Non-combustible products are rising in popularity in South Korea, especially the heated tobacco market. According to the latest government data, 210 million packs of heat-not-burn devices were sold in the first half of 2021, up 16.2 percent from the same period a year earlier.
The category’s share in Korea’s entire tobacco market has also increased to 12.4 percent in 2021 from 2.2 percent in 2017, according to Korea Biz Wire.
The country is a key market for the BAT’s glo device, with its market share growing twofold in the past two years. “Our local share has grown greatly since the launch of our heat-not-burn glo pro in 2019. Glo’s share in the non-combustible tobacco market has doubled from two years ago,” BAT’s Country Manager Kim Eun-ji said at the news conference.
BAT’s share in Korea’s non-combustible tobacco market has grown from 6.04 percent in 2017 to around 12 percent in June 2022, said Kim.
In line with such a trend, BAT, the maker of Dunhill and Lucky Strike cigarettes, has invested over $488 million in Korea, which includes a factory in Sacheon, 440 kilometers south of Seoul, which has served as a core export base of BAT since 2002.
“We are aware that the industry’s position is different from that of the health ministry. If we continue to push with more ‘data-driven’ (ways of) communication, we think it will create momentum (that can push) the government to take a step forward, but it will take time,” Kim said.
BAT is the third-largest player in the Korean market for non-combustible tobacco products. The front-runner is KT&G, which accounts for 47 percent of the local market as of June.
BAT Rothmans, the Korean arm of BAT, also reported Tuesday its tobacco heating device glo can reduce health risks of traditional cigarettes, according to a recent study published in the medical journal “Internal and Emergency Medicine.”
The study compared the health effects of glo against traditional cigarettes among 500 British adults aged between 23 and 55 over a one-year period. Researchers found that aerosol produced from glo had 90 to 95 percent less toxicant compared with smoke from traditional cigarettes.
Toxic compounds produced by burning tobacco were either not detected or significantly reduced through the glo device, the company added. “This real-world study allows us to assess the changes that adult smokers switching exclusively to glo experience. It reinforces glo’s potential as a reduced-risk product,” Sharon Goodall, BAT’s head of regulatory science, said at the news conference.
The study results come amid growing calls from the Korean government to increase regulations on e-cigarettes. In September, the health ministry pointed out that e-cigarette devices should go under tighter regulations, citing a growing number of teenage users of such products in the country.
E-cigarette heating devices, like glo, are categorized as ‘industrial products’ in Korea and are subject to looser regulations compared with cigarettes. “It’s hard to entirely trust a clinical study result unilaterally conducted by the tobacco industry. The World Health Organization has concluded that there’s insufficient evidence to support that e-cigarettes are less harmful than traditional cigarettes,” a health ministry official said. He asked not to be identified, citing the issue’s sensitivity.
It shouldn’t be this complicated. Magellan Technology says it didn’t receive a marketing denial order (MDO). The U.S. Food and Drug Administration says it did. It wouldn’t be the first time the regulatory agency made a mistake. The FDA seems to be making a habit of it recently.
Magellan claims that the FDA made a “glaring error” and the company did not receive an MDO for its 32 products under the Hyde brand. In an email, Jon Glauser, CEO of Magellan, stated that the FDA’s announcement is false for two reasons. First, the regulatory agency only issued the company a Refuse to Accept (RTA) letter and, second, the FDA failed to conduct a proper review of Magellan’s scientific evidence in its premarket tobacco product application (PMTA) review for its Hyde products.
“Contrary to the FDA’s statement, FDA only issued a Refuse to Accept letter for the identified Magellan products, not an MDO,” stated Glauser. “A Refuse to Accept letter is a refusal based on nothing more than a technical review of the applications’ contents which, in this case, was a missing document, i.e., a sworn certification related to the translation of certain components of the application. In other words, the Refusal to Accept was based on bureaucratic technicalities.
“This is much more than a misnomer or clerical error by the FDA since the agency elaborated that it had conducted a scientific review and reached a conclusion that the PMTAs ‘lacked sufficient evidence.’ However, no such scientific review was referred to and no scientific justification was provided in FDA’s correspondence today.”
Magellan currently has pending litigation against the regulatory agency with the Second Circuit Court of Appeals concerning an MDO issued by the FDA last year for Magellan’s pod-based Juno vaping products.
New FDA data from the 2022 National Youth Tobacco Survey (NYTS) shows that 2.5 million U.S. youth use e-cigarettes, according to the published findings in the Morbidity & Mortality Weekly Report released by the FDA in conjunction with the Centers for Disease Control and Prevention. This is a slight rise over last year’s data.
Armed with this information, the FDA also issued Puff Bar (no relation to Magellan products) a warning letter for receiving and delivering e-cigarettes in the U.S. without a marketing authorization order. The FDA also requested a response within 15 working days of receiving the letter, detailing how the company intends to address the FDA’s concerns.
It’s at least the second letter the FDA has sent to Puff Bar without any follow-up action. The FDA issued at least two warning letters for Puff Bar’s non-tobacco nicotine disposable products.
During a Next Generation Nicotine Conference in Miami, Patrick Beltran, CEO of Puff Bar, said his disposable products were the “end of the road” for vaping products. “This is the end of the road for vaping in my opinion. It doesn’t get any more convenient for the consumer than a disposable vape device.”
Beltran then blamed U.S. retailers and Chinese manufacturers for the youth initiation issues. “We’re pioneering the disposable industry and the disposable sector of this industry, and it’s very tough when I go to the store and I see people and I see these brands being pushed and there is no enforcement whatsoever,” he explained. “I have to go … I have to spend millions of dollars on a PMTA. Juul, [expletive] Juul, and I’m sure everyone here has heard the news what happened … It’s all [expletive],” referring to Juul’s MDO that the FDA later retracted.
During GTNF 2022, a nicotine industry conference held in Washington D.C. in September, Brian King, director of the the FDA’s Center for Tobacco Products, the division charged with regulating next-generation tobacco products, discussed the FDA’s ability to force companies to comply with its MDOs (and warning letters). So far, very few companies that have been told to remove their products from the market have complied (including Puff Bar). King said the agency has multiple enforcement options to bring both manufacturers and retailers to heel.
“We have several tools available to us, including advisory actions,” he said. “We also have regulatory enforcement actions, including voluntary recalls as well as various other requested recalls. We can also take administrative action, civil money penalties (in terms of manufacturers, that penalty cannot exceed $15,000 for any single violation or $1 million for any number of violations related to a single action),” explained King. “When it comes to judicial action, we can do seizure, injunction and also criminal prosecution. I will say that when it comes to enforcement and compliance, nothing is off the table.”
The FDA has not taken any serious action against any vaping company for violating it’s orders. Puff Bar products can still be found at retailers across the U.S., even though the company has received multiple warning letters from the FDA.
Puff Bar has not received an MDO from the regulatory agency to date.
After reviewing PMTAs for 32 Hyde e-cigarettes, however, the FDA issued MDOs for the applications submitted by Magellan (the company argues they were actually RTAs). In conducting its scientific review, the FDA determined that the applications lacked “sufficient evidence demonstrating that the products would provide a benefit to adult users that would be adequate to outweigh the risks to youth.”
No Hyde products have received marketing authorization orders from the FDA.
“To be sure, the FDA expressly wrote to Magellan that ‘The absence of these required FDA forms impedes FDA ingestion and processing of applications.’ In other words, FDA could not have conducted any scientific review because it refused to accept the application,” wrote Glauser. “Our counsel has demanded that FDA not only retract the press statement it made but also issue a corrective statement making clear that FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.”
The FDA has a history of making mistakes in the PMTA process. It’s currently facing more than 20 lawsuits and has had to retract MDOs from numerous companies, including Juul Labs, Turning Point Brands and Kavial Brands, among others.
“Magellan Technology looks forward to addressing whatever administrative technicalities are present so that FDA can, in fact, conduct a full scientific review of its products,” wrote Glauser.
The U.S. Food and Drug Administration’s Center for Tobacco Products and the National Institute of Health’s National Institute on Drug Abuse announced the availability and location of newly released and updated data files from the Population Assessment of Tobacco and Health (PATH) Study, including the following:
The Wave 5.5 Special Collection data were collected from youth participants ages 13 to 19 between July and December 2020. Data in the PATH-ATS were collected between September and December 2020 from a subsample of adult participants ages 20 and older, complementing the Wave 5.5 Special Collection. Additionally, Restricted-Use Files have been updated to include Wave 5 Ever/Never Reference Data, and the Restricted-Use and Public-Use Master Linkage Files have been updated.
Questions about the collection, content, weighting, documentation, or structure of PATH Study data (this excludes questions on statistical analysis or analytic guidance) may be submitted to PATHDataUserQuestions@Westat.com.
All nontobacco nicotine is now subject to the same regulations as tobacco-sourced nicotine in the U.S.
By Timothy S. Donahue
It was both expected and unexpected. Everyone in the vaping industry knew that at some point the U.S. Congress and the Food and Drug Administration were going to decide on how to handle synthetic and nontobacco nicotine. It was generally believed that regulation would appear in an appropriations bill in September, meaning vaping advocates thought they had time to fundraise and prepare for a battle.
They did not. Instead, the language for changing the definition of the Tobacco Control Act (TCA) to include all nicotine products was buried on page 1,861 of the 2,741-page omnibus spending bill that was signed by President Joe Biden in March. How the rider found its way into the omnibus has caught the ire of many in the industry who say major tobacco companies are seizing the vaping industry away from the small business owners who got it started.
Senator Richard Burr was allegedly approached by R.J. Reynolds and Juul Labs representatives about getting the synthetic nicotine rider in the omnibus that at the time was winding its way through Congress. Burr joined forces with fellow senators Dick Durbin and Patty Murray and Representative Frank Pallone to get the nontobacco nicotine language into the omnibus, according to two Senate sources familiar with the discussions, as reported by Bloomberg Law.
Azim Chowdhury
Azim Chowdhury, a partner with the law firm Keller and Heckman, said he interprets the rule to mean that all synthetic products already on the market or newly marketed within 30 days after the enactment date can continue to be marketed during the 60-day period following the enactment date. The law became effective on April 14, and manufacturers will have until May 14, 2022, to either submit a premarket tobacco product application (PMTA) to the FDA for each vaping product that contains synthetic nicotine or pull their products from the market.
Manufacturers that submit PMTAs to the agency by the May 14 deadline can continue marketing their products until July 13, 2022. Beyond that date, all products must be removed from retail stores unless the FDA has issued a marketing authorization, according to Chowdhury.
“We do not anticipate FDA authorizing any synthetic nicotine products by the end of the 90-day period, though they may take another Fatal Flaw (the term Fatal Flaw was used by the FDA for PMTA submissions that didn’t have specific studies and were subsequently denied) approach to quickly deny applications,” said Chowdhury. “Significantly, the rider in its current form indicates that a synthetic nicotine version of a product that already went through the PMTA process and is subject to a refuse-to-accept, refuse-to-file, marketing denial order (MDO) or withdrawal of a marketing order would have to come off the market as of the effective date—i.e., after 30 days of the law’s enactment.
“In simpler terms, for products that were previously formulated with tobacco-derived nicotine—and the only change was a switch to synthetic nicotine—and whose PMTAs have already been refused or denied, those products will effectively be banned on the effective date—30 days after enactment—with no opportunity to submit a new PMTA. This is Congress’ way of punishing companies whose PMTAs were denied and then, in their view, sought to circumvent the law by switching to synthetic nicotine.”
MIchelle Minton / Credit: Competitive Enterprise Institute
Michelle Minton, writing for the Competitive Enterprise Institute, states that given the FDA’s sluggish track record, many of the applications may not even be reviewed, let alone approved, in that time, which would make the bill a de facto prohibition on those products. “FDA has made it painfully clear that there is no way for those companies to earn its approval,” Minton said. “All it will do is guarantee that companies and consumers are pushed in ever-greater numbers toward a growing illicit market where there are no consumer protections and no age restrictions—or back to smoking.”
Stately response
Beyond the PMTA conditions, if a marketing order is granted, manufacturers of synthetic nicotine products are also subject to all the regulations for tobacco products. Keller and Heckman interpret this to include all additional TCA requirements, including tobacco product establishment registration and product listing; ingredient listing; ensuring that labeling is compliant, including required warning statements; and health document submissions, among others.
Many states had already started to ban synthetic nicotine unless a product gets marketing approval from the FDA. Legislation has been introduced in four state capitals and enacted in one state, Alabama, that effectively bans all products containing synthetic nicotine. Patrick Gleason, vice president of state affairs at Americans for Tax Reform, said Alabama, then Mississippi, Maryland and Georgia, were the first states to introduce legislation effectively banning synthetic nicotine products. However, he says there will be no need for more state legislation to ban synthetic nicotine now that the federal government has added it to the TCA.
Yaël Ossowski
Yael Ossowski, deputy director of the Consumer Choice Center, said that making companies ask permission to sell harm reduction products in the 21st century is “asinine.” Using “sleight of hand” during an emergency government funding bill to “castigate millions of vapers and the entrepreneurs who make and sell the products they rely on,” he noted, is the definition of active harm.
“Only the largest and most powerful vaping and tobacco companies can afford the lawyers and the time necessary to complete the paperwork necessary to pass the FDA’s process, meaning thousands of hardworking American business owners will now be forced to close, depriving millions of adult consumers of harm-reducing options. Many will be forced back to cigarettes,” said Ossowski. “Synthetic nicotine is an innovative method of providing nicotine independent of tobacco, and millions of American adults now use these products as a less harmful method of consuming nicotine. A backdoor bureaucratic power move like this represents a sledgehammer to the men and women of our country who have sought out vaping devices to kick their cigarette habit.”
There is no sell-through period for retailers of synthetic nicotine products if the manufacturer does not file a PMTA with the FDA by May 14. While some manufacturers plan to end sales of their synthetic products by the deadline, as Ossowski suggests, others plan on submitting robust and timely applications. Patrick Mulcahy, CEO and co-founder of Streamline Group, parent to the Streamline Vape Co., wrote in an email that his company has been working toward a solution to navigate the regulatory landscape for newly deemed synthetic nicotine products.
“We have recently contracted with Accorto Regulatory Solutions to manage, submit and deliver a complete set of premarket tobacco [product] applications. To date, their track record of applications submitted have received zero MDOs. Their commitment to submitting a complete and robust PMTA is the level of service Streamline aims to provide the market with our current and future line of products,” he said.
“Streamline’s goal during this process is a commitment to provide full transparency, informational updates and other news related to these regulatory requirements as we progress through the various phases of the PMTA,” Mulcahy stated, adding that market confidence is a top priority for Streamline Group, which was submitting PMTAs for its Juice Head brand e-liquids, disposables and nicotine pouches along with its NIIN brand e-liquid and pouches.
Organized approach
April Meyers, SFATA
April Meyers, owner of Connecticut-based Northeast Vapor Supplies and CEO of the Smoke-Free Alternatives Trade Association (SFATA), told Vapor Voice that her organization believed the industry would have more time to hold discussions with legislators on the Clarifying Authority Over Nicotine Act of 2021 (HR 6286) introduced by Representative Mikie Sherrill in December of last year. SFATA members were aware of the mounting pressure on the subject of synthetic nicotine and had been developing strategies to counter the pressure.
Given the inclusion of vapor in the Prevent All Cigarette Trafficking (PACT) Act in the 2021 omnibus, the nonprofit vapor industry advocacy group was not completely surprised to learn that HR 6286’s language had been included in the 2022 omnibus bill, according to Meyers.
“We went immediately to work educating our members on the issue, executing a call to action and making a volley of calls to sources at the Capitol, including our contacts at the freedom caucus,” said Meyers. “Those sources confirmed that a handful of large vapor companies and several Big Tobacco companies were in support of the measure. We were also informed that the House and Senate votes would move quickly and that there was little opportunity to get the provision removed. This was discouraging, to say the least, but did not dissuade us from acting. This industry has learned to mobilize quickly and has achieved several victories under similar circumstances.”
Meyers said that while the sponsors of the synthetic nicotine rider claimed the intent was to close a loophole on synthetic nicotine-derived products from large companies now popular among youth, the rule, and others like it, are very unlikely to have that intended effect. Instead, she said, consumers using these products as a harm reduction option will suffer alongside all the small businesses that have always operated in full compliance with federal, state and local laws.
“The FDA created a problem by overregulating a product used by millions of adults who find vaping a safer alternative to smoking. When a market in high demand is overregulated, gray and black markets emerge where there are no regulations requiring safe products or ID checks. The vapor industry is incredibly resourceful,” Meyers said. “SFATA believes our government should have learned its lesson from the 1920s that prohibitionist policies never work. In this country, and particularly, this industry, where there is a will, there is a way. Despite the attempt to bring the vapor industry to heel, adults have been vaping flavored products in the U.S. for [nearly 15 years]. It is delusional to think that will be snuffed out with the signing of a law. Our fear is that this will pave the way to a growing illicit trade market while simultaneously increasing smoking rates across the country as studies have already demonstrated in localities with flavor bans.”
Tony Abboud, VTA
Tony Abboud, president of the Vapor Technology Association (VTA), said that everyone who understands anything about PMTAs knows that an application cannot be filed within the 90-day time frame, particularly because the FDA requires at least six months of scientific data for such an application. He said the new rule could become a de facto ban on synthetic nicotine that would have some unintended consequences.
The VTA hired economic research firm John Dunham & Associates to evaluate the negative economic impacts that a synthetic nicotine ban would have in the U.S., according to Abboud. The results included 16,100 lost jobs, over $800 million in lost wages and $2.5 billion in lost economic output. It would also cost the U.S. more than $500 million in yearly taxes.
Amanda Wheeler
Amanda Wheeler, owner of Jvapes and president of American Vapor Manufacturers, said during the 103rd annual meeting of Vapor Voice’s parent company, TMA, that she hopes the FDA offers “some kind of enforcement discretion” to small businesses, especially those manufacturers that are trying to follow the rules.
“I can only plead with the FDA at this point not to repeat the mistakes of 2020 and 2021, finding an arbitrary reason to toss all of those applications out on their ear. The consequences this time are even more dire,” said Wheeler. “We have this serious handicap on our hands as far as the time frame … I think we need to treat businesses equitably and recognize that there is only so much that people can do in 60 days. And enforcement discretion would be the thing that’s most helpful to prevent companies from having to look for an alternative solution.”
ALD Group Limited (ALD) is set to launch the first biodegradable vaping product worldwide in mid-2023, the company announced at today’s In Focus event. The product will also be 90 percent recyclable (including the packaging, plastic shell, PCBA, mouthpiece and battery).
Currently named the Eco-friendly, Biodegradable Vape Solution (EBVS), the new device will take as little as three months to biodegrade, and was created in response to consumer and market demand.
Founded in 2009 and headquartered in Shenzhen, China, ALD is a high-tech enterprise specializing in electronic atomization technology research and applications. ALD′s business covers electronic nicotine delivery systems, inhaled medical vaporizer and heated tobacco products.
The plastic components in ALD’s eco-friendly vape solutions use innovative biodegradable raw materials like PBS, and the shell and structural parts do not come into contact with e-liquid; addressing the challenge of vaping producers whose single-use plastic pod products cannot be recycled due to the residues left over from e-liquids.
“The innovative factor is that our extensive research showed that in the e-cigarette sector there was currently no ready-made solution for the application of biodegradable materials,” said Eric Ding, founder and president of ALD Group.
“During development, we screened dozens of materials, repeatedly verified product performance and, finally, determined the seven best mixes of materials. Our processes included the verification of material strength, chemical resistance, extractability and degradability.”
The engineering validation and testing evaluation of its new device was completed in mid-2021, and the shelf life and biodegradability testing are expected to be completed in mid-2022.
Vapor Voice profiles ALD’s environmental efforts in its Issue 2, 2022 print edition (see “Combating Waste).
Draft rules to strictly control e-cigarette production were released by China‘s tobacco regulator on Monday, as the country continues to tighten its oversight of the industry.
The State Tobacco Monopoly Administration said it would “reasonably” control the scale of e-cigarette production capacity to prevent overcapacity, according to a Reuters report.
Foreign investment in the retail sector of the e-cigarette market would be banned, the regulator said, and it would review foreign investment in production, requiring e-cigarette firms that want to list in China or abroad to obtain pre-approval. It has long been expected that China would not allow outside competition into it local vaping market.
China has in recent months been tightening its scrutiny of e-cigarettes, and last year amended its tobacco monopoly law to include vaping products. Since then, it has ruled that e-cigarette and vaping companies may only sell their products through authorized channels, and barred vendors from selling e-cigarette flavors other than tobacco.
Earlier this month, China unveiled technical standards for e-cigarettes and vaping products.
China’s cigarette industry operates under a state-run monopoly directly controlled by the tobacco regulator, which dictates pricing and distribution for brands and generates tax income for the government.
The Blinc Group has been issued a patent for its revolutionary The Ring System. The regulatory-focused designer and provider of premium customized vaporizer technologies received patent No. 11116251 from the U.S. Patent and Trademarks Office for the technology that is designed “to save brands thousands in lost inventory” and give consumers “peace of mind and clarity in their vape product experience,” the firm stated in a press release on Tuesday.
“Cannabis businesses have been struggling to maintain the proper amount of inventory in the vape space while also keeping their customers informed of what’s in their product,” said Sasha Aksenov, co-founder and chief innovation officer of The Blinc Group. “Companies shell out thousands of dollars for packaging and fill their cartridges with a specific cultivar to shortly find out that it’s not selling as expected. They are left with huge losses in branded hardware, but our Ring System allows the brands and licensed producers to label their products on demand during production, and, if they have to – pivot and relabel for pennies, not dollars.”
The Ring System consists of two bands one at the base of the mouthpiece or “top” and the other at the base of the cartridge – Top Ring and Base Ring. Before capping a compatible “Powered by Blinc” cartridge or disposable, operators can snap the Top Ring onto the mouthpiece of the cartridge with the strain name. The ring is also easily removed if the strain is not being sold or brands decide to pivot on the formulation or experience.
Arnaud Dumas de Rauly / Credit: The Blinc Group
“At the Blinc Group we strive every day to promote innovation, quality, safety, and integrity in every one of our products, the Ring System is no different. It is imperative that the entire industry take those goals to heart,” said Arnaud Dumas de Rauly, co-founder & CEO of The Blinc Group. “Consumers need to know what’s in their cartridges at all times and for this industry to thrive companies need to be able to increase their productivity and flexibility, without spending huge amounts of working capital on an unsold inventory. There are enough hurdles in the cannabis space, what’s in your vape cartridge shouldn’t be one of them.”
Headquartered in New York City, The Blinc Group designs, develops, supplies, and supports premium cannabis vaping hardware. The company offers a curated collection of proven cartridges, batteries, ready to use vaporizers, and complete bespoke device development to major multi-state operators, licensed producers, and brands.
When U.S Food and Drug Administration authorized several tobacco-flavored products from Logic Technology Development for sale in the U.S. the vapor industry wasn’t surprised. Vaping advocacy groups have long expected the FDA to approve many of the brands that had premarket tobacco product applications (PMTAs) submitted and are owned by major tobacco companies.
“Although we are not surprised to learn that Japan Tobacco Inc., brand owner of Logic, is now among the Big Tobacco companies with FDA market authorization, we certainly aren’t pleased with FDA’s consistent rejection of flavored products and will continue to apply pressure in that regard, as well as in the enforcement discretion arena – particularly for the manufacturers with products still in review that participate in our Responsible Industry Network program,” said April Meyers, CEO of the Smoke-Free Alternatives Trade Association (SFATA). “As the nation’s leading regulatory body, the agency appears to be cherry-picking what science it utilizes for decision making. That FDA cited the recent NYTS data but failed to acknowledge the steep decline in youth use while coining the low rates an “epidemic”, makes its rejection of flavored products today seem more an act of fear over what might happen than a decision based on scientific evidence. This is disappointing, at best, but again, not surprising.”
Logic, based in Teaneck, New Jersey, is a part of the JT Group of companies. JTI is a international tobacco and vaping company headquartered in Geneva, Switzerland, with operations in more than 130 countries. JTI employs over 50,000 people. In a release, Logic stated that it submitted PMTAs for its Logic Pro, Logic Power, and Vapeleaf products on August 19, 2019, well before the Sept. 9, 2020, PMTA deadline.
“We take the quality of our products extremely seriously, along with the way they are marketed and sold, and we are proud that we have received marketing orders from FDA for our Logic products to remain on retailers’ shelves,” said Corrado Mautone, president of Logic. “By receiving FDA marketing orders now, Logic can remain a reliable partner for retailers going forward.”
Amanda Wheeler, owner of Jvapes and the president of American Vapor Manufacturers, said that it is good to see that the FDA is acknowledging that vaping is safer than combustible cigarettes, but the fight for small business owners continues.
“People forget that in the story, Dr. Jekyll was a benevolent physician in a lab coat who only wanted to help people. But tomorrow morning, (FDA Commissioner) Robert Califf and (director of the FDA’s Center of Tobacco Products) Mitch Zeller will transform back into their Mr. Hyde alter-egos and resume their hellbent mission to sabotage the single-most effective smoking cessation device ever devised,” said Wheeler. “Well, the American people are watching and I for one am not going to stand by and let them get away with it. So, here’s my own announcement for today: FDA and CDC have my approval to stop deceiving the American public about the safety and efficacy of nicotine vaping.”
The agency also issued marketing denial orders to Logic for multiple other electronic nicotine-delivery systems (ENDS) products, mostly non-tobacco flavors.
“While Logic received marketing orders for its tobacco-flavored products, it is still awaiting a determination from the FDA on its menthol products. At the FDAs discretion, products like Logic’s menthol capsules can continue to be marketed while under review,” Logic stated in the release. “Additionally, Logic received marketing denial orders (MDOs) for flavored products that are not currently on retailers’ shelves. Logic is reviewing the FDAs determination and rationale before taking further action.”
The FDA also indicated that it was moving closer to issuing decisions on other applications that account for “a large part” of the marketplace, which based on Nielsen ratings, are mostly owned by large tobacco companies.
Logic is only the second company to have vaping products approved for marketing by the FDA. In Oct. of 2021, the agency authorized the marketing approval of three outdated vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse Solo device and two tobacco-flavored pods. The agency also denied Vuse PMTAs for flavored products other than tobacco.
The U.S Food and Drug Administration today authorized several tobacco-flavored products from Logic Technology Development for sale in the U.S.. The brands include Logic Vapeleaf, Logic Power and Logic Pro, including hardware devices. The agency also issued marketing denial orders to Logic for multiple other electronic nicotine-delivery systems (ENDS) products. Any of those products currently on the market must be removed or FDA may take enforcement action, according to the FDA.
These products were authorized after the agency said its review of the product applications concluded, among other things, that the “likely benefit for adult smokers who significantly reduce their cigarette use (or who switch completely and experience cigarette use cessation) outweighs the risk to youth, provided that the company follows postmarketing requirements to reduce youth access and youth exposure to their marketing.
While today’s action permits these specific products to be sold in the U.S., it does not mean these products are safe nor are they “FDA approved.”
“Retailers should contact Logic with any questions about products in their inventory. Applications for Logic’s additional products, including menthol, remain under FDA review,” an FDA release states. “The FDA has taken action on approximately 99 percent of the nearly 6.7 million ENDS products submitted for premarket authorization, including issuing marketing denial orders for more than 1 million ENDS products.”
The agency is close to making additional decisions on applications for popular ENDS products that account for a large part of the market. The continued marketing of these products has the potential to have a substantial public health impact—either positively or negatively—as they hold an overall large market share and are used by a lot of people.
“As a cardiologist, I’ve personally seen the devastating health effects of tobacco use, so I’m highly motivated for the FDA to help reduce death and disability caused by these products,” said FDA Commissioner Robert M. Califf. “We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine. The balance of these issues was considered by the agency’s career scientists when evaluating the potential marketing of e-cigarette products. They have made great progress and I know they will use the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health.”
Under the premarket tobacco product application (PMTA) pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of a new tobacco product would be appropriate for the protection of the public health. That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The FDA must also consider the likely impact of the products on people’s behavior—specifically, the likelihood that existing users will stop using such products and the likelihood that those who do not use tobacco products will start using such products.
This is especially important for youth. Before a product is authorized under the PMTA pathway, the agency reviews a tobacco product’s components, ingredients, additives, constituents and health risks, as well as how the product is manufactured, packaged and labeled.
“Ensuring new tobacco products undergo premarket evaluation by the FDA is a critical part of our work to reduce tobacco-related disease and death,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “For the authorized products, the manufacturer demonstrated that possible benefits to adult smokers outweigh the risk of youth possibly initiating. We are making progress in our review of flavored ENDS, and we will continue to deny marketing of products where the applicant hasn’t provided enough evidence to show that the potential benefit to adult smokers outweighs the considerable risk to youth. We are committed to continuing to take the appropriate actions to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States.”
Logic is only the second company to have vaping products approved for marketing by the FDA. In Oct. of 2021, the agency authorized the marketing approval of three outdated vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse Solo device and two tobacco-flavored pods. The agency also denied Vuse PMTAs for flavored products other than tobacco.
China’s State Tobacco Monopoly Administration (STMA) regulations for e-cigarettes are strict. The country will begin enforcing the license management for e-cigarette production, wholesale and retail entities starting from May 1, according to a translated version of updated regulations. They apply to all hardware and e-liquid products, including all components and ingredients. The announcement follows preliminary draft rules authorities issued in December 2021.
“The administrative department in charge of tobacco monopoly of the State Council takes charge of national supervision and management of electronic cigarettes, and is responsible for the formulation and organization of implementing electronic cigarette industry policies,” the regulations state. “The administrative department in charge of tobacco monopoly of the State Council shall organize professional institutions for technical review of electronic cigarette products based on inspection and testing reports and other application materials.”
Rules for products being produced for export could be market changing, and crushing for destination countries. China states that all products produced for export must comply 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.
“Electronic cigarette products not sold in China and only used for export shall comply with the laws, regulations and standards of the destination country or region,” the rules state. “If the destination country or region does not have relevant laws, regulations and standards, they shall comply with China’s relevant laws, regulations and standards.”
One industry expert with knowledge of China’s vapor industry said that China may choose to not enforce its export rules, however. “China doesn’t want to crush vaping exports,” he said. “They could choose to hold back enforcing the export provisions.”
The most critical changes locally in China’s rules is the country will now ban all non-tobacco flavors. China will also not allow for the sale of open systems, only closed pod systems will gain marketing approval. The importation of any vaping related products, such as pre-mixed e-liquids, must also be approved by Chinese authorities, according to the regulations.
Any company that produces e-cigarettes in China must now get a license. If a company wants to expand its production or product portfolio, the company must garner approval from the STMA. All nicotine must be tobacco derived and purchased from approved sellers in China, the regulations state. Chinese regulators will also establish a unified e-cigarette traceability system to strengthen the whole-process management of vaping products.
“Electronic cigarette wholesale enterprises shall not provide electronic cigarette products to units or individuals that are not qualified to engage in electronic cigarette retail businesses,” the regulation states.
The rules also state that “enterprises or individuals that have obtained the tobacco monopoly retail license … shall purchase electronic cigarette products from local … wholesale enterprises, and shall not exclusively operate the electronic cigarette products sold on the market.” One industry expert explained to Vapor Voice that the statement means all retail outlets must sell multiple brands and not just a single brand. Traditionally, stores such as RELX, the largest vaping retailer in China, only sold its own brands.
Additionally, authorities will establish a “unified national electronic cigarette transaction management platform” that e-cigarette industry businesses that have obtained tobacco monopoly licenses must conduct all transactions through. It is unclear if China will also begin cracking down on manufacturers of counterfeit products for export, however, the rules do encourage the reporting of these and other illegal manufacturers.
“Rewards will be given to units and individuals who have made meritorious deeds in reporting cases of illegal production and sales of electronic cigarette products, e-atomization material products and electronic cigarette nicotine,” the rules state.
“Although we are not surprised to learn that Japan Tobacco Inc., brand owner of Logic, is now among the Big Tobacco companies with FDA market authorization, we certainly aren’t pleased with FDA’s consistent rejection of flavored products and will continue to apply pressure in that regard, as well as in the enforcement discretion arena – particularly for the manufacturers with products still in review that participate in our Responsible Industry Network program,” said April Meyers, CEO of the Smoke-Free Alternatives Trade Association (SFATA). “As the nation’s leading regulatory body, the agency appears to be cherry-picking what science it utilizes for decision making. That FDA cited the recent NYTS data but failed to acknowledge the steep decline in youth use while coining the low rates an “epidemic”, makes its rejection of flavored products today seem more an act of fear over what might happen than a decision based on scientific evidence. This is disappointing, at best, but again, not surprising.”
“People forget that in the story, Dr. Jekyll was a benevolent physician in a lab coat who only wanted to help people. But tomorrow morning, (FDA Commissioner) Robert Califf and (director of the FDA’s Center of Tobacco Products) Mitch Zeller will transform back into their Mr. Hyde alter-egos and resume their hellbent mission to sabotage the single-most effective smoking cessation device ever devised,” said Wheeler. “Well, the American people are watching and I for one am not going to stand by and let them get away with it. So, here’s my own announcement for today: FDA and CDC have my approval to stop deceiving the American public about the safety and efficacy of nicotine vaping.”
