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.”)
Virginia has long been the epicenter of the tobacco industry, Now, two bills that would ban flavored vaping products have been filed with the state’s General Assembly.
Sponsors say Virginia should step in where Washington has been ineffective in blocking unregulated flavored e-cigarettes, such as Elf Bar disposables, off of store shelves.
The bills, House Bill 1069 and Senate Bill 550, call for a fine of $1,000 a day for each product sold that the U.S. Food and Drug Administration has not authorized to be marketed in the U.S.
The Attorney General would maintain a directory of legal products, much like Alabama and Louisiana. Products not listed in that directory could not be legally sold in Virginia.
The bill states any retailer and wholesaler that sells or distributes any liquid nicotine or nicotine vapor product in the state is subject to scheduled or unscheduled compliance checks carried out by the Attorney General’s Office for enforcement purposes.
Manufacturers must certify, in a filing with the Attorney General, that their product is covered by an FDA marketing authorization order, or is exempt from that because it was sold in the U.S. before 2016 or subject to a premarket tobacco product application dating from before 2020.
“It’s a public health issue,” said Del. Rodney Willett, who sponsored the House of Delegates bill.
“They’re targeting kids with the flavors,” he said, according to media reports. “When I walk into a convenience store, I’m just stunned by the number of these products that are for sale.”
Innokin launched Trine, a redefinition of the structure of pod systems, namely atomizer, control and battery (removable), according to a press release.
The new 3-in-1 solution improves the reusability of the battery, according to the press release.
Trine features removable batteries for pod systems, extending the life cycle of devices far beyond that of an individual battery while enabling safe recycling, according to Innokin.
Trine ensures safe battery disposal by integrating EcoDrain, a battery discharge technology setting a new industry standard as an eco-safe solution for battery disposal. It addresses the challenges associated with handling discarded batteries, ensuring safe battery discharge before recycling.
The technology minimizes fire hazards and actively reduces the detrimental environmental impact caused by battery waste, according to the company.
The United States Court of Appeals for the 2nd Circuit on Dec. 26, 2023, affirmed a district court’s dismissal of a putative class action asserting claims against Philip Morris International that the company made false or misleading statements regarding both the scientific studies it conducted in support of an application to the Food and Drug Administration and the outlook for the company’s sales growth in Japanese markets, according to Lexology.
The district court held that the plaintiffs failed to adequately prove falsity or scienter. The 2nd Circuit affirmed the dismissal, holding that the plaintiffs failed to adequately plead falsity.
The court decided two questions of first impression in the 2nd Circuit, holding a securities fraud defendant’s statement that its scientific studies comply with a methodological standard that is published and internationally recognized, but stated in general and inherently subjective terms, is properly analyzed as a statement of opinion rather than a statement of fact, and holding that, whereas a securities fraud defendant’s statement expresses an interpretation of scientific data that is ultimately endorsed by the FDA, such a statement is per se “reasonable” (i.e., supported by “meaningful inquiry”) as a matter of law.
The plaintiffs alleged that PMI made misrepresentations in securities filings and public statements about clinical studies it conducted in support of an application to the FDA to sell IQOS in the U.S. and market IQOS as reduced risk. The plaintiffs also alleged that PMI made misleading statements about its growth projections in Japan regarding IQOS. The district court found that none of the challenged statements were false or misleading because all the challenged statements were true, inactionable puffery or inactionable statements of opinion. Furthermore, the district court found that the plaintiffs failed to establish the required strong inference of scienter, either by alleging facts showing motive and opportunity to commit fraud or strong circumstantial evidence of conscious misbehavior or recklessness. Accordingly, the district court granted the defendants’ motion to dismiss the plaintiffs’ first amended complaint and denied the plaintiffs’ motion for reconsideration. After the district court dismissed the plaintiffs’ second amended complaint, this time with prejudice, the plaintiffs appealed.
The Singapore government said that the potential loss in revenue from tobacco tax was not a factor in its decision to ban the use of e-cigarettes in 2018.
In his reply to a question by a Workers’ Party and Sengkang Member of Parliament, Deputy Prime Minister Lawrence Wong, who is also the Minister for Finance, said, “The Government’s decision to ban the use of e-cigarettes in 2018 was based on public health considerations, to protect our population from the harms of these products. The potential loss in tobacco tax revenue from the reduced consumption of tobacco products was not a factor in this decision.”
… our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans.”
Lawrence Wong
Wong added that if the government were to legalize and tax e-cigarettes “the challenges would be similar to those we encounter for cigarettes and other tobacco products today.
“In any case, the government has no plans to change our current approach, as our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans.”
U.S. Senate Majority Whip Dick Durbin has again decried the Food and Drug Administration on its unacceptable failure to “protect children from the dangers of vaping” as the agency continues to miss and delay critical deadlines.
In a press release, Durbin stated that he has repeatedly criticized theFDA for its long-overdue review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers, which originally had a federal court deadline of September 9, 2021.
FDA has missed that court-ordered deadline by 28 months as unauthorized e-cigarettes flood the market.
During his speech, Durbin also called on the Biden Administration to swiftly implement a proposed public health rule to prohibit the production and retail sale of menthol cigarettes and flavored cigars.
“I know this President cares deeply about the toll of cancer. It has touched his family personally, as it has mine,” the Senator said. “If we want to make a difference in the health of Americans—and set a legacy for future generations—then the Administration must finalize this public health measure to end Big Tobacco’s predatory promotion of menthol cigarettes. Lives hang in the balance.”
The FDA stated in prior status reports for PMTAs that the agency would complete a review of 100 percent of the applications by the end of 2023. The agency is now estimating that completion of the reviews may be delayed as the FDA considers the D.C. Circuit’s opinion in Fontem US v. FDA, affirming in part and vacating and remanding in part marketing denial orders for certain vaping products.
The latest Nielsen report shows that the market share of R.J. Reynolds’ top-selling Vuse e-cigarette remained flat at 42 percent in December at convenience stores.
While Vuse’s market share was unchanged, No. 2 Juul dropped from 24.3 percent to 24.2 percent for the report covering the four-week period ending Dec. 30.
As recently as May 2019, Juul held a 74.6 percent share in the U.S. electronic cigarette market. That’s when a series of regulatory actions led to product-reduction concessions, according to media reports.
Meanwhile, Altria Group’s ownership of No. 3 NJoy hasn’t resulted in a meaningful market-share increase so far. Nielsen cited a research error by why it did not include an update for NJoy in the latest report. It was at 2.6 percent in the previous report.
Fontem Ventures’ blu eCigs, an affiliate of Imperial Brands Plc, was unchanged at 1.2 percent.
The overall e-cigarette category was down 9.9 percent.
What can the next-generation nicotine industry expect in 2024?
By Paul Hardman
The U.K. government’s proposal for a “smoke-free” generation and changing consumer opinions toward nicotine products are causing a shift in consumer habits. The year 2023 shone a spotlight on e-cigarette compliance, with a potential ban on disposable vapes on the horizon. So, how will this year’s events impact the manufacturing of nicotine products, and what trends and regulations are we likely to see going into 2024?
Nicotine Pouches
Nicotine pouches represent an extraordinary opportunity to support tobacco harm reduction in adult smokers. Sweden, the world’s most advanced nicotine pouch market, is on the brink of being smoke-free, with less than 5 percent of its population smoking.
However, in the U.K., there is a regulatory gap that allows those under 18 to purchase nicotine pouches legally. In addition, there are concerns that nicotine pouch manufacturers could fall into the same traps as some disposable e-cigarette companies, by creating products that appeal to youth.
If youth use becomes an issue, the easiest move for regulators is to categorize nicotine pouches in the same way as oral tobacco products like snus—rendering them illegal. An alternative response might be to categorize these products as nicotine-replacement therapies and place them under medical product regulations, which would restrict their access.
To keep these products available to adult smokers who wish to quit, manufacturers can act as if regulation is already in place: generate data, devise safety frameworks and ensure the quality of products entering the market. Importantly, manufacturers should present and market their products in responsible ways, including avoiding bright colors, not imitating other consumer goods (e.g., soft drinks) and refraining from using any type of cartoon/video game characters.
Non-Heated Technologies
We have yet to witness a vape product approved via the U.K. Marketing Authorization Application (MAA) pathway, which enables nicotine products to be marketed as smoking cessation nicotine-replacement tools and prescribed by healthcare professionals. However, non-heated vape technology might facilitate MAA approval by addressing the core problem of delivered dose uniformity (DDU).
One example of a non-heated vape technology involves ultrasound sonication, which enables the atomization of e-liquids to create an aerosol, similar to technology used in medical nebulizers. The droplet size and dosage can be predefined according to the dimensions of the mesh, ensuring uniformity in the vapor, thus improving DDU. As we go into 2024, we will likely see more manufacturers exploring this approach. In parallel, e-liquids will be developed specifically for this technology.
Product Development
Nicotine product manufacturers have been moving toward a quality-by-design (QbD) development process, and we will see this continue in 2024. There are no specific guidelines or requirements for the stability testing of nicotine products other than the scientific justification for shelf life. Employing a QbD approach demonstrates a higher level of due diligence, which could produce safer, higher quality nicotine-delivery systems.
In addition, manufacturers are starting to implement extractables and leachables studies during the development process in anticipation of the new guidelines being set out by the European Committee for Standardization. Once these guidelines are published, we can expect to see a more standardized approach throughout the industry.
Paul Hardman is a managing consultant at Broughton, an independent life sciences contract research organization offering analytical testing services integrated with scientific consultancy and global regulatory support.
Attorney General William Tong today filed seven new enforcement actions against wholesalers and retailers engaging in the distribution and sale of potent, illicit cannabis products in Connecticut.
Wholesalers include Shark Wholesale Corp. in Bridgeport, Star Enterprise 74, LLC, in New Britain, and RZ Smoke, Inc., in Suffield. The four retailers are Greenleaf Farms in New London, Smoker’s Corner in Norwich, Anesthesia Convenience & Smoke in New Haven, and Planet Zaza in East Haven.
In each instance, the Office of the Attorney General is alleging violations of the Connecticut Unfair Trade Practices Act, which carries fines of up to $5,000 per violation, according to press release.
“Cannabis is legal for adults in Connecticut, but it’s not a free-for-all—retailers must be licensed and legal cannabis products must comply with strict safety standards. Today, we are suing seven businesses—three wholesalers and four retailers– who have sold potent, high-THC cannabis products in violation of Connecticut laws,” said Tong. “None of these products have been subject to Connecticut’s rigorous testing standards or contain appropriate warnings.
Connecticut Attorney General William Tong
“Some are sold in dangerous and misleading packaging designed to appeal to children. These products are designed to deceive consumers into believing they are safe, tested, and regulated—that is false. We have multiple active investigations into additional retailers and wholesalers, and we will keep the heat on so long as these dangerous, illegal products are sold.”
Residents over age 21 can legally possess and consume cannabis in Connecticut. Cannabis products may only be sold in the regulated market and must meet rigorous testing and packaging requirements. Cannabis products sold outside of the regulated market continue to be illegal and may subject sellers to civil and criminal penalties.
Despite that, the sale of illegal delta-8 and delta-9 cannabis products and other high-THC cannabis products continues in Connecticut, according to Tong.
In unannounced visits to vape shops and gas stations, investigators from the Office of the Attorney General and the Department of Consumer Protection continue to routinely find illegal cannabis products for sale, including blunts, marijuana flower, and edibles mimicking popular youth-oriented snack foods, including Fritos, Skittles, Airheads, and more.
Illegal look-alike cannabis products pose a unique health threat to children, who may unknowingly ingest high doses of potent psychoactive chemicals. In the regulated adult-use market, edible cannabis products may only be sold in containers that contain a maximum of 100 milligrams of total THC and 5 milligrams of total THC per serving size. Children who accidentally eat an entire snack-sized bag of “chips” or “candy” may be exposed to more than 100 times the maximum adult serving.
Since 2021, the Connecticut Poison Control Center has received 400 calls regarding cannabis exposure in children, including 181 children under the age of 6 exposed to cannabis edibles. The majority of those cases required treatment at a health care facility.
Greenleaf Farms New London
Greenleaf Farms is a CBD retailer in New London with no license to sell cannabis products in Connecticut. Despite that, investigators from both the Department of Consumer Protection and Office of the Attorney General on multiple visits discovered numerous illegal high-THC products for sale, including potent edibles designed to look like children’s cereal. Greenleaf Farms also offered for sale marijuana “blunts,” which were offered in various THC concentrations.
The products lacked a variety of required warning statements and labels, and do not appear to be produced by licensed facilities or tested in accordance with state law.
Further, Greenleaf Farms represented itself as a licensed dispensary in the sign shared below despite lacking such a license.
Smoker’s Corner
Smoker’s Corner is a smoke shop in Norwich with no license to sell cannabis products in Connecticut. During multiple visits, an investigator from the Office of the Attorney General observed illegal high-THC edibles for sale. Further, after the investigator asked if there was any “pot” available for purchase, a Smoker’s Corner employee retrieved a mason jar full of marijuana flower from a back room. The employee then weighed the marijuana on a scale, bagged it, and sold it to the Office of the Attorney General’s investigator. The cannabis products lacked required warnings and labels, did not appear to be produced by licensed facilities or tested in accordance with state law, according to Tong.
Anesthesia Convenience & Smoke
Anesthesia Convenience & Smoke is a smoke shop in New Haven that is not licensed to sell cannabis in Connecticut. On multiple unannounced visits, investigators from the Department of Consumer Protection and Office of the Attorney General observed thousands of high-THC products, including those more potent than any product available in the regulated cannabis market. Products included potent edibles, as well as marijuana flower. The cannabis products lacked required warnings and labels, did not appear to be produced by licensed facilities or tested in accordance with state law, according to Tong.
Planet Zaza
Planet Zaza is a smoke shop located in East Haven with no license to sell cannabis in Connecticut. Investigators with the Department of Consumer Protection and Office of the Attorney General inspected the store on multiple dates, finding numerous high-THC cannabis edibles for sale more potent than any authorized for sale in Connecticut.
Further, investigators discovered unauthorized labels, including fake prescription labels falsely indicating that the store is a licensed dispensary and that the illegal products were medical-use cannabis. The products did not appear to be produced in a licensed facility or tested in accordance with state law, according to Tong.
Wholesalers: RZ Smoke, Star Enterprise, and Shark Wholesale
Star Enterprise is a New Britain-based smoke and vape wholesale business. Shark Wholesale is based in Bridgeport. RZ Smoke is a New York-based smoke and vape wholesale business with a warehouse in Suffield. These wholesalers each supply illicit cannabis products to retailers throughout Connecticut. All three provide products packaged in a manner that deceives consumers into reasonably believing they are purchasing cannabis products from Connecticut’s legal, regulated market. In fact, each wholesaler offered highly potent products far in excess of allowable serving sizes and THC levels.
Star’s products contained THC levels 35-times the maximum permissible in Connecticut’s regulated cannabis market, as well as serving sizes at least five times the maximum allowed. Further, the packages were labeled in such a way as to appeal to youth, including brand names and packaging identical or similar to non-cannabis snacks. Shark’s products contained THC levels 15-times the maximum limit, and serving sizes six times the maximum legal serving size. RZ Smoke’s products contained THC levels 10-times the maximum allowed, with serving sizes five times over the legal limit. Their products were also designed to mimic existing names and packaging of non-cannabis snacks, according to Tong.
Ongoing Cannabis Enforcement Actions
“Today’s filings follow a series of enforcement and educational actions taken by Attorney General Tong to combat the sale of illegal cannabis in Connecticut, including high-THC delta-8 and delta-9 edibles. Last year, Attorney General Tong sent warning letters to all Connecticut licensed retailers of electronic vaping products advising them that sale of delta-8 THC by unlicensed retailers may be illegal,” the release states.
The Office of the Attorney General now has 10 pending enforcement actions, and has secured judgments against four additional Connecticut retailers totaling $40,000 for alleged violations of the Connecticut Unfair Trade Practices Act over the sale of illegal delta-8 THC products.
A portion of the payments will be suspended if the retailers comply with terms of the judgment, including ceasing all sales of illegal cannabis. Additional investigations are active and ongoing. Last week, Tong issued a cease and desist letter to HighBazaar organizers that its unlicensed cannabis marketplace appears to violate multiple state statutes. An additional letter was sent to the Masonic Temple Day Spring Lodge in Hamden, which currently hosts the market, according to Tong.
The city of Hallowell seeks to become the latest community in Maine to ban the sale of flavored vaping and other tobacco products.
Monday night, the city held a public hearing on an ordinance that would do exactly that. During the meeting, 300 signatures supporting the flavored tobacco ban were delivered to the council, according to local media.
During the hearing, people argued both for and against the ban, with those against saying the city should be looking at the bigger picture and consider enacting a smoking ban citywide. Those in favor cited not only the negative health effects, but also that it’s intentionally marketed to young people.
If Hallowell does pass a ban, they will join the towns Falmouth, Portland, South Portland, Brunswick, Bangor and Bar Harbor in passing similar bans on selling flavored tobacco products.
