Author: Staff Writer

U.S. FDA Envisions Harm Reduction Approach to CBD

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The U.S. Food and Drug Administration envisions a harm reduction framework for CBD (cannabidiol, an active ingredient in cannabis that doesn’t make you high) through which consumers could make informed choices.
That’s the pathway described last week by Patrick Cournoyer, who heads the FDA’s Cannabis Product Committee, at the annual Food and Drug Law Institute (FDLI) conference.
In January, the FDA announced that it would not issue long-awaited guidelines for the inclusion of CBD in food and beverages, because the agency’s existing regulatory framework was not appropriate.
The FDA’s decision came nearly five years after the federal government legalized hemp-derived CBD containing less than 0.3 percent of the psychoactive compound Delta-9 THC via the 2018 Farm Act.
Concerns over the ingestion of CBD derive from the 2018 approval of the prescription drug Epidiolex, which contains CBD for the treatment of seizures associated with two forms of epilepsy.
Studies at the time showed a significant potential risk of liver disorder and other side effects from ingesting CBD.
Cournoyer shed more light on the FDA’s January decision by calling safety concerns regarding CBD in food and beverages “important toxicological red flags that are not typical for food ingredients,” as reported by Cannabis Wire.
“What’s envisioned here is really a harm reduction framework. The existing pathways that we have for foods and supplements don’t really allow for risk or harm. If it’s shown to be harmful or we can’t really show that it won’t be harmful, then it’s not allowed to be there,” Cournoyer said.
“What we’re proposing here is a more permissive category where it is acknowledged that there’s a risk here. We can’t eliminate it, but we would view that people can make an informed choice.”
He did not provide a timeline for the development of a harm reduction framework the FDA could develop in collaboration with the U.S. Congress.
Congressional lawmakers in the U.S. have refiled a pair of bills meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.
Earlier versions of the bills were filed last Congress and ultimately did not advance, but advocates and industry stakeholders feel that the U.S. Food and Drug Administration’s recent announcement that it wouldn’t be taking steps to regulate CBD will put pressure on lawmakers to act this time around.
May 23, 2023
Malaysia Ready to Table New Tobacco Endgame Bill

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Malaysia’s Ministry of Health is ready to table the Control of Smoking Product for Public Health Bill, which includes the Generational Endgame (GEG) policy, reports the New Straits Times.
If enacted, the legislation would prohibit anyone born in 2007 or later from buying and using cigarettes or vaping products in Malaysia. A provision to ban possession of those products has been dropped from the bill on the recommendation of the Parliamentary Special Select Committee.
The bill also governs registration, advertising, promotion and sponsorship, packaging and sales of smoking products.
“Any violation, including selling of cigarettes to children in the GEG group will be an offence when the bill is passed,” said the health minister’s special adviser, Helmy Haja Mydin.
People in the targeted age group caught buying or using tobacco or vaper product risk fines of MYR500 and community service. The fines had been reduced from a previous proposal to avoid unduly burdening the GEG group.
According to Mydin, the order is meant to educate and show that the policy is not purely punitive.
After its enactment, the bill requires periodic reports to measure the legislation’s effectiveness in combating underage smoking.
May 23, 2023
Alaska Senate Again Sends Tobacco 21 Bill to House

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Last week, the Alaska Senate voted 14-6 in favor of S.B. 89, a bill that would change the state’s minimum age to purchase and possess vaping and other tobacco products from 19 to 21 years old.
If approved, the bill would align Alaska’s state law with the federal standard.
The bill also would impose a statewide tax of 25 percent on e-cigarettes. A similar bill was vetoed by Gov. Dun Mike Dunleavy last fall.
The 25 percent statewide tax would add to Alaska municipal nicotine taxes already in place, such as Juneau, which currently taxes 45 percent, or $3 a pack, on the wholesale price of tobacco products, according to City and Borough of Juneau Finance Director Jeff Rogers.
The action would also allow local law enforcement to enforce the federal Tobacco 21 standard and ensure the state doesn’t lose out on grants and other funds it can receive for having its tobacco laws in line with the federal standard, reports Charlie Minato with Halfwheel.
S.B. 89 would make it illegal for anyone to sell or give tobacco or vaping products to anyone under the age of 21 years old. Those caught selling or giving tobacco or vaping products to someone under the age of 21 would be subject to a fine of at least $300.
The bill would also introduce fines for those under the age of 21 years old caught possessing tobacco or vaping products. They would be subject to a fine of no more than $150 and could be subject to a tobacco education program.
In December 2019, President Donald Trump signed a large federal spending bill that also included a provision increasing the minimum age to purchase tobacco products from 18 to 21 years old at the federal level.
While the federal law already exists, its enforcement is restricted to those who sell tobacco products and not the consumers. The vast majority of U.S. states have updated their laws to make them consistent with the federal standard.
S.B. 89 now moves onto the Alaska House of Representatives.
Last year, Alaska’s governor vetoed a Tobacco 21 bill because it included a 35 percent tax increase on vaping products.
May 23, 2023
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

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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

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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

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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

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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