Jan Muecke (Photo: German Association of the Tobacco Industry and Novel Products)
Recent calls to ban e-cigarettes lack a scientific basis, according to the German Association of the Tobacco Industry and Novel Products (BVTE).
In a recent interview with Deutsche Presse-Agentur, Manne Lucha, minister of social affairs, health and integration for Baden-Württemberg, said that e-cigarettes should be treated the same as combustible cigarettes and that flavored vapor products should be banned.
“It is a scientific consensus that the intake of harmful substances when vaping e-cigarettes is much lower than when smoking tobacco. With his ‘post-factual’ statements, the minister is causing consumer uncertainty with counterproductive consequences for health policy,” said BVTE CEO Jan Muecke in a statement.
Muecke cited a 2020 statement by the German Cancer Research Center, which acknowledged that a complete switch from smoking to vaping reduces the consumer’s exposure to harmful substances. He also quoted Public Health England’s finding that e-cigarettes are at least 95 percent less harmful than smoking.
According to the BVTE, e-cigarettes are the most frequently used smoking-cessation tool in Germany, ahead of less effective methods such as medical nicotine replacement products. The wide choice of flavored liquids, meanwhile, is a significant factor for adult smokers to switch to vaping, the organization wrote.
“Instead of fueling fears with false claims and misguided demands for bans, e-cigarettes should finally be promoted in Germany as an opportunity to minimize risks for smokers,” Muecke said.
A U.S. federal judge in North Carolina lowered the rate of ongoing royalties R.J. Reynolds Vapor Co. will have to pay to Altria Client Services in an intellectual property dispute involving RJR’s Vuse Alto e-cigarette, reports Law360.
In September 2022, the U.S. District Court for the Middle District of North Carolina awarded Altria Client Services more than $95 million after finding that Reynolds Vapor Co.’s Vuse Alto e-vapor product infringed three Altria patents.
In his Jan. 27 opinion, U.S. District Judge N. Carlton Tilley Jr. ruled that continuing royalties on Vuse Alto are justified but not at double the rate decided by the jury.
The opinion lowers Altria’s requested rate for ongoing royalties from 10.5 percent to 5.25 percent, which Reynolds will have to pay quarterly until the last of Altria’s patents expire on April 22, 2035.
“Altria has not shown that the pod patents’ contribution to the Alto’s performance since May 2019 justifies increasing the jury’s royalty rate of 5.25 percent,” Judge Tilley wrote.
Reynolds Vapor Co. has requested a new trial, stating that “Altria’s improper injection of inflammatory evidence regarding patent infringement allegations against Reynolds in other cases denied Reynolds a fair trial.”
In a court filing this week, the U.S. Food and Drug Administration stated it will take until possibly December 31, 2023, before it completes a premarket tobacco product application (PMTA) review process for some of the most popular vapes on the market.
Upon being informed of the delay, Senator Dick Durbin of Illinois began demanding the FDA act immediately in removing e-cigarettes and vaping products from store shelves saying the agency has ignored a court order requiring them to take action by September 2021.
“On Tuesday, in a stunning filing to the federal judge, the Food and Drug Administration disclosed that it will take another six-month delay in fulfilling the public health duty announced by the court years ago. That the Food and Drug Administration will not finish reviewing applications for the most popular e-cigarettes until the end of 2023, is another outrageous delay,” said Durbin. “How can this federal agency knowingly, willingly ignore this court order to protect America’s children?”
Durbin, who has repeatedly urged FDA to complete the premarket review of e-cigarettes, called on FDA to use its authority to swiftly remove any and all unreviewed vaping products from store shelves for the safety of American consumers.
“While the FDA has dithered, dallied and delayed, more than one million of America’s kids have started vaping,” Durbin stated this week calling on the agency to obey the court order. “Not next year. Not next month. Immediately. Today,” Durbin stated in a release.
Multnomah County in the U.S. state of Oregon in December passed a law banning the sale of flavored tobacco products. Opponents of the ordinance filed a lawsuit in county circuit court Jan. 26, seeking to block the ban.
The plaintiffs, 21+ Tobacco and Vapor Retail Association of Oregon and a smoke shop called Division Vapor, argue that state law “specifically authorizes the licensed sale of tobacco products and inhalant delivery systems statewide” and that Multnomah County lacks the authority to ban the sale of flavored products used for vaping and in hookahs, according to Willamette Week.
The ban is scheduled to go into effect in January 2024.
“Plaintiff Division Vapor requires that anyone entering its store be at least 21 years old and has signs posted at the entrance stating this requirement,” the lawsuit says. “Division Vapor vigorously enforces its restrictions prohibiting entry of underaged individuals.”
The lawsuit follows an earlier effort by tobacco sellers in Washington County to overturn a ban passed by the board of commissioners there. In that case, a Washington County circuit judge ruled the county didn’t have the authority to issue such a ban. Multnomah County officials say that ruling has no bearing on their ban.
Lawmakers in Oregon recently introduced a new bill that would end the sale of flavored vaping and other tobacco products across the state.
Concept Photo of Huachengda Precision cotton products (Credit: Huachengda Precision)
Flavor bans are challenging e-liquid and hardware manufacturers to produce adaptive products.
By Ellesmere Zhu, 2Firsts
Since China’s e-cigarette control measures took effect on Oct. 1, 2022, consumers can legally purchase only tobacco-flavored vapes in that country. Meanwhile, on the other side of the globe, several U.S. states and cities have banned flavored e-cigarettes. The European Union passed a ban on flavored heated-tobacco products recently, perhaps signaling what may come for flavored e-cigarettes. The once wide range of flavored electronic nicotine-delivery system (ENDS) products is now rapidly narrowing.
Many industry insiders believe the move to ban flavors could expand globally, pushing tobacco flavors into the mainstream market. The current wave of tobacco flavors are testing the tolerances of both e-liquids and the hardware (vaporizers). Manufacturers are now challenged with producing a flavor that customers are willing to purchase and enjoy in markets where any flavor other than tobacco is outlawed.
Reproducing the taste of traditional tobacco in an e-cigarette is no easy matter. It is one of the major hurdles that many enterprises are working on currently. The key to emulating the flavor and taste of traditional tobacco is the vaporizer (coil), a core component of any e-cigarette product. If a vaporizer manufacturer wants to tackle the flavor challenge, it must focus on hardware and software strength.
Technical Troubles
In the face of the global trend of enforcing tobacco-only flavors, e-cigarette manufacturers are having a difficult time making the transition. Most manufacturers rely on diluted tobacco flavors to help customers who have traditionally preferred fruit flavors through the transition, which results in the homogenization of tobacco-flavored vapes. This has many manufacturers trying to determine what features are necessary for a true tobacco flavor. Complicating the issue, no country regulates which combination of flavors make up a tobacco flavor nor how a tobacco flavor should taste.
A representative from Shenzhen Huachengda Precision Industry Co., a global vaping manufacturer specializing in R&D, says that any juice aiming to achieve a global presence must have several characteristics. High recognition, rich fragrance and superior taste are the key to building memorable experiences for customers while dry burning, burnt core, condensation and exploding juice (spitback) are issues to avoid.
Ceramic wick surface under electron microscope
The vaporizer, meanwhile, should have a stable structure, which can be achieved by proper assembly and material selection. An unstable liquid absorption rate causes dry burning and burnt cores while unstable heating leads to inconsistency of taste.
Currently, the two most popular vaporizer materials on the market are ceramic wick and cotton wick. The current ceramic wick is hard in texture and easy to assemble, but due to technical limitations, its fine and small-size pore textures result in unstable liquid discharge as the juices with a higher viscosity (such as tobacco flavors) cannot flow through smoothly, according to Chen Ping, CEO and chief engineer for Huachengda.
Cottonwick surface under electron microscope
In comparison, the cotton wick is fully permeable and has a larger pore size, which allows the juice to pass smoothly (see Figure 2). However, for all cotton wicks offered on the market today, there is a risk of the wicking being burnt if the temperature on the device is set too high.
“There is a great difference between the characteristics of tobacco-flavored and fruit-flavored e-liquids. If we apply the vaporizer designed for fruit flavor to tobacco flavor, the taste performance and performance of the core is completely different, really an unsatisfactory reproduction of the tobacco flavor,” says Chen. “Taking into consideration the different features between tobacco-flavored and fruit-flavored juice, Huachengda has come up with optimized tobacco flavor through its vaporizers. Ideally, different flavors of juice require different vaporizers, just like one key can only open one lock.”
The Next Generation
After the instability issues are resolved, manufacturers like Huachengda must still find the proper hardware to truly unleash the authentic tobacco flavor in e-liquids. To this end, Chen says his company has invested heavily in R&D. The vaporizer’s structure, materials, formulations and heating element must all be optimized, he explains.
For example, the previous generation of vaporizers were heated by wires, causing overheating, scorching and even burning. However, the heating element comprising a mesh coil can heat the core evenly, thus producing a richer vapor. It has a solid structure that is not easy to burn off, and the flavor can still be maintained at the initial level of quality over long periods of use, according to Chen.
Looking forward on the path of innovation, Huachengda has been developing its new “fiber wick” for which the company applied for a patent in 2021. The manufacturing process of the fiber core is to break the fiber into a pulp and then “stick it together” with a binder to ensure the consistency of the material while improving uniformity, stability and vaporization, according to the company.
However, there is still room for improvement in this technology. When mixed with e-liquid, the fiber wick will absorb the juice and expand gradually. This affects the liquid absorption speed. More performance and material testing are needed before the technology can be applied on a mass scale. As for now, Huachengda has COTTONX, a larger coil that is suitable for disposable e-cigarettes, and its still-in-development fiber wick, a smaller, more compact coil suitable for pod system ENDS products.
“Improving the user experience has always been the focus of the entire industry,” says Chen, adding that a good example is how cotton dividers on the edge of coils were designed to prevent leakage; however, consumers complain of waste because it would absorb some of the liquids. The need to limit wasted e-liquid has spurred further innovation.
The development of the vaporizers differs from that of the microchip, clarifies Chen. “For chips, from 10 nm [nanometers] to 5 nm to 2 nm, the smaller the better,” he says. “But for vaporizers, the development direction is still to be explored. We need to develop and customize the products according to specific laws and regulations and user needs in a decentralized manner. This means that only manufacturers with a large pool of technology reserves and strong R&D can go far in this industry.”
Exterior view of Huachengda, a global professional vaporizer manufacturing base
Taking Retail’s Product of the Year 2023 for the Vaping and Heated Tobacco Products category has been awarded to Juul Labs’ new Juul2 system following an independent nationwide survey of 8,000 adult consumers.
Juul2 was launched in April 2022 following a successful pilot launch on the brand’s website, according to Talking Retail. The rechargeable pod-based system was updated from previous versions with new technologies and features, which the brand said includes the capability to combat potentially harmful and compatible pods.
“We are extremely proud that our commitment to product quality and innovation has been recognized by the voters who awarded Juul2 this accolade,” said Efe Abebe-Heywood, senior director of communications and brand at Juul Labs UK. “Our new Juul2 system has marked a step change in vapor technology, providing adult smokers with a product that more closely resembles the consistency and experience of combustible cigarettes to support them on their switching journey.
“Smoking remains the leading cause of preventable death and disease in the UK, and we remain committed to our mission at Juul Labs to transition even more adult smokers from cigarettes, while combating underage use.”
The award also coincides with the launch of a new Juul2 Blackcurrant Tobacco variant – a classic tobacco flavor with ripe blackcurrant notes, which further extends the Juul2 portfolio in the UK.
The new Blackcurrant Tobacco Juul pods launched on the brand’s website in January and will be rolled out across all major retailers nationally from early February.
In the U.S., Juul2 is under review by the U.S. Food and Drug Administration.
The products receiving marketing granted orders are Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks.
The three HeatSticks products are “heated tobacco products” (HTPs) used with the IQOS device.
Based on FDA’s review of the supplemental PMTAs, the agency determined that the marketing of these products should be authorized because, among other things, the net population-level benefits to adult smokers outweigh the risks to youth.
In 2019, FDA authorized the marketing of IQOS and several other Marlboro HeatSticks products through the PMTA pathway. Philip Morris pursued marketing authorization for these new Marlboro HeatSticks by submitting supplemental PMTAs for modified versions and line extensions of the tobacco-flavored product for which the company had previously received a marketing granted order.
A supplemental PMTA can be submitted in situations where an applicant is seeking authorization for a new tobacco product that is a modified version of a tobacco product for which they have already received a marketing granted order.
“Following FDA’s rigorous scientific evaluation of the applications, the agency determined that Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks are comparable to the previously authorized tobacco-flavored product,” according to FDA. “Like the previously authorized products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure.”
“FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward”
The U.S. Food and Drug Administration has concluded that a new regulatory pathway for cannabidiol (CBD) is needed. The regulatory agency states it will seek guidance from the U.S. Congress. The new rules would need to balance individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks, according to a press release.
The FDA is also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” the release states. “Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”
FDA Principal Deputy Commissioner Janet Woodcock stated that a working group she chaired on the subject of CBD regulations closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency.
“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” she stated. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.
“CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.”
Woodcock said the FDA will continue to take action against CBD and other cannabis-derived products to “protect the public, in coordination with state regulatory partners,” when appropriate.
The U.S. House Oversight Committee plans to grill U.S. Food and Drug Administration Commissioner Robert Califf about why the agency still hasn’t developed CBD regulations.
Juul Labs is in talks with leading cigarette manufacturers about a partnership, alliance or sale of its business, reports The Wall Street Journal.
Juul executives have had separate discussions with Philip Morris International, Japan Tobacco and Altria Group, according to the newspaper.
The talks are at an early stage and might not result in a sale of partnership, The Wall Street Journal’s sources pointed out. Altria, which owns one-third of Juul, valued the vaping company at $1 billion in October.
Once the undisputed leader of the U.S. vape market, Juul reached the brink of bankruptcy last year after the Food and Drug Administration denied its marketing applications and ordered the company to remove its products from the market.
The order has been stayed pending appeal but the still-unresolved dispute made it difficult for Juul to raise money to cover its legal liabilities. In December Juul agreed to pay $1.7 billion in a broad legal settlement covering more than 5,000 lawsuits accusing the company of marketing its products to teens and children. Juul denies targeting underage consumers.
To pay for the deal, Juul secured an equity investment from a group including two Juul directors. The settlement and financing put Juul on firmer ground and allowed the company to begin talks with potential strategic partners.
On Sept. 30 Altria announced it was ending its noncompete agreement with Juul. The decision gave Juul the freedom to sell itself—or a significant stake—to one of Altria’s competitors.
Altria can’t buy Juul outright because of antitrust concerns: The Federal Trade Commission is seeking to unwind Altria’s 2018 investment in Juul. Altria and Japan Tobacco in October formed a partnership to develop and sell heated-tobacco devices in the U.S. and other new tobacco products abroad.
If the FDA ultimately halts Juul’s sales, Juul could seek U.S. authorization for a newer version of its vaporizer that has been released in Canada and the U.K. Juul also has other products under development.
The California federal judge presiding over multidistrict litigation regarding Juul vaping products has agreed to postpone a trial that would have parent company Altria Group Inc. facing RICO claims, allowing the Ninth Circuit to first review the trial court’s certification of four classes of plaintiffs who brought the suit, according to Law360.
Last week, A U.S. district judge handed Juul Labs Inc preliminary court approval of a $255 million settlement resolving claims by consumers that it deceptively marketed e-cigarettes, as the company seeks to resolve thousands of lawsuits.
The class action settlement resolves claims by people who say they would have paid less, or not bought the e-cigarettes at all, if Juul had not downplayed the products’ addictiveness and appeal to teenagers through social media campaigns and other means.
The settlement is part of a larger, global agreement by Juul to resolve thousands of lawsuits by school districts, local governments and individuals accusing it of contributing to a youth vaping epidemic.
