PAX Labs, our focus on vaporization delivery products will fuel continued growth, especially as we enter new market segments. In addition to PAX, our industry-leading, loose-leaf vaporization product, we anticipate rapid rollouts of new products and further expansion into international markets.” PAX is an open system vaporizer that heats loose-leaf tobacco. It is currently available in the U.S. and Canada. More than 500,000 PAX units have been sold.

About PAX Labs, Inc.

Founded in 2007 by two Stanford Design Program Masters program graduates, PAX Labs applies design principles to reinvent the smoking experience. Headquartered in San Francisco, the company produces innovative premium vaporizers that provide a cleaner, modern alternative to smoking. PAX Labs strives to be a trustworthy leader in vaporization products.

For more information, please visit www.PAX-Labs.com.

Dr. Michael Siegel Announces Discontinuation of Crowdfunding Campaign for BSCiTS Study

September 27, 2014

It is with great regret that we announce that we are discontinuing the Behavioral Study of Cigarette and Tobacco Substitution (BSCiTS) fundraising campaign, and canceling the proposed study. For those of you who have donated to the campaign, your donations will be returned to you.

Although we officially launched the BSCiTS campaign just a week ago, our team at Boston University has invested substantial intellectual, logistical, and spiritual effort into this project for more than a year. We truly believed this campaign would be a success, and we want to extend our sincere gratitude to those from the vaping community and electronic cigarette industry who supported the development and launch of the campaign, as well as the administrative and development offices of Boston University School of Public Health.

We would like to explain our reasons for discontinuing BSCiTS.

1. Divisiveness within the e-cigarette community. The passion of the engaged, vocal members of the vaping community and e-cigarette industry is what inspired us to develop the BSCiTS project in the first place. Unfortunately, however, we discovered that there is great divisiveness within the e-cigarette community regarding the role of research—including what type of research should be done, who should do it, and who should pay for it. We welcomed feedback and suggestions about creating an optimal study design for BSCiTS, and we sought to be responsive to concerns about study methodology. However, the tone of feedback directed at our team quickly became hostile. Our integrity as researchers was questioned, and criticism quickly shifted from concerns about study methods to personal attacks.

2. BSCiTS was sparking further divisiveness. Our campaign was only public for a week, but in that short period of time it became evident it was exacerbating other, deeper fissures and ideological differences within the e-cigarette community. We were disturbed to find one organization in particular actively undermining our campaign efforts. It became apparent there is disagreement in the e-cigarette community about the need for rigorous research of the caliber that the FDA will require.

3. Initial reception from e-cigarette industry was not positive enough. Though we received much encouragement to develop and launch the BSCiTS campaign, the response from industry to our funding appeal was lukewarm. We are not confident that BSCiTS could receive enough financial support from independent e-cigarette companies to fund a rigorous study design.

4. Pressure to compromise study objectivity. Finally, and most importantly, we received pressure from a major e-cigarette advocacy group to alter our proposed study design in order to produce a more positive outcome. Attempting to exert influence on independent researchers to produce more favorable results is deeply unethical and extremely problematic. Moreover, this is hypocritical given the e-cigarette community’s rejection of biased research studies produced by tobacco companies and public health professionals alike. We are unwilling to compromise our scientific integrity in order to conduct a study on behalf of the e-cigarette community. We came to realize that the current climate within the e-cigarette community is not conducive to conducting objective behavioral research at the level of rigor upon which we insist. Ultimately, we have to place our own scientific integrity ahead of the desire to successfully secure research funding.

It is a sad day for us. We want to reiterate how much we appreciate those in the e-cigarette community—from individual vapers to entire companies—who believed in BSCiTS. Your encouragement and support has been incredibly meaningful.

Yours sincerely,

Michael Siegel, MD MPH and Sarah Roberts, MPH

 

VMR Partners With Republic Technologies to Bring OCB-Branded Vaporizers to Europe  

Vaporizer for Europe’s Popular OCB Brand to Be Launched by Leading Vapor Technology Company

 MIAMI, FL–(Marketwired – Oct 2, 2014) – VMR Products, a global leader in the electronic cigarette industry and the makers of V2®, one of the nation’s leading brands of electronic cigarette products, today announced a partnership with Republic Technologies International (RTI), a global manufacturer and distributor of rolling papers and smoking accessories, to launch a new line of advanced vaporizers for the EU market. The new line of vaporizers will be manufactured by VMR and distributed by RTI under the OCB brand.

OCB is renowned among the EU’s “Roll Your Own” and “Make Your Own” markets, with a strong presence across France, Spain, Germany and Austria. OCB is also well-known for its decorated holograph motif and innovative products. It is, without a doubt, the EU’s most modern brand of rolling papers today.

Following the success of VMR’s recently launched V2 Pro vaporizer, the fastest-selling product in the company’s history, the new line of OCB-branded devices will be designed for the emerging large-scale vapor device category. Models will feature the ability to vaporize e-liquid, loose leaf tobacco, and wax. The multi-medium devices are expected to be one of the most disruptive innovations to enter the vaporizer category in the EU.

The partnership marries VMR’s impressive technology with RTI’s unparalleled distribution network, which reaches more than 800,000 locations across Europe. The OCB vaporizer line will be gradually rolled out across that network over the next year, with one million devices expected to be sold by 2016.

“By partnering with RTI, we can quickly scale across the EU, bringing European consumers the first-rate technology and experience that VMR is known for,” said Jan Verleur, CEO and co-founder of VMR. “Abroad, we’ve seen consumers demand larger, open system devices that are naturally more customizable and powerful than their closed system counterparts. We’re eager to meet that growing demand with RTI’s expansive distribution network and the OCB brand.”

The new OCB vaporizers will feature several industry innovations, such as a one-piece aluminum body with drop-in cartridges to eliminate the breakage and leakage that plague traditional large-scale devices. The cartridges will couple to the vaporizers magnetically — rather than with threading — and will be “smart,” automatically controlling temperature. The vaporizers will also feature a breakaway magnetic charger that permits usage of the devices while plugged into a power source.

“We’re combining VMR’s excellence in product design and manufacturing with RTI’s record of popular, world-class products in the ‘Roll Your Own’ and ‘Make Your Own’ markets,” said Santiago Sanchez, Managing Director of Republic Technologies International. “Through this partnership, we can provide OCB customers who want high-performing vaporizers with a proven winner at both retail and online.”

“Earlier this month the new line of OCB Premium Vaporizers was launched at InterTabac, the world’s largest trade show for tobacco products, and has already generated tremendous interest,” continued Sanchez. “Traditional outlets such as retailers and tobacco shops will benefit from the availability of this breakthrough technology, allowing them to create a distinctive market advantage.”

About VMR Products

Founded in 2009, VMR Products LLC  has quickly become a global leader in the electronic cigarette industry. Famous for the V2® brand of electronic cigarette products, VMR designs, manufactures, and supports an expanding catalog of products under a variety of recognized brand names. Headquartered in Miami, the company has a global presence in more than 30 countries. VMR is the only vertically integrated electronic cigarette company, managing the entire product lifecycle to ensure the highest commitment to quality control and customer service. VMR is the world’s largest volume online retailer of electronic cigarettes, with over six million monthly visitors to the company’s websites, including v2.com the company’s flagship online store.

For more information on VMR Products, please visit: www.vmrproducts.com

About Republic Technologies International

Member of Republic Group since 2000, RTI’s origins goes back to the early 19th century and is the joint history of a number of companies that have met and joined forces over the years. Based in Perpignan, in the South of France, the company distributes its products in more than 100 countries being a key player in the growing roll-your-own and make-your-own sectors. RTI has factories in France, Spain, Austria and Canada and distribution companies in France, Germany, Austria and UK.

Owner of a number of well-known iconic brands, the company has positioned the OCB® trademark as the indisputable leader in Europe. RTI designs, manufactures and distributes the largest range of products in the category:

  • The world famous French manufactured rolling papers: JOB®, Zig-Zag®, OCB® and traditional Swan® products in Great Britain and Ireland.
  • A complete range of RYO/MYO products : filter tubes, filter tips, rolling machines, injectors, e-liquids and e-vape products under brands : JOB®, Zig-Zag®, OCB®, Rolling®, Altesse®, Memphis®, e-CG®, Swan® (for Great Britain & Ireland).

For more information on RTI Products, please visit: www.republic-technologies.com

 

E-cig rules draw more than 70,000 comments

Tobacco companies and public health officials are debating the health consequences of using electronic cigarettes, as the comment period for the Food and Drug Administration’s new e-cigarette regulations closed Friday.

A group of public health organizations, including the American Cancer Society, American Heart Association and Campaign for Tobacco-Free Kids, are asking the FDA to strengthen the regulations and speed up implementation.

But e-cigarette companies say such rules would have a “negative” impact on public health, because they would limit the access people to have a product that may actually help them quit smoking.

The FDA will wade through these and more than 72,000 other remarks, as the agency enters the final stages of the rule-making process.

“The serious adverse public health consequences of the current unregulated market for cigars, e-cigarettes, and other products demand that FDA exhibit a sense of urgency in its rulemaking process on deeming,” the group of health organizations wrote in a letter to the agency. “FDA should commit itself to issuing a final deeming rule within one year of publication of the proposed rule, which is on or before April 25, 2015.”

But the Consumer Advocates for Smoke-free Alternatives Association (CASAA), which believes e-cigarettes are a healthy alternative to traditional cigarettes, says that “there is ample reason to believe the net public health effects (of the rule) will be negative.”

That notion is backed by Lorillard, the largest e-cigarette maker which controls about 40 percent of the market.

“Electronic cigarettes hold the potential to advance the public health dramatically by moving existing users of conventional tobacco products to lower risk options,” Lorillard writes in its comment. “In fact, an international expert panel recently estimated that electronic cigarettes have only four percent of the maximum relative harm of conventional cigarettes, suggesting that substitution of electronic cigarettes for conventional cigarettes is likely to provide a significant public health benefit.”

The FDA proposed the e-cigarette regulations in April and extended the comment period through Friday, so that both sides would have more time to consider the rule.

Once the comment period closes, the FDA will begin reviewing each of the comments, which could take months as more than 72,000 people responded. After this, the agency can move forward with a final rule.

Reynolds American to Buy Lorillard for $27.4 Billion

By MICHAEL J. DE LA MERCED and CHAD BRAY JULY 15, 2014 7:18 AM New York Times

Reynolds American agreed on Tuesday to buy its smaller rival, Lorillard, for $27.4 billion, uniting two of the country’s biggest tobacco producers in a bet that bigger is safer in a declining industry.

Under the terms of the deal, Reynolds will pay $68.88 for every  Lorillard share.

Two other companies are also involved in the complicated transaction. The Imperial Tobacco Group plans to buy several billion dollars’ worth of brands — including Kool, Salem and Winston cigarettes and Blu e-cigarettes — from the combined company for $7.1 billion.

And British American Tobacco, which already owns 42 percent of Reynolds, will buy additional shares to maintain that same level of ownership in the combined company and help finance the deal.

The long-awaited combination, over a year in the making, will reshape America’s tobacco industry as companies grapple with a decadeslong drop-off in smoking. Buying Lorillard will make Reynolds a stronger competitor to the Altria Group, whose Marlboro brand alone accounts for nearly half of all cigarette sales in the United States.

Perhaps more important, the deal will also give Reynolds a foothold in two of the fastest growing products in the industry: menthols and e-cigarettes. Lorillard owns both Newport, the bestselling brand of menthols, and Blu, one of the leaders in the booming e-cigarette market.

And the sale of some brands will make Imperial, whose offerings include Galouises, the third- biggest cigarette maker in the United States. A deal involving Imperial had long been viewed as an important way to persuade antitrust regulators to approve of any merger of Reynolds and Lorillard.

Analysts have said that the four-way transaction could spur other mergers in the industry, particularly as established manufacturers seek to gain ground in e-cigarettes.

The outlook for traditional tobacco appears dimmer. Though still big — together, Reynolds and Lorillard reported $13 billion in sales last year — the number of Americans who smoke has fallen sharply over the last five decades. Government statistics show that just about 18 percent of adult Americans smoke cigarettes, compared to 43 percent from the same time in 1965.

And health advocates have succeeded in pushing for more stringent anti-smoking campaigns and limiting smoking in public places.

One potential hurdle for Reynolds is if the government cracks down on menthols, one of the fastest growing parts of the industry. The Food and Drug Administration has said that it considers that particular flavor of cigarette to be more harmful and signaled that it may seek greater restrictions on its sales.

Lazard is lead financial adviser to Reynolds, JPMorgan Chase and the law firm Jones Day are also advising Reynolds.  Centerview Partners, Barclays and the law firm Simpson Thacher & Bartlett are advising Lorillard.

FDA extending comment period on e-cigarette rules

RICHMOND, Va. (AP) — The public will have more time to weigh in on a federal proposal to regulate electronic cigarettes and other tobacco products.

The Food and Drug Administration said Friday that the public comment period slated to end July 9 is being extended an additional 30 days to Aug. 8 after getting lots of input on how to regulate e-cigarettes. Those are battery-powered devices that heat a liquid nicotine solution, creating vapor that users inhale. The FDA also proposed extending its authority to regulate cigars, hookahs, nicotine gels and pipe tobacco.

In April, the FDA proposed banning sales of e-cigarettes to anyone under 18, adding warning labels and requiring agency approval for new products. But the FDA didn’t immediately place any marketing restrictions on e-cigarette makers or ban fruit or candy flavors, which are barred for use in regular cigarettes. The agency has left the door open to further regulations, but says it wants more evidence before it rushes into more restrictions.

In addition to mandating warning labels that say nicotine is an addictive chemical, the rules would require e-cigarette makers to disclose their products’ ingredients. They would not be allowed to claim their products are safer than other tobacco products. In addition, they couldn’t give out free samples or sell e-cigarettes in vending machines unless they are in a place open only to adults, such as a bar.

The agency has received more than 33,700 comments on the proposal. By comparison, it received around 176,000 comments on potential menthol cigarette regulations during a 120-day comment period.

There is no timetable for when the FDA will issue its final rules, which could be shaped by the public input the agency receives. Many believe the final regulations will wind up in court.

The market for e-cigarettes has grown from thousands of users in 2006 to several million worldwide and reached nearly $2 billion in sales last year. Tobacco companies have noticed that e-smokes are eating into cigarette sales, and they have jumped into the business, too.

Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn’t contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. Scientists haven’t finished much research on e-cigarettes, and the studies that have been done have been inconclusive.

Still, some wonder whether e-cigarettes keep smokers addicted or hook new users and encourage them to move on to tobacco. And others warn that the FDA regulations could have unintended consequences.

___

Michael Felberbaum

It’s Official: Big Pharma is Lobbying Against Electronic Cigarettes- Dr. Michael Siegel

I have long argued that tobacco control advocates who have financial ties to Big Pharma must disclose these ties if they opine about national strategies for electronic cigarette regulation because these ties represent a conflict of interest. My argument was based on the premise that electronic cigarettes represent a major form of market competition with pharmaceutical cessation aids and that drug companies therefore have a financial interest in seeing electronic cigarettes squashed.

Today, I reveal that this speculation about pharmaceutical financial interests in the demise of e-cigarettes was not just speculation, but it has now been confirmed.

According to an article in the London Times, GlaxoSmithKline – a major player in the pharmaceutical smoking cessation industry – has lobbied vigorously on behalf of stringent electronic cigarette regulation in the European Union. Specifically, a leaked memo apparently showed that Glaxo was telling policymakers that electronic cigarettes could be a gateway to smoking and that these products should be regulated as medicines, not as a type of nicotine or tobacco product.

According to the article: “One of the world’s biggest pharmaceutical companies has warned lawmakers that electronic cigarettes could act as a “gateway to tobacco”. The leaked correspondence from GlaxoSmithKline, whose nicotine patches, gums and lozenges are being undermined by the burgeoning e-cigarette market, reveals the opposition from the pharmaceutical industry to impending regulation of e-cigarettes across the European Union. The pharmaceutical industry wants medicines licences to be mandatory for e-cigarettes, as they are for nicotine products. Instead, the EU is set to introduce a system in which e-cigarette companies can opt in for medicines regulation or be regulated in a similar way to traditional cigarettes.”

Christopher Snowdon reported the details of the story here back in February. He wrote:”This is a blatant attempt at rent-seeking by an obvious vested interest. We know that the pharmaceutical industry has been lobbying hard to hamper the growth of e-cigarettes so it comes as no surprise to find Glaxo using the tired old gateway argument. The truth is that e-cigarettes will only “seriously disadvantage” the NRT market if they work better as quitting aids. In my experience—and the experience of countless other people—e-cigarettes are much better substitutes for smoking. If they were really a “gateway” to smoking, e-cigarettes would be good for companies like Glaxo as they would create more smokers (NRT companies need there to be smokers just as much as cigarette companies do).”Snowdon also noted that the UK National Smoking Cessation Conference was funded by GlaxoSmithKline and Pfizer. He wrote:

“As usual, both these companies are main sponsors of the conference—apparently there is no problem having corporations that are vociferously opposed to the most promising development in smoking cessation paying for a conference about smoking cessation.”

The Rest of the Story

Financial interests in Big Pharma must now be recognized as conflicts of interest for any organization or individual who is offering opinions about national strategy, policy, or regulations regarding electronic cigarettes. Therefore, the authors of all scientific articles regarding electronic cigarettes must disclose any financial interests with pharmaceutical companies. Furthermore, organizations must also disclose any financial ties to Big Pharma when they offer recommendations regarding electronic cigarette policy.

Unfortunately, there have been numerous violations of this disclosure standard, as several commentators on electronic cigarette policy have failed to disclose their Big Pharma ties in published articles. I have highlighted many of these stories on my blog, but for one demonstrative example, see my column on failed disclosures by an individual and an organization in the New York Times debate on electronic cigarettes.

Another inexcusable conflict of interest is the fact that Mitch Zeller, the director of the FDA’s Center for Tobacco Products and therefore the chief author of the proposed electronic cigarette regulations, came to the FDA directly from a consulting job with GlaxoSmithKline and therefore has a severe conflict of interest regarding the electronic cigarette issue.

Moreover, several former members (and one current member) of the FDA’s Tobacco Products Scientific Advisory Committee have (or have had) financial conflicts of interest with Big Pharma, and thus are not in a position to offer opinions about national tobacco product regulation in the context of this expert advisory panel.

And finally, it appears that most of the national tobacco control conferences continue to be funded by pharmaceutical companies. There is no way that these conferences can be objective about smoking policy, especially regarding electronic cigarettes and smoking cessation, when they are funded by Big Pharma.

Swedish Match submits 100,000+ page Modified Risk Tobacco Product (MRTP) application to FDA to truthfully market General Snus to smokers as less hazardous alternative to cigarettes

RICHMOND, Va. — Copyright 2014 The Associated Press- Smokeless tobacco maker Swedish Match is asking the Food and Drug Administration to certify its General-branded pouches of tobacco as less harmful than cigarettes.

The company with its North American headquarters in Richmond, Virginia, is filing an application with the FDA to approve the snus (pronounced “snoose”) products as “modified risk.”

Snus — teabag-like pouches that users stick between their cheek and gum to get their nicotine fix — are popular in Scandinavian countries and are part of a growing smokeless tobacco market in the U.S.

How the FDA handles the products is being closely watched by both the public health community and bigger tobacco companies, which are looking for new products to sell as they face declining cigarette demand due to tax increases, health concerns, smoking bans and social stigma.

The company is proposing to say that the product is addictive but is “substantially less risky than smoking,” Jim Solyst, director of federal government affairs for Swedish Match North America, said in an interview with The Associated Press. Swedish Match also wants permission to remove one of the required health warning labels because Solyst said there’s “excellent scientific evidence” that the product doesn’t cause oral cancer.

The application also highlights a philosophical debate over how best to control tobacco. One camp says there’s no safe way to use tobacco and pushes for people to quit above all else. Others embrace the idea that lower-risk alternatives like smokeless tobacco or electronic cigarettes can improve public health, if they mean fewer people smoke.

A 2009 law gives the FDA authority to evaluate tobacco products for their health risks and lets the agency approve ones that could be marketed as safer than others. None has been given the OK yet, but the agency has noted that some tobacco products could pose less of a health risk to users than smoking. Once Swedish Match’s more than 100,000-page application is accepted by the agency, the FDA has one year to evaluate it.

Tobacco companies want to market more smokeless tobacco and other alternatives like electronic cigarettes to make up for falling cigarette sales. But they can’t explicitly market them as less risky than cigarettes.

The question remains whether smokers, which total about 42 million adults in the U.S., are willing to switch, even if it means saving their lives.

“You would hope that products like General and, for that matter, other alternative products would encourage people to move from smoking to the alternative products,” Solyst said.

Total sales of snus are about 50 million cans per year in the U.S., growing from virtually nothing in the mid-2000s, said the subsidiary of Stockholm-based Swedish Match AB.

Market researcher Euromonitor International estimates U.S. sales at $342 million in 2013 and predicts that snus retail volume will grow by about 20 percent in the U.S. by 2017.

General (pronounced gen-er-AHL) snus was first sold in Sweden in mid-1860s and has been sold in the U.S. since 2007. It is currently available nationwide in more than 20,000 stores and is kept in small chillers to preserve the product. The brand has at least a 6 percent share of the retail market, which is dominated by Winston-Salem, North Carolina-based Reynolds American Inc., which sells the market-leading Camel-branded snus, and Richmond, Virginia-based Altria Group Inc., which sells Marlboro-branded snus.

Swedish Match’s snus brands make up 75 percent of the market in Scandinavia. But in the U.S., the company said it only has a 10 percent share of the overall smokeless category.

The category grew about 5.5 percent in the U.S. last year but is still small when compared with cigarettes.