Category: Featured

Compliance Guidance Issued for Disposables

Photo: steheap
The U.K. Vaping Industry Association (UKVIA) has issued compliance guidance for U.K. retailers who sell disposable vape products. Earlier, the association had called on regulators to crack down on resellers and retailers who were found to be flouting U.K. regulations for such products.
An investigation by the UKVIA has revealed mounting evidence of illicit and inappropriately branded disposable vape products hitting the U.K. market and noncompliant sales of such products, particularly in convenience shops and on major online marketplaces. U.K. regulations mean they should contain no more than 20 mg/mL of nicotine, yet evidence collected by the UKVIA reveals that some listed as this amount contain higher concentrations of nicotine and some products are being openly sold with 50 mg/mL strength. Furthermore, product packaging is not including warnings about the nicotine content, which is a legal requirement.
The association has been in discussions with the Medicines and Healthcare Products Regulatory Agency and Trading Standards to address the problem.
“We are doing all we can as a trade association to ensure the industry’s reputation is not tarnished by a minority of resellers and retailers intent on making a quick buck out of a trending product,” said John Dunne, director general of the UKVIA, in a statement. “Whilst disposables have a major role to play in the vape market, like all products, they need to adhere to the legislation.
“Our guidance is designed to ensure retailers keep on the right side of the law. We’re also working closely and are in discussions with leading disposable vape product manufacturers and the major online marketplaces to ensure they play a key role in taking a hard line against those behind the sale of noncompliant products in the country.”
The free guide, available for download here, which has been produced in conjunction with leading vaping compliance specialists Arcus Compliance, provides information on current U.K. regulations in relation to tank/reservoir capacity of devices, nicotine levels and the elements that must be contained on packaging. It also provides details in respect to registrations with and notifications from the MHRA.
September 10, 2021
No Clarity for Top Brands at FDA Deadline

Photo: Araki Illustrations
The much-anticipated deadline for the U.S. Food and Drug Administration to decide on millions of premarket tobacco product applications (PMTAs) passed without bringing the clarity about the future of tobacco harm reduction that many health advocates and industry representatives had hoped for.
On Sept. 9, the agency issued marketing denial orders (MDOs) to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. However, despite a court order to complete the PMTA review process by that date, the FDA failed to make decisions on some of the best-selling vapor products on the U.S. market.
There were no updates on high-profile submissions, such as those submitted by Juul Labs, BAT and Japan Tobacco International. The agency also offered no response to any submitted open-system hardware products or tobacco-flavored e-liquids.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” acting FDA Commissioner Janet Woodcock and FDA Center for Tobacco Products Director Mitch Zeller wrote in a joint statement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
Interestingly, the agency saw fit to issue marketing orders for more than 350 combustible tobacco products under the standard equivalency pathway, many of which, hookah tobacco for example, are flavored tobacco products. All of the issued MDOs were for flavored electronic nicotine-delivery system products.
The FDA’s announcement baffled health advocates and vapor industry representatives alike.
“This looks like being a public health own-goal of historic proportions,” Jonathan Foulds, professor of public health sciences and psychiatry at the Penn State University College of Medicine, wrote on Twitter. “Will be interesting to see whether the stock value of cigarette manufacturers goes up.”
“I want Juul’s five applications to be authorized. I want Reynolds’ two or three dozen applications to be authorized,” echoed Greg Conley, president of the American Vaping Association. “But to see them likely get more time from @FDATobacco after good small businesses spent the last month getting wrecked … Just wrong.”
Vuse owner BAT, for its part, was sanguine. “We remain confident in the quality of our applications, which are supported by scientific evidence that our Vuse and Velo products are appropriate for the protection of public health,” the company wrote in a statement. “In addition, we believe that these categories of important, innovative products may be potentially less harmful than traditional tobacco products.”
Vapor industry representatives have long complained that the PMTA system favors big players. In 2019 court filings, the Vapor Technology Association noted the expenses greatly exceeded the $300,000 to $500,000 per product the FDA estimated in its regulatory impact analysis. Such a burden, say critics, can be borne only by the best-resourced players—i.e., the established tobacco companies. As a result, the products denied market access on Sept. 9 are unlikely to have been rejected because they present a greater health risk than any approved products. Rather, they failed because their manufacturers were unable to navigate the FDA’s complex and costly system.
Meanwhile, the Campaign for Tobacco-Free Kids (CTFK), which helped set the Sept. 20, 2021, deadline through litigation, hinted it might resume legal action to have the court enforce its order requiring the FDA to begin to remove unauthorized products.
“While FDA has said it has ruled on 93 percent of the applications, it hasn’t ruled on the products that have driven the youth e-cigarette epidemic,” said CTFK President Matthew Myers. “Every day those products remain on the market, our kids remain in jeopardy.”
September 9, 2021
Think Tank: Banning E-Cigs Will Boost Smoking

Photo: jedsadabodin
Guy Bentley
Banning many e-cigarettes from the market could harm public health, warns Guy Bentley, director of consumer freedom research at the Reason Foundation, ahead of the deadline for the U.S. and Drug Administration to decide the fate of millions of premarket tobacco product applications (PMTAs).
In a commentary published on the Reason Foundation’s website, Bentley says that the sooner that U.S. public health officials embrace vaping’s potential to improve public health by reducing smoking and smoking-related deaths, the better off we’ll all be.
Today, the FDA is expected to announce which electronic nicotine-delivery systems (ENDS) will be allowed to remain on the U.S. market. The sheer volume of PMTAs—the agency has received more than 6.5 million applications—means that there may not be decision on every product, but the FDA’s announcement will likely cover the majority of the vape market.
To remain on the market, every vapor product must prove to the FDA that it is “appropriate for the protection of public health.” Because the process is expensive and complex, larger companies enjoy a big advantage over their smaller competitors. Experts expect considerable consolidation in the vapor market after today’s announcement.
Most of the vapor products that are likely to be banned are the nontobacco flavors that have proved popular among America’s 15 million vapers. Bentley pointed to a recent study on the effects of San Francisco’s ban on flavored tobacco products, which showed an increase in high school smoking following prohibition. He also cited research by the Centers for Disease Control and Prevention revealing that sweet or fruity flavors are not the primary reason youth vape.
On the positive side, argues Bentley, if the FDA approves some e-cigarettes today, it will help put to rest the arguments about whether these products are beneficial to public health. Many studies suggest that vaping is considerably less harmful than smoking. It has also proven effective in helping people quit smoking traditional cigarettes. Public Health England has famously found e-cigarettes to be 95 percent safer than smoking, for example.
An FDA seal of approval for some cigarettes would force policymakers and anti-smoking advocates to justify their crusades against products that the agency deems to play a role in improving public health.
The majority of vapor products are likely to be banned today, however. In most cases, it won’t be because they are inherently riskier than approved products but because the applicants were unable to navigate the FDA’s complex regulatory system, according to Bentley.
The result of shutting down a vast portion of the vape industry, he warns, will be more smoking.
September 9, 2021
Merchants to Finance Woodlots in Zimbabwe

Since Zimbabwe’s land reform program at the turn of the millennium, the main source of energy for tobacco curing has been wood—a development that has contributed to deforestation. (Photo: Taco Tuinstra)
Leaf merchants operating in Zimbabwe will be required to finance the planting of trees on 0.2 hectares for every hectare of tobacco contracted starting this year, reports The Herald. Firewood is the principal source of energy for curing tobacco in Zimbabwe.
With close to 150,000 farmers, the tobacco industry has been blamed for a massive deforestation in Zimbabwe.
Prior to Zimbabwe’s land reform program at the turn of the millennium, the main source of energy for curing tobacco was coal. The tobacco industry was dominated by large, mostly white-owned plantations at the time.
Today’s tobacco sector, by contrast, is dominated by smallholder farmers who cannot afford coal and the associated infrastructure.
Rodney Abrose, chief executive of the Zimbabwe Tobacco Association, said alternative fuels are needed more than ever.
“Provision of coal is not a sustainable source, and in the near future, tobacco cured with nonsustainable curing fuel may not be accepted by key customers,” he said.
September 9, 2021
Bhutan to Foster Distribution Competition

Photo: satori
Lawmakers in Bhutan are drafting rules to promote greater competition in the distribution of tobacco products, reports Kuensel.
Currently, the country has only one tobacco distributor—Bhutan Duty-Free Limited (BDFL)—according to Economic Affairs Minister Loknath Sharma. “We cannot allow only BDFL to be the sole distributor because the aim is to stop illegal trade and at the same time make tobacco and tobacco products available,” he said.
The Tobacco Control Rules and Regulations (TCRR) 2021 would create “a good distributor wholesale system” in Bhutan, Sharma noted.
The rules are expected to be ready by December, according to Ugyen Tshering, the officiating director general of the Bhutan Narcotics Control Authority (BNCA).
He said that the revision of TCRR was completed and was awaiting the endorsement from the BNCA board to be submitted to the Cabinet.
As interim measures, the government has allowed micro-license holders, such as paan shops and grocery shops, to import tobacco products to meet the growing demand.
With the limited supply of tobacco and tobacco products from BDFL, the paan shops had resorted to the black market.
Bhutan recently moved to lift a longstanding ban on the sale tobacco products. By legalizing tobacco, legislators hope to help check the spread of Covid-19, which they believe has been worsened by the continuous smuggling of tobacco products through Bhutan’s porous southern border.
The manufacture of tobacco products remains illegal, however—as does public smoking.
Tshering said that if someone was caught smoking in a public place—defined as any place with more than two persons—that person would be subject to a BTN500 ($6.77) fine.
Bhutan banned tobacco sales in December 2004. Tobacco Reporter was the first to report from the world’s only officially smoke-free nation.
September 8, 2021
Zimbabwe OKs Tobacco Transformation Plan

Photo: Taco Tuinstra
Zimbabwe’s Cabinet has approved a plan to generate more value from tobacco by localizing financing, increasing production and exporting cigarettes, among other measures, reports The Herald.
“The initiatives should contribute significantly to gross domestic product growth, foreign currency generation and employment creation, thereby raising household incomes,” said Monica Mutsvangwa, minister of information, publicity and broadcasting services.
The plan calls for local funding of tobacco production to complement external funders, raising tobacco production to 300 million kg by 2025, and diversifying into crops such as medicinal cannabis. By 2025, farmers should derive 25 percent of their incomes from alternative crops, according to the plan.
Mutsvangwa said the immediate objective of the plan was to increase tobacco production and productivity through increasing the yield per unit, increasing the area under crop and minimizing losses.
September 8, 2021
Juul Plans Research Facility in North Carolina

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Juul Labs plans to open a research facility in Research Triangle Park, North Carolina, USA, reports WRAL.
The new facility is expected to create 35 full-time jobs, according to a company spokesman.
“We will continue to seek to earn the trust of key stakeholders, including local officials, as we advance the potential for harm reduction for adult smokers while combating underage usage,” Juul said in a statement.
In June, Juul Labs settled a lawsuit brought by North Carolina Attorney General Josh Stein, who accused the company of marketing its product to young people. Juul agreed to pay $40 million but denied wrongdoing or liability. North Carolina was the first state to take legal action against Juul.
At least 13 states, including California, Massachusetts and New York, as well as the District of Columbia, have filed similar lawsuits. The central claim in each case is that Juul knew, or should have known, that it was hooking teenagers on pods that contained high levels of nicotine.
A lawsuit brought against Juul by North Carolina’s Wake County Public School System is currently ongoing.
In 2020, e-cigarette usage decreased by 19.6 percent in high-schoolers and among middle-schoolers by 4.7 percent, according to the U.S. Federal Drug Administration. The U.S. Centers for Disease Control and Prevention contends nicotine can harm adolescent brain development.
September 8, 2021
ENDS Makers Prepare for U.S. Shakeout

Photo: Grispb
The U.S. vaping industry is about to change fundamentally. By tomorrow, Sept. 9, the U.S. Food and Drug Administration must decide whether millions of electronic nicotine-delivery systems are “appropriate for the protection of public health.” Products that don’t meet its standard will have to come off the market or risk enforcement by the agency.
To date, vapor companies have operated without many of the restrictions on sales and marketing governing traditional cigarettes. But the FDA has come under increasing pressure from politicians and public health groups in recent years to limit the sale of vapes, largely over concerns about the products’ popularity with teenagers. E-cigarette companies argue that flavored vapes can help smokers switch to less damaging nicotine products.
Due to the cost and the complexity of submitting a premarket tobacco product application, industry observers expect only a handful of applications, submitted by the wealthiest companies, to survive the vetting process. Many vaping products are produced by smaller companies that lack the resources to thoroughly answer the FDA’s scientific questions about safety, according to Ken Warner, a professor emeritus of public health and tobacco control at the University of Michigan. “Large companies such as Juul only sell a handful of types of e-cigarettes but have the financial resources to stack their applications to make them more likely to be cleared by the agency,” he told Politico.
The FDA, which has said it will likely miss the Sept. 9 deadline for some applications, is prioritizing its review queue based on applicants’ market share. Juul Labs alone controls over 40 percent of the e-cigarette market.
The agency has already rejected a significant share of the estimated 6.5 million applications it received from more than 500 companies. On Aug. 9, the agency issued a “refuse to file” letter to JD Nova Group, notifying the company that the applications it submitted for approximately 4.5 million of its products do not meet the filing requirements for a new tobacco product seeking a marketing order.
In a statement, the FDA said the company’s applications for these products lacked an adequate environmental assessment. Under the FDA’s regulations implementing the National Environmental Policy Act, an environmental assessment must be prepared for each proposed authorization.
On Aug. 26, the agency issued marketing denial orders (MDOs) for about 55,000 flavored ENDS products from JD Nova Group, Great American Vapes and Vapor Salon. In a news release, the FDA explained that the applications from the three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the levels of youth use of such products.
According to Filter, the FDA on Aug. 31 denied an additional 800 flavored vaping products due to incomplete applications. The companies had reportedly planned to submit additional information after the Sept. 9, 2020, deadline. The FDA did not make a separate announcement of these denials on its website.
September 8, 2021
Vuse Becomes No. 1 Global Vaping Brand

Photo: BAT
Vuse is now the No. 1 global vaping brand by value share, according to its manufacturer, BAT.
Vuse is the category value share leader in four of the top five vapor markets (Canada, France, Germany and the U.K.), and BAT’s U.S. momentum in vapor means Vuse is now leader by value share in 22 states, up from 20 in July, BAT announced on its website.
In May this year, BAT also announced that Vuse became the world’s first global carbon neutral vape brand.
“We are delighted that Vuse has become the number one global vaping brand,” said Jack Bowles, CEO of BAT. “It is proof that we are building brands of the future, underpinned by strong innovation, as part of our vision for ‘A Better Tomorrow.’
“In the first half, we delivered 50 percent New Category revenue growth and added 2.6 million consumers of our noncombustible products, our highest ever increase, to reach 16.1 million consumers. This momentum is powered by our strong global brands Vuse, Glo and Velo. Each New Category brand grew its category share by more than 280 base share points [bsp] across key markets and recorded volume growth of 70 percent or more.”
At its half-year results, BAT reported that its vapor business performed strongly, with revenue up 59 percent, volume grew by 70 percent and consumer numbers were up by 0.9 million to reach 7.5 million. Since December 2020, Vuse’s value share is up 340 bsp, reaching 34 percent in July 2021.
September 8, 2021
PMI Reaffirms Full-Year Guidance

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Philip Morris International reaffirmed the company’s 2021 full-year reported diluted earnings per share forecast range of $5.76 to $5.86.
Speaking at the Barclays Global Consumer Staples Conference, PMI CEO Jacek Olczak said the company remained on track for an excellent performance in 2021 underpinned by better combustible volumes and continued strong demand for IQOS. “We are today reaffirming our full-year EPS forecast and now expect to be toward the upper end of our 12 percent to 14 percent organic growth range,” he told investors.
Even as the current global shortage of semiconductors limits PMI’s ability to realize the full potential of IQOS, the underlying momentum of the brand is clear, said Olczak, citing the positive early results for IQOS Iluma in Japan following the launch last month.
At the same time, PMI cautioned that the ongoing global semiconductor shortage could reduce device assortment and availability impacting IQOS user acquisition and the timing of second-half 2021 Iluma launches in certain markets. As a result, full-year 2021 heated-tobacco unit shipment volume could be toward the lower end of the 95 billion to 100 billion unit range, if shortages persist, with third-quarter heated-tobacco unit shipment volume of 23 million to 24 billion units.
An archived copy of the Barclay’s presentation and Q&A session will be available at http://www.pmi.com/2021barclays%20 until Oct. 7, 2021.
September 8, 2021