Tag: e-cigarettes

ATR Submits Comment to Reagan-Udall FDA Review
Credit: Araki Illustrations
Americans for Tax Reform (ATR) has submitted a comment to the Reagan-Udall Foundation as the Foundation continues its external review of the U.S. Food and Drug Administration‘s Center for Tobacco Products (CTP)’s policies and procedures.
The ATR states that the FDA has “significantly and substantially failed” to fulfill the regulatory agency’s congressional mandate to act on behalf of the protection of public health.
Tim Andrews, ATR’s director of Consumer Issues, wrote that his organization is hopeful that the Reagan-Udall Foundation’s review could help the agency better the PMTA review process.
“[The PMTA] process has created impossible administrative burdens on applicants. When processes and requirements were changed, FDA failed to notify applicants and is alleged to have applied a new and different standard to certain applicants,” said Andrews. “FDA’s failures are structural. Our submission is cognizant of that and emphasizes that these issues can’t be solved with increased funding, especially not through user fees on small vape manufacturers.”
In its comment, the ATR also offered seven FDA reforms that the ATR hopes the Reagan-Udall Foundation would consider:
FDA should introduce cross-disciplinary expert analysis factoring input from fields like psychology and behavioral economics, to increase public awareness and engagement in the decision-making process.
FDA must provide an easy, streamlined, PMTA pathway, as initially promised.
FDA’s PMTA process should focus on product safety and individual risk, not behavioral and population assessments that are better gathered by a singular post-market surveillance team.
FDA should be in regular, proactive contact with all PMTA applicants, as opposed to merely issuing MDO’s after year long periods of silence.
FDA should consider implementing product standards, to assist in the streamlining process, and look also to countries such as the United Kingdom as a model for a regulatory system that works.
FDA must urgently act to combat significant public misinformation that it admits exists in the community and is a barrier to smoking cessation.
FDA must reform its approach to youth risk behavior. FDA should accept that youth can benefit from harm reduction and properly evaluate the consequences of reduced vape access for both adults and youth.
The ATR also complained about stringent rules vape manufacturers and retailers are forced to follow, such as being forbidden by law from sharing scientific studies about their products with consumers. The responsibility for correcting the public’s perception of reduced-risk products “lies at the feet” of the CTP.
“There is a desperate need for widespread public messaging that vaping is safer than smoking and can save lives,” Andrews stated. “[The] FDA should be the agency that educates the public about the safer nicotine products that exist to help adults who smoke quit the deadly habit of cigarettes.”
The ATR comment also mentions significant and fundamental structural problems at the agency. After numerous purported FDA staffers have revealed that FDA’s tobacco program “has a toxic internal culture, rife with racism, sexism, and unconscious bias. FDA employees have shared concerns that [the] FDA allows political pressure to influence scientific decisions and that scientific staff feel intimidated in the workplace.”
November 8, 2022
Study Finds Teen Vaping Down, Some Start Younger

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Although the prevalence of teen vaping has declined in recent years, those who do vape are starting younger and using e-cigarettes more intensely, according to a new study published in JAMA Network Open by investigators at Massachusetts General Hospital (MGH) in collaboration with Stanton A. Glantz, a retired professor from the University of California at San Francisco.
In the analysis of data from the annual National Youth Tobacco Survey, a nationally-representative survey of middle and high school students in grades 6–12, researchers found that e-cigarette prevalence among youth peaked in 2019 then declined, but e-cigarette initiation age dropped between 2014 and 2021, and intensity of use and addiction increased after the introduction of protonated nicotine products
Protonated nicotine is created by adding acid to the e-cigarette liquid, which makes the nicotine easier to inhale. Since Juul pioneered protonated nicotine, it has been widely adopted by other e-cigarette companies.
Age at first use of e-cigarettes fell by 1.9 months per year, while age at first use of cigarettes, cigars, and smokeless tobacco did not change significantly. By 2017, e-cigarettes became the most common first tobacco product used.
E-cigarette nicotine addiction, measured as the odds of use within 5 minutes of waking, an indicator of addiction, increased over time. By 2019 more youth e-cigarette users were using their first tobacco product within five minutes of waking than for cigarettes and all other products combined. The percent of sole e-cigarette users who used e-cigarettes within five minutes of waking was around 1 percent through 2017, but then it increased every year, reaching 10.3 percent youth using their first e-cigarette within five minutes of waking by 2021.
Median e-cigarette use also increased from three to five days per month in 2014–2018 to six to nine days per month in 2019–2020 and 10 to 19 days per month in 2021.
The recently released 2022 National Youth Tobacco Survey data show that 2.55 million adolescents use e-cigarettes and 27.6 percent of adolescents use e-cigarettes daily. The comparable numbers reported in this paper for 2021 were 2.1 million and 24.7 percent.
“The increasing intensity of use of modern e-cigarettes highlights the clinical need to address youth addiction to these new high nicotine products over the course of many clinical encounters,” said senior author Jonathan P. Winickoff, a pediatrician at MGH and a professor of pediatrics at Harvard Medical School, in a press note.
“In addition, stronger regulation including state and local comprehensive bans on the sale of flavored tobacco products such as voting YES on Proposition 31 on California’s November ballot, should be implemented,” said first author Stanton A. Glantz, a retired UCSF professor of medicine
November 8, 2022
FDA Expected to Attack Names of E-liquids Next

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After rooting out ENDS flavors, regulators may turn their attention to flavor names.
By Neil McKeganey
In the world of illegal drugs, there are few substances that have become popular as quickly as 3,4-Methylenedioxymethamphetamine. If you are wondering what that awkwardly named substance is, you will almost certainly recognize it by its street name, Ecstasy. In advance of its marketing, the drug developers thought about calling it Empathy but decided on Ecstasy instead—who, after all, could turn down the opportunity of experiencing “ecstasy”? And so it proved with a drug that sold in the millions in countries around the globe. That anecdote tells you something that every marketing person worth his or her salt knows all too well: names matter. Indeed, when it comes to driving consumers to your product, names may matter more than the substance itself.
In recent years, the vaping world has seen the heavy hand of regulatory intervention focused on limiting the range of flavors that can be legally sold. Senior health officials, sections of the media, lobbyists, parent groups and others have forcefully argued for banning “kid-appealing flavors.” Restrictions on flavors, though, have gone well beyond the flavors that are seen to be appealing to vulnerable groups.
Out of some 1.6 million products for which premarket tobacco product marketing authorizations have been sought in the U.S., not a single flavor has been approved. Recent pronouncements from Brian King, head of the Food and Drug Administration’s Center for Tobacco Products, suggest that menthol is now in the regulatory agency’s crosshairs. In the face of such expanding regulatory action, it is by no means a stretch of the imagination to ponder a world in which only a single electronic nicotine-delivery system (ENDS) flavor—tobacco—remains, bringing vaping products that much closer to combustibles and in the process almost certainly weakening their capacity to offer a route out of smoking.
In a mono-flavored ENDS world, flavor names may become the new fertile terrain—promising consumers a realm of limitless variations in taste that, like the world of expensive Hi-Fi, where differences in quality are barely discernible, nevertheless draw in consumers seeking particular sensorial and taste experience.
With the removal of flavors from the market, next in line may be flavor names, with regulators galvanized by the belief that it is the names more than the flavors that are driving consumers to these products. In that event, it will become increasingly important for manufacturers to be able to present regulators with evidence that their specific-named tobacco-flavored products are not attracting young people and that those named flavors are assisting adults in quitting smoking.
If anyone is inclined to think that this is an unlikely scenario, it is worth remembering that regulatory authorities within the U.S. already involve themselves in determining what words can and cannot be used when referring to tobacco products. Some states already ban the use of food terms when referring to tobacco products, and the Family Smoking Prevention and Tobacco Control Act bans words like mild, light and ultra-light when referring to tobacco products. In the face of such regulatory restrictions, companies replaced the names mild, light and ultra-light with terms such as gold, silver and blue. Research undertaken by Gregory Connolly and Hillel Alpert and published in Tobacco Control in 2014 showed that even in the face of such name-switching, smokers were still able to identify their preferred product.
Within the world of ENDS, some e-liquid manufacturers have already chosen to move away from taste-based flavor names. Bidi Vapor, for example, uses product names such as Winter, Summer, Dawn and Marigold in describing its product range. Years before Bidi opted to anonymize the taste experience in its product names, e-liquid manufacturer Five Pawns opted to use words derived from chess, like Gambit and Grandmaster, to name its products. These are names that convey nothing about the taste or sensorial experience.
In time, there may be a push from the anti-e-cigarette lobby to reduce the variety of tobacco flavor names even further, requiring manufacturers to differentiate their products by numbers alone. Seems unlikely? Probably not for those who remember Players No. 6, No. 10 and No. 555. Flavor names may be the next item on the regulatory hit list.
Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.

November 7, 2022
Reynolds Reignites Vuse IP Suit With Rival Altria

R.J. Reynolds Vapor Co. has asked for a new trial after a U.S. District Court awarded rival Altria Client Services $95.23 million in damages related to an e-cigarette intellectual property dispute, reports the Winston-Salem Journal.
In early September, a federal jury determined that Reynolds Vapor’s Vuse Alto product infringes on three Altria patents.
In its retrial request, Reynolds Vaper stated that “Altria’s improper injection of inflammatory evidence regarding patent infringement allegations against Reynolds in other cases denied Reynolds a fair trial. Erroneous evidentiary rulings also prejudiced Reynolds’ ability to present its defense. Those errors independently, and under the cumulative error doctrine, affected the verdict such that a complete new trial is required.”
Altria said in a statement that “this was a fair trial. There is no basis for another trial, and we are pleased that the jury correctly found that Reynolds Vapor has infringed a number of our patents.”
The complaint concerns three patents awarded to Altria Client Services by the U.S. Patent and Trademark Office based on filings in April 2015.
Altria alleged Reynolds Vapor violated Altria’s patents covering the pod assembly used in Vuse Alto.
Reynolds believes the lawsuit was filed in retaliation for patent infringement complaints filed by Reynolds in April 2020 for infringement by Philip Morris International’s IQOS tobacco-heating device of six Reynolds patents.
Until recently, Altria was the exclusive U.S. distributor for IQOS in the United States.
On Sept. 29, 2021, the U.S. International Trade Commission upheld an initial determination from May 2021 that Philip Morris International’s IQOS device infringes on two patents owned by Reynolds. The ruling barred Altria Group from importing IQOS products into the U.S.
November 7, 2022
Heated Tobacco Flavor Ban Begins on Nov. 23 in EU

The European Union on Nov. 3 published the directive officially banning flavors in heated tobacco product throughout the union, reports TobaccoIntelligence.
The publication follows the end of the scrutiny period on Oct. 29, during which neither the European Council nor the European Parliament raised objections to the ban.
The ban, which covers all flavors except tobacco, officially takes effect Nov. 23. EU member states than have until July 23, 2023, to transpose the rule into national legislation.
In the runup to the ban, critics suggested the European Commission was overstepping its delegated powers by introducing a new legal category – of heated tobacco products.
Some member states raised concerns over whether the Commission was empowered to introduce a definition of a new category of tobacco products in a Delegated Act.
More recently, Bulgaria, Cyprus, Greece and Italy issued a joint statement, saying the introduction of a definition of heated tobacco products “goes beyond the delegated power under Directive 2014/40/EU and involves essential elements reserved for the European legislators and, as such, should be submitted to the ordinary legislative review process.”
November 7, 2022
Thailand: Activists Detect New ‘Teen Vaping Crisis’

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Tobacco control activists have expressed concern about the number of young people smoking e-cigarettes in Thailand, reports The Bangkok Post. While e-cigarettes are illegal in Thailand, they remain readily available across the country.
According to a health survey conducted in 2019 and 2020, 5.3 percent of Thais aged 10 to 19 years have tried vaping and 2.9 percent do so regularly. Around 30 percent of people in this age bracket who smoke e-cigarettes are women, the study showed.
Patcharapan Prajuablap, secretary-general of the Thailand Youth Institute, attributed the popularity of vaping in part to the fact that it is considered safer and more trendy than smoking cigarettes, especially among high school students.
Over the past year, Thai lawmakers have mulled legalizing e-cigarettes to offer smokers a less harmful method of nicotine consumption and to tap a new source of tax revenue.
Alarmed by the underage vaping numbers, Roengrudee Patanavanich, a lecturer at the Faculty of Medicine at Ramathibodi Hospital, urged the government to keep e-cigarettes illegal.
November 7, 2022
Hong Kong Considers Generational Cigarette Ban

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Hong Kong residents who were born in 2009 or after should be banned from buying cigarettes by 2027, the Council on Smoking and Health proposed on Nov. 3, reports the South China Morning Post
The city’s smoking population dropped to 9.5 percent last year—hitting single digits for the first time since tracking began—but Chief Executive John Lee Ka-chiu has pledged to lower the rate to 7.8 percent in three years.
Other measures proposed include doubling the current tobacco tax by 2023-2024, which means a pack of cigarettes currently priced at HKD60 ($7.64) would rise to around HKD100. The council said the tax should be further raised in the following two years, so a pack of cigarettes would cost HKD200 by 2025-2026.
The council also recommended expanding the city’s nonsmoking areas to cover taxi and bus stands, as well as spaces that fall within 10 meters of hospitals, schools and community facilities.
Hong Kong currently does not allow smoking on public transport, including its interchanges, in hospitals, schools, parks and indoor areas of restaurants, bars and malls.
Some lawmakers expressed concern about the proposed measures. Representing the wholesale and retail sectors, Shiu Ka-fai, said poorer smokers would not be able to afford the product following the proposed tax increases.
He also opposed the idea of “smoke-free generation” as the policy would limit freedom of choice.
The Long-term Tobacco Policy Concern Group, which represents smokers, opposed the tax hike, saying that consumers might buy illicit cigarettes instead of quitting, and that the measure would impact the city’s economic recovery.
Council Chairman Henry Tong Sau-chai also opposed a proposal to reverse Hong Kong’s ban on the re-export smoking alternatives as a means to boost the economy.
In April, Hong Kong prohibited the import, sale or manufacture smoking alternatives, such as e-cigarettes, heated tobacco products and herbal cigarettes.
The legislation also prohibits smoking products from being transshipped through Hong Kong when brought in by truck or ship for transport onwards overseas, although air transshipment cargo and transit cargo that stays on a plane or ship are exempt.
Tong worried that the reverse would create a “loophole” where alternative tobacco products would slip to the community.
November 6, 2022
‘Tobacco’ E-Liquid Flavors Evolving After FDA Ban

E-liquids marketed as tobacco-flavored contain higher levels of sweet and fruit-flavored chemicals today than they did a decade ago, according to a new study published on Nov. 3 in a special supplement to Tobacco Control.
This recent development coincides with the U.S. Food and Drug Administration’s ban on the sale of flavors other than menthol and tobacco in cartridge-based e-cigarettes.
To find out if e-cigarettes marketed as “tobacco flavored” contained sweet and fruit flavor chemicals, researchers drew on an extensive database of e-liquid and aerosol flavor chemicals to identify any trends and changes in chemical composition and levels since 2010-11.
They compared the number and amount of flavor chemicals in 63 “tobacco-flavored” e-cigarette refill fluids purchased between 2011 and 2019 and two popular pod-style e-cigarette brands—Juul and Puff.
They found that tobacco-flavored products purchased in 2010 and 2011 had very few flavor chemicals; overall, the levels of which were generally very low.
Nearly two thirds (63 percent) of the refill fluids bought before 2019 had levels of flavor chemicals below 2 mg/ml, and most (84 percent) were below 5 mg/ml.
But the total number and level of flavor chemicals in “tobacco flavored” refill fluids purchased in 2019 and in Puff Bar Tobacco e-cigarettes, were higher than expected.
Among the 13 refill products bought in 2019, more than half (54 percent) had total flavor chemical levels above 10 mg/ml. Products with total flavor chemicals of more than 10 mg/ml contained 1 to 5 dominant flavor chemicals (each more than 1 mg/ml).
The five most frequently used flavor chemicals in “tobacco flavored” e-liquids were fruity and caramellic: ethyl maltol (sweet or caramel, 60 percent); corylone (caramellic, maple, 44 percent); menthol (33 percent); vanillin (25 percent), maltol and triacetin (fruity, creamy, 24 percent).
Nine sweet and fruit flavor chemicals, used mainly in products bought in 2016 and 2019, were at levels above 2 mg/ml.
The flavor chemical levels for Juul Classic and Juul Virginia were below 0.35 mg/ml, while levels of the individual chemicals were, in most cases, equal to, or less than, 0.05 mg/ml.
Different flavor chemicals were used in the Classic and Virginia products, suggesting these were added intentionally to create distinct tastes for each product, according to the researchers.
Puff “Tobacco,” on the other hand, had 27 different flavor chemicals adding up to a total of 34.3 mg/ml. Individual chemicals ranged from 0.03 to 15 mg/ml.
Four flavor chemicals (vanillin, ethyl maltol, ethyl vanillin and corylone), which were the highest (range 2.07–15 mg/ml), are typically used in sweet-flavored e-cigarette products, such as Dewberry Cream, which is popular with young vapers, note the researchers.
For the dominant flavor chemicals found in both brands, levels of vanillin were 300 times higher in Puff than in Juul, while ethyl maltol was 239 times higher, and corylone 41 times higher.
The total number of flavor chemicals used in Puff Bar Tobacco was greater than those found in nearly all (94 percent) the refill fluids evaluated.
“Concern has been raised previously about the safety of flavor chemicals when inhaled at these high concentrations,” the researchers noted.
“Although these particular flavors are Generally Regarded As Safe by the Flavor Extract Manufacturers Association (FEMA) for ingestion, FEMA has not evaluated them for inhalation toxicity.”
In a press note, the researchers said there were two reason for the FDA to identify and quantify flavor chemicals before authorizing Premarket Tobacco Applications (PMTA). “First, flavor chemicals are often used in e-liquids without safety data at concentrations much higher than those found in other consumer products,” they wrote. “Second, our data show that e-cigarette manufacturers are manipulating e-liquid formulations apparently to circumvent flavor chemical regulations.”
November 4, 2022
New Senate Bill Would Create Marijuana Commission

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For the 10th anniversary of Colorado voters approving marijuana legalization, Sen. John Hickenlooper said that he intends to file a congressional bill to prepare the United States for federal cannabis reform.
Specifically, the Preparing Regulators Effectively for a Post-Prohibition Adult-Use Regulated Environment Act (PREPARE) Act would direct the attorney general to create a commission charged with making recommendations on a regulatory system for marijuana that models what’s currently in place for alcohol, according to Marijuana Moments.
The measure is identical to a House companion bill that Reps. Dave Joyce, Hakeem Jeffries and Brian Mast filed in April. Hickenlooper’s staff told Marijuana Moment that the Senate version will be formally introduced when the chamber returns from recess in mid-November.
The senator sees the commission that would be created by the legislation as similar to a task force he empaneled when he was Colorado’s governor to steer implementation of legalization at the state level.
November 4, 2022
Several States set to Vote on Recreational Marijuana

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Recreational marijuana legalization is on the ballot in Arkansas, Maryland, Missouri, North Dakota and South Dakota next week.
If approved, the states would join the 19 (along with Washington, DC) where recreational use is currently legal. Thirty-seven states, three territories and the District of Columbia allow the medical use of marijuana products, according to the National Conference of State Legislatures.
Medical marijuana is currently legal in each of the five states that will vote on recreational use on Tuesday.
Marijuana is illegal under federal law, even as individual states have moved toward legal use for recreational and medical purposes.
But in October, the Biden administration announced that President Joe Biden pardoned all people convicted of federal marijuana possession through executive action.
Leaders in the U.S. Senate introduced sweeping legislation earlier this year that would end federal prohibitions on marijuana more than 50 years after Congress made the drug illegal.
November 4, 2022