The government in the Philippines is being urged to raise the minimum age of people allowed to use vaping products to 25, ban flavored products, online sales, and “eventually” e-cigarettes entirely.
Southeast Asia Tobacco Control Alliance Executive Director Ulysses Dorotheo said also wants the introduction of “standardized packaging” on vaping products – removing colors, scents, and indications of flavors in a proposal issued to lawmakers during a Senate committee hearing on sustainable development goals, innovation, and future thinking on Friday.
“To raise the minimum age to 25 which is the cut-off for adolescent brain development so as to reduce the risk of nicotine addiction,” he said, reports the Inquirer.
Individuals as young as 18 years old may legally smoke vaping products in the Philippines.
The country’s Food and Drug Administration backed the suggestion of Dorotheo.
Restricting the sales of vaping products online is likewise pushed by Dorothero, noting it “is where our youth spend much of their time.”
Further, Dorotheo sought to increase the excise taxes on vaping products, pointing out that a lower tax rate is levied on such items compared to tobacco products.
Dorotheo eventually emphasized that the “long-term ideal outcome” is to ban vaping products.
The Philippine Tobacco Industry (PTI) recently called on the Philippines’ Bureau of Internal Revenue (BIR) to crack down on illicit vapor products.
British American Tobacco says that it expects its next-generation tobacco products division to be profitable earlier than previously anticipated, but its share price was down as diluted earnings per share declined.
Total revenue for BAT is set to come to £27.7 billion for 2022, up 7.7 percent from 2021.
Its “new categories” arm – made up of vaping products, heated tobacco products and nicotine pouches contributed £2.9 billion of 2022 revenues, which was up by 40.9 percent, reports the Evening Standard.
CEO Jack Bowles said the division was now expected to turn a profit in 2024, one year earlier than previously thought.
“Our new category business delivered strong volume, revenue and market share growth and has become a significant contributor to the group’s financial delivery,” he said. “In 2022, we invested more than £2 billion in new categories to drive long-term sustainable growth, while making excellent progress in reducing operating losses by 62 percent.”
Adjusted operating profit for BAT as a whole was in line with expectations at £12.4 billion.
However, BAT shares are down 4.5 percent so far today.
The top-selling Vuse electronic cigarette of BAT subsidiary R.J. Reynolds Vapor Co. continued to expand the market-share gap with Juul in both monthly and yearly comparisons.
The U.S. Food and Drug Administration has submitted a new timeline for its expected finish to the review of premarket tobacco product applications (PMTAs) in a court-mandated status report. As previously reported by Vapor Voice, the agency doesn’t expect to complete PMTAs for the most popular vaping products until the end of the year.
In prior status reports, the FDA indicated that it expected to finalize actions on all covered applications by June 30, 2023. Filed with the Maryland Federal District Court on Jan. 24, 2023, the agency’s fourth report states that it now expects to have taken action on PMTAs as follows:
52 percent of Covered Applications by March 31, 2023
53 percent of Covered Applications by June 30, 2023
55 percent of Covered Applications by Sept. 30, 2023
100 percent of Covered Applications by Dec. 31, 2023
The FDA is expected to give its next status update to the court on April 24.
The FDA is under a Maryland Federal District Court order to file regular status reports on the agency’s review of PMTAs. The court case that ended in a court-imposed deadline for the FDA was filed by health groups seeking a timeline for the review of the PMTAs that were filed with the agency by Sept. 9, 2020.
In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players’ reports.
The original completion date was Sept. 9, 2021, however, the FDA was unable to meet it due to the extremely large number of PMTAs filed by manufacturers.
The most recent delay is partially being caused by ongoing litigation and by the agency accepting some amendments to already filed PMTAs that the agency now needs to review, according to the report.
Connecticut Attorney General William Tong submitted testimony concerning House Bill 6488 stating that he fully supports the state’s proposed ban on flavored vaping and other tobacco products.
He also expressed concern that the “An Act Concerning Cigarettes, Tobacco Products, Electronic Nicotine Delivery Systems and Vapor Products” bill as currently written exempts the most widely used flavor—menthol—which must be included in the ban to deter youth addiction.
“Ending the sale of flavored tobacco products, including menthol, will have an enormous impact in reducing the number of people who die or suffer debilitating preventable illness from tobacco use, significantly reducing the number of young people who become addicted to tobacco products, and reversing the youth e-cigarette epidemic,” Tong states. “A comprehensive flavor ban that includes menthol will save thousands of Connecticut lives, protect public health, and advance health equity. It should be implemented immediately.”
Connecticut Attorney General William Tong
Tong stated that his office has a long history of battling tobacco companies “from negotiating the Master Settlement Agreement in the 1990s to the recently announced settlement with Juul, we have focused our efforts on combatting the insidious ways that Big Tobacco has marketed to children.”
The bill is the most recent effort by members of the legislature’s Public Health Committee to take flavored nicotine products off the market in an effort to reduce smoking and vaping among young people. Similar legislation has failed to make it across the finish line during recent legislative sessions.
Connecticut lawmakers heard testimony on legislation that would ban the sale of flavored tobacco and vape products as well as prohibit the use of vapes while in a vehicle with a child.
Connecticut is one of few states in the region that has not adopted a prohibition on flavored e-cigarettes. New York, New Jersey and Rhode Island have barred the sale of flavored vaping products. Massachusetts banned all flavored tobacco items, including flavored cigars, cigarettes and vaping goods.
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.
The U.S. Court of Appeals for the Fifth Circuit has granted an administrative stay of a U.S. Food and Drug Administration marketing denial order (MDO) for two R.J. Reynolds Vapor Co. menthol flavored refill pods.
The order was granted as a temporary stay pending a motion to file a stay with the court by Feb. 1, 2023.
On Jan. 24, the FDA denied marketing applications for two menthol refills used in Vuse Vibe and Vuse Ciro vaporizers, which are sold in the U.S. by BAT subsidiary R.J. Reynolds. According to the agency, Reynolds’ applications presented insufficient evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.
British American Tobacco said on Jan. 25 that it intended to appeal the MDO for its Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%, the company announced in a statement.
Tobacco harm reduction advocates are keen to clarify controversies surround the science on nicotine and vaping ahead of the Conference of the Parties (COP10) to the World Health Organization’s Framework Convention on Tobacco Control (FCTC), which will take place in November 2023.
The Coalition of Asia Pacific Tobacco Harm Advocates (CAPHRA) has written FCTC delegation heads to help inform their respective countries’ positions.
In its letter, CAPHRA notes that two high-profile studies, which have been quoted by tobacco controllers regarding the dangers of nicotine and vaping, have since been retracted and removed from significant medical journals.
“The first retraction is an article published in February 2022 in The World Journal of Oncology, claiming that nicotine vapers face about the same cancer risk as cigarette smokers,” CAPHRA wrote.
Another article, in the Journal of the American Heart Association, which reported an association between vaping and heart attacks was also retracted. Astoundingly, advocates noted, this article is still used as a reference in the FCTC guidelines around e-cigarettes.
Consumers’ rights to choose to use less harmful products to switch from smoking remain under tremendous threat from FCTC’s continuing failure to address scientific evidence, democratic processes and human rights.
In addition, the THR regional advocacy group sent delegates a bibliography of key and current studies that disprove some of the more outrageous claims around harm.
On the supposed “youth vaping epidemic,” CAPHRA noted “a new survey from the Centers for Disease Control and Prevention and Food & Drug Administration suggests that youth vaping rates appear to be dropping, compared to pre-pandemic levels… In fact, youth vaping in the U.S. has plummeted by 60 percent over the past two years.’
“Consumers’ rights to choose to use less harmful products to switch from smoking remain under tremendous threat from FCTC’s continuing failure to address scientific evidence, democratic processes and human rights,” says CAPHRA executive coordinator Nancy Loucas.
The CAPHRA representatives reminded the health leaders that the FCTC has a mandate to pursue Harm Reduction as a core tobacco control policy—a position it has failed to acknowledge or implement since its inception, according to CAPHRA.
“WHO and its FCTC continue to press for signatory states to adopt ever more restrictive policies, including outright bans, based on dubious science. Delegates to COP10 should be representing the rights and aspirations of the citizens,” wrote the CAPHRA member organizations.
“Consumers have the right to make choices that help them avoid adverse health outcomes and smokers have the right to access less harmful nicotine products as alternatives to smoking. Please take account of these rights when making and presenting your submissions to COP10,” the letter concluded.
In a sudden change of policy, Google will allow the advertising of hemp and topical CBD products in California, Colorado and Puerto Rico under an update to its policies on “Dangerous Products and Services and Healthcare and Medicines.”
Google did not make clear why it is restricting the advertising to the three distinct markets, according to Hemp Today.
Advertising for CBD for internal human consumption remains off limits, the company said, including those for “supplements, food additives, and inhalants.” Also, masthead advertising on YouTube (owned by Google), which appears at the top of the page in the main feed across all devices, is not available to hemp and CBD products, under the policy revisions.
Google also said pharmaceuticals approved by under the Food and Drug Administration (FDA) may now also be advertised in those jurisdictions. That part of the rule change will benefit only one producer, Jazz Pharmaceuticals, whose high-CBD Epidiolex is the lone such product approved by the agency to date. Epidiolex is prescribed for severe seizure disorders in children. It was approved by the FDA in 2020.
The changes take effect Jan. 20. Advertisers can request certification with Google starting on that date, when an application form will be published.
Google said it has contracted with LegitScript, a Portland, Oregon-based internet and payments compliance company that provides certification in high-risk industries, as a clearinghouse to determine products’ advertising eligibility. Only products that pass muster with LegitScript can be promoted on Google platforms.
Those seeking certification to advertise on Google must provide samples of their products or THC testing and provide LegitScript with third-party certificates of analysis, according to Google.
A new report from University of North Carolina researchers pushes the false claim that nicotine vaping products cause e-cigarette or vaping product use-associated lung injury (EVALI).
“At its core, EVALI is a serious disease that primarily affects the lungs and results in a substantial number of hospitalizations and deaths in a relatively young and otherwise healthy population across the United States,” said Meghan Rebuli, PhD, assistant professor in the Department of Pediatrics in the UNC School of Medicine, stated in a press release. “This epidemic is largely caused by the unregulated and quickly evolving nature of the e-cigarette industry and certainly highlights the need for continued action by both researchers and government agencies.”
In 2021, Rebuli co-led a virtual workshop which brought together pulmonologists, public health officials, epidemiologists, and toxicologists from across the U.S. to discuss their latest research findings and recommendations. A new report, with Rebuli as its lead author, was published in the Annals of the American Thoracic Society in December 2022.
The the U.S. Centers for Disease Control and Prevention (CDC) has stated that vitamin E acetate used in THC-based vaping products was “more than likely responsible” for causing EVALI. However, Vitamin E acetate wasn’t found in all of the EVALI-associated products, according to Rebuli.
“So, it is still quite possible that there are other components in e-cigarettes that can cause EVALI,” said Rebuli. “We just have not identified many of those yet.”
No components of nicotine-based vaping products have been associated with EVALI, according to the CDC.
In July of 2020, the CDC said states no longer have to track lung-related injuries caused by marijuana-based vapor products, partly because cases have dropped. The CDC said it stopped requiring states to report the numbers after it “pinpointed vitamin E acetate as the culprit in THC e-cigarettes” making people sick. The CDC said it is monitoring EVALI cases and hasn’t seen an uptick nationwide. However, It said the agency will continue to provide assistance to states as needed.
EVALI and false reporting surrounding its cause has boosted misinformation surrounding nicotine vaping products. A new study led by researchers at the American Cancer Society (ACS) shows perceptions of e-cigarettes as being “more harmful” than cigarettes by adults in the United States more than doubled between 2019-2020 and perceptions of e-cigarettes as “less harmful” declined between 2018-2020, when the EVALI concern was at its peak.
Dr. Kumar Subaramaniam, a physician based in Malaysia, says he finds the increased usage of the term EVALI worrisome, as it is often discussed in the wrong context, according to the New Strait Times. Kumar said that the issue lies with certain parties, who bring up EVALI at the mention of vaping, while repeating and spreading mistruths about vaping.
When the CDC identified the real culprit behind the EVALI outbreak, the presence of vitamin E acetate that was added into illegal tetrahydrocannabinol (THC) products, Kumar said the CDC’s slow reaction to announcing the cause caused the mishap that left a bad reputation on vaping, which was touted to give many smokers a chance to quit smoking tobacco products for good.
“So, it was not vaping that was the problem, rather the misuse and abuse of the products. But the damage has been done and the half-baked truths surrounding EVALI live on to this day,” he says. “The EVALI saga should not be used as a ‘boogeyman’ to dissuade us from seeking to regulate vaping and adopt a ‘zero-tolerance’ attitude. In fact, the EVALI saga in the U.S. shows above all the importance of regulations.”
It was more adversity for the vapor industry as many companies are still waiting on PMTA results.
By VV Staff
The year 2022 was tough on the vaping industry. While several countries banned or began heavily regulating vaping products, the United States banning most premarket tobacco product applications (PMTAs) probably had the greatest impact on the industry. Industry analysts estimate that 50 percent to 60 percent of vaping-related businesses in the U.S. had closed by late 2022 after the Food and Drug Administration began issuing mass marketing denial orders (MDOs) for nearly all the 6.5 million PMTAs submitted by 500 companies in 2021.
Companies had until May 14 to submit a PMTA to the FDA to keep their synthetic nicotine products on the market. Companies that failed to secure authorization were supposed to pull their products from the market by July 13. However, the regulatory agency has been using some discretion in its enforcement of synthetic nicotine products as it continues to review both tobacco and nontobacco PMTAs.
One of the biggest stories of the year is the rise of R.J. Reynolds Vapor Co.’s Vuse e-cigarettes, which took over as U.S. market leader from Juul in 2022. Juul’s fall came after the FDA issued an MDO for Juul Labs’ PMTAs on June 23. On July 5, the FDA stayed the MDO, announcing that it would review the decision after determining “there are scientific issues unique to this application that warrant additional review.” By October, Vuse had expanded its market share lead over Juul to 12 percent in the Nielsen analysis of convenience store data.
January
Credit: Selen Geren
Thirty U.S. states plus the District of Columbia kick off the new year on Jan. 1 with taxes on vaping products. Filipino vapers appeal to Duterte to sign a bill that would legalize vaping. The U.S. Congress begins review the Clarifying Authority Over Nicotine Act of 2021—a bipartisan bill designed to give the FDA the authority to regulate synthetic nicotine products just as it regulates nicotine products made or derived from tobacco. South Africa begins considering taxes on hardware and e-liquids, with high-nicotine products getting higher rates. Malaysia postpones implementing a tax that would have more than doubled the retail prices of e-liquid bottles for open systems. FEELM Air launches in the U.K.
February
Credit: Timon
Triton Distribution makes opening arguments in its battle with the FDA over how the regulatory agency conducted its PMTA reviews. A court of appeals stays Bidi Vapor’s MDO. Judges grant stays to Diamond Vapor, Johnny Copper and Vapor Unlimited in MDO lawsuits. The U.S. Senate confirms FDA Commissioner Robert Califf. Philip Morris International announces its plans to bypass an import ban by manufacturing IQOS in U.S. The FDA posts its first warning letter for vaping hardware products. The letter is issued to China-based Sigelei Vapor for two coil brands. The U.S. International Trade Commission (ITC) issues a general exclusion order that bans the importation of any unauthorized cartridges compatible with the Juul vaping system that infringe Juul Labs’ patents. The FDA submits its proposal to ban menthol to the Office of Management and Budget for review.
March
Credit: V. Chalup
The Swedish government proposes a ban on nontobacco-flavored vaping devices, including menthol. The National Youth Tobacco Survey (NYTS) 2021 finds youth cigarette smoking rates in the U.S. at historically low levels, with just 1.9 percent of high school students reporting current use of cigarettes. U.S. President Joe Biden signs a bill giving the FDA power over synthetic nicotine. Companies have 60 days to file PMTAs. China announces e-cigarette regulations, including flavor bans and compliance of all products produced for export with the regulations and laws in the destination country. If a country does not regulate e-cigarettes, China’s rules for vaping products would apply to those exports, including bans on flavors and synthetic nicotine. Myth of a gateway from vaping to smoking is debunked … again. FDA issues marketing orders to eight Logic brand vaping products.
April
Credit: Jarretera
Mitch Zeller retires as director of the FDA’s Center for Tobacco Products (CTP). Vuse surpassed Juul to become the No. 1 e-cigarette brand in the U.S., according to Nielsen. Smoore International, the largest vaping company in the world, reports 2021 annual revenue of $2.16 billion. Canada proposes the first federal nicotine-only vape tax. China releases its rules listing the requirements for design, chemical compounds and the mechanics for manufacturing e-cigarettes. New York Stock Exchange rules force RLX Technology co-founder Kate Wang to resign from RLX committees. Fontem Ventures, a subsidiary of Imperial Brands, receives an MDO for its MyBlu products. Judge orders the FDA to give PMTA updates every 90 days for products with at least a 2 percent market share. Juul begins settling marketing lawsuits with several states. Hong Kong’s ban on vaping products makes it illegal to use or carry an activated vaping device in no-smoking areas. The FDA publishes rules for the menthol ban. Several Njoy vaping products receive marketing orders.
May
For the first time, the FDA issues warning letters for marketing products containing delta-8 THC. Several R.J. Reynolds Vapor Co. Vuse branded e-cigarette products receive marketing orders, including six new tobacco products, through the PMTA pathway. The San Diego City Council passes an ordinance for the second time banning vape flavors, and it’s effective Jan. 1, 2023. In its first status report, the FDA states that it expects to have resolved 63 percent of PMTAs set out in its original priority by June 30. Altria Client Services pays $100.5 million for assets and properties used in Poda Holdings’ business of developing, manufacturing and marketing multi-substrate heated capsule technology. FEELM wins four Red Dot Awards, an international competition for product, communication and concept design. Longtime Centers for Disease Control and Prevention alumnus Brian King succeeds Mitch Zeller at the FDA’s Center for Tobacco Products (CTP).
June
Credit: Premium Collection
Mexico bans all vaping and heated-tobacco products. Mexican President Andres Manuel Lopez Obrador signs a decree that outlaws the sale of e-cigarettes in line with continuing the government’s ongoing anti-vaping policy. Heated-tobacco products are not exempt from the ban as previously reported that they would. Njoy Daily disposables get marketing orders; however, the FDA issued MDOs to Njoy for multiple other flavored Daily e-cigarette products. A study finds e-cigarette or vaping product use-associated lung injury (EVALI) and Covid-19 boosted misinformation on vaping. A federal court jury finds R.J. Reynolds’ Vuse Solo and Alto devices infringe two Philip Morris patents. Zinwi is among the first to get a green light to produce e-liquids under China’s new regulatory framework. Juul receives an MDO, which is subsequently stayed in court. The FDA places Juul’s application back under review. EU lawmakers propose a flavor ban for heated-tobacco products.
July
PMI opens its flagship IQOS store in South Africa. Confronted with rising prices for batteries, engineers in Ukraine begin using power cells from vapes to power drones. A U.S. administrative tribunal invalidates two claims in an R.J. Reynolds vaping patent. Panama bans the sale and import of vapes, joining more than a dozen Latin American and Caribbean countries with such restrictions. Brazil also maintains its ban on vaping products. The FDA issues first warning letters for synthetic products. Juul Labs begins exploring financing options to avoid bankruptcy. Juul quarterly revenues drop 23 percent. FDA Commissioner Robert Califf says the nonprofit Reagan-Udall Foundation—a nongovernmental research group created by Congress to support the FDA’s work—will convene experts to evaluate the CTP within 60 business days. Matt Holman, the director of the CTP’s Office of Science, announces he is stepping down. Altria reduces the value of its investment in Juul Labs to $1.3 billion, a nearly 70 percent loss of its original $12.8 billion evaluation. The Philippine president allows a bill that legalizes e-cigarettes to lapse into law.
August
Credit: Savvapanf Photo
CTP Director Brian King states that the agency is “making significant progress” in reviewing synthetic nicotine applications. Chinese car maker BYD gets a vape production permit and its stock price soars. Monroe County becomes the first in New York state to accept e-cigarettes and e-liquids for safe disposal. VPR Brands receives an FDA warning letter for its nicotine gummies. FEELM, one of the largest and most influential e-cigarette brands, earns its production license in China. The U.S. Court of Appeals for the Eleventh Circuit grants petitions for review filed by Bidi Vapor, Diamond Vapor and four other companies challenging the FDA’s rejection of their e-cigarette applications in a 2-1 decision. Great Britain reports record levels of vaping in a report that found 2.4 million vapers are ex-smokers. Vuse’s market grows from 37.4 percent to 39 percent, with Juul declining from 30.7 percent to 29.4 percent. A U.S. appeals court denies a petition to review the FDA’s marketing denial order to Illinois-based e-liquid manufacturer Gripum.
September
Credit: Kristina Blokhin
Juul Labs agrees to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products, which critics have blamed for sparking a surge in underage vaping. A jury in the U.S. District Court for the Middle District of North Carolina awards Altria Client Services more than $95 million after finding that Reynolds Vapor Co.’s Vuse Alto e-vapor product infringes three Altria patents. The FDA states it sent more than 44 warning letters to manufacturers and over 300 warning letters to retailers for violations relating to nontobacco nicotine. Alaska’s governor vetoes an age-to-vape bill because it also included the implementation of a tax on e-cigarettes. Nicaragua bans the import of e-cigarette products. Altria Group exercises its option to be released from its noncompete deal with Juul Labs. Maine backs out of a Juul settlement claiming it would cancel out school district suits.
October
Credit: Charlottes Web
The Colorado Supreme Court rules that the Colorado attorney general’s office’s lawsuit against electronic cigarette manufacturer Juul Labs cannot include four of the company’s executives. The FDA announces that as of Oct. 7, it has issued refuse to accept (RTA) letters for more than 889,000 synthetic nicotine product applications that did not meet the criteria for acceptance. Magellan CEO Jon Glauser says the FDA acknowledged in writing that it had “erred in failing to inform the company” about its MDOs before announcing the move publicly. An analysis suggests that over 90 percent of FDA warning letters were sent to small online retailers. For the first time, the U.S. Department of Justice files requests for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the FDA. Charlotte’s Web signs the first CBD licensing deal with Major League Baseball. A health regulatory body for Mexico’s government says its scientists have developed a new methodology to analyze the aerosols in electronic nicotine-delivery systems because “no one else has come up with one.” PMI reaches a deal with Altria Group to pay nearly $2.7 billion for exclusive U.S. commercialization rights to IQOS. FDA staff comments for the Reagan-Udall assessment of the performance of the CTP suggest the regulatory agency is in a state of disarray and being influenced by outside forces not scientific research. The FDA issues its first menthol MDOs for the Logic Pro Menthol E-Liquid Package and the Logic Power Menthol E-Liquid Package.
November
Credit: Vege Fox
China’s Ministry of Finance imposes a consumption tax on e-cigarettes sold in China from Nov. 1. China bans celebrities from endorsing vaping products. Logic is granted a temporary stay of the FDA’s menthol MDO. The EU publishes a directive officially banning flavors in heated-tobacco products throughout the union. Magellan sues the FDA and the U.S. Department of Health and Human Services, claiming the agencies violated the Administrative Procedure Act in the PMTA reviews. Maryland and Missouri become the 20th and 21st states to legalize marijuana for adult recreational use, but cannabis reform efforts meet defeat in Arkansas, North Dakota and South Dakota. Vuse’s market share rises from 40 percent in the previous report to 40.4 percent compared with Juul declining from 28 percent to 27.6 percent in Nielson’s four-week period ending Nov. 5. The European Union proposes a bloc-wide vaping tax policy as part of a shake-up of levies on the tobacco industry.
December
Credit: Sharaf Maksumov
Macau’s blanket ban on vaping products goes into effect. The rules prevent people from carrying e-cigarettes across the border with fines up to mop20,000 ($2,505). The Netherlands bans all e-cigarette flavors except tobacco effective Oct. 1, 2023. U.S. President Joe Biden officially signs the first piece of standalone federal cannabis reform. The Marijuana and Cannabidiol Research Expansion Act is aimed at providing federal support to facilitate research of cannabis and its potential health benefits. Juul Labs settles more than 5,000 lawsuits covering more than 10,000 individual plaintiffs. Financial terms of the deal were not disclosed. Costa Rica for the first time gives a company authorization to grow and process hemp. Canada’s Minister of Mental Health and Addictions and Associate Minister of Health released a report finding that vaping products offer the 3.8 million Canadians who smoke a less harmful source of nicotine than tobacco products, and do help people to stop smoking. The Reagan-Udall Foundation submitted its recommendations to the commissioner of the FDA. The report concludes that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the Center for Tobacco Products (CTP), particularly with respect to tobacco harm reduction and the requirements needed to navigate the PMTA process. A separate investigation, conducted by the U.S. Office of Special Counsel (OSC) after a whistleblower complaint, found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.
Looking ahead
It’s impossible to predict what the vaping industry will look like by the end of 2023. The U.S. will probably see a decline in product variety because the FDA is unlikely to approve many devices. However, globally, especially in the EU and the U.K., the industry should continue to thrive and expand, according to industry analysts. More importantly, innovation should continue to thrive outside the U.S.
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, said the global fight for fair and sensible regulation of vaping products will continue throughout 2023. “Regrettably, just like years prior, some battles will be lost, and the end result will be fewer adults who smoke fully switching to vaping,” he said. “However, the silver lining is that—as we see today in Australia and Thailand—even prohibitions with criminal sanctions are not enough to stop illicit markets from popping up. This industry will never be able to stop every attempt at prohibition, but it can continue to document and expose how black markets follow whenever these bans are implemented.”
On the U.S. state level, Conley said his major concern is PMTA registry bills being put forth by the tobacco industry. He explained that these bills would devastate law-abiding vape shops and smoke shops by banning any vaping product that does not have a PMTA granted or explicit enforcement discretion from the FDA. “This means that synthetic nicotine, nicotine-free [products] and CBD/delta products would all become illegal to sell,” said Conley.
Nationally in the U.S., Conley said the FDA’s policy on vaping products in 2023 is likely to still be characterized by regulatory paralysis and the eternal search for the least politically controversial regulatory option. “Despite declines in youth vaping and the admonishment of federal judges, leadership at FDA remains steadfastly committed to having more combustible cigarettes on the market than vaping products,” he said. “On the plus side, the pace of FDA review has been slow to say the least, so we won’t hear rulings on many applications until 2024 or later.”
For the first time, the FDA issues warning letters for marketing products containing delta-8 THC. Several R.J. Reynolds Vapor Co. Vuse branded e-cigarette products receive marketing orders, including six new tobacco products, through the PMTA pathway. The San Diego City Council passes an ordinance for the second time banning vape flavors, and it’s effective Jan. 1, 2023. In its first status report, the FDA states that it expects to have resolved 63 percent of PMTAs set out in its original priority by June 30. Altria Client Services pays $100.5 million for assets and properties used in Poda Holdings’ business of developing, manufacturing and marketing multi-substrate heated capsule technology. FEELM wins four Red Dot Awards, an international competition for product, communication and concept design. Longtime Centers for Disease Control and Prevention alumnus Brian King succeeds Mitch Zeller at the FDA’s Center for Tobacco Products (CTP).
PMI opens its flagship IQOS store in South Africa. Confronted with rising prices for batteries, engineers in Ukraine begin using power cells from vapes to power drones. A U.S. administrative tribunal invalidates two claims in an R.J. Reynolds vaping patent. Panama bans the sale and import of vapes, joining more than a dozen Latin American and Caribbean countries with such restrictions. Brazil also maintains its ban on vaping products. The FDA issues first warning letters for synthetic products. Juul Labs begins exploring financing options to avoid bankruptcy. Juul quarterly revenues drop 23 percent. FDA Commissioner Robert Califf says the nonprofit Reagan-Udall Foundation—a nongovernmental research group created by Congress to support the FDA’s work—will convene experts to evaluate the CTP within 60 business days. Matt Holman, the director of the CTP’s Office of Science, announces he is stepping down. Altria reduces the value of its investment in Juul Labs to $1.3 billion, a nearly 70 percent loss of its original $12.8 billion evaluation. The Philippine president allows a bill that legalizes e-cigarettes to lapse into law.
