Author: Staff Writer

U.S. FDA has Made Decisions on Over 99 Percent of PMTAs

The U.S. Food and Drug Administration today stated it has made determinations on more than 99 percent of the nearly 26 million deemed tobacco products for which premarket tobacco products applications (PMTAs) were submitted. The agency has said previously that reviews for some of the most popular vaping products may take until the end of the year.
The FDA also announced it issued a refuse-to-accept (RTA) letter on Feb. 21, to one applicant notifying a company that their PMTAs, which are associated with approximately 17 million individual tobacco products, do not meet the acceptance requirements outlined in FDA’s regulations.
“The applications were for a grouped submission of e-liquids in varying size, nicotine strength, and flavor combinations, each of which was treated as an individual product application according to existing premarket review processes,” the FDA wrote in a statement.
The agency’s overall determinations include authorizing 23 new e-cigarette products and devices, and issuing refuse to accept (RTA) letters, refuse to file letters, or marketing denial orders for millions of products.
The data includes determinations on applications for nearly 6.7 million products received by the Sept. 9, 2020, deadline, more than 18 million products received after the Sept. 9 deadline, and applications for nearly 1 million non-tobacco nicotine products submitted by May 14, 2022, in accordance with the new federal law passed in April 2022.
Under a federal court order, manufacturers of deemed new tobacco products that were on the market as of the deeming rule’s effective date (Aug. 8, 2016) were required to submit premarket review applications by Sept. 9, 2020.
March 15, 2023
Congress Seeks to Close E-Cigarette Ad Loophole

For more than five decades, tobacco ads have been prohibited on radio, but advertising for e-cigarettes and other vaping related products have made their way onto the airwaves in recent years.
In an effort to make such marketing less attractive, the U.S. Congress wants to close a tax loophole that allows manufacturers to claim federal tax deductions for the cost of advertising for e-cigarettes and tobacco products. That includes the ads they buy on the radio.
Senators Jeanne Shaheen and Richard Blumenthal have reintroduced the No Tax Subsidies for E-Cigarette and Tobacco Ads Act (S. 464), which if passed would not make the direct-to-consumer ads illegal, but would end the ability for companies to take tax deductions for advertising expenses related to vaping and other tobacco products, according to Insider Radio.
“Tax breaks for tobacco and e-cigarette giants allow the industry to profit from its manipulative marketing,” Blumenthal said. “Our legislation ends these write-offs to protect kids and other consumers from being lured into lifetimes of addiction.”
Radio and television advertising for traditional tobacco products has been banned under federal law since January 1971, and certain other forms of tobacco advertising are restricted under the 1998 Tobacco Master Settlement Agreement. However, none of these restrictions apply to e-cigarettes.
March 15, 2023
New Bill Proposes Combustible ‘Endgame’ in Nevada

Credit: Peter Zayda
A new bill in the U.S. state of Nevada seeks to end all combustible cigarette sales in the state by 2030 and would also include flavored e-cigarettes.
The bill would ban all e-cigarettes that are flavored to taste like something other than tobacco, but spares most other non-combustible tobacco products.
Assemblyman David Orentlicher has introduced A.B. 294, which would make several changes to how combustible tobacco products other than premium cigars are sold in the state, essentially outlawing their sale by 2030, reports Charlie Minato of Halfwheel.
Among other things, the bill would bar the Nevada Department of Taxation from issuing any license to any vending machine operator, manufacturer or wholesale dealer of combustible cigarette products on or after Jan. 1, 2029.
The licenses are only valid in the calendar year they are issued, meaning there would be no licensed wholesale dealers beginning on Jan. 1, 2030.
It would also make it illegal to sell combustible tobacco products to anyone born on or after Dec. 31, 2002.
March 15, 2023
Hearing Set for FDA Manufacturing Requirements

Photo: Jon
Registration is open for U.S. Food and Drug Administration’s upcoming public oral hearing on April 12, 2023, from 9:30 am to 5 pm.
The hearing is an opportunity for the public to verbally comment on the agency’s proposed rule “Requirements for Tobacco Product Manufacturing Practice.” The FDA is proposing new requirements for vaping and other tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. Registration also includes a “listen-only” option for those who want to attend the session but do not want to request to speak.
Speaking spots are limited, and the FDA says it cannot guarantee that it will be able to accommodate all requests. Groups and organizations should select a single spokesperson to help the agency hear as many different perspectives as possible. While speaking spots are limited, listening spots are unlimited. Registration to provide oral comments will close on March 31, 2023.
The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.
March 14, 2023
Court: Prohibition of Vapes in County Jail ‘Went too Far’

Credit: Methaphum
An attempt by county commissioners in the U.S. state of Indiana to regulate e-cigarette and nicotine use in the local jail went too far, the state’s Court of Appeals has affirmed.
In 2012, the Indiana Legislature prohibited smoking in places of employment, state government vehicles, public places, and within eight feet of an entrance to a public place or place or employment.
After passage of that legislation, the commissioners of Clinton County enacted an order prohibiting smoking in all county offices and places of employment, including the county jail, according to The Indiana Lawyer.
Then in 2019, the Clinton County Sheriff’s Office received a certificate from the Indiana Alcohol and Tobacco Commission authorizing it to sell e-cigarettes and nicotine pouches to inmates. The inmates began purchasing the products and using them while housed in the jail.
According to the sheriff’s office, “disciplinary incidents and property damages … significantly decreased” after it received the certification, and the sales were generating enough income to be used for educational programs, religious literature and extra training opportunities for the inmates.
However, in 2021, the county commissioners passed an order that prohibited e-cigarettes and any smokeless tobacco in all county offices and buildings. The sheriff’s office immediately stopped selling e-cigarettes and nicotine pouches at the jail.
But the sheriff’s office also filed a complaint for declaratory judgment in Montgomery Superior Court, arguing the commissioners were attempting to regulate the conduct of inmates, which exceeded their authority.
For their part, the commissioners claimed they had authority to enact the order based on Indiana’s Home Rule Law.
Both parties moved for summary judgment, and the trial court ruled in favor of the sheriff’s office. It also denied the commissioners’ subsequent motions to correct error and for relief from judgment based on newly discovered material evidence.
The commissioners appealed and the Court of Appeals affirmed.
“In circumstances like those before us, where the Sheriff’s Office is required to take reasonable precautions to protect the life, safety, and health of an inmate in the county jail, ‘county commissioners do not have control over the acts of a sheriff,’” Judge Melissa May wrote, citing Robins v. Harris, 740 N.E.2d 914, 919 (Ind. Ct. App. 2000). “While the Commissioners have the power to enact a general ordinance governing the use of e-cigarettes in county buildings under the Home Rule Act, the Commissioners do not have the authority to regulate the use of e-cigarettes in the county jail because that power is entrusted in the Sheriff’s Office pursuant to the Take Care Provision (Indiana Code § 36-2-13-5(a)(7)).”
March 14, 2023
ZoVoo, VoPoo to Launch Dragbar Z700 SE Today

The disposable e-cigarette brand ZOVOO and its sister brand VOOPOO are launching the revolutionary Dragbar Z700 SE in 2023. The new Dragbar will be officially launched on March 15.
Equipped with the self-developed Gene Tree ceramic coil technology solution, the Dragbar Z700 SE features the largest puff count among the TRPR & TPD compliant products, according to an emailed release.
Compared with the competitors in the market, the Gene Tree ceramic coil is 26 percent better for taste reproduction and 60 percent more consistent in flavor.
Its vaping aerosol has a stable release, with an overall attenuation of 3.8 percent rather than the 10 percent of competitors, according to the release.
Dragbar Z700 SE is the first disposable with a fully visible oil tank that allows you to see the changes in e-liquid capacity at a glance.
March 14, 2023
VPZ Plans to Open 20 More Stores by End of Year
Credit: VPZ
VPZ says it plans to have opened 20 additional stores by the end of the year as its expansion plans continue.
The Scottish vaping group’s director Doug Mutter is calling on the U.K. Government to follow the lead of New Zealand and increase regulation of the vaping market.
Edinburgh-headquartered VPZ plans to grow to 170 stores by the end of the year, according to insider.co.UK.
The chain has this year already opened stores in Hexham, Sheffield, Nottingham, Derby and Newquay.
It says Falkirk and seven “major shopping center sites” are going through the acquisition process and that further growth is planned in the North East of England and Yorkshire.
Mutter also called for tighter controls and licensing for selling vaping products.
“At VPZ, we are firmly focused on helping adult smokers quit and have helped over 700,000 people quit smoking since we were established in 2012,” he said.
March 13, 2023
Police in Thailand Seize $2.3 Million in Illegal Vapes

Credit: a3701027
Police in Thailand seized vaping devices and accessories valued at over 80 million baht ($2.294 million) during police raids in Bangkok and Nakhon Pathom on Saturday.
Cyber Crime Investigation Bureau deputy commissioner Maj-General Pairoj Sukruaythanachote told a press conference that three locations, including a warehouse, were searched in Nakhon Pathom’s Mueang district.
He said two people were arrested and nearly 50 million baht worth of vaping devices and accessories was confiscated during the raids, according to Nation Thailand.
In Bangkok, police searched a condominium in Ratchathewi district where another nearly 50 million baht worth of vaping devices and accessories was confiscated, Pairoj said, adding that a suspect was arrested during the raid.
Those arrested were charged with importing prohibited items, violating the Consumer Protection Act and the Export-Import Act. Further investigations are underway to find other people involved, police said.
Activists are confident that Thailand will legalize vaping after the likely general elections in May.
Vaping is currently prohibited in the kingdom, but discussions are ongoing to end the ban, according to ENDS Cigarette Smoke Thailand (ECST).
March 13, 2023
Regulations Hurt RLX Technology’s 2022 Revenues

Kate Wang / Credit: RELX
RLX Technology’s 2022 financial performance was heavily impacted by new industry regulations and e-cigarette taxes, along with Covid-related disruptions, in China.
The company reported net revenues of RMB340 million ($49.3 million) in the fourth quarter of 2022, down from RMB1.9 billion in the same period of 2021. Its GAAP net loss was RMB225.1 million, compared with GAAP net income of RMB494.4 million in the comparable 2021 quarter.
For the full fiscal year, net revenues declined to RMB5.33 billion in 2022 from RMB8.52 billion in 2021. U.S. GAAP net income was RMB1.41 billion, down from RMB2.03 billion in the prior year.
“2022 was a year full of unprecedented challenges,” said RLX Technology co-founder, chairperson and CEO Ying Wang in a statement. “A combination of Covid-related disruptions and the introduction of a substantial package of industry regulations and policy updates throughout the year impacted the e-vapor sector and our operations.
“We retained our core strategy in this volatile operating environment while proactively adapting our business to the new regulations. In the fourth quarter, we continued to invest in R&D and product innovation and development, offering superior products to adult smokers. We believe our core competencies will enable us to attract continued support from users.
“Looking ahead, given the benefits of the clearer regulatory framework and China’s reopening, we remain confident in the long-term growth of our industry. We are well-positioned to adapt to these shifting market forces and capture new opportunities while further deepening our commitment to honoring our social responsibilities.”
RLX Technology was particularly affected by the vast wave of coronavirus infections as China suddenly relaxed its zero-Covid policy toward the end of 2022. In addition, its gross margin in the fourth quarter suffered as a result of the imposition on Nov. 1, 2022, of a 36 percent excise tax on e-cigarettes in China.
“Despite the headwinds, we strove to improve operational efficiency to mitigate the adverse impact on our business,” said RLX Technology Chief Financial Officer Chao Lu. “As a result, we maintained a healthy level of profitability during 2022. We believe our company’s resilience will enable us to overcome near-term obstacles, and we remain dedicated to creating long-term sustainable value for our stakeholders.”
March 13, 2023
Queensland Lawmakers to Inquire About Vape Safety
Credit: FellowNeko
The Queensland Parliament will hold an inquiry into the health risks, use, and prevalence of e-cigarettes, amid concerns that some vaping products marketed as “nicotine free” contain the addictive chemical.
Queensland laws allow the sale of nicotine-free vaping devices in tobacco shops. E-cigarettes containing nicotine are only available with a prescription, according to The Guardian.
But the state health minister, Yvette D’Ath, said on Sunday that “we know” that some products sold off the shelf in Queensland contain nicotine and other chemicals like nail polish remover.
She offered no evidence of or support for the claim.
The premier, Annastacia Palaszczuk, said the inquiry would examine measures to discourage children from vaping.
“Critically, we need to have greater knowledge about what vaping devices contain,” Palaszczuk said.
The parliament’s Health and Environment Committee will carry out the inquiry.
March 13, 2023