The Vapor Technology Association (VTA) has again met with the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) to help clarify any questions the regulatory agency may have surrounding synthetic nicotine.
VTA representatives met with dozens of CTP regulators from seven different offices inside CTP to confront any concerns about premarket tobacco product applications (PMTAs) for synthetic products that are due on May 14, according to a VTA email.
Credit: Opolja
During the meeting, several speakers joined the VTA in shedding light on how synthetic nicotine is manufactured, its purity, and its similarities and differences compared to tobacco-derived nicotine. Dr. Bill Jackson, PhD (Organic Chemistry), Dr. David Johnson, PhD (Physical Analytical Chemistry), Dr. Ray McCague, PhD (Organic Chemistry), and Dr. Willie McKinney, PhD (Inhalation Toxicology), all have experience in synthetic products and shared that expertise with the regulatory agency.
Johnson and McKinney also have extensive experience with the FDA having previously served on FDA’s Tobacco Products Scientific Advisory Council, according to the VTA.
“As with our first meeting, we are encouraged by the level of engagement by the CTP’s Office of Science on this issue,” the VTA stated in a release. “And, we greatly appreciate the participation of numerous FDA scientists from the various responsible divisions within the office with whom we were able to share our scientific knowledge and advanced thinking on the key issues.”
The VTA is hoping to continue to engage the FDA to help the agency better understand the nature of synthetic nicotine, according to Tony Abboud, executive director of the VTA.
“Our work is not done. These meetings, and the additional meetings that we are working on, are just part of VTA’s multi-pronged strategy to ensure the proper and full assessment of synthetic nicotine PMTAs,” said Abboud. “If your company is manufacturing products containing synthetic nicotine and is serious about regulatory compliance, or if your retail operation wants the ability to continue to diversify its retail offerings with synthetic nicotine products, or if you want to have continued access to innovative products containing synthetic nicotine, you should strongly consider being engaged in our strategic efforts.”
Nearly every school district in the state of Utah joined a mass tort lawsuit against Juul Labs. Park City Schools is the only Utah school district not participating in the lawsuit.
The lawsuit claims Juul Labs was deliberately using youthful marketing strategies. The lawsuit also claims the company misrepresents and fails to mention that its e-cigarettes are “more potent or addictive” than cigarettes, according to KUTV.
Juul Labs removed all flavors other than tobacco, mint and menthol from their offerings in 2019 after federal regulators accused the vape maker of using the flavors to lure minors to vape. That same year, the company announced it was suspending its print, broadcast and online advertising in the United States.
The Frantz Law Group of California has filed the mass tort lawsuit on behalf of 700 school districts across the country. Salt Lake City law firm Kirton McConkie will head up the Utah portion of the lawsuit. Attorney Jim Frantz and William Shinoff say Juul Labs directly marketed to minors, “because we’re dealing directly with minors, and undermining them and addicting them and that’s really as low as you can go,” says Frantz.
The return of sCOPe, a global livestream featuring leading tobacco harm reduction (THR) advocates, this year will broadcast again on both World Vape Day and World No Tobacco Day.
During the event, European, African, Indian, North and South American, and Asia-Pacific THR consumer organizations will discuss advocacy and issues in their countries and take questions from viewers.
The two-day sCOPe22 livestream will broadcast for World Vape Day 2022 on May 30 and broadcast for World No Tobacco Day 2022 on May 31. It will run for eight hours each day from 07:00 CDT/13:00 BST.
“This sCOPe livestream is so important. Too many smokers continue to die from the narrow-mindedness of an anti-vape agenda that has been funded by the likes of American billionaires,” says Nancy Loucas of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).
“The global evidence is overwhelmingly in favor of vaping, yet hundreds of millions of smokers are blocked from accessing harm reduced alternatives. People’s health and human rights are denied in favor of greed and ego. sCOPe 2022 will discuss where the money is coming from and expose the motivation,” says Loucas.
The organizations set to feature include European Tobacco Harm Reduction Advocates, the Campaign for Safer Alternatives in Africa, Vaping Saved My Life South Africa, the Association of Vapers India, and the CAPHRA.
The Americas are represented by Latin American-based ARDT Iberoamerica, Rights for Vapers Canada, the Tobacco Harm Reduction Association of Canada, and United States-based Consumer Advocates for Smoke-Free Alternatives Association.
Last year, sCOPe livestreamed around the clock from Nov. 8 to Nov. 12 during COP9—the Ninth Conference of the Parties to the World Health Organization Framework Convention on Tobacco Control. The unprecedented broadcast gave a global voice to leading consumer advocates who were shut out of COP9.
A growing number of government officials in Thailand are calling for vaping products to remain illegal. However, one politician is promoting legalization of less harmful nicotine products to help smokers quit combustibles.
The country’s Digital Economy and Society Minister, Chaiwut Thanakamanusorn, on Friday urged Thailand’s National Tobacco Products Control Committee to revise its ban on the import and sale of e-cigarettes in the country, according to the Bangkok Post..
Chaiwut said he has petitioned the committee to revise its decision to ban e-cigarettes on March 28 because a committee set up by the ministry found that people opted for e-cigarettes because they believed them to be less harmful to their health. Despite the ban, they are illegally imported and sold online.
If the government allows the lawful import and sale of e-cigarettes, it will be able to set standards for selling and gain benefits through a tobacco tax, he said. Chaiwut claimed that the National Tobacco Products Control Committee was unlikely to have conducted the most thorough of surveys or have interviewed a broad number of proponents of electronic cigarettes.
“E-cigarettes have been accepted in many countries as being less of a health hazard than ordinary cigarettes,” he said.
Many tobacco harm reduction advocates say Thailand will eventually legalize vaping.
Hong Kong’s ban on the importation and sale of alternative smoking products, including vaping and heat-not-burn products, will take effect on April 30.
In a statement, the government said that, under the Smoking (Public Health) (Amendment) Ordinance 2021, people will not be allowed to use or carry an activated vaping device in no-smoking areas. Offenders will be fined HK1,500 ($191).
The ban covers electronic smoking products, heated tobacco products, herbal cigarettes, and their accessories, the government said, reports The Standard.
The ordinance prohibits the importation of any novel tobacco product by way of parcels, cargoes or bringing in by incoming travelers. People bringing such products into the city must declare them to customs.
Starting Saturday, inspectors from the Department of Health’s Tobacco & Alcohol Control Office will conduct inspections, investigate complaints and carry out enforcement actions, the government said.
The ordinance also prohibits the promotion, manufacture, and possession for commercial purposes of novel tobacco products. Those convicted of violating the law will be fined HK50,000 and imprisoned for six months.
Kenya’s Treasury Cabinet Secretary, Ukur Yatani, has proposed to change the excise tax on liquid nicotine to Sh70 ($0.60 cents) per milliliter in a bid to make it less accessible to users, including school children and the youth.
Vaping industry advocates warn the new proposals to raise excise tax on nicotine products will push safer alternatives for smokers out of reach and help the black market thrive, according to The Standard.
Campaign for Safer Alternatives (Casa), a lobby that aims for smoke-free environments in Africa, said the tax changes would result in higher prices of e-cigarettes and negatively impacting those who rely on them to help them stay off cigarettes.
“Doubling the tax on vapes and nicotine pouches is the opposite of a cash cow. If anything, it will drain more money from the Treasury by forcing vapers into the black market,” said Casa chairman Joseph Magero on the proposals contained in the Finance Bill.
“Already, Kenya’s sky-high vaping taxes have created a thriving black market for vape products, with many shops selling un-taxed vapes in broad daylight.”
He said the tax increase will also raise the healthcare costs for Kenya’s government by leaving vapers with no choice but to revert to smoking or using unregulated black market vapes.
The U.S. Food and Drug Administration has received from the U.S. District Court of Maryland a 14-day extension to file the first premarket tobacco product application (PMTA) status reports required by the Court’s revised remedial order.
The plaintiffs in the case consent to the requested extension, according to the motion filed today.
“The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and Defendants have been working with Plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states. “Also, a number of FDA employees helping to prepare the status report were out of the office on pre-planned leave last week, and a key FDA employee responsible for the status report will be out of the country on pre-planned leave next week.
“Defendants do not seek to modify any other deadline, and the FDA’s second status report would remain due July 28, 2022. Defendants are prepared to have this letter serve as their consent motion for a 14-day extension.”
Judge Grimm granted the motion. The new deadline for the first PMTA status reports are due May 16.
The ban on menthol cigarettes is closer to becoming a reality. After years of discussion, the U.S. Food and Drug Administration has instituted a proposed rule to place a ban on menthol combustible cigarettes and flavored cigars. Whether the menthol ban will also cover next-generation tobacco products, such as e-cigarettes, has not yet been clarified.
“The authority to adopt tobacco product standards is one of the most powerful tools Congress gave the FDA and the actions we are proposing can help significantly reduce youth initiation and increase the chances that current smokers quit. It is clear that these efforts will help save lives,” said FDA Commissioner Robert M. Califf, M.D. “Through the rulemaking process, there’s an important opportunity for the public to make their voices heard and help shape the FDA’s ongoing efforts to improve public health.”
When finalized, the FDA states that the proposed menthol product standard will:
reduce the appeal of cigarettes, particularly to youth and young adults, decreasing the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking; and
improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation.
The FDA states that the proposed product standards are based on clear science and evidence establishing the addictiveness and harm of the products. Many organizations were quick to condemn the regulatory agency for proposing the rule that is opposed by all major law enforcement, civil rights and criminal justice reform organizations. Opponents of the menthol ban say that evidence clearly shows that banning menthol products will do nothing to reduce combustible cigarette smoking rates but will lead to an increase in people purchasing products on the black market.
Credit: FDA
“This misguided proposal will have disastrous impacts on public health and public safety. It will do nothing to reduce smoking rates and instead make the United States less safe.” said Tim Andrews, director of Consumer Issues for Americans for Tax Reform (ATR). “It is unfortunate that as violent crime rates rise across the country, the FDA chooses to divert valuable police resources to pursue an unnecessary ban on menthol products.”
Andrews argues that a menthol ban exposes “vulnerable members of minority communities to conflict with law enforcement, and their purchases could also fund sophisticated international criminal syndicates.” According to the U.S. Department of State, illicit tobacco’s links to funding terrorist organizations already present a “serious threat” to national security. “This policy would worsen the problem while also depriving state governments of excise revenue, putting state government programs at risk,” says Andrews.
Richard Marianos, a senior law enforcement consultant who has served more than 27 years at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and who is now a consultant and adjunct lecturer at Georgetown University, says that in many foreign markets, such as Asia, companies are creating products to make mentholated cigarettes, because those types of products are not covered by the rule.
“They are flavor packets you just slide into a pack of cigarettes. You buy your cigarettes, you put that in there and by the time you get home, the whole pack is mentholated. They also have these – it’s like a little Tic Tac box with a round, small, little mint … but what it does is you put it into the filter, shake, crush and now it’s a menthol cigarette,” said Marianos. “Are we eventually going to be asking border protection to now start looking for minty flavor packets or Tic Tac boxes when they have to concentrate on biological and nuclear threats? When you overlook public safety surrounding this matter, you’re creating an unhealthy situation, not just for smokers, but anybody who’s out there.”
Marianos says that a menthol ban will create a greater level of diversion and criminal activity with high-value targets overseas, it’ll bring more organized crime into the United States. It’ll also create a greater market for border countries to begin manufacturing menthol and bring it into the United States.
“There was one investigation in particular, I remember, where the individual said on a wire that once they banned menthol cigarettes in the United States, you can pave the roads in gold because of the boost in sales of black market and DIY menthol cigarettes,” he said. “Prohibition doesn’t work. Your quality of police work goes down; they can’t concentrate on violent crime as much and it creates a greater wedge between themselves and the community.”
Guy Bentley
Guy Bentley, director of Consumer Freedom Research for the Reason Foundation, said that similar bans have had minimal effects on tobacco consumption in other countries such as Canada and the U.K., adding that a menthol ban is likely to lead to more policing in minority communities, more incarceration, boost black market sales and undermine criminal justice reforms in the U.S.
In an email to Vapor Voice, Bentley explained that a recent study funded by the Norwegian Cancer Society in partnership with the Polish Health Ministry found that in Poland – the EU state with the largest pre-ban menthol share – found “mixed evidence” that the ban is working as intended.
Bentley argues the FDA and Biden administration should apply a harm reduction model, educating the public about safer alternatives to conventional cigarettes and the latest smoking cessation options. Andrews concurs with Bentley, adding that the proposed rulemaking will inevitably lead to further growth of illicit markets, put members of minority communities in danger and divert law enforcement resources away from real crime.
“It ignores best practice expert recommendations on how to reduce smoking rates through proven harm reduction technologies, is a disaster for public health, and will make all Americans less safe,” Andrews said. “If the Biden Administration truly cared about the American people, they would junk this anti-science and genuinely harmful proposal immediately.”
Beginning May 4, 2022, the public can provide comments on these proposed rules, which the FDA will review as it considers future action. The agency also will convene public listening sessions on June 13 and June 15 to expand direct engagement with the public, including affected communities.
The public will have the opportunity to submit either electronic or written comments directly to the dockets on the proposed rules through July 5, 2022. Once all the comments have been reviewed and considered, the FDA will decide whether to issue final product standards.
The FDA also states that it cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars. If the proposed rules are finalized and implemented, FDA enforcement will only address manufacturers, distributors, wholesalers, importers and retailers who violate the rules.
The Bangor City Council plans to repeal an ordinance that would have implemented a ban on flavored tobacco sales in the city.
Bangor initially approved the ban back in October. It was set to go into effect June 1, but during a meeting on Monday, city officials said they did not give businesses enough warning about the new law.
City officials were required to give businesses at least 30-days’ notice, which they reported did not happen, according to News Center Maine. Because of that, officials said the ban would be difficult to enforce and could even open the city up to possible lawsuits. The city council was not sure why the notice never happened.
Councilors can still pass a new ordinance in the future. Bangor was the first community in Maine to approve a ban on flavored tobacco. Portland and Brunswick also have bans that are set to start June 1.
A proposal for a statewide ban on flavored tobacco is still working its way through the Maine Legislature.
When the U.S. Food and Drug Administration issued marketing granted orders to the NJoy Ace and its tobacco-flavored e-liquid pods on April 26, the ACE became the first e-cigarette authorized by the FDA equipped with a ceramic coil. That coil is manufactured by FEELM, the flagship atomization tech brand belonging to Smoore International.
The Ace marketing orders mark the first approval by the FDA of a pod vaping product. It is also the first approval of any vaping product manufactured by a company that is independent of the tobacco industry.
Smoore is no stranger to seeing its products get marketing approval from the FDA. The first brand to receive marketing orders through the premarket tobacco product application (PMTA) pathway, Vuse Solo, is a strategic partner of Smoore, a Smoore representative explained to Vapor Voice. The second set of approved electronic nicotine-delivery system (ENDS) products, produced by Logic, are also manufactured by Smoore.
“NJoy has partnered with Smoore since 2009. The NJoy Ace was launched in 2018 and is powered by FEELM inside, the world’s first black ceramic atomization coil with metallic film. As the first ceramic coil e-cigarette and pod vape authorized by the FDA, NJoy Ace’s approval for sale fully showcases the harm reduction potential of FEELM ceramic coil,” the representative said. “According to the FDA, NJoy Ace is authorized for sale because ‘chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke.’”
Based on PMTA requirements, Smoore established a comprehensive analytical testing and safety assessment system, including the vaping industry’s first corporate toxicology laboratory, which explores the health impacts of exposure to e-cigarette vapor by means of cytotoxicity test, evaluating the reaction of living cells to different components of e-cigarette vapor, according to Smoore.
The company has also developed the third generation of in-house safety standards – Smoore 3.0 – that covers all of required PMTA tests, including for HPHCs listed by the FDA.
“The principle of PMTA is to scientifically and systematically substantiate harm reduction performance of the vaping product and show it is appropriate for the protection of the public health (APPH)”, said Dr. Long, director of the Smoore Analytical Testing and Safety Assessment Center. “The manufacturer must demonstrate the product’s potential to switch adult smokers while preventing youth and non-smokers from nicotine addiction.”
Long said this could explain why all the FDA-authorized vaping products so far have been for tobacco flavors, and popular flavored products the agency has said promote youth use have been issued marketing denial orders. It is also an indication that vaping manufacturers should focus on “tobacco flavor reproduction and improve harm reduction performance” in order to be approved under the PMTA pathway.
According to Nielsen, for the two weeks ended April 9, 2022, Vuse has now surpassed Juul and become No.1 in U.S. e-cigarette sales with a market share of 35 percent. Its flagship product Vuse Alto is also equipped with FEELM ceramic coils.
As the No. 3 player in the U.S., NJoy accounts for approximately 3.1 percent market share. Moreover, a federal judge has required the FDA to provide progress reports on PMTAs submitted by major vaping brands and the first reports are due on April 29.
The FDA also found that the risk to youth initiation with NJoy’s Ace was outweighed by the benefit to adult smokers, warning that NJoy must comply with strict post-marketing requirements.
The return of sCOPe, a global livestream featuring leading tobacco harm reduction (THR) advocates, this year will broadcast again on both World Vape Day and World No Tobacco Day.
