Category: News This Week

Change is coming. Nine years after the Family Smoking Prevention and Tobacco Control Act (TCA) was signed into law and one year since it announced its Comprehensive Plan for Tobacco and Nicotine Regulation, the U.S. Food and Drug Administration (FDA) announced today, Aug 2, its intent to “quickly advance” three new initiatives concerning tobacco and vapor products.

In a joint blog post, Scott Gottlieb, commissioner of the FDA, and Mitch Zeller, director of the FDA’s Center for Tobacco Products, wrote that the regulatory agency would be expediting action of flavored products, is developing an e-cigarette product standard and will explore various ways to accelerate enforcement of the marketing of vapor products to youth, as well as youth access. Comment periods for three advanced notices of proposed rule making (ANPRM) related to flavors, youth access and premium cigars are now closed for comment.

In its post, the FDA states that flavors are at the forefront of any discussion of youth use. However, some flavored tobacco products may also play a role in helping some adults quit smoking cigarettes.

“We intend to expedite the review and analysis of the comments so that we can leverage the information into policy as quickly as possible, should the science support further action,” the blog states. “Input on these issues will assist in the consideration of the most impactful regulatory options the FDA could pursue to achieve the greatest public health benefit. We’re proceeding in a science‐based fashion, building a strong administrative record by securing more information about the potential positives and negatives of flavors in both youth initiation, and in getting adult smokers to quit or transition to potentially less harmful products.”

The FDA has also announced the regulatory agency had begun exploring a product standard for e‐cigarettes to help address existing concerns. This has been a major issue for vapor industry product manufacturers as the lack of guidance has slowed innovation. The FDA states that, as part of the standard, the agency will consider, among other things, levels of toxicants and impurities in propylene glycol, glycerin and nicotine in e‐liquids. “While the process for establishing a product standard takes time, we recognize the urgency in setting some minimum, common sense standards and will work to address this on an accelerated timeline,” the blog states.

The FDA is also looking at how it can act more efficiently when the agency becomes aware of violations affecting youth use of e‐cigarettes, such as illegal product marketing. “We need to be faster and more agile when we identify new risks. We’ve also become aware of reports that some companies may be marketing new products that were introduced after the FDA’s compliance period and have not gone through premarket review,” the blog states. “These products are being marketed both in violation of the law and outside of the FDA’s announced compliance policies. We take these reports very seriously. Companies should know that the FDA is watching and we will take swift action wherever appropriate.”

The FDA is now evaluating new ways to strengthen its partnership with its sister agencies, including the Federal Trade Commission, and will soon announce a robust series of additional enforcement actions in the coming months, according to the blog post. “Today, we’re committing to redoubling our efforts. Too many kids are still starting to use tobacco products and getting addicted,” the blog states. “Too many adults are still struggling to quit or to switch to less harmful options. To reduce the disease and death caused by tobacco use, the FDA will do everything within our power to help all ages.”

Additionally, the FDA is pursuing additional new policies as part of its comprehensive plan for nicotine and tobacco regulation. Part of these efforts are aimed at making the pathway for developing nicotine replacement therapy (NRT) products more efficient and to promote the development of novel NRT products.

“The agency’s efforts to re‐evaluate and modernize its approach to the development and regulation of NRT products is aimed at opening up new pathways for the development of improved products, regulated as new drugs, that demonstrate that they are safe and effective for the purpose of helping smokers quit,” the blog states. “Many of our new efforts, as part of our comprehensive plan, are aimed at using our existing authorities under the TCA to minimize addiction to the most harmful products, principally cigarettes, while encouraging innovation in new products that may offer adults less harmful forms of nicotine delivery.”

A key part of achieving these goals is issuing “foundational rules and guidances” to help the vapor industry better understand what is needed to submit product applications. At the same time, the agency is pursuing “new efforts to improve the transparency and efficiency” of its premarket review process.

“These important foundational steps are a key element of our efforts to advance the pre‐market review of tobacco [and vapor] products. This review is one of the most important responsibilities we have. It’s how we can … determine how a product [or new products] may positively or negatively affect both non‐users and current users,” the blog states. “To address these goals, we’re committing to a number of steps, some new, to respond to stakeholders and to make the regulatory process more efficient, predictable, and transparent for industry … establishing a rigorous, predictable, science‐based framework for the pre‐market review of tobacco products is a key element of our program.”

The steps the FDA is pursuing to better achieve these goals are proposing foundational rules, holding a public meeting on the premarket authorization process and seeking ways to make those processes more efficient. The agency will begin publishing these foundational proposed rules in the coming months.

“They will lay out a transparent, modern and science-based framework for manufacturing practices and the development of tobacco product applications that meet the legal requirements. We’re working to propose new rules to help industry on topics including Substantial Equivalence (SE), Premarket Tobacco Applications (PMTA), Modified Risk Tobacco Product Applications (MRTP), and Tobacco Product Manufacturing Practices,” the blog states.

Within the next few months, the FDA expects to hold a public meeting on the premarket application and review process. The goal of the meeting is to “solicit comments on our processes and provide a dedicated venue for specific suggestions on how to further improve them.

“If carefully developed, rulemaking and guidance efforts in this area could help ensure that our public health standards for premarket review are met while mutually benefiting both the industry and the FDA,” the blog states. “For example, an opportunity may exist to allow for faster and cheaper development of products that will benefit public health … We also plan to advance a comprehensive suite of improvements to the review process, as part of a Regulatory Modernization, to make our program more efficient, transparent, predictable, and efficient.”

The FDA expects to unveil these program-related reforms in advance of its upcoming public meeting, which has not yet been scheduled.

The original blog post can be found here: https://blogs.fda.gov/fdavoice/index.php/category/tobacco-products/

Japan Tobacco Inc. is aiming to capture 40 percent of what it refers to as Japan’s T-vapor market by the end of 2020.

The T-vapor (tobacco vapor) category, which is otherwise known as the heat-not-burn or heating-tobacco category, is subdivided, among other ways, according to the method of heating the tobacco contained in the consumable units of the various devices on offer.

JT’s Ploom TECH is described as a tobacco-infused vapor product with low-temperature heating technology unique to JT. ‘The technology, which does not involve combustion or direct heating of tobacco, enables Ploom TECH to offer a clear taste with no smoke, smoke smell or ash and no negative impact on the surrounding air quality,’ the company said in a press note issued today.

‘Since the expansion of Ploom TECH’s sales area to nationwide in June 2018, the total sales volume of the device has reached more than four million units as of July 2018.’

JT said it had been receiving positive consumer feedback, including references to the device’s producing “no smoke smell” and being “easy to use”.

Meanwhile, the company said that it intended to take 40 percent of the T-vapor market by providing ‘a wider range of choices that satisfy the varying needs of consumers’.

And to this end it announced today that it would be launching a tobacco capsule with a new flavor, MEVIUS Mix Green Cooler for Ploom TECH.

‘MEVIUS Mix Green Cooler for Ploom TECH is one of JT’s menthol products, which has a flavor that reminds consumers of a mixture of European and Asian pear, with 100 percent natural menthol,’ the note said. ‘These features offer a rich and pleasant taste.’

The new-flavor capsules are due to be made available gradually in convenience stores across the country and selected tobacco retail stores from September 3.

A proposal in the US to lower the maximum amount of nicotine in legally available cigarettes to non-satisfying and non-addictive levels would cause deadly problems for years to come, according to Jeff Stier, a senior fellow at the Consumer Choice Center and a policy advisor to The Heartland Institute, writing at blog.heartland.org.

Stier described the Food and Drug Administration proposal as policy candy that provided public health groups with a head-rush, but he said that evidence was scant that it would help smokers quit. And he added that it would be a boon to the already-thriving black market for these highly addictive products.

Stier was writing on July 27, a day ahead of the one-year anniversary of the FDA’s announcement about what it called a “new comprehensive plan for tobacco and nicotine regulation” that “places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts”.

‘When rolling out the multi-year plan, [FDA] Commissioner Scott Gottlieb said that “the overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes”,’ said Stier ‘Never was a more obvious statement more necessary, given the recent media hysteria over e-cigarettes.’

In his piece, Stier looks at the agency’s two-pronged approach to reduce smoking, the first of which involved a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels.

‘The second part of the plan voiced a commitment to reform regulations to foster innovation for both recreational (e-cigarettes) and medicinal (nicotine replacement therapy) products,’ he said. ‘This component of the plan gave hope to countless former smokers who are smoke-free today because of e-cigarettes.’

But, Stier said, FDA regulations already in force had put a freeze on innovation within this category. ‘And unless the FDA quickly makes regulatory changes, nearly all currently available e-cigarettes will be removed from the marketplace in just a few years,’ he warned.

Stier goes on to evaluate what the FDA has achieved one year into its plan.

British American Tobacco says that it has received from the US Food and Drug Administration clearance in respect of two substantial equivalence applications for its improved, carbon-tipped tobacco-heating product (THP), Eclipse and Eclipse Menthol, according to a story in the Winston-Salem Journal relayed by the TMA.

The clearance, which was apparently received on July 19, was referred to in the company’s first half report, published yesterday.

The story said that Eclipse had been developed in the 1990s and was in distribution from 2003 to 2007 as R.J Reynolds’ first national attempt at the HTP category.

BAT’s chief Executive Nicandro Durante said his company was delighted to be the first tobacco company to be able to launch a THP in the US.

He said the company planned to launch the products within a small test market by the end of the year, with national distribution likely in 2019.

The plant in Tobaccoville, North Carolina, which manufacturers Eclipse and Vuse, could experience demand for a substantial production increase as a result of the new products having been given clearance.

In launching last week in Switzerland Logic Pro, a nicotine-containing electronic cigarette, Japan Tobacco International became the first international company to introduce such an e-cigarette in the country, according to a note posted on the company’s website.

The launch was said to have followed the Federal Administrative Court’s decision on April 24 to lift Switzerland’s ban on the sale of e-cigarettes containing nicotine.

‘Logic Pro comes one year after the success of PLOOM TECH, its [JTI’s] tobacco-infused vapor product that heats tobacco at very low temperatures without combustion,’ the company said.

‘With Logic Pro, JTI widens its reduced risk products portfolio in Switzerland to satisfy consumer demand for e-cigarettes.

‘Logic Pro is a closed-tank electronic vapor device which heats a nicotine-containing liquid to produce an inhalable vapor. Its replaceable capsules come in five flavors – regular, menthol, cherry, berry mint and vanilla – and two different strengths. E-liquids for Logic Pro capsules are made in Europe in line with strict international quality standards, and use food flavoring agents, pharmacopeial nicotine, propylene glycol, and vegetable glycerin. All of this comes together in one sleek, convenient and satisfying vape.’

“Vapers today are looking for a superior and easy vaping experience,” said John Aurlund, JTI’s GM in Switzerland. “Thanks to the combination of its Europe-made e-liquid and first-class hardware, Logic PRO gives users a quality vapor with an enjoyable taste. With Logic, already the number one e-cigarette in several European countries, we can now meet a growing consumer need in Switzerland. We’re happy the new regulatory environment allows for more consumer choice in the country.”

Logic is an American brand of electronic cigarettes acquired by JTI in 2015.

The company said that it was a leading brand in major e-cigarette markets. It was the number one e-vapor brand in Ireland and the number one closed-tank e-vapor device in France, Italy and the UK.

‘In the UK, Logic Pro was voted the 2018 E-Cigarette of the Year, recognizing JTI’s dedication to the consumer,’ JTI said. ‘Already the number three global leader in the e-cigarette category, Logic is currently sold in 11 major e-cigarette markets.’

JTI said that Logic would be made available across Switzerland in independent trade and kiosk stores. The device would retail for CHF19,90, with refill packs of three capsules available for CHF5,90.

British American Tobacco Korea on Monday launched in South Korea its second-generation tobacco-heating device, glo, according to a story on pulsenews.co.kr.

At the launch, BAT Korea said consumers would be able to buy the new edition of glo from July 30 at the brand’s flagship store, nationwide from convenience stores and via the official web site.

The second-generation glo device, which is being launched about a year after the previous model was launched, will be priced at 90,000 won.

BAT Korea said that the upgraded version of glo came with enhanced function and design. The all-in-one device was simple to operate, the company said, because users did not need a separate charging device.

The device could be used up to 30 times on a full charge, it added.

BAT Korea has unveiled also neo, a new heated-tobacco consumable unit for the new device, which will replace Neostiks, the existing heated tobacco unit.

Pulse quoted an unnamed official of BAT Korea as saying the company would continue to provide more diverse and satisfying options to Korean smokers seeking potentially reduced-risk, alternative products.

Despite the Ministry of Food and Drug Safety’s health warning about vapor products, demand for smokeless tobacco devices has been growing.

Indonesia’s Ministry of Finance estimates that the Government may collect up to Rp3 trillion ($207 million) in additional revenue next year from a new excise on vaping liquids, according to a story in The Jakarta Globe.

At the beginning of this month, the Government imposed a 57 percent excise tax on e-liquids containing tobacco extracts or nicotine, a rate the Globe said was more than four times the maximum excise on ‘regular cigarettes’.

The country’s 200 domestic producers are required to start paying excise on e-liquids by October. 31.

Noegroho Wahyu, acting director of excise, said that so far three e-liquid producers were registered to pay excise, but that the government expected the remaining producers to register before the deadline.

The Government is expected to collect Rp50-70 billion in additional revenue from the new excise this year, but it estimates that will rise to about Rp3 trillion per year once all manufacturers are registered.

Aryo Andrianto, chairman of the Indonesian Personal Vaporizer Association (APVI), was quoted as saying that the excise rule meant the government had officially acknowledged the industry and provided it with legal certainty.

Vaping liquid producers were planning to increase their prices by a maximum of 20 percent to soften the blow on consumers, Aryo said, before indicating that the producers were not opposed to the excise tax.

Meanwhile, producers hope that, following the imposition of the excise tax, the government may be more willing to support the industry’s export efforts.

Deni Syarifa, chairman of the E-Liquid Micro-Entrepreneurs Association, estimates that manufacturers could export up to two million bottles of vaping liquid per month.

“There is currently demand for around 5,000 to 10,000 bottles per month from just one country,” Deni said, adding that producers planned to ship the liquid to countries in Asia, Central America and Europe.

Juul Labs is launching its vaping device in the UK this week, according to a story by Martinne Geller for Reuters.

Since launching in the US in 2015, Juul has transformed the market there, where it now accounts for nearly 70 percent of tracked electronic-cigarette sales.

The Juul device will reportedly be available in 250 vape shops across the UK by the end of this week.

A starter pack, including the device and four nicotine pods, will cost about £29.99 ($39.66).

Grant Winterton, Juul Labs’ president for Europe, the Middle East and Africa, told Reuters that the UK had been chosen as Juul’s third market after the US and Israel, partly because it had the world’s “most supportive government” when it came to encouraging smokers to vape. Also on the radar are France, Germany and Italy.

The number of prescriptions issued for drugs aimed at helping smokers quit their habit fell by 75 percent in England during the past decade, according to a story in The Guardian published ahead of the release of a new report.

The report, based on an analysis of NHS prescribing data, was due to be published by the British Lung Foundation (BLF) under the name Less Help to Quit: What’s happening to stop-smoking prescriptions across Britain.

General Practitioners were said by the Guardian to be the most common first port of call for smokers who wanted to beat their addiction in England, with 38 percent of them choosing this route.

However, primary care prescriptions of nicotine replacement patches and gum and the smoking-cessation drugs bupropion and varenicline had fallen by three-quarters in England between 2005-06 and 2016-17.

The report is said to indicate also wide regional variations in the prescribing of such products across Great Britain.

In Scotland, there was said to have been a 40 percent drop in prescriptions for stop-smoking drugs, while in Wales prescription rates had fallen by two-thirds.

The drop in prescriptions had come about even though a combination of support and medication had been shown to be the most effective way to help smokers quit, the Guardian reported.

Such a combination, which was recommended by the National Institute for Health and Care Excellence, was said to increase the chance of a smoker’s beating her addiction threefold, when compared with going “cold turkey”.

Alternative routes to getting help, such as specialist clinics, are also declining in some areas, the report finds.

In the English county of Worcestershire, for example, where 15 percent of the population smokes, the local authority decommissioned its stop-smoking services, and local clinical commissioning groups advised GPs in April 2016 not to prescribe stop-smoking aids for new patients.

As a result of these changes, the Guardian said, 98 people last year were helped to quit smoking across the Worcestershire council area, down from 2,208 the previous year. And there were no recorded attempts to quit through GPs and only one in a hospital setting.

The BLF was quoted as saying that smokers were bearing the brunt of government budget cuts and were being discriminated against.

British American Tobacco plans to launch its electronic cigarettes in Nigeria in the near future, according to a story in the Nation, relayed by the TMA.

Chris McAllister, MD of BAT Nigeria and West Africa, reportedly said the stability of the exchange rate and the revival of consumers’ purchasing power had given the company “the confidence to continue to invest in our state-of-the art factory in Ibadan and our recently commissioned West African headquarters in Lagos”. 

He added that the company planned to launch “our world leading range of e-cigarettes in Nigeria in the near future”.

McAllister said the company was aware of the health risks of smoking and was investing in products that had the potential to reduce harm.

He said also that BAT Nigeria had worked with the government to reduce the illegal trade in tobacco from 80 percent to about 20 percent. This was the result of having a local manufacturing operation that stimulated a value chain of local businesses.

Commenting on an amendment to the excise tax law, under which the current ad-valorem tax rate will remain at 20 percent while an additional specific rate will be introduced over a three-year period, McAllister said there should be collaboration and consultation between relevant stakeholders for tax policies to be balanced and reasonable, reducing the potential for unintended consequences in respect of both the economy and wider government objectives.