Tag: science

Ispire Technology Adds Partners for Joint Venture
Credit: Kamiphotos
Ispire Technology has partnered with Touchpoint World Wide, parent to Berify, a platform that links physical products to the digital world, digital engagement, and brand protection, and Chemular International, a multi-disciplinary regulatory consulting firm to form a joint venture.
The group hopes to expedite innovation in the e-cigarette technology space, including developing secure, user-friendly solutions for age verification and age-gating nicotine vapor devices.
“The U.S. market is ripe for technological disruption that addresses age-verification, safety, and counterfeit issues,” said Berify Founder and CEO Dan Kang. “Our mission is also to create smart products that generate a new level of consumer satisfaction. We plan to achieve this by leveraging our blockchain authentication, tokenized rewards, and creating true decentralization while keeping companies in control of their products and data.”
Leveraging Berify’s multi-patented technology, Chemular’s regulatory consulting and PMTA expertise, and Ispire’s hardware capabilities, the joint venture’s goals are to introduce an industry-standard age-verification solution for vapor devices as well as the submission of PMTA applications that incorporate new technologies across the U.S. e-cigarette market.
“Our commitment is not only to create next-gen vapor devices but also to elevate market education. This venture includes additional partnerships that will bring together biometric identity and access control, ensure the solution is embedded into vapor devices during manufacturing, and provide safety, security, and privacy for consumers,” Kevin Burd, CEO of Chemular, added. “It is also a testament to our dedication to positively shaping the future of vape hardware innovation.”
Some of the possible solutions include:

Next-generation e-cigarette hardware with a user-friendly point-of-use age-verification and geo-fencing capability that eliminates the use of hardware in certain designated areas such as schools and sensitive areas;
E-cigarettes with end-to-end a range of dynamic features such as authentication, direct-to-consumer engagements, and exclusive offerings all built on the foundations of blockchain technology;
A real-time biometric identity platform for user access controls, creating added security and reliability that deters counterfeiting.
“By combining our collective expertise in hardware, blockchain and regulatory consulting, we aim to set a new standard for age verification, security and overall quality in the e-cigarette space,” said Ispire Technology Co-CEO Michael Wang. “Our hope is that this JV will be a large step forward in innovative device control, safety, counterfeit prevention and enhanced user experiences that increase overall market and consumer satisfaction.”
February 22, 2024
SWT Global Asks 8th Circuit to Stay PMTA Denials

A Missouri-based maker of menthol-flavored e-liquids urged a federal appeals court to revive its application with the U.S. Food and Drug Administration to continue selling its products, saying the agency had not given it fair notice of what approval would require.
The appeal by SWT Global Supply Inc. is one of a slew of similar cases by e-cigarette companies in the wake of the FDA’s rule deeming e-cigarette products to be subject to the same law as combustible cigarettes and the agency’s subsequent denial of millions of premarket tobacco product applications (PMTAs) by manufacturers to sell their products, according to media reports. The question of whether the FDA acted fairly has already created a split among federal appeals courts.
Jerad Najvar, a lawyer for SWT, told a three-judge panel of the 8th U.S. Circuit Court of Appeals that the FDA had denied SWT’s applications because the company had not presented a controlled trial or study showing that the menthol liquids can help adult smokers quit smoking as compared to tobacco-flavored liquids. He said the agency’s guidance gave no hint that it would require such a study for approval.
The question of whether the FDA acted fairly has already created a split among federal appeals courts. Most other appeals courts that have considered similar appeals by manufacturers over denied applications – including the D.C., 2nd, 3rd, 4th, 7th and 9th Circuits – have sided with the FDA. However, the 5th Circuit last month ordered the agency to reconsider the denial of two companies’ applications in a case also involving menthol-flavored products.
Jerad Najvar, a lawyer for SWT, told a three-judge panel of the 8th U.S. Circuit Court of Appeals that the FDA had denied SWT’s applications because the company had not presented a controlled trial or study showing that the menthol liquids can help adult smokers quit smoking as compared to tobacco-flavored liquids. He said the agency’s guidance gave no hint that it would require such a study for approval.
Navjar said the lack of fair notice was particularly hard on small companies like SWT with limited resources. “A client like mine doesn’t have a lot of arrows in its quiver when it’s trying to fight a decision by a federal agency,” he said.
Catherine Padhi, a lawyer for the FDA, said that comparing products’ effectiveness to tobacco-flavored products was “a natural part of the risk-benefit analysis,” given that tobacco-flavored products have a “much-reduced risk of enticing children.” She also said that SWT could submit additional information to support its application.
February 16, 2024
CoEHAR’s Replica 2.0 Team to Meet in Catania

Photo: CoEHAR
The Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) will hold the Annual International Meeting for its Replica 2.0 project in Catania, Italy, March 25–29.
The Replica project is one of CoEHAR’s most successful projects, according to the organization. In the last couple of years, the research team replicated and validated the results from well-known international studies in the field of tobacco harm reduction.
The project benefits from its collaboration with an international network of independent laboratories all around the world, which includes the Universitas Padjadjaran in Indonesia, the Institute of Research and Development Nosmoke in Greece, the Faculty of Medical Sciences, University of Kragujevac in Serbia, the Sultan Qaboos University in Oman, the Temple University-SHRO in the United States and Kazan Federal University, Russia.
During the event, the Replica team will discuss lessons learned, harmonize standard operation procedures for the project and continue the laboratory training emphasizing critical steps for harmonization.
On March 29, CoEHAR will host the ceremony for its Talent Research Award.
Tobacco Reporter profiled CoEHAR in its January 2024 print edition and online (see, “Reviewing their Peers”).
February 14, 2024
Study Finds Vaping may be Altering Some Senses

Photo: fotofabrika
Research from the University of Otago shows that a side effect of vaping may be a distaste for “sweet” smells, reports the Otago Daily Times.
The study had more than 200 participants who vaped regularly, occasionally or never. It aimed to assess potential impacts of vaping on taste and smell.
The results showed that nonvapers found “sweet” smells more pleasant than vapers, according to Jessica McCormack, researcher from the university’s Department of Food Science.
The distaste may be a result of vapers’ overexposure to sweet vape flavors, according to McCormack.
Study participants rated pleasantness and intensity of smell and taste samples and did a sensory detection test where they guessed between plain water and the taste or smell at a very low concentration.
Results showing a smell dysfunction and taste changes in vapers were consistent with studies looking at smokers, McCormack said.
“We still have more we need to know about what the mechanisms might be here—is it related to the use of flavors or nicotine or a combination?”
The study was conducted in collaboration with the National Institute for Health Innovation and published in the journal Appetite.
February 14, 2024
U.S. House Lawmakers Push FDA Chief on Vaping

Credit: Rafel
A news media outlet is reporting that U.S Reps. Rob Wittman and Raja Krishnamoorthi wrote a letter to Robert Califf, head of the Food and Drug Administration, asking for answers to inquiries they had sent to the agency in November.
“While we appreciate the recent joint federal operation resulting in the seizure of more than 1.4 million units of illegal e-cigarettes in December 2023, much more needs to be done,” the letter exclusively provided to The Hill states. “Illegal vaping products from the PRC [People’s Republic of China] now make up more than half of all vaping products sold in the United States and contribute significantly to underage vaping rates.”
The lawmakers specifically cited the brand Elf Bar as being “illegally imported” from China. The product line features brightly colored e-cigarettes with various fruity flavors, which anti-vaping advocates say attract youth.
The lawmakers asked what the FDA planned to do to stem the flow of e-cigarettes from China and whether it planned to enforce legal proceedings against manufacturers. They also asked why the FDA has not issued a rule requiring foreign manufacturing registration, which the Tobacco Control Act allows for.
The agency has repeatedly delayed its reviewing of premarket tobacco product applications (PMTAs), which are required for new tobacco products to be legally marketed in the U.S. The FDA previously said it would finish reviewing applications by the end of December 2023.
The FDA now states that it will complete all covered marketing applications by June 30. In its latest court-ordered status report, the agency stated that continued review is necessary in light of recent judicial decisions, including the D.C. Circuit’s decision in Fontem US.
Krishnamoorthi and Wittman asked when the FDA would complete its reviews and pressed the agency over the delay.
February 7, 2024
FDA Issues MDO for Tobacco-Flavored Bidi Stick
The U.S. Food and Drug Administration has issued a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick classic e-cigarette. The Bidi Stick is a closed-system, disposable, tobacco-flavored vaping device.
“FDA has a key role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products (CTP). “Integral to that role, our tobacco application review process relies on scientific evidence that demonstrates a product provides a net benefit to public health that outweighs the known risks. The science in this application did not show that.”
The company must not market or distribute this product in the United States or they risk FDA enforcement action. The company may submit a new application to the agency for review that addresses these deficiencies.
After reviewing the company’s PMTA, the FDA determined that the application lacked sufficient evidence to demonstrate that permitting marketing of the product would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act, an FDA press release states. Specifically, evidence submitted by the applicant did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks.
“The Center has made considerable progress in reviewing the massive volume of tobacco product applications submitted to the agency, thanks to the tireless efforts of our dedicated legion of civil servant scientists,” said Brian King, director of the CTP. “The Center remains committed to processing submitted applications as expeditiously as possible while ensuring the utmost scientific integrity of the reviews.”
Kavial Brands, the manufacturer of Bidi Stick, is expected to appeal the decision.
China-based Shenzhen IVPS, the parent to SMOK brand vaping devices, filed an appeal with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit after it received an MDO and was joined in the suit by a Dallas, Texas-based distributor of the SMOK products that were denied marketing.
on Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
January 23, 2024
New PMTA Finish Date is June 30: FDA Status Report

Credit: Postmodern Studio
The U.S. Food and Drug Administration now states that it will complete all covered marketing applications by June 30. In its latest court-ordered status report, the agency stated that continued review is
necessary in light of recent judicial decisions, including the D.C. Circuit’s decision in Fontem US.
“Further, several of these remaining applications present complex scientific issues that require careful review and consideration.
In the Fontem case, the court’s unanimous decision in Fontem US v. FDA upheld the regulatory agency’s denial of Fontem’s application to market flavored vaping products, in line with prior D.C. Circuit precedent but rejected the FDA’s denial of Fontem’s applications for unflavored products.
The agency stated that it was also facing challenges from manufacturers that filed premarket tobacco product applications (PMTAs) that made amendments to their applications after several legal decisions were handed down by courts.
“Many of these amendments contain substantial data and scientific explanation,” the agency wrote. “The amendments range from a few pages to hundreds of pages and were received on a rolling basis, with the most recent 2023 amendment being filed in December 2023.”
Also, on Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
The regulatory agency is under court order to file regular status reports on the agency’s review of pending PMTAs for new tobacco products that were on the market as of Aug. 8, 2016.
For such new tobacco products to be lawfully marketed in the United States, the Family Smoking Prevention and Tobacco Control Act requires the FDA to complete a substantive review of the PMTA for each new tobacco product and issue a marketing granted order authorizing the sale of the product.
The court order stems from litigation filed by health groups against the FDA seeking a court-imposed deadline for finalizing the review of the PMTAs that were filed with the agency by Sept. 9, 2020.
The court-imposed deadline to complete the agency’s review was originally Sept. 9, 2021, which the FDA could not meet due to the extremely large number of PMTAs filed by manufacturers.
The most recent and FDA’s seventh status report was filed on Oct. 23, 2023. Specifically, in these reports, the FDA provides an update on the progress to finalize the agency’s review of pending PMTA “covered applications.”
A “covered application” is for new electronic cigarette/vapor products that were on the market as of Aug. 8, 2016, which had a PMTA filed with the FDA by Sept. 9, 2020, are sold under the brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin, or Puff Bar, and reach 2 percent or more of the total retail sales volume in NielsenIQ’s various retail e-cigarette sales reports.
The agency also stated that it now expects to take action on 94 percent of covered applications by March 31. The FDA stated that it would file another status report on or before April 22.
January 22, 2024
Researchers to Study Health Impact of Dual Use

Photo: tcsaba
A new project sponsored by the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) will investigate the consequences of the combined use of conventional cigarettes and electronic cigarettes on human health.
Titled, “MAGnitude of cigarette substitutioN after Initiation oF e-cigarettes and its Impact on biomArkers of exposure and potenTial harm in dual users” (“Magnificat”), the study will involve more than 300 dual users.
Using specific biomarkers, clinical endpoints and behavioral correlations, researchers will be monitoring participants’ health to quantify the impact of transitioning to combustion-free products.
Participants will be asked to reduce the consumption of conventional cigarettes and switch to electronic cigarettes for a controlled period. According to CoEHAR, the results of the study will be of great interest in addressing questions related to smoking harm reduction in both clinical and behavioral contexts.
Tobacco Reporter profiled the work of CoEHAR in its January 2024 issue (see “Reviewing their Peers.”)
January 15, 2024
Study Claims Freebase Nicotine Safer than Salts

A new University of Louisville study shows the nicotine in certain types of electronic cigarettes can increase the risk for an irregular heartbeat, according to a press release.
Tests in mice showed that nicotine salts used in pod-based e-cigarettes led to heart arrhythmias and could trigger a fight-or-flight response in higher doses.
“This suggests the nicotine is harmful to the heart and counters popular claims that the nicotine itself is harmless,” Alex Carll, an assistant professor in UofL’s Department of Physiology who led the study, said in a news release Thursday. “Our findings provide new evidence that nicotine type and concentration modify the adverse cardiovascular effects of e-cigarette aerosols, which may have important regulatory implications.”
Researchers state that regulating nicotine salts could help mitigate the health risks of vaping.
The research also suggests choosing e-cigarettes with freebase nicotine instead of nicotine salts, or using e-cigarettes with a lower nicotine content could reduce the risk of harm.
January 6, 2024
Study Finds Cytisine More Effective than NRTs

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Cytisine, a low-cost, generic stop-smoking aid that has been used in eastern Europe since the 1960s, increases the chances of successful smoking cessation by more than two-fold compared with placebo and may be more effective than nicotine replacement therapy, according to a new study published in Addiction. The cessation tool reportedly has a benign safety profile, with no evidence of serious safety concerns.
Cytisine is a plant-based compound that eases smoking withdrawal symptoms. It was first synthesized in Bulgaria in 1964 as Tabex and later spread to other countries in eastern Europe and Asia, where it is still marketed. In 2017, the Polish pharmaceutical company Aflofarm began selling it as Desmoxan, a prescription-only medicine, and Canada approved it as an over-the-counter natural health product, Cravv.
This study pooled the results of eight randomized controlled trials comparing cytisine with placebo, with nearly 6,000 patients. The combined results showed that cytisine increases the chances of successful smoking cessation by more than twofold compared with placebo.
The study also looked at two randomized controlled trials comparing cytisine with nicotine replacement therapy, with modest results in favor of cytisine, and three trials comparing cytisine with varenicline, without a clear benefit for cytisine.
“Our study adds to the evidence that cytisine is an effective and inexpensive stop-smoking aid,” said lead author Omar De Santi in a statement. “It could be very useful in reducing smoking in low- and middle-income countries where cost-effective smoking cessation drugs are urgently needed.”
Cytisine is currently not licensed or marketed in most countries outside of central and eastern Europe, making it unavailable in most of the world. At the end of January, cytisine pills are due to become available in the U.K., according to National World.
January 5, 2024