Category: News This Week

Mistic has made sub-ohming simple. Today, Ballantyne Brands, parent to Mistic, is reinventing the vaping experience with the introduction of 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, ergonomically designed 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 cig-alike. 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 $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.

British American Tobacco said today that it was leading efforts to develop and harmonize standards around vaping products to further reassure consumers of these products’ potential ‘in reducing the harm from smoking’.

The company said that this effort was being made against a backdrop of a growing number of electronic cigarette users globally. It cited the Ernst & Young’s May 2016 report, E-cigarettes: an emerging category, as saying that the number of electronic cigarette users in seven examined countries grew by 86 percent to 5.1 million in 2015.

Marina Trani, Head of R&D at Nicoventures (a wholly owned subsidiary of BAT) will tell delegates at the EuroScience Open Forum 2016 (ESOF 2016) on July 26 that standards need to be harmonised in order to promote innovation, according to a BAT press note. Different rules in different jurisdictions made it overly burdensome and expensive, especially for smaller companies. It stifled growth and innovation, which in turn could stifle the potential these products had for reducing the harm of smoking.

The EU and the US, for example, were worlds apart in terms of how they regulated electronic cigarettes. Draft regulations in the US, to be enacted in August, would require pre-approval before any change was made to a vaping product. Whereas, the EU Tobacco Products Directive required a less-restrictive, six-month prior notification (rather than approval) for ‘substantial modification’.

There was a growing body of evidence that electronic cigarettes were substantially safer than were cigarettes, the press note said. Kevin Fenton, Public Health England’s Director of Health and Wellbeing, had said recently, “The wider body of evidence consistently finds that e-cigarettes are less harmful than smoking”.

BAT said that in 2013 it had become the first tobacco company to launch an electronic cigarette and that it had been proactive in both developing the first voluntary product standard with the British Standards Institute (BSI) and advocating for more harmonised standards. It was currently contributing to the European standards development work.

BAT said too that it had taken a ‘particular leadership position’ in toxicological risk assessment through the publication of its 2015 best practice guide for how to comply with that aspect of the BSI guidelines. The guide helped ‘to safety assess’ flavours for inhalation rather than ingestion. It set out a scientific rationale that would help determine if particular flavours could be used safely.

Trani is due to tell the ESOF that the vaping industry should continue on a journey towards standards that can protect consumers, increase understanding of next generation products, and that are clear and harmonized globally while not inhibiting innovation.

Altria’s Nu Mark has told the US Food and Drug Administration that its pre-market tobacco application (PMTA) requirements for electronic cigarettes are unduly burdensome, unnecessary, and beyond the scope of the agency’s jurisdiction under the Tobacco Control Act (TCA), according to Dr. Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health.

Siegel said that in the comments made by Altria Client Services on behalf of Nu Mark, the maker of Mark Ten electronic cigarettes, particular concern was expressed that the burdensome PMTA requirements would force many manufacturers out of business, undermining the TCA’s public health goals.

‘The Draft Guidance is not aligned to the FSPTCA’s [Family Smoking Prevention and Tobacco Control Act – TCA] goal of promoting public health because the complexity of information recommended for the application process and the short compliance period for FDA to complete PMTA reviews may result in some existing ENDS [electronic nicotine delivery systems] products being forced off the market,’ Altria was quoted as saying.

Altria noted also that the FDA had acknowledged that a large number of electronic cigarette companies would go out of business, yet had failed to account for this in its regulatory impact analysis.

Siegel said that in order to remedy the situation, Altria had suggested an approach similar to one that he had been advocating. He quoted Altria as saying that the FDA should ‘establish baseline performance standards for ENDS products that, when met, would serve as the basis for an abbreviated or alternative marketing authorization pathway to satisfy the statutory PMTA requirements’.

Two of Altria’s main goals, as stated in the comments, were to:

1) ‘support manufacturers’ efforts to develop and bring to market innovative products that may advance the public health’.

2) ‘allow industry participants to engage and compete in a dynamic market’.

Siegel opened his piece by saying that Altria’s intervention had cast ‘serious doubt on anti-tobacco groups’ maligning of the motives of the tobacco companies in marketing vaping products’.

Siegel’s full blog, The Rest of the Story is at: http://tobaccoanalysis.blogspot.co.uk/2016/07/altria-urges-changes-in-fda-e-cigarette.html

The Health Ministry in Greece has drafted a bill that would prohibit the use of electronic cigarettes in enclosed public places, according to a story by Kerry Kolasa-Sikiaridi for the Greek Reporter.

The bill was tabled in parliament on Friday by the ministry, which has decided that electronic cigarettes are a potential gateway to nicotine addiction.

The bill also transposes provisions of the revised EU Tobacco Products Directive.

The bill’s vapor-product provisions have met with much objection from vapers, who say the government should have conducted more research and consulted scientists and researchers on vaping before drafting a bill that equates them with smokers.

The Kathimerini newspaper reported last week that electronic cigarette users in Greece had held a press conference to denounce government plans to outlaw them from vaping in enclosed public places.

The association of Greek vapers was said to have criticized the government for preparing the bill without first consulting with researchers, scientists, former smokers and electronic cigarette users.

Vapers said that by lumping them together with regular smokers, the new legislation denied them the right to avoid tobacco smoke.

During the press conference, the vapers presented an open letter with their grievances addressed to Prime Minister Alexis Tsipras and a letter of support signed by vapers’ associations from 16 European countries.

A US public health expert has accused the Food and Drug Administration of botching the cost-benefit analysis of its electronic cigarette deeming regulations.

In a blog, Dr. Michael Siegel, a Professor in the Department of Community Health Sciences, Boston University School of Public Health, said the FDA had drastically underestimated the costs of the regulations and not attempted to quantify the benefits.

‘As such, this represents a violation of the Administrative Procedures Act, providing strong grounds for the D.C. District Court to overturn the regulations,’ he wrote.

Siegel made his assessment after reviewing the declaration of Nicopure Labs’ CEO Jeff Stamler in the company’s lawsuit against the FDA,

‘In its declaration, Nicopure reveals that it has 2,400 stock keeping units (SKUs), including e-liquids, vaporizers, and component parts,’ Siegel said. ‘This means that in order to keep its products on the market, Nicopure will have two years to complete 2,400 pre-market tobacco applications (PMTAs), each of which is estimated by the FDA itself to cost approximately $300,000 and to require 1,500 hours to complete. ‘Nicopure estimates the actual cost of each PMTA to be between $3 million and $5 million. ‘But even if we use FDA’s more conservative estimate, it would cost Nicopure $720,000,000 ($720 million) to keep its products on the market. ‘The company estimates that at very best, it could complete PMTAs for 12 of its products.

‘Thus, the regulations – if not overturned – will decimate the overwhelming majority of Nicopure’s offerings to vapers.’

Siegel’s blog, The Rest of the Story, is at: http://tobaccoanalysis.blogspot.co.uk/.

Three Alabama-based e-cigarette companies challenged the finalized rule that expands the U.S. Food and Drug Administration’s (FDA) ability to regulate all tobacco products, contending in a lawsuit filed on Tuesday that the measure goes too far and will likely push them out of business.

Cyclops Vapor 2, Tiger Vapor and Karma S Clouds object to the FDA’s rule, which goes into effect  August 8, requiring manufacturers to show the agency that vapor products brought to market after February 2007 meet federal public health standards and will have to submit applications to market new products, according to a story published on Law360.

The rule doesn’t reflect that vaping devices are a safer alternative to tobacco products and consequently puts an unfair burden on e-cigarette companies, which are often small operations that can’t afford to go through the rigorous approval process, the complaint says.

“Because the deeming rule ignores the health benefits of vaping products, as opposed to tobacco products, the burdens imposed by the deeming rule appear to be nothing more than an arbitrary and capricious regulatory system designed to regulate the entire vaping industry out of existence,” the complaint says.

Cyclops is a distributor of e-liquids and Tiger and Karma both manufacture e-liquids and sell vaping devices, the complaint says. All of the companies offer e-liquids that contain nicotine derived from tobacco, as well as products that don’t, according to the complaint.

Studies confirm that those vaping products are far less harmful than cigarettes and that most of the chemicals leading to smoking-related disease aren’t present in e-cigarette vapor, the complaint says.
Although the FDA recognizes this reduced risk, the rule subjects vaping devices and e-liquids to the same regulatory requirements designed for cigarettes and smokeless tobacco, which Congress has said cause more than 400,000 deaths in the United States every year, the companies allege.

The agency estimates that a single pre-market tobacco application will cost hundreds of thousands of dollars, a tall order for vaping companies that produce scores of e-liquids, each of which would require its own approval, according to the complaint. Ultimately, the cost-prohibitive and lengthy process will force existing products out of the market and make it incredibly difficult to introduce new ones, likely driving consumers back to cigarettes and undercutting the purpose of the Family Smoking Prevention and Tobacco Control Act, a 2009 statute intended to address the cancer, heart disease and other health issues associated with tobacco use, the companies say.

The complaint asks the court to vacate the rule and declare that it exceeds the FDA’s authority, is arbitrary and capricious, applies an unlawful cost-benefit analysis and defies the First Amendment. Four other lawsuits also challenge the rule, one in Los Angeles and three in Washington, D.C., bringing primarily the same claims.

Joe Hubbard of the Joe Hubbard Law Firm, a lawyer for the three Alabama companies, said that the litigation comes down to the FDA’s overreach of its constitutional and statutory authority in issuing regulations that are intended to “regulate this industry out of existence, according to the story.

“The vapor industry and these three businesses have no objection to reasonable and lawful regulations,” he said. “What they object to is the FDA using its power not to regulate, but to annihilate their business.”

The suit is Cyclops Vapor 2 LLC et al. v. U.S. Food and Drug Administration et al., suit number 2:16-cv-00556, in the U.S. District Court for the Middle District of Alabama.

People in Saudi Arabia have been told by the executive director of the Anti-Smoking Association (Naqa), Dr. Mohammed bin Sulaiman Al-Mayouf, that electronic cigarettes cause as much harm to users and those around them as do traditional tobacco cigarettes, according to a story in the Arab News.

Al-Mayouf was quoted as saying also that there was ‘great need to change the common perception among people that nicotine in electronic cigarettes is less concentrated’.

He cited the World Health Organization as having issued ‘serious warnings’ against electronic cigarettes.

However, many tobacco control advocates believe that nicotine is not in itself harmful and that vaping electronic cigarettes is hugely less risky than is smoking traditional tobacco cigarettes.

Public Health England, an executive body of the UK Department of Health, has published a report saying that the use of electronic cigarettes is 95 percent safer than is smoking cigarettes and that electronic cigarettes are an important tool to help smokers quit altogether.

The Arab News story opened with Al-Mayouf saying that studies had shown that 6.1 percent of Saudis smoked shisha.

He said that this was an ‘alarming indicator’ of the power of the tobacco companies’ propaganda, which portrayed smoking as a sign of urbanization and self-assertion.

“It makes it easier to convince adolescent girls to take up the habit, especially when it is propagated by the media, mostly soap operas that are very popular among them,” he said.

Studies, said Al-Mayouf, had indicated that one session of shisha smoking lasted two to three hours, which was equivalent to the time taken to smoke about 25 cigarettes, and that one cigarette contained 4,000 toxic and 43 carcinogenic substances.

Al-Mayouf said shisha smoking was one contributor to lung, bladder and stomach cancer. It also contributed to lower birth weights, to gum and throat diseases, and to the spread of tuberculosis when one shisha was used by several people.

‘Many sites promote the electronic shisha, arguing that it helps gradually quit smoking, but this is a delusional solution and profitable propaganda spread by tobacco companies and the marketers of electronic cigarettes, against which the WHO has issued serious warnings,’ the story said.

‘Al-Mayouf stressed that e-cigarettes harm the smokers and those around them, the so-called passive smokers, as much as regular cigarettes, so there is great need to change the common perception among people that nicotine in electronic cigarettes is less concentrated.’