Author: Timothy Donahue

ITC Recommends Ban on U.S. Imports of Njoy Ace

Photo: JHVEPhoto
An administrative law judge (AJL) of the International Trade Commission (ITC) has recommended a ban on importing Njoy Ace products into the United States following a patent-infringement claim filed by Juul Labs.
Ace is the first pod-based vapor product and the only pod-based menthol vapor product authorized by the U.S. Food and Drug Administration as appropriate for the protection of public health. According to Njoy parent company Altria Group, an exclusion order banning the importation of Ace would severely limit FDA-authorized choices for adults and undermine public health.
“Altria and NJOY respectfully disagree with the ALJ’s initial determination, and Njoy looks forward to presenting its position to the full ITC, which is expected to issue a final decision by December 23, 2024,” Altria Group wrote in a statement.
In August 2023, Njoy filed a similar, independent patent infringement complaint against Juul with the ITC seeking a ban on the importation and sale of Juul products in the U.S. A hearing before the ALJ was held in June 2024, and an initial determination is expected in late September. A positive outcome in this case would not preclude an exclusion order against Njoy Ace from taking effect.
“We continue to work to bring this issue to resolution,” Altria wrote in its statement. “The parties have engaged with a mediator to attempt to negotiate a resolution of these disputes. In addition, Njoy recently filed substantial equivalence (SE) exemption requests with the FDA to allow Njoy to market an already-developed Ace product with minor modifications that we believe avoid three of the four Juul patent claims at issue in the case.”
August 27, 2024
DEA Sets Hearing on Cannabis Rescheduling

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The U.S. Drug Enforcement Administration has scheduled a Dec. 2 public meeting on a proposal to lower cannabis to a less dangerous Schedule III classification under U.S. law.
The U.S. Drug Enforcement Administration has scheduled a Dec. 2 hearing on its proposal to lower the classification of marijuana to the less dangerous level of Schedule III, according to a public announcement late Monday.
The DEA had never issued any timeline for its process to potentially change the Schedule I classification of cannabis for the first time since the Controlled Substances Act went into effect in 1970. Still, some in the cannabis industry had hoped for a final decision before the U.S. election.
The DEA had already received 43,000 comments on its proposal, initially made on May 21, with a comment period that closed late in July. The DEA said the comments included requests to hold a public hearing.
DEA Administrator Anne Milgram said she would determine who will participate in the hearing and name a presiding officer to run the meeting, which will take place on Dec. 2 at 9 a.m. Eastern Time at 700 Navy Drive, Arlington, Virginia.
The government said the meeting may also be moved to a different location, continued from day to day, or recessed to a later date without notice.
August 27, 2024
Zyn Adds 450 Jobs, $232 Million Investment in Kentucky

Credit: PMI
The expansion will deliver $277 million annually in regional economic impact and increase the plant’s workforce by 40 percent.
Philip Morris International’s Swedish Match affiliate is announcing an investment of $232 million to expand the production capacity of its manufacturing facility in Owensboro, Kentucky.
The expansion is expected to create an additional 450 direct jobs with an ongoing annual economic impact of $277 million and 410 indirect jobs for the Commonwealth of Kentucky. The facility produces ZYN nicotine pouches to help meet the growing demand from legal-age consumers switching from cigarettes or other traditional tobacco products.
“Philip Morris International’s Swedish Match affiliate has been an important partner and job creator in this region for many years, and I’m excited to see this incredible new investment and the 450 great job opportunities it is creating for families in Owensboro and the surrounding region.”
Kentucky Gov. Andy Beshear
“Philip Morris International’s Swedish Match affiliate has been an important partner and job creator in this region for many years, and I’m excited to see this incredible new investment and the 450 great job opportunities it is creating for families in Owensboro and the surrounding region,” Kentucky Gov. Andy Beshear said. “Our economy continues to set records, and today’s announcement shows we’re bringing jobs to our people instead making our people move to the jobs. I want to thank and congratulate company leadership for doubling down here in the Commonwealth and look forward to many more years of prosperity.”
Construction of the expanded facility is already underway, including adding more production space. Progressive production increases are expected during the project, which is targeted for completion by the second quarter of 2025. The construction phase alone is expected to create nearly 2,800 jobs and have an economic impact of about $414 million.
Career opportunities at the facility cover a wide range of skill levels, including positions such as engineers, production staff, technicians, and quality control. Career opportunities can be found here.
In addition to facility expansion and ongoing optimization of processes to increase capacity progressively over the coming quarters, the Kentucky facility will move from a 24-hour, five-days-per-week schedule to a 24-hour, seven-days-per-week schedule to boost production starting in the fourth quarter of this year.
The Swedish Match Owensboro facility currently has about 1,100 employees. The ongoing expansion of the facility in Kentucky is expected to provide around 900 million cans of capacity by 2025.
In July, PMI announced an investment of $600 million over the next two years through its U.S. affiliate to open a nicotine pouch manufacturing facility in Aurora, Colo. The Aurora facility and Owensboro expansion are designed to provide the capacity needed in the near and mid-term to meet ZYN’s current growth rate with U.S. legal-age nicotine consumers.
August 27, 2024
Potential CBD Treatment for Fentanyl Addiction

Credit: Anankkml
Researchers at Augusta University have identified a new method to treat fentanyl addiction using a cannabidiol, or CBD, based therapy. The new research, which was published in “Cannabidiol reverses fentanyl-induced addiction and modulates neuroinflammation” by Cold Spring Harbor Laboratory’s bioRxiv, offers a promising alternative approach to combat the opioid epidemic, which has claimed hundreds of thousands of American lives.
Babak Baban, a neural immunologist and associate dean of research at AU’s Dental College of Georgia, has pioneered medical use of CBD. Baban partnered with Phillip Wang, a neuroscientist in the Medical College of Georgia’s Department of Neurology, to co-lead the collaborative research efforts to shed new light on effective treatments for fentanyl addiction.
Nearly 250,000 Americans have died from opioid overdose since 2018. At the center of the opioid epidemic is fentanyl.
“Our method is not only effective but also easily applicable, enabling individuals to navigate their journey to recovery safely and with minimal supervision. This is a vital step in addressing the broader social and health impacts of this pervasive issue.”
Babak Baban
When studying a mouse model of fentanyl addiction, the AU team found that fentanyl use dramatically elevated neural inflammation and significantly changed innate lymphoid cells (ILCs), part of the innate immunity in the brain, according to a press release. With mounting evidence implicating neural inflammation and ILCs in maintaining and modulating the functions of the central nervous system (CNS), this led them to hypothesize that altered CNS immune systems may also be crucial in fentanyl-induced maladaptation.
Baban and Wang have shown previously that CBD can reduce neural inflammation restore changes in ILCs, so they decided to apply a similar approach to fentanyl addiction. They found CBD treatment significantly reversed both the elevated neural inflammation and many addiction-related behaviors.
“With most labs focusing mainly on the neuronal and synaptic plasticity mechanisms of fentanyl addiction, the association between changes in neural inflammation, especially ILCs and addiction, is somewhat surprising and very interesting,” said Wang. “This study helps to improve our understanding of the pathophysiological mechanisms subserving drug addiction.
“There is clearly a lot to be learned how inflammation and ILCs interact with learning and memory at behavioral level, with neural plasticity at the synaptic and neural network level, and with the reward pathways at the anatomical level.”
August 26, 2024
Canada Flavored Pouch Ban Begins Wednesday

Canada’s federal government will impose new restrictions beginning Aug. 28 on nicotine pouches, making it illegal to sell them anywhere but from behind a pharmacy counter.
The pouches, which carry the brand name Zonnic, will be completely banned from convenience store and gas station shelves. Berry Frost and Tropic Breeze flavors will be recalled, and only menthol—and mint-flavored pouches will be allowed in pharmacies.
“All the stuff that’s clearly designed to target youth — it’s over,” Health Minister Mark Holland told CBC News.
Ottawa has been promising to crack down on sales of nicotine pouches for nearly 10 months. National health groups have warned about the risk of teenagers using them and becoming addicted to nicotine.
“It has been so deeply disturbing to see so many young people becoming addicted to these nicotine pouches who’ve never had any interaction with cigarettes,” Holland said.
Holland has accused Imperial Tobacco, the cigarette manufacturer that makes the pouches, of using a loophole in Canadian law to get approval from Health Canada.
The federal government says it will give Imperial Tobacco six months to change its packaging and advertising. The new containers must include an addiction warning on the front label and any advertising that could appeal to youth must be changed by the end of February.
Holland said the new measures may come too late for some.
“I’m very concerned that there are kids who are already addicted. I am very concerned that tobacco companies have already achieved their goal,” he said. “It repulses me.”
Eric Gagnon, vice president of corporate and regulatory affairs at Imperial Tobacco Canada, believes Holland has a “personal vendetta” against the company, which went through a two-year approval process to legally sell nicotine pouches.
“Apparently, because we’re a tobacco company, we’re treated differently than anybody else,” he told CBC News. “The biggest losers right now are the adult smokers that have been using Zonnic.”
August 26, 2024
Japan Tobacco to Process Leaf for HTP in Trier

The products prepared in Trier will be finalized at a JTI factory in Poland (pictured) Photo: JTI
Japan Tobacco International is investing €30 million in its Trier, Germany, factory, reports Tagesschau.
The company plans to build a new facility to process leaf tobacco for heated-tobacco sticks. According to the company, these products will be prepared in Trier and then completed at a JTI plant in Poland.
JTI-Trier Plant Manager Peter Kilburg views the investment as a sign of trust in the factory and its workforce.
According to the company, Trier is the only JTI plant worldwide to establish such a facility. It is expected to be operational in the first quarter of 2026.
The Trier factory employs about 1,800 people.
August 26, 2024
Kurdistan Bans Imports, Sales of Vaping Devices

Credit: Dalpings
Local authorities have vowed to take legal action against those who defy the ban.
The Kurdistan Regional Government (KRG) has intensified efforts to crack down on the use of e-cigarettes, with both the Ministry of Health and the Ministry of Interior enforcing a decision to ban their import and sale.
E-cigarettes are prohibited under the new regulations, and local authorities are committed to taking legal action against anyone who violates the ban.
According to media reports, Akar Mohammed, a local cigarette and hookah seller, supported the measure. “Dozens of men and children ask me about vapes and e-cigarettes every day,” he said. “This decision is appropriate.”
In Erbil, the governor’s office has been leading the crackdown on e-cigarettes, announcing that more than 26,000 devices were seized and destroyed this month. Many were found hidden in shops and warehouses.
Authorities are stepping up their efforts by increasing inspections at checkpoints and markets and monitoring online sales.
Erbil Mayor Nabaz Abdulhamid stated on Aug. 19 that investigations have uncovered the illegal smuggling of e-cigarettes into Erbil from Sulaimani. “We want to control this phenomenon together,” Abdulhamid said, emphasizing the need for collective action to tackle the issue.
August 25, 2024
Golden, Colorado has First-Ever Fund for Shop Owners

Welcome to Golden sign along Washington street in Golden, Colorado (Credit: PaBrady63)
Lawmakers in Golden, Colorado, dropped the hammer on more than two dozen retail outlets last year when they banned the sales of all flavored tobacco and nicotine products in the city.
The move is costing the businesses thousands of dollars in revenue.
Now, this city on the western edge of the Denver metro area is setting up a one-time $100,000 relief fund for smoke and vape shops, gas stations, and convenience stores to soften the financial hit they’ve taken since Golden’s prohibition went into effect on Jan. 1, according to media reports.
The City Council earlier this month directed staff to create a competitive grant program for businesses to apply for funds. No single store can receive more than $10,000, and the money must be allocated before the end of the year.
About 30 businesses in Golden are affected by the city’s prohibition.
“The City Council is trying to say they’ve heard the concerns of local businesses and they want to be responsive to local businesses that were impacted by an ordinance they weren’t anticipating,” said Rick Muriby, Golden’s community development director.
While several Colorado municipalities, including Boulder, Aspen, Glenwood Springs, and Edgewater, have passed similar flavored tobacco sales bans in recent years to combat youth nicotine product consumption, Golden appears to be the first willing to backfill revenues lost to a law it passed.
Muriby said the $100,000 figure wasn’t based on sales data from city businesses but was a figure the council and city manager “felt was a reasonable amount for the city to spend.” While Golden wants to ensure its businesses remain healthy, he said, it has no intention of taking a second look at its flavored nicotine ban.
In March, for the second time in the last three sessions, a bill to regulate flavored nicotine products has died in Colorado’s General Assembly.
August 22, 2024
Brazil Considers Legalizing Vaping Products, Again

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The Brazilian Senate’s Economic Committee was set to vote on Tuesday on a bill that would legalize e-cigarettes in the country. Currently, e-cigarettes are prohibited in the country for manufacture, import, marketing, distribution, storage, transportation, and advertising.
The vote on the text has been repeatedly postponed due to a lack of consensus among legislators, according to media reports.
Although the National Health Surveillance Agency (ANVISA) banned them in Brazil in 2009, the products are still on the market and are sold illegally.
In a joint statement led by the Brazilian Medical Association (AMB) and the Brazilian Society of Pulmonology and Tisiology (SBPT), the medical entities unequivocally reiterate their stance against any changes to the regulation of electronic cigarettes, also known as vapes, “without any reservations.”
Ricardo Meirelles, coordinator of the AMB Anti-Smoking Commission, argues, “This project is a disservice to the Brazilian population because it intends to release a product that causes a lot of harm to health.”
In April, the board of directors for the Brazilian Health Surveillance Agency (Anvisa) voted unanimously on April 19 to maintain a ban on the sale of e-cigarettes and other vaping products.
August 22, 2024
VPR: $1.77 Million in Revenue, Down From $1.9 Million
VPR Brands reported revenues of $1.77 million for the second quarter of 2024, down from $1.9 million in the comparable 2023 quarter. Gross profit was $451,469, compared with $1.1 million in the second quarter of 2023.
“While the second quarter presented some challenges, we are encouraged by the solid growth in our product sales and the positive trajectory of our business,” said VPR Brands CEO Kevin Frija.
“Our ability to generate consistent revenue, coupled with our strategic investments, positions us well for future success. We are committed to driving innovation and expanding our market presence, and we believe that our focus on quality and customer satisfaction will continue to deliver value to our shareholders.”
Looking ahead, VPR Brands says it remains focused on expanding its product lines and enhancing its market footprint. “With a solid balance sheet and a dedicated team, the company is well-positioned to capitalize on emerging opportunities in the electronic cigarette and vaporizer markets,” the company wrote in a press note.

Photo: crizzystudio
August 22, 2024