Tag: news

Massachusetts: Flavor Ban Pushes Sales Next Door

Credit: Aboltin
Massachusetts’ ban of flavored tobacco products is not the success its proponents make it out to be, according to Ulrik Boesen of the Tax Foundation.
While a study published in JAMA Internal Medicine found that the sale of flavored tobacco in Massachusetts decreased more than in 27 control states in the wake of the state ban, the authors failed to consider the impact of cross-border trade.
According to Boesen, increased sales in neighboring New Hampshire and Rhode Island almost completely made up for the decrease in Massachusetts.
“The end result of the ban, in fact, is that Massachusetts is stuck with the societal costs associated with consumption, while the revenue from taxing flavored tobacco products is being raised in neighboring states,” Boesen wrote on the Tax Foundation’s website.
Looking at the New England region as a whole confirms that the flavor ban did not work as intended, according to Boesen. “Sales moved around rather than disappeared, and the ban evidently did not impact consumption,” he wrote. “Total sales for the region decreased by slightly more than 1 percent comparing the 12 months preceding the ban to the 12 months following the ban—largely comparable to the national sales trends.”
Last year, a study by the New England Convenience Store and Energy Marketers Association (NECSEMA), found excise tax lost income in Massachusetts from selling fewer menthol cigarettes alone amounted to $62 million in the first six months of the ban. No specific figures were given for electronic nicotine delivery systems in the release for that study.
The previous study also found that losses simply transferred to Massachusetts’ neighboring states. Cigarettes excise tax stamp sales dropped 23.9 percent in Massachusetts while New Hampshire gained $28,574,340 or 29.7 percent. Rhode Island gained $12,100,000 or 18.2 percent in excise taxes.
The previous study’s estimated Massachusetts loss including the sales tax is $73,008,000 while Rhode Island saw a gain of $14,066,740.
As the U.S. Food and Drug Administration and other states consider Massachusetts’ example, Boesen urges lawmakers to think twice before banning flavored tobacco products. “The experience out of Massachusetts has not been a success story and other states should be wary of conducting their own expensive experiments,” he wrote.
February 4, 2022
Court of Appeals Stays Bidi Vapor Marketing Denial Order
The U.S. Court of Appeals for the Eleventh Circuit has stayed the marketing denial order (MDO) issued by the U.S. Food and Drug Administration to Bidi Vapor in September 2021. The FDA had previously issued an administrative stay to Bidi Vapor, however, the agency rescinded that stay in December.
The Feb. 1, 2022, ruling allows Bidi Vapor and Kaival Brands to market and sell all of its Bidi Stick electronic nicotine-delivery systems (ENDS), including its tobacco, menthol and flavored products, while Bidi Vapor continues with its merits lawsuit compelling the FDA to place Bidi Vapor’s premarket tobacco product application (PMTA) for the flavored ENDS back under scientific review.
With the judicial stay decision going in favor of Bidi Vapor, the company expects many distribution partners to reestablish their previous sales volumes, with potentially new distribution chains added as well.
“We expect this judicial stay will result in a rebounding of Bidi Stick sales,” said Niraj Patel, president and CEO of both Kaival Brands and Bidi Vapor, in a statement. “Many wholesale and retail partners had discontinued or slowed purchases of the Bidi Stick until we heard back from the courts on the likelihood of our merits case succeeding. This is what our wholesale and retail partners have been waiting for.”
“We believe that Bidi Vapor has developed substantial, robust and reliable scientific evidence through, among other things, surveys, behavioral studies and clinical trials establishing support that the product is appropriate for the protection of the public health,” Patel said. “Following on FDA’s initial administrative stay of the MDO, we believe that this recent judicial stay is a good indication that the court finds some merit in Bidi Vapor’s arguments and puts Bidi Vapor’s PMTA one step closer to being properly and fully evaluated by FDA. We are extremely pleased with the court’s decision on this judicial stay order and continue to expect to be successful on the merits case as well.”
“The company believes that this decision signals a new milestone in the path toward providing adult smokers 21 and older with a viable alternative to combustible cigarettes. Distributors, wholesalers, retailers and adult consumers are all anxious to see positive outcomes not just for Bidi Vapor, but for the vaping industry as a whole. We believe in science-based regulation of ENDS and hope the courts will require FDA to adhere to the law as it reviews Bidi Vapor’s PMTAs,” Patel said.
February 3, 2022
South Africa Public Comment Period on Vape Tax Ends Soon
Credit: Tim Johnson
South Africa’s National Treasury (SANT) says the public comment period on its proposals to impose a specific excise tax on both the non-nicotine and nicotine e-liquids for vaping products will end on Feb. 7, 2022. The SANT published a draft discussion paper in December 2021 on the proposed taxation of electronic nicotine delivery systems (ENDS) and electronic non-nicotine delivery systems (ENNDS).
Traditional tobacco products in South Africa are subject to excise duties at a rate of 40 percent of the price of the most popular brand in each tobacco category, according to Longevity. When applied to e-cigarettes, users could pay excise duty ranging from ZAR33.60 to ZAR346.00 ($22.50) per product, depending on the nicotine content and size of that product. The average excise rate for e-cigarettes is proposed at ZAR2.91 per mL and apportioned in a ratio of 70:30 between nicotine and non-nicotine elements.
Basically, users could pay ZAR2.03 per mL of e-liquid containing nicotine and 87 cents per mL of e-liquids that contains no nicotine, if the draft proposals are accepted and become legislation. Products with a higher nicotine content will attract a higher rate of duty compared with lower nicotine products.
Manufacturers and importers who become liable for the proposed excise taxes on e-cigarettes will need stringent certifications by accredited laboratories, which use either South African National Accreditation or International Laboratory Accreditation Co-operation (ILAC) approved methodologies.
According to 2021 study commissioned by the Vapor Products Association of SA, the vapor industry in 2019 contributed ZAR2.49 billion to South Africa’s GDP while paying ZAR710 million in taxes. More than 350,000 South Africans use vapor products.
February 2, 2022
Triton Unleashes its Opening Argument in FDA Lawsuit
In a highly anticipated case for the vapor industry, Triton Distribution made its opening arguments Monday in its battle with the U.S. Food and Drug Administration over how the regulatory agency conducted it premarket tobacco product application (PMTA) reviews. Triton’s lawyer urged a three-judge panel of the 5th U.S. Circuit Court of Appeals in Houston to conclude the FDA could not force manufacturers to provide studies that the agency had previously stated would not be required.
“The question before the court concerns how exactly the FDA ended up denying Triton’s PMTA—with potential implications for comparable applications by many other denied companies,” said Triton’s attorney Eric Heyer, a partner at Thompson Hine.
Credit: Sergign
In August, the FDA rejected applications to market 55,000 flavored e-cigarettes, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval, according to Reuters. The new requirement for long-term studies differed from earlier FDA guidance and was a “surprise switcheroo,” a 5th Circuit panel concluded in October when it allowed Triton to keep selling e-cigarettes until another panel could hear its appeal.
In recently released internal FDA correspondence, the agency’s scientific staff conducted “fatal flaw” reviews that only looked for the presence of the newly required long-term studies, and if those studies were not present the agency issued a marketing denial order (MDO). During oral arguments, Heyer said the FDA’s new requirement was “arbitrary and capricious, a position conservative U.S. Circuit Judge Edith Jones appeared to agree with.
“It seems to me that’s the height of arbitrariness and capriciousness, to say we are the FDA, trust us, which I might say some of us are becoming skeptical about in light of recent vaccine experiences,” she said, alluding to COVID-19 vaccines.
Heyer argued that the process the FDA established set Triton up for failure because the new requirements were only conveyed after the deadline for when PMTAs needed to be submitted (Sept.9, 2020) had passed. It was only then that the FDA indicated that applicants would likely need randomized controlled trials (RCTs) and longitudinal cohort studies to demonstrate “comparative efficacy.”
The other two judges questioned Triton’s case. U.S. Circuit Judge Gregg Costa asked whether Triton’s products, such as one called Jimmy the Juiceman Strawberry Astronaut, were really targeted to adults. “That’s supposed to be appealing to a 40-year-old?” he asked.
U.S. Circuit Judge Catharina Haynes questioned why companies like Triton did not have enough time to develop such support for their products’ health benefits for adults given the years they have had to prepare for FDA regulation. The FDA in 2016 deemed e-cigarettes to be tobacco products like traditional cigarettes subject to agency review under the Tobacco Control Act. Manufacturers were ultimately given until 2020 to seek approval to market them.
If the court disagrees with Triton’s argument, Heyer has requested that the judges “enjoin FDA from taking further adverse action on the Petitioners’ PMTAs for 18 months to allow Petitioners to conduct the necessary studies to prove comparative efficacy,” according to legal documents.
There is no timeline for a decision in the Triton lawsuit. Judges are expected to take at a minimum weeks, if not months, to make a decision.
February 1, 2022
Israel: Knesset Finalizes Modified Version of Vapor Tax

Photo: Spiroview Inc.
The finance committee of Israel’s Knesset has approved a slightly modified version of the tax on vaping hardware and e-liquid that was imposed last November, reports Vaping360.
Although the committee reportedly eliminated a separate tax on disposable products, Israel will still have the highest vape tax in the world. Effective immediately, all vaping products will be subject to a tax equaling 270 percent of the wholesale cost, plus NIS15.6 ($4.94) per milliliter of e-liquid.
Both the finance and health ministries aimed to tax vaping products at the same rate as cigarettes. Maintaining that vaping is just as dangerous as smoking, the health ministry initially sought an even higher tax. According to Israel Hayom, Finance Committee Chairman Alex Kushnir “reduced the conversion formula by 30 percent compared to what the Ministry of Health wanted.”
February 1, 2022
Malaysia Proposes Vaping Ban for People Born After 2005
Malaysia’s Ministry of Health (MOH) clarified that its proposed smoking ban for everyone born after 2005 does not only cover cigarettes and tobacco products, but also vape, e-cigarettes, and heated tobacco products.
Credit: Peter Nguyen
Health Minister Khairy Jamaluddin announced at the World Health Organization’s (WHO) executive board meeting in Geneva about Malaysia’s plans to prohibit the sale of cigarettes and tobacco products to people born after 2005 in a bid to outlaw smoking for the next generation.
This means that Malaysians who are 17 years old today will not be able to legally buy tobacco, vape, or e-cigarettes next year when they turn 18, the current legal age for smoking in Malaysia, or ever, in their lifetime. Neither will subsequent generations be ever permitted to purchase cigarettes and other smoking products.
An MOH official said the prohibition covered all tobacco products, including cigarettes, cigars, tobacco leaves, and smokeless tobacco, as well as electronic devices like vape or e-cigarettes and heated tobacco products.
“Tobacco products, smoking substances, substitute tobacco products, and smoking devices,” the MOH official told CodeBlue.
Disposable e-cigarettes or vape pens are also sold in Malaysia. Some e-liquids and disposable vapes do not contain nicotine.
“Wait for RUU,” the MOH official said when asked if the proposed generational ban on the sale of tobacco and smoking products covered zero-nicotine vape liquids. He was referring to the new Tobacco and Smoking Control Act that the government plans to table in the upcoming Parliament meeting, according to the story.
The government previously announced during the tabling of Budget 2022 plans to tax vape and e-cigarette liquids containing nicotine, essentially legalising vape products that are presently under a grey area of regulation.
Current tobacco control legislations under the Food Act 1983 do not cover vape or e-cigarettes. However, under the Poisons Act 1952, nicotine can only be supplied by pharmacists or medical practitioners.
January 31, 2022
Halo Granted USPS Exemption for Mailing Vape Products
Pure Labs, parent to the Halo brand of vaping products, is now approved by the U.S. Postal Service (USPS) to ship e-liquid and other vaping products to compliant businesses through the brand’s Master Distributors; Syndicate Global Distribution and Halo Wholesale Direct, according to a press release.
The approval allows both Syndicate Global Distribution and Halo Wholesale Direct to ship Halo products, categorized as electronic nicotine delivery systems (ENDS), as a business and regulatory exception to the PACT (Prevent All Cigarette Trafficking) Act.
The original PACT Act (2009) was amended by Congress on December 27, 2020 to incorporate e-cigarettes and vaping products.
“This is a huge win for Halo and for all of our retail partners.”, said Kevin Dietz, director of Halo brand sales. “Halo’s tobacco and menthol vape products are in-demand by adult consumers throughout the country, and we are excited to have USPS solidify the supply chain. Halo has been here from the start and has numerous ENDS products in the final stage required for FDA Authorization, furthering Halo’s commitment to remain America’s #1 tobacco-flavored e-liquid brand”.
January 31, 2022
Korea: E-Cigs Gain Ground as Combustibles Stagnate

Photo: Dzmitry
Sales of cigarettes in South Korea were flat from 2020 to 2021 but demand for electronic cigarettes rose amid the protracted pandemic, reports the Yonhap News Agency, citing data from the finance ministry.
South Korean smokers purchased 3.59 billion 20-cigarette packs in 2021, similar to the number logged the previous year, according to the Ministry of Economy and Finance.
Sales of traditional cigarettes fell 2 percent on-year to 3.15 billion packs last year, while those of heat-not-burn tobacco products rose 17.1 percent to 440 million packs.
Compared with 2014, however, cigarette sales declined 17.7 percent last year—a development the government attributed to rising prices and anti-smoking campaigns.
In January 2015, South Korea increased cigarette prices by 80 percent to KRW4,500 ($3.72). The next year, the government required tobacco companies to print graphic images depicting the harmful effects of smoking on the upper part of cigarette packs.
As of 2020, the smoking rate among Korean men aged 19 or older dropped to a record low of 34 percent, down 1.7 percentage points from a year earlier, according to the health ministry.
January 30, 2022
Philippine Vaping Bill Heads to President Duterte’s Desk

Photo: Oleksii
The Philippine House of Representatives and Senate have ratified a vaping bill that critics describe as too industry friendly. The legislation will now be forwarded to President Rodrigo Duterte for his signature.
Among other provisions, the bill transfers regulatory powers from the Food and Drug Administration to the Department of Trade and Industry (DTI) and lowers the legal purchase and consumption age for vapor products from 21 to 18. The DTI is also in charge of setting technical standards for the safety, consistency, and quality of these smoking alternatives.
Philippine College of Physicians (COP) President Maricar Blanco-Limpin said he was particularly concerned about the lower vaping age. “We have been telling all the legislators that making these more available at a younger age is making these e-cigarettes and heated tobacco products more available to all including the non-smokers,” she told CNN Philippines.
Limpin said vape products could lead to health concerns and the “mandate to protect the health of the country falls under the FDA, not the DTI.”
If the President signs the measure, Blanco-Limpin said the COP would consider all actions, including bringing the issue to the Supreme Court.

January 30, 2022
FDA Seeking Applicants for New CTP Director

Credit: Sean Locke Photography
The U.S. Food and Drug Administration is now accepting applications for the position of director, Center for Tobacco Products (CTP). The current director, Mitch Zeller, plans to retire in April.
The CTP director is responsible for planning, managing, directing and coordinating major tobacco program objectives to implement the Tobacco Control Act and related regulations.
This senior-level FDA position advises the FDA Commissioner, senior FDA officials and others on all matters involving tobacco product regulation that have an impact on policy development and execution and long-range program goals. The director develops and executes the strategies for compliance outreach, enforcement, regulations and guidance formulation, science-based application review and other product regulation activities.
The individual selected for this position will represent the agency and establish/maintain relationships in meetings and conferences with top level FDA and Health and Human Services officials, national industry representatives, members of Congress, counterparts from federal, state, local and foreign governments.
Candidates must complete their applications by 11:59 p.m. on Feb. 25, 2022.
January 29, 2022