Author: GTNF Trust Staff

British American Tobacco and the board of Kind Consumer Ltd have devised a new way to commercialize their Voke nicotine inhaler, according to a note posted on BAT’s website.

In 2014, BAT received a medicinal license for Voke from the UK’s Medicines and Healthcare Products Regulatory Agency and the plan was to launch it in the UK by the end of 2015.

Voke was billed as a safer alternative to cigarettes – in line with nicotine gum or patches – and one that could be prescribed by doctors.

In its recent note, BAT said the two companies had reached a mutually satisfactory agreement on the financial aspects of the new way of commercializing the product.

‘BAT’s manufacturing, intellectual property and know-how assets will be assigned to Kind in return for deferred, contingent payments,’ the note said.

‘Accordingly, Kind will take back ownership for the commercialization of Voke, allowing Kind to embrace the full economics of the opportunity.’

Kingsley Wheaton, MD next generation products at BAT, was quoted as saying: “We will be prioritizing and focusing on the vapor and tobacco heating consumer segments within our next generation product portfolio with our Vype and Glo brands. We do recognize the focus and single-mindedness Kind can bring will be an asset to the speedy commercialization of Voke.”

Meanwhile, Paul Triniman, chief executive of Kind, said that his company would be working hard to ensure that this new medical product got to consumers as fast as possible. “We will be seeking a new global partner, or possibly several regional partners, to accelerate the distribution of the nicotine inhaler during 2017,” he said

“We believe the differentiated technology, effective nicotine delivery and discreteness of Voke offers an important niche in the multi-billion dollar, fast-growing, harm-reduction market. We are excited about bringing this unique product to the market as soon as possible.”

The US Food and Drug Administration has sought to clarify what in its view tobacco products and products derived from tobacco are, and which part of the agency deals with those products.

The clarification comes in the form of a recently issued final rule entitled: Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses’.

‘This rule describes circumstances in which a product made or derived from tobacco is subject to regulation by the FDA’s Center for Drug Evaluation and Research, Center for Devices and Radiological Health, or Center for Tobacco Products,’ the FDA said in a recent posting.

‘This rule is intended to help manufacturers and researchers better understand which regulatory standards apply to their products or studies, respectively.

‘The agency also anticipates that the rule will help consumers clearly distinguish products made or derived from tobacco that are intended for tobacco cessation from those intended for other uses.’

Increasing the use of e-cigarettes as an aid to quitting smoking would increase the number of people who successfully quit and would be cost-effective, according to Ireland’s Health Information and Quality Authority (HIQA).

However, this would only be applicable if the currently available evidence on their effectiveness was confirmed by further studies, the Authority noted, while also cautioning that e-cigarettes were “unlikely to be harmless”.

HIQA today (January 5) commenced a national public consultation on a draft health technology assessment (HTA) of smoking cessation interventions – the first of its kind in the EU to examine the cost-effectiveness of e-cigarettes, according to a story in the Irish Medical Times.

The independent analysis has identified what improvements could be made in the mix of interventions offered by the HSE to increase overall quit rates at an acceptable cost, and will help in the developments of national clinical guidelines to guide healthcare professionals and smokers on how best to quit smoking, the story states.

While HIQA considered that it was likely e-cigarettes were less toxic than cigarette smoke, they were also unlikely to be harmless, and long-term use might increase the risk of chronic obstructive pulmonary disease, lung cancer, and possibly cardiovascular disease, as well as some other diseases also associated with smoking.

“The magnitude of these risks is likely to be smaller than from tobacco smoke, with Public Health England estimating e-cigarettes to be 95 per cent safer than smoking,” the draft HTA stated. It noted that some parties had called for the prohibition and or further regulation of e-cigarette products, as was discussed at the WHO Conference of the Parties to the WHO Framework Convention on Tobacco Control in November 2016, the story states.

According to HIQA’s Director of Health Technology Assessment Dr Máirín Ryan, the HTA found a high level of uncertainty surrounding both the clinical and cost-effectiveness of e-cigarettes. “While the long-term effects of using e-cigarettes have not yet been established, data from Healthy Ireland reveals that 29 per cent of smokers currently use e-cigarettes as an aid to quitting smoking, according to the story.

“HIQA’s analysis shows that increased uptake of e-cigarettes as an aid to quitting would increase the number of people who successfully quit compared with the existing situation in Ireland and would be cost-effective, provided that the currently available evidence on their effectiveness is confirmed by further studies,” she added.

A public consultation seeking feedback on the report will remain open until February 3, 2017. Following this, a final report will be prepared for consideration by the HIQA Board, before being submitted to the Minister for Health and the HSE.

The report, along with details on how to take part in the consultation, is available at www.hiqa.ie.

Vapers must follow the same rules as combustible cigarette smokers in New York City, an appellate court ruled Thursday, according to a New York Daily News article.

Enforcement of the ban on vaping in public places like bars, bistros and beaches began in 2014, but was challenged as unconstitutional by a smokers’ rights group, Citizens Lobbying Against Smoker Harassment (NYC CLASH). The organization argued that the city violated the state constitution by lumping unrelated subjects into one bill because vaping and smoking tobacco are different, according to the article.

In May 2015, a lower court ruled against NYC CLASH and the Manhattan Appellate Division agreed.

A spokesman for the city Law Department issued a statement saying city lawyers are pleased that the judges recognized “the amendment was not buried, unrelated legislation and the subject of the bill was clearly and transparently identified to the public during the legislative process.”

See story here: http://www.nydailynews.com/new-york/manhattan-court-upholds-city-ban-e-cig-public-places-article-1.2934414

The government of Hong Kong has been urged to regulate electronic cigarettes rather than ban them, according to a story by Alex Fok for the Harbour Times.

On December 24, the acting Secretary for Food and Health, Professor Sophia Chan, said that the government would step up measures on electronic cigarette control because of ‘worries over possible cancer-causing substances and e-cigarettes being a potential gateway to smoking’.

But on a visit to Hong Kong, Dr. Stephen Jenkins, director of regulatory and medical affairs for Nicoventures’ [British American Tobacco] Asia-Pacific region, renewed his call for electronic cigarettes to be regulated instead of banned.

He said that electronic cigarettes had undergone significant public health scrutiny.

“Canada and New Zealand are moving towards regulating e-cigarettes, and Vietnam is considering it,” Jenkins said. “These are governments that have had a very strong position [on electronic cigarettes] for many years. But the evidence is compelling and they are considering it.”

Meanwhile, Fok reported that David Sweanor, an adjunct law professor at the University of Ottawa, Canada, had compared fear of vapor products to the demonization of immunization techniques.

Speaking at TEDxHongKong earlier this month, Sweanor said that science was indicating that the real problem was the smoke. And given that some people would not be able to quit their habit soon, the question arose as to what would happen if encouragement were given through regulatory interventions to make less harmful products more readily available.

Companies were trying to move into this area because they had to, Sweanor was quoted as saying. Companies either innovated when faced with disruptive technology or they got blown away by it, unless they were protected by regulators or by, in this case, anti-smoking groups that prevented the alternative products coming out and, by doing so, protected traditional tobacco cigarettes.

“The first jurisdictions that get it right have the potential of creating an enormous business by being able to then export that technology worldwide,” Sweanor said. “So this is an opportunity where some people can make billions of dollars saving billions of lives.”

Vapor Corp. has appointed John A. Ollet to serve as its new chief financial officer.

“We are extremely pleased to welcome John to the Vapor executive team,” said Jeffrey Holman, CEO of Vapor.

“He brings the financial experience Vapor needs as we continue to advance our growth and acquisition strategy. This is an exciting stage in our company’s growth and John’s strong public company experience makes him ideal for our organization.”

Ollet previously served as executive vice president-finance for Systemax, North America Technology Division from 2006 to 2016.

His prior chief financial officer experience also includes serving as vice president and chief financial officer of Arrow Cargo Holdings, an airline logistics company, and VP finance/CFO – The Americas – Cargo Division, KLM Royal Dutch Airlines.

Next Generation Labs (NGL), the makers of proprietary TFN Nicotine – non-tobacco derived synthetic nicotine liquid and crystals – says that it has noted court statements made by the US Food and Drug Administration (FDA) in the Nicopure vs. FDA lawsuit that confirms products not made or derived from tobacco are not regulated tobacco products under the recent deeming rule, according to a cstoredecisions.com story.

The story said that, in a response brief to the court dated November 1, the FDA had stated that not all nicotine-free e-liquids (NFLs) were subject to the deeming rule. “Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a ‘component or part’ – that is, if it is ‘intended or reasonably expected’ either…(1) To alter or affect [a] tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product; and is not an accessory,” the FDA was quoted as having said.

‘The FDA’s Deeming Rule was designed to extend the agency’s regulatory authority over a variety of tobacco products, which greatly impacts the vape industry,’ according to cstoredecisions. ‘However, the recent clarification from FDA attorneys appears to confirm that the deeming rule does not extend to e-liquids that are either nicotine-free, or not made or derived from tobacco, when marketed and sold appropriately.

‘TFN Nicotine is not made or derived from tobacco, nor is it a component or part of any tobacco product; as such Next Generation Labs does not believe e-liquids made with TFN Nicotine are required to list their product as a tobacco product with the FDA, or prepare a Pre-Market Tobacco Application (PMTA) submission before launching a new vape liquid brand in the USA.’

“The FDA’s statements to the court seem to confirm our long-held position: TFN Nicotine products cannot be regulated under the deeming rule as they simply are not tobacco products,” said Vincent Schuman, CEO of NGL. “In order to comply with the FDA, the onus is on e-liquid manufacturers to consider how their TFN Nicotine product is marketed, distributed and positioned to adult consumers to ensure a complete disassociation from tobacco and tobacco devices.”

Whether or not the FDA will regulate synthetic nicotine as a drug is still a question.

Researchers at Stanford University in California, U.S., are trying to find a way to prevent the explosions and fires associated with lithium-ion batteries, which are used in a wide variety of consumer electronics products, including eVapor devices, according to a KCBS story relayed by the TMA.

Doctoral candidate Austin Sendek said that the problem stemmed from the flammable liquid electrolytes used in the batteries.

His research team was trying to identify solid materials that could replace those volatile liquids because solids were “much more stable” and “tend not to vaporize or to blow up”.

Since the number of known lithium-containing compounds is in the tens of thousands, the researchers used a new computer algorithm using artificial intelligence that reduced the list to 21 components.

“The next work that comes out of our labs will be, I think, actual devices, or really in-depth computer simulations done with these materials,” Sendek said.

“We’ve already begun that process and found some really interesting things so far.”

Sen. Ron Johnson (R-Wis.), chairman of the Senate Homeland Security and Governmental Affairs Committee, and Rep. Duncan Hunter (R-Calif.) sent a letter Monday to Vice President-elect Mike Pence concerning the U.S. Food and Drug Administration’s regulation of e-cigarettes.

Johnson and Hunter are raising concerns about the agency’s recent e-cigarette regulation, which could create undue burdens on small businesses and possibly lead to negative unintended health consequences. The lawmakers are hopeful that, under a new administration, these harmful regulations can be repealed.

 “We are hopeful that through both executive and legislative action, burdensome regulations imposed by the Obama administration will be re-examined and undone,” the lawmakers wrote. “The U.S. Food and Drug Administration’s deeming regulation of e-cigarettes is an example of a burdensome rule that could eliminate an entire emerging industry.  The FDA’s rule threatens to crush the e-cigarette industry and potentially hurt the public’s health by making it harder for consumers to access products that serve as an alternative to smoking.”