Category: Featured

Additional Products Denied Market Access

Photo: chase4concept
The U.S. Food and Drug Administration on Sept. 3 issued another round of marketing denial orders to 31 companies. “After issuing marketing denial orders (MDOs) to three companies for their flavored ENDS products last week, @FDATobacco issued MDOs to an additional 31 companies for approximately 300,000 flavored ENDS products from Aug. 27 through Sept. 2,” the agency tweeted.
Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products. The regulatory agency did not release the names of the companies.
According to its website, the FDA plans to release the names of the companies that received MDOs. Previously, the agency gave the names only of the first three manufacturers to receive MDOs for vapor products. “FDA understands that the public may be interested in the specific names of the currently marketed products subject to the negative decisions,” the FDA wrote. “However, before releasing this information, FDA needs to ensure the agency is not releasing the applicant’s commercial confidential information. Given the large number of products involved, sharing this information requires additional time and resources. Accordingly, FDA is actively exploring options related to this issue.”
In a release, the FDA wrote that companies receiving these MDOs may have submitted premarket applications for other products “(such as ENDS devices, tobacco-flavored ENDS or menthol-flavored ENDS),” and those products, if still pending, remain under review at FDA.
“FDA continues to make substantial progress reviewing the unprecedented number of applications received by the Sept. 9, 2020, court-ordered deadline for submission of premarket applications for deemed new tobacco products,” the agency stated. “The aggregate information on these actions will be provided within our regular updates on the ‘Tobacco Product Applications: Metrics and Reporting’ page.”
As of Sept. 3, the FDA website lists 27 companies that have been issued MDOs:
    Great American Vapes
    JD Nova Group LLC
    Vapor Salon
    Big Time Vapes
    J-Vapor LLC dba North Shore Vapor
    SS Vape Brands Inc. dba Monster Vape Labs
    Custom Vapors
    The Vaping Tiger
    Gothic Vapor
    TrendSetters E-liquid LLC
    SWT Global Supply
    Diamond Vapor
    American Vapor Group
  MV Enterprises
    Planet of the Vapes
    CITTG dba Orgnx E Liquids
    Vapors of Ohio Inc. dba Nostalgic Vapes
    Buckshot Vapors Inc.
    Royalty Premium E Juice
    Imperial Vapors
    Midwest Vape Supply
    Dominant Vapor
    Mountain Vaporz
    Sir Vapes -A-Lot
    Loveli Design LLC dba
    Alice in Vapeland
    Nicquid
The first MDOs were announced on Aug. 26. According to the FDA, JD Nova Group, Great American Vapes and Vapor Salon didn’t provide adequate information to show their rejected products offered enough benefit to adult smokers sufficient to overcome the public health threat posed by the “well-documented, alarming levels” of youth use of such products.
The FDA has received applications from over 500 companies covering more than 6.5 million tobacco products. The agency refused to file more than 4.5 million applications from the JD Nova Group alone. The agency has until Sept. 9, 2020, to decide on the remaining PMTAs.
September 6, 2021
Indonesia Plans Cigarette Tax Hike

Photo: Taco Tuinstra
The Indonesian government is planning to raise the nation’s cigarette excise tax rates in an effort to reduce smoking prevalence, particularly among children, reports Tempo. The amount of the increase has not yet been determined.
“If we look at the data in 2019, it (the smoking prevalence among children) was still 9.1 percent. So there’s still quite a lot to be dropped,” said Titik Anas, the Finance Ministry’s special staffer for sectoral fiscal policy.
“The price of cigarettes in Indonesia is actually higher compared to the Philippines, Thailand and Vietnam. But if we compare it with Singapore and Malaysia, it is still relatively cheap.” Titik also warned that the government must be careful in increasing the cigarette excise tax as it will potentially spur illicit cigarette trade.
September 3, 2021
Filter: FDA Denies Additional 800 Products

Photo: Boki
The Food and Drug Administration on Aug. 31 denied the premarket tobacco product applications for 800 vaping products from three e-liquid manufacturers, according to Filter. The marketing denial orders have not been published on the agency’s website.
Earlier in August, the FDA announced its first outright denial of 55,000 flavored vaping products from three other companies. Prior to that, the FDA refused to file 4.5 million of the 6.5 million applications sent to the agency because the company that put them together did not include appropriate environmental assessments for each product.
All of the products rejected on Aug. 31 were flavored, and consumer advocates and manufacturers are worried that the FDA is moving toward an effective flavor ban.
According to industry consultant Dimitris Agrafiotis, the applications he helped the three companies file were unfinished. The companies had intended to send more data piecemeal to the agency as substantial product stability testing wrapped up. Just last week, his clients drafted a letter to the FDA, stating that they would be sending further information.
Agrafiotis said that each company he represents is now moving into the synthetic nicotine space, a legal gray area. The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”
The FDA has until Sept. 9 to determine the legality of other vaping products, though the agency has signaled it will rule on the major players but not complete the process for everybody else by then.
September 2, 2021
TJP Launches Pouch Factory in Canada
TJP Labs has launched Canada’s first modern oral nicotine contract manufacturing facility for oral nicotine pouches in Pickering, Ontario. TJP Labs will provide international brands (and when authorized for sale in Canada, domestic brands) contract manufacturing capacity to service the rapidly expanding category. Production is expected to commence in the first calendar quarter of 2022.
Spread over a 30,000-square-foot campus, the factory will include G.D nicotine pouch manufacturing machinery. The new facility will have high-speed pouch filling and packaging rebuild lines, internal precision x-rays for automated purity control and auto weighing and photography to ensure the highest standards of consumer safety and product efficacy.
Phase 1 is expected to provide TJP Labs the capacity to produce over 36 million pouches per month, and Phase 2 should double that capacity. Phase 1 is expected to be completed by December 2021 and Phase 2 by the fourth quarter of 2022.
“Our team set out on our mission of engineering harm reduction solutions for a global network of customers seven years ago when my mother passed away from a combustible tobacco-related illness,” said David Richmond-Peck, CEO of TJP Labs, in a statement.
“The launch of this facility sets the foundation of our goal to build a network of international facilities for this rapidly growing category. We are proud that we will be able to provide manufacturing solutions to companies that give adult consumers a less harmful alternative to combustible tobacco products. Our multiple licenses, including Health Canada site license, FDA FEI, ISO 9001:2015, HACCP and cGMP, speak to the rigorous standards that we uphold and look forward to serving companies globally.”
September 2, 2021
KT&G Publishes 2020 ESG Report
KT&G published its 2020 KT&G Report, which presents the company’s environmental, social and governance (ESG) management and social contribution activities.
In this report, KT&G disclosed its mid-term to long-term vision for ESG and its sustainability management strategy to achieve this vision. The company has defined six key ESG value creation areas linked with business and plans to enhance future growth potential by strengthening these areas: strengthening the growth potential of businesses contributing to sustainability; performance of environmental responsibility across the value chain; responsible product development; creating a sustainable industrial ecosystem; strengthening human resource management and human rights protection; and advancement of governance and strengthening of implementation capacity.
By 2025, the company will use packaging materials made from recyclable materials for 100 percent of its products as part of its step-by-step strategy for achieving environmental management goals such as 2050 carbon neutrality, and it will conduct a company-wide human rights impact assessment, not only in Korea but also in overseas subsidiaries. In addition, the scale of business-related social contribution projects conducted by the company has more than doubled compared to 2020.

Environmental responsibility across the value chain and sustainable supply chain management are no longer the responsibilities of future generations but are risks and opportunities for us.
Bok-in Baek, president and CEO, KT&G
“Environmental responsibility across the value chain and sustainable supply chain management are no longer the responsibilities of future generations but are risks and opportunities for us,” said Bok-in Baek, president and CEO of KT&G, in a statement. “We will lay the foundation for enhancing corporate value through the creation of business-related sustainable management values, and based on this, we will strengthen future business growth potential.”
September 2, 2021
New MD at German E-cigarette Association

Michal Dobrajc (left) and Oliver Pohland (right) (Photo: VdeH)
Oliver Pohland has been named managing director of the German e-cigarette association Verband des e-Zigarettenhandels (VdeH). He succeeds Michal Dobrajc, who served in the position since Dec. 21, 2018.
Pohland has years of experience in the private sector and political association management. He also has an extensive network at the state, federal and EU levels. Most recently, Pohland served as the federal manager of the THW Federal Association.
Pohland, who successfully quit smoking through vaping, plans to advocate for reasonable regulation of vapor products at all levels. In his view, the beleaguered vaping sector should be given an opportunity to grow and assist smokers in switching to less harmful nicotine products.
Earlier this year, the VdeH campaigned vigorously against government plans to significantly raise taxes on vapor products.
“I am really looking forward to my new job,” said Pohland in a statement. “As managing director, I will use all my expertise and experience to create a legal framework that benefits all member companies. My goal is to give the members of VdeH a strong voice at all levels of politics.”
Dobrajc, who will continue chairing the VdeH for the time being, said he looked forward to working with Pohland.
“In Oliver, we have gained an experienced expert on the German and European political landscape,” he said. “I am confident that the VdeH will benefit from his pragmatic and honest way of working.”
September 1, 2021
Imperial Launches HnB Products in Czechia

Photo: Imperial Brands
Imperial Brands has launched its heated-tobacco products in the Czech Republic.
The launch is the first of two planned European pilot trials for the company’s Pulze device and iD heat sticks.
Imperial is investing in heated-tobacco opportunities in a focused number of markets in Europe as part of its new strategy to build a targeted and sustainable next-generation product (NGP) business.
The Czech pilot is the first step in Imperial’s approach of entering markets where the category is already established and where the business is able to leverage an existing strong route to market.
“Heated-tobacco offers significant growth opportunities in Europe where, in many territories, it is the biggest NGP category and the fastest growing,” said Joerg Biebernick, Imperial Brands’ president of the European region, in a statement. “Detailed market testing will allow us to quickly expand our consumer insights and inform the potential to launch validated heated-tobacco products in further European markets.”
Heated-tobacco currently accounts for around 10 percent of the total nicotine sector in the Czech Republic, with further strong growth anticipated.
The Pulze device heats rather than burns iD heat sticks to provide nicotine and tobacco aromas containing fewer and substantially lower levels of the harmful chemicals found in cigarette smoke.
Unlike other heated-tobacco products, the Pulze device does not require a charging case, offering up to 20 consecutive uses. It is available in copper and silver colors.
iD heat sticks are being made available in five flavors: Rich Bronze with rich tobacco flavor and triple flow filter technology, Balanced Blue, Mint Polar Green, Mint Ice and Capsule Polar.
September 1, 2021
FCTC Conference of the Parties Moves Online

Photo: Olrat
The Ninth Session of the Conference of the Parties (COP9) to the World Health Organization Framework Convention on Tobacco Control (FCTC) and the Second Session of the Meeting of the Parties (MOP2) to the Protocol to Eliminate Illicit Trade in Tobacco Products will take place virtually, with COP9 running Nov. 8–13, 2021, and MOP2 running Nov. 15–18, 2021.
The meetings were originally scheduled to take place in The Hague. In view of the ongoing Covid-19 pandemic and related travel restrictions, the WHO has decided to move the events online.
The virtual format means participants will consider abridged agendas, the WHO wrote on its website. Several issues, including ones relating to tobacco harm reduction, will be deferred for discussion until the next regular meeting of the governing body, COP10, in 2023.
September 1, 2021
‘Spike in Seizures Hints at Illegal Production’

Photo: Veronika Kovalenko
A recent spike in loose tobacco seizures by authorities suggests there are “large-scale” illegal cigarette factories operating in Ireland, according to Retailers Against Smuggling (RAS).
To date, law enforcement has seized 13.5 tons of loose raw tobacco with a combined estimated retail value of €8.1 million ($9.57 million), representing a potential loss to the Exchequer of €6.7 million.
“The significant volume of the consignments being seized and the elaborate means being used to conceal this raw tobacco suggests that it’s unlikely the product is intended for direct resale to the consumer on the black market,” RAS national spokesperson Benny Gilsenan was quoted as saying by The Journal.
Instead, such shipments are likely destined for illegal cigarette-making factories operated by criminal gangs in either the Republic of Ireland or Northern Ireland, he said.
Ireland’s first illegal commercial-scale cigarette production plant was uncovered in 2018. Authorities seized up to 66 tons of raw tobacco during that operation.
The 13.5 tons seized this year is sufficient to manufacture between 13 million and 15 million cigarettes.
In its pre-budget 2022 submission to Minister for Finance Paschal Donohoe, RAS argued that continuous excise increases on tobacco are fueling demand for a growing black market, urging against an increase in October’s announcement.
“The continued growth of the black market can only be halted by stopping the continuous excise increases on tobacco products, the retail price of which is 121 percent above the EU average, according to a new Eurostat survey issued today,” Gilsenan argued.
September 1, 2021
Imperial Names New Nonexecutive Directors

Photo: akub Jirsák | Dreamstime.com
Ngozi Edozien and Diane de Saint Victor will join the Imperial Brands board as nonexecutive directors, effective Nov. 15, 2021.
Edozien brings over 30 years’ experience in general management, finance, consultancy and business development gained at multinational companies in Europe, the U.S. and Africa. She has considerable experience of consumer goods, having spent six years on the board of PZ Cussons and four years on the board of Vlisco, and she is currently a nonexecutive director on the board of Guinness Nigeria, a listed subsidiary of Diageo.
During a nine-year career with Pfizer, she led strategy and planning for pharmaceuticals, based in New York, before taking up a regional director role in Africa. Prior to Pfizer, she spent five years with McKinsey, working mainly in the consumer goods and pharmaceuticals sectors. She gained strong commercial experience over five years with Actis, the Africa-focused private equity business, where she originated and led deals in West Africa.
Edozien is the founder and managing director of Invivo Partners Limited, a Nigerian venture capital firm. In addition to her membership on the board of Guinness Nigeria, she is a current nonexecutive director of Stanbic IBTC Holdings and of Barloworld.
De Saint Victor will bring strong legal, regulatory and ESG experience, having held a number of general counsel and other key roles in an international career spanning more than 30 years. Her 13-year tenure as general counsel and company secretary for ABB, a global technology company based in Switzerland and her general counsel role at Airbus before that are reinforced by her prior listed U.K. board experience as a nonexecutive director at Barclays.

I am delighted to welcome both Ngozi and Diane to the board. They will bring considerable international experience across our developed and developing markets.
Therese Esperdy, chair, Imperial Brands
De Saint Victor has experience transforming organizations in sectors undergoing change, most notably at ABB where she was an executive committee member. She also brings a wealth of regulatory and government relations experience, having served as vice president of government relations for Europe at Honeywell International and as part of the U.S. government relations team in Washington for General Electric Co. She is currently a nonexecutive director at Transocean, an international oil drilling business, and is also a nonexecutive director of Natixis, the French financial services firm.
“I am delighted to welcome both Ngozi and Diane to the board,” said Imperial Brands chair Therese Esperdy in a statement. “They will bring considerable international experience across our developed and developing markets.
“These appointments reflect our continued drive to enhance our board capabilities to bring insight and experience from relevant markets and sectors whilst focusing on all aspects of diversity to ensure we have the best possible mix of skills, experience and perspective to drive the business forward.”
September 1, 2021