Tag: e-cigarettes

CTP Hires Its First Senior Advisor for Health Equity
Charlene Le Fauve (Credit: NIH)
The tobacco and nicotine product regulatory arm of the U.S. Food and Drug Administration has hired a senior advisor for health equity for the first time. The Center for Tobacco Products (CTP) announced Charlene Le Fauve will fill the role.
“Beginning today, she will join CTP’s Senior Leadership Team within the Office of the Center Director,” a release states. “Dr. Le Fauve is a behavioral scientist and addiction researcher with 25 years of federal work experience related to health equity and health disparities research. She has dedicated her career to advancing health equity and the health of underserved and underrepresented populations through research and research workforce development.”
Most recently, Le Fauve served as the senior advisor to the Chief Officer for Scientific Workforce Diversity at the National Institutes of Health (NIH). In this role, she educated national audiences about NIH’s role in scientific workforce diversity and health equity research, according to the release.
Prior to her NIH role, Le Fauve held various leadership roles, such as the deputy director of Disparities Research and Global Mental Health at the National Institutes of Mental Health and the senior policy coordinator and lead for the Center for Medicare and Medicaid Services Team at the Department of Health and Human Services.
“Diversity, Equity, Inclusion, and Accessibility (DEIA) are core values of CTP, and efforts are underway to ensure that the full scope of the Center’s work is reflective of these principles. In this new position, which is the first of its kind for any Center at FDA, Dr. Le Fauve will work with all of CTP’s Offices to ensure health equity is integrated into the Center’s programmatic plans and priorities,” the release states, “She also will serve as CTP’s primary representative in a variety of activities that promote and facilitate the reduction of tobacco-related health disparities, including during external meetings, conferences, and presentations.”
May 22, 2023
Ispire Technology Banks $24 Million in 3Q 2023
Ispire Technology Inc. released its financial results for the third quarter of the fiscal year 2023 ended March 31. The China-based company reported revenue of $24.1 million, an increase of 26.9 percent compared to $19.0 million in Q3 2022.
Q3 FY 2023 Financial Highlights

Regarding its revenue increase to $24.1 million, tobacco vaping products contributed $16.5 million and cannabis vaping products contributed $7.6 million to revenue during the third quarter of 2023;
Gross profit increased 51.9% to $4.5 million as compared to $3.0 million in the same period of 2022;
Gross margin increased to 18.7% as compared to 15.7% in the same period of 2022.
Total operating expenses increased 106.2% to $8.0 million as compared to $3.9 million in the same period of 2022; and
Net loss of $3.1 million as compared to net loss of $1.0 million in the same period of 2022.
“We are very pleased with our financial results during our third quarter. Revenue growth was a robust 26.9 percent while gross profit grew 51.9 percent due to a favorable product mix and the realization of economies of scale on higher sales volume,” said Michael Wang, Ispire CFO. “We look forward to a strong finish to the fiscal year with a projected sequential revenue increase for cannabis vaping products of between 58% and 98% during our fourth quarter.”
Liquidity and capital resources: As of March 31, 2023, Ispire had $24.0 million in cash and cash equivalents and $5.2 million in working capital, according to a press release.
Initial public offering: In April 2023, Ispire completed its initial public offering, selling 3.1 million shares of common stock at $7.00 per share, including the overallotment option.
The stock began trading on NASDAQ on April 4, 2023. The offering generated gross proceeds of approximately $21.7 million, with net proceeds of $18.5 million after deducting expenses and underwriting discounts.
May 22, 2023
Fuma Fire Launches ‘Fire’ Vape Brand in Costa Rica

Credit: Fuma Fire
Hollywood, California-based Fuma Fire has launched its new “Fire” brand vaping products in Costa Rica.
“We’re excited to say that FIRE has received all necessary approvals from the Ministry of Health and the University of Costa Rica, making it the first exclusive vape brand designed specifically for the Costa Rican market,” a company press release states. “With its exceptional quality and undeniable appeal, FIRE is set to become a staple of the Costa Rican vaping scene.”
The Fire 2-in-1 vape is the only approved vape on the market that has been approved by the Ministry of Health and the University of Costa Rica.
“At Fire, we believe in igniting the senses and delivering a truly unforgettable vaping experience,” the release states. “Our vapes are crafted with care to provide you with the very best in flavor and quality, and we’re confident that you’ll love every single puff.”
May 22, 2023
Virginia Alcohol Board to Asses Scheme for Liquid Nicotine

Credit: Adobe
The Virginia ABC will assess a regulatory scheme for liquid nicotine, with the consultation of stakeholders, and issue a report and recommendations.
On April 12, the Virginia General Assembly enacted House Bill 2296 and Senate Bill 1350, incorporating recommendations of Governor Glenn Youngkin to have the Virginia Alcoholic Beverage Control Authority (ABC) “assess” a potential licensing scheme for liquid nicotine manufacturers, distributors, and retail dealers, as well as administrative and enforcement matters relating to liquid nicotine licensing, age verification, product verification, and advertising restrictions.
These bills effectively instruct the ABC to tell the Virginia General Assembly whether and how the Commonwealth should regulate liquid nicotine. The ABC’s report and recommendations are due by November 1, and will be informed by stakeholder input, according to attorneys with Troutman Pepper.
The enactments specify that the ABC will conduct its assessment “in consultation with stakeholders, including public and community health organizations, retailers, tobacco and vaporized nicotine companies, and wholesalers.”
May 21, 2023
Flavor Ban Bill Dies in Vermont General Assembly

Credit: Rabbit75_fot
A bill that would have banned the sale of flavored tobacco products and flavored e-liquid products has died after the Vermont General Assembly adjourned for the year.
S.B. 18 would have banned the sale of vaping products such as e-liquids and other tobacco products that have a characterizing flavor other than tobacco.
Like bills recently introduced in other states, the bill contained a provision that said if a company claims that the product has “a distinguishable taste or aroma other than the taste or aroma of tobacco, ” it would be considered flavored, according to Halfwheel.
The Vermont Senate passed S.B. 18 in late March, but it failed to get out of the Vermont House Committee on Human Services.
Several states in the Northeast have or are considering flavor bans. Connecticut also introduced a bill that would ban flavored e-cigarettes. New York, New Jersey and Rhode Island have barred the sale of flavored vaping products. Massachusetts banned all flavored tobacco items, including flavored cigars, cigarettes and vaping goods.
Vermont’s ban was originally proposed in early 2020 as a way to prevent youth use, but was sidelined after the Covid-19 pandemic began to impact the country.
May 21, 2023
Study: Legal Marijuana States See Lower Tobacco Use

Credit: J Doms
While some public health experts have expressed concerns that the legalization of marijuana could fuel a rise in the use of tobacco products, a new study instead concludes that state-level cannabis reforms are mostly associated with “small, occasionally significant longer-run declines in adult tobacco use.”
Researchers did find “consistent evidence” that the adoption of state recreational marijuana laws (RMLs) led to a slight uptick in cannabis use among adults—of between about two and four percentage points, depending on the data source—but tobacco didn’t follow that trend.
If the apparent substitution effect from cigarettes to marijuana that’s being driven by legalization were extended nationally, it could result in healthcare cost savings worth more than $10 billion per year, the study concluded, reports Marijuana Moment.
“We find little empirical support for the hypothesis that RMLs increase the net consumption of tobacco, as measured across a wide range of combustible tobacco products as well as [e-cigarettes],” they wrote. “Rather, the preponderance of evidence points to small, occasionally significant longer-run declines in adult tobacco use.”
Authors at Bentley, San Diego State and Georgia State universities published the findings in the Journal of Health Economics last month, calling the report “the first to comprehensively examine the impact of recreational marijuana legalization on tobacco use.” The study draws on federal data from the Population Assessment of Tobacco and Health (PATH) and the National Survey on Drug Use and Health (NSDUH).
At a time of surging public support for cannabis legalization, the researchers write, “public health experts have taken a more cautious approach, urging more research to assess the health benefits and costs of marijuana use, as well as to understand potentially unintended consequences on other health behaviors.” Some have raised concerns that reform could lead to the “renormalization” of smoking, potentially reversing nearly half a century of declining cigarette use.
May 19, 2023
South Africa’s E-Liquid Tax Begins Next Month

Credit: Pavlo Fox
South Africa will introduce a sin tax for vaping products for the first time beginning June 1.
The introduction of the R2.90/ml ($0.15 cents) tax on vape juice on 1 June could more than double the price of the product in some instances, according to Asanda Gcoyi, CEO of the Vapour Products Association South Africa (VPASA).
R290 ($15) tax will be levied on a 100-milliliter bottle of vape juice, which costs R200, raising the price to R490 if all of the tax is passed on to consumers, according to News24.
Asanda Gcoyi
Gcoyi says the vaping industry is not surprised by the decision to impose the tax because it was discussed over several years.
“What is perhaps not ideal is the rate,” she adds. “The R2.90/ml as an introductory rate, in our view, is too high.”
The VPASA is expecting a 26 percent decrease in the demand for vape juice after the excise is introduced, which will affect businesses and employment, Gcoyi says.
The VPASA’s estimates show that 2,250 jobs could be lost by the end of the year. She believes people will “go back” to smoking relatively cheaper tobacco products.
May 19, 2023
Mother’s Milk Denied Marketing for More Than 250 E-Liquids

Credit: Kraken Images.
The U.S. Food and Drug Administration on May 18 issued marketing denial orders to Mother’s Milk WTA for more than 250 flavored and tobacco-flavored e-liquids.
After completing an initial acceptance review and subsequently proceeding to and completing a substantive scientific review of the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence to show the products are appropriate for the protection of public health.
For example, the applications did not provide sufficient evidence to show comparative health risk data relative to other tobacco products on the U.S. market, information assessing the abuse liability of the new products, or that the new products could be manufactured consistently.
“One of our most important responsibilities is to ensure new tobacco products undergo scientifically rigorous premarket review,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products, in a statement. “We remain committed to evaluating these applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”
The agency has received premarket tobacco applications for more than 26 million deemed products, most of which are e-cigarettes. The agency says it has made determinations on 99 percent of these applications. This includes more than 1 million applications for non-tobacco nicotine products, including those containing synthetic nicotine, after Congress clarified FDA’s authority to regulate these products in April 2022.
Further, FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S. FDA has also denied marketing applications for millions of products that did not meet the requirements in the law.
May 19, 2023
U.S. FDA Issues ‘Import Alert’ to Seize Illegal Vapes

Credit: Photo Spirit
In a move that could be devastating to the vaping industry, the U.S. Food and Drug Administration has issued “Import Alert 98-06” that states the regulatory agency will detain new tobacco products such as e-cigarettes without marketing authorization at the border.
The companies impacted would include all importers, manufacturers and transporters of vaping product brands such as ELFBAR, EB DESIGN, Eonsmoke, Esco Bar and Stik that are on the agency’s “Red List.”
The alert covers China, South Korea and the United States.
“Divisions may detain, without physical examination, the tobacco products identified on the Red List of this Import Alert. If the division is not sure whether a tobacco product is the same product as one identified on the Red List, the division should consult with the Center for Tobacco Products (CTP)” the alert states. “CTP concurrence is required to add a product to the Red List.”
In order to remove a firm’s product from the Red List, companies must provide information to the FDA that adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation.
“The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, ‘Detention without Physical Examination (DWPE),’” the alert states.
The FDA states that the import alert is to prevent the sale of potentially illegal goods in America; release agency resources to inspect other goods; provide uniform coverage across the country; shift the blame back to the importer to ensure that products imported into the United States comply with FDA laws and regulations, according to the agency.
In June 2009, the Family Smoking Prevention and Tobacco Control Act gave the FDA the authority to regulate tobacco products, recognizing that it is the primary federal regulator for the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, and smokeless tobacco.
The designation rule, published in the Federal Register on May 10, 2016, and effective August 8, 2016, extends FDA’s authority to designated tobacco products, such as e-cigarettes, cigars, hookahs, and pipe tobacco, as well as their components and parts, but not their accessories.
This story will be updated as more news and industry reaction becomes available.
May 18, 2023
Juul Labs’ Minnesota Settlement Tops $60 Million

Credit: Ontronix
Leaders in the U.S. state of Minnesota reported a $60.5 million settlement with Juul Labs over youth vaping on Wednesday, one month after the state abruptly ended a Hennepin County jury trial before closing arguments were set to begin.
The money, which is front-loaded, according to Attorney General Keith Ellison and Gov. Tim Walz, is expected to go toward fighting tobacco use, vaping and smoking. Under the settlement, the terms weren’t public for 30 days, according to the Star Tribune.
In opening statements on March 28, Ellison made the state’s case, saying youth smoking was nearly eliminated before the e-cigarette maker lured teens with fruity flavors, fun ads and sleek, colorful designs. He portrayed the suit as a continuation of the earlier fight against Big Tobacco.
Many states sued Juul Labs in recent years over their marketing to teens, but Minnesota was the only one to take the manufacturer to trial. Before trial, Ellison said he wasn’t satisfied with the settlement offers made by the manufacturer.
May 18, 2023