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.
Tobacco harm reduction advocates remain optimistic that Thailand will legalize e-cigarettes, despite vocal opposition from the country’s health minister.
On April 26, Public Health Minister Anutin Charnvirakul said he opposes legalization of vapor products in the country, citing concern about underage consumption and the plight of tobacco farmers.
Asa Saligupta, director of ENDS Cigarette Smoke Thailand (ECST), suggested Charnvirakul was playing politics. “After his abysmal handling of the pandemic, among other things, he could easily lose his seat at Thailand’s upcoming general election. He’s simply panicking but has completely underestimated the wide support for legalizing and regulating vaping,” said Saligupta.
With draft legislation to legalize e-cigarettes currently before a sub-committee, the ECST director remains confident that the vaping bill will be passed by Thailand’s parliament this year.
“The Thai government can and will regulate safer nicotine products regardless of what one minister says,” said Saligupta. “Let’s not forget that Digital Economy and Society Minister Chaiwut Thanakamanusorn, government officials and public health experts have all been key to finally confronting Thailand’s failed tobacco control policies,” he says.
According to Saligupta, Thailand’s harsh ban and penalties on vape imports and sales have failed.
“Smoking continues to kill about 50,000 Thai people each and every year. Too many smokers have been stuck with cigarettes or are forced onto the black market for vapes where there’s no control over the purchase age or product safety standards. An effective public health minister would not accept this dire situation, let alone support it,” he says.
ECST believes it’s no surprise the minister made his anti-vaping statement to ThaiHealth board members. Its senior adviser, Prakit Vathesatogkit, recently received the Dr Lee Jong-wook Memorial Prize by the World Health Organization for his work against tobacco. He has also been a high-profile voice against legalizing vaping.
“ThaiHealth along with some local conservative health voices continue to publicly scaremonger, conveniently ignoring the growing tobacco harm reduction success globally,” said Saligupta. “By joining the minority, Thailand’s Public Health Minister is now among an increasingly isolated crowd who continue to follow the WHO’s discredited anti-vape agenda,” he says.
According to Saligupta, nearly 70 countries have now adopted regulatory frameworks on safer nicotine products despite the WHO position, leading to dramatic declines in their overall smoking rates. The Philippines and Malaysia are also set to legalize vaping.
“Thankfully the Thai government remains on the right side of the debate,” he said. “Regulating will give consumers better protection, encourage more smokes to quit deadly cigarettes, and ensure we have much better control over youth vaping with a strict purchase age,” he says.
The U.S. Food and Drug Administration on April 26 authorized four NJOY products through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to NJOY for its Ace closed e-cigarette device and three accompanying tobacco-flavored e-liquid pods—NJOY Ace Pod Classic Tobacco 2.4%, NJOY Ace Pod Classic Tobacco 5% and NJOY Ace Pod Rich Tobacco 5%.
Simultaneously, the FDA also issued marketing denial orders to NJOY for multiple other Ace e-cigarette products, which must now be removed from the market. These are presumed to be for flavors other than tobacco. Applications for two menthol-flavored Ace e-liquid pods remain under FDA review.
Under the PMTA pathway, the applicant must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health, the FDA explained in a statement.
The authorized NJOY products were found to meet this standard because, among several key considerations, 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.
Further, data provided by the applicant demonstrated that participants who had used only the authorized NJOY Ace products had lower levels of exposure to HPHCs compared to the dual users of the new products and combusted cigarettes. Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption.
Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. This included review of available data on the likelihood of use of the product by young people. For the authorized products, the FDA determined that the potential benefit to adult smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided that the company follows post-marketing requirements to reduce youth access and youth exposure to their marketing.
Additionally, this authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.
Public Health Minister Anutin Charnvirakul insisted that Thailand’s Public Health Ministry will not support legalizing electronic cigarettes in the country.
He made his remark on Monday during a meeting with board members of the Thai Health Promotion Foundation (ThaiHealth) to discuss tobacco control.
Anutin, in his capacity as chairman of the ThaiHealth board, said he has noticed e-cigarettes trending among teenagers and some of them are aiming to have sales legalized.
To help boost e-cigarette control, Anutin said he has assigned a tobacco control panel under the Department of Disease Control (DDC) to review current regulations to determine whether they should be revised or new rules should be issued.
However, current laws can still suppress the rise of e-cigarettes, he said.
“The DDC has also been instructed to coordinate with police to come up with a solution in preventing e-cigarettes from becoming more popular in the future,” he said.
Dr Surachet Satitniramai, second deputy chairman of ThaiHealth, said that currently, many business operators are attempting to legalize the import of e-cigarettes to the country, which is a topic of concern among members of the committee.
“E-cigarettes will have a widespread effect on tobacco farmers in the country,” he said. “As the materials of e-cigarettes don’t consist of tobacco but chemical, farmers will suffer income loss.”
The vapor industry has welcomed Egypt’s decision to allow the import and commercialization of e-cigarette product.
“The lifting of the ban highlights the Egyptian authorities’ progressive approach to e-cigarettes and sets the stage for the creation of a regulated market rich with business opportunities, through serving the demand for easily accessible, quality products by legal age (adult) consumers across the country,” wrote RELX International, a leading player in the segment, in a statement dated April 24.
With its recent decision, Egypt joins global and regional markets, such as Kuwait, Saudi Arabia and the United Arab Emirates, which have legalized and commercialized the consumption of e-cigarettes. As regulators around the world become more accepting of e-cigarettes, the market is expected to continue its steady growth in the coming years.
As of March 2022 global e-cigarette market revenues were $22.95 billion, and the market is expected to expand annually at a compound annual growth rate of 4.19 percent until 2027, according to Statista.
“The decision by Egyptian authorities reflects its commitment to support legal businesses in the country while cracking down on the illicit trade of those products, in line with what we are seeing in an increasing number of markets around the globe,” said Robert Naouss, REXL International’s external affairs director for the Middle East, Northern Africa and Europe
“The business and investment environment in the country will significantly benefit from this decision, as will adult consumers who can now conveniently, and legally, purchase better alternatives to combustible cigarettes. We look forward to working with our partners to grow and protect their income via our portfolio of quality products”
By lifting the ban on e-cigarette products, Egyptian authorities have opened the door to a plethora of business and investment options, according to RELX International. “Authorized e-cigarette products are traditionally retailed by small- and medium-sized businesses, so the move will bolster existing businesses that sell such products, and will attract entrepreneurs wishing to set up new retail points across the country. It will likewise draw investment into the country from e-cigarette brands who wish to set up shop in the country and address the market,” the company wrote in its statement.
“Adult consumers stand to benefit from the move, as they now have legal access to e-cigarettes whether they wish to switch to a better alternative to traditional cigarettes. Several health authorities and regulators including the U.K.’s NHS and the Ministry of Health of New Zealand have positively clarified their position on vaping as a way for people to move away from smoking combustible cigarettes.
“In addition, the decision will contribute to the country’s economic recovery post-pandemic via the collection of tax revenues from legally imported products. Simultaneously, it will allow Egyptian authorities to clamp down on tax evasion issues associated with illegal market players. In a similar vein, the move and balanced regulation of the market offers authorities and e-cigarette vendors a path to stem the spread of inferior and dangerous black-market products that do not meet the standards and regulations outlined by Egyptian and international authorities. In doing so, adult consumers can rest assured the products they do find on sale are indeed a reliable alternative to traditional cigarettes.”
The New York State Senate is moving forward with proposed legislation that would allow bars and restaurants to use facial recognition or fingerprint scanners to verify someone’s age before they buy alcohol, tobacco or electronic cigarettes, according to the New York Post.
“This is the new frontier of age verification,” said state Sen. James Skoufis, who is sponsoring the biometrics bill. “It does advance the interests of convenience.”
Skoufis envisions that bars and restaurants could scan fingerprints, faces or retinas of customers who want to be spared the trouble of showing an ID when they return to an establishment in the future. The proposed legislation requires all data to be encrypted and prohibits businesses from selling biometric data to third parties.
“No one’s forced into engaging with this technology, but they would have the choice,” Skoufis said. “There’s no big brother involved.”
The U.S. Food and Drug Administration on April 26 authorized four NJOY products through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to NJOY for its Ace closed e-cigarette device and three accompanying tobacco-flavored e-liquid pods—NJOY Ace Pod Classic Tobacco 2.4%, NJOY Ace Pod Classic Tobacco 5% and NJOY Ace Pod Rich Tobacco 5%.
