Author: Timothy Donahue

Warning Letters for 5 Online Illegal Vape Retailers

Credit: Marcus Krauss
The U.S. Food and Drug Administration has again  issued warning letters to five online retailers for selling unauthorized disposable e-cigarette products marketed under the brand names Geek Bar, Lost Mary, and Bang. It’s the second wave of warning letters issued in July.
The retailers included Smoke and Vape Company, LLC d/b/a Smoke and Vape Co.; Smoking Vibes LLC d/b/a Smoking Vibes; Cavalry Industries d/b/a Select Vape; HTXW LLC d/b/a FOMO Culture; and Global Supply Allies Inc. d/b/a Vapor Grab.
These warning letters were a result of FDA’s ongoing monitoring of multiple surveillance systems, including a review of various data, to identify emerging products of particular concern that are popular among youth or have youth appeal, according to an agency press release. For example, emerging data showed that Geek Bar – a Chinese-owned and manufactured brand – has recently seen an uptick in sales and can appeal to youth.
Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.
FDA holds retailers accountable for selling unauthorized tobacco products, particularly those popular with youth. To date, FDA has issued over 680 warning letters to firms for manufacturing, selling, and/or distributing unauthorized new tobacco products, issued more than 690 warning letters to retailers for the sale of unauthorized tobacco products, and filed civil money penalty complaints against 64 manufacturers and more than 140 retailers for distribution and/or sale of unauthorized tobacco products.
As of August 1, 2024, the FDA has authorized 34 e-cigarette products and devices. The agency maintains a printable one-page flyer of all authorized e-cigarette products that retailers can easily consult to determine which products can be lawfully marketed and sold in the U.S. Entities manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement.
August 1, 2024
PMI Urges More Collaboration Against Illicit Trade

Photo: PMI
International collaboration, stringent regulation and enforcement are the cornerstones in the fight against illicit trade, according to Rodney van Dooren, head of illicit trade prevention at Philip Morris International.
Speaking at a trademark and brand protection conference, held in Delhi, July 23-24, van Dooren pointed out how prohibition has not been a viable option, while regulation and enforcement would be the solution to curb illicit trade.
“Approximately 12 percent of the global cigarettes consumed are illicit, which impacts governments across the globe to the tune of $40.5 billion in tax losses, van Dooren said.
“According to the Euromonitor report, one in four cigarettes consumed in India is illicit which translates to close to $2 billion in tax losses. There are various smuggling routes around the world for both counterfeit and contraband products, making this challenge not a domestic but a transnational issue that requires transnational solution.”
Van Dooren urged authorities to better leverage the existing free trade agreements and provisions within the World Trade Organization to raise awareness with transit and source countries.
“The next recommendation is to promote harmonization of existing gold standard regulations around ASEAN, supported by implementing rules, including the law enforcement agency that has jurisdiction and the related penalties,” he noted.
“The adoption of the regulation requires manufacturers and exporters to ensure that the goods being exported comply with the destination market regulation. Additionally, in transshipment, adopt regulation that allows for inspection of suspicious shipments and exercise jurisdiction by Customs or any appropriate law enforcement agency on IP-infringing violations. Lastly, strengthen domestic enforcement effectiveness by enhanced cooperation with the legal industry and inter-law enforcement agency cooperation.”
August 1, 2024
Playing with Numbers

Photo: Hafiez Razali
How research methods distort nicotine effects and risks
By Cheryl K. Olson
“The paper seems like a joke.” That’s what Harvard researcher Miguel Hernan said recently to the journal Science about a report linking e-cigarettes and strokes.
The article was concocted by a dubious research group, founded to help young international medical school graduates get coveted authorship credits. Its analysis of U.S. government survey data claimed that respondents who vaped had a higher risk of stroke, at younger ages, than those who smoked. Its glaring flaws included inflating the number of survey takers by tens of thousands and failing to correct for the relative youth of vapers.
Despite this, the 2022 paper’s findings found their way into media headlines and anti-vaping advertising. The Science article credits Gal Cohen and Floe Foxon with sounding the alarm on this appalling study.
Subtler issues that affect research quality, and how research is perceived by the public, are harder to spot. Research methods may seem a dull or arcane topic. But a peek at how the research sausage is made reveals some simple yet surprising ways that the process can go wrong.
Sometimes old habits or unquestioned assumptions are to blame. Just as typewriters affect how we text on our mobiles, legacy cigarette research methods and mindsets influence how we study noncombustible nicotine products.
Hours of Vaping?
Everyone understands cigarettes. When it comes to totting up use, cigarettes are easy. They come in standard units. You light, puff and extinguish. Not so for products such as vapes. How, then, do researchers compare smoking with these new nicotine-delivery systems?
“There’s a lot of research showing that people who use e-cigarettes graze throughout the day,” says Arielle Selya, who conducts nicotine product research at Pinney Associates. “Unlike cigarettes, there’s no defined stopping and starting. They don’t have to finish a discrete unit; they just puff on and off.” Measuring this kind of variable, intermittent activity is a challenge.
This problem is not unique to vaping. Studying nicotine pouch use, I found unexpectedly wide variations in what people did and what they thought was normal. Some tossed a pouch in the trash after 10 minutes or 15 minutes. Others kept one in their mouth for a couple of hours. A few sometimes reused a pouch they’d started earlier or cheeked pouches of two different flavors at once.
As an example of what can go wrong, Selya pointed to a recent study of vaping and respiratory symptoms. To the authors’ credit, they tried to measure heaviness of e-cigarette use. The problem was the poor fit between their question and the behavior. They asked, “How many hours did you use electronic cigarettes per day?”
“I’m not a vaper, but that seems like such a strange question,” says Selya. “Like asking how many hours do you spend drinking water?”
Better approaches to measuring nicotine product use include writing down what you’re doing whenever a device pings you (ecological momentary assessment) or in a daily diary.
Twisted Terminology
Another holdover from cigarettes is the way tobacco is seen as the default flavor for all nicotine-containing products. “With e-cigarettes, you have to add a tobacco flavor,” notes Selya. “But researchers often say ‘flavored’ when they mean ‘non-tobacco flavored’–in some communications even the NYTS team does this–but tobacco itself is a flavor! This generates misunderstandings.”
Nicotine research terminology can defy common sense. Consider the concept of “abuse liability.” In everyday English, abuse implies harm. When the U.S. Food and Drug Administration assesses new drugs, stricter regulation may be required if there’s abuse potential, defined as “intentional, nontherapeutic use” to “achieve a desired psychological or physical effect.” An effect like euphoria, hallucinations or distorted thoughts or perceptions.
When it comes to reduced-harm nicotine products, abuse potential becomes, weirdly, a plus. A backhanded compliment. If you want to attract someone away from cigarettes, features like rapid nicotine absorption, relaxation and relief of withdrawal encourage that transition.
Abuse liability also illustrates another nicotine methodology vexation: there is no agreed-on way to measure it. One article looked at comments made by the FDA on manufacturers’ submissions for multiple types of nicotine products. Regulators considered a whole range of measures related to abuse liability, from product chemistry and pharmacokinetics to subjective factors. Of the latter, “liking” the product turned out to be the most reliable and sensitive abuse liability measure!
Misleading Measures
Again, cigarettes are simple and familiar. Novel nicotine products, by contrast, come in ever-evolving variations. U.S. government surveys, such as the Population Assessment of Tobacco and Health (PATH) and National Youth Tobacco Survey (NYTS), measure trends in who is using what products. The results are widely used and reported. However, for survey results to make sense, people must understand the questions.
Discrepancies in results suggest that research participants often misunderstand nicotine products and/or the terms being used to describe them. For example, answers about vaping brands and device types often don’t match. In the NYTS, just two-thirds of teens who said they “usually” used a pod/cartridge brand of e-cigarette (such as Juul, Logic or Vuse) also said they “most often” used a pod/cartridge device. Almost one in five adults in the PATH study had these kinds of mismatched answers about their vaping behavior.
Some questions have even larger errors. “The NYTS asks whether your e-cigarette product contains nicotine salts,” says Selya. “And overall, about 50 percent said they don’t know.”
This is also true for so-called “concept” flavors, she notes. “Not strawberry-banana, but something like cosmic fusion. When youth are asked about concept or ice flavors, they don’t know the characteristics of their product, or maybe don’t understand those words.”
NYTS first asked youth about tobacco-free nicotine pouches in 2021. That year, just 1.9 percent of teens reported ever using one. Checking the details, I found a flaw: The questionnaire defined nicotine pouches as “flavored.” However, over a third of teen ever-users said the pouch product they used was unflavored. (Perhaps they confused pouches and snus?)
A further example: the 2023 NYTS found that 1 percent of youth—an estimated 370,000—had ever used a heated-tobacco product. At the time, that product category was not sold in the United States.
As Ray Niaura of New York University told me, “That can’t be right. Literally, it’s impossible. So that means it’s measurement error.”
This suggests young survey takers were befuddled. “Kids aren’t going to know,” says Niaura. “‘Heated tobacco: Yeah. I smoked a cigarette. It’s heated. I light it on fire.’”
Yet the Centers for Disease Control and Prevention reported the result without comment or explanation.
If a product is only used by a small percentage of people, these sorts of errors could create unreal changes in year-to-year trends. The reporting of those potentially misleading trends affect the perceptions of academics, regulators and the public. “With that amount of uncertainty and some of the low numbers, it’s hard to figure out what’s the signal versus the noise,” notes Selya.
Questionable Choices
Another seemingly simple but complicated issue: Who counts as a current product user? Youth surveys typically ask “have you used e-cigarettes at all, even a puff, in the last 30 days?” Surveys aimed at adults commonly ask, “Do you currently use e-cigarettes some days, every day or not at all?”
If you assume capturing any youth e-cigarette use is important, then “even a puff” makes sense. But it also makes it difficult to separate teens who are briefly experimenting from teens at risk for problematic ongoing use.
In studies that look at how using nicotine products affect some aspect of health, researchers choose what outcomes to measure. Their choices can suggest biases or suspicious holes in what’s reported.
A recent study using PATH data tried to compare e-cigarette use and the age at which people developed asthma. “Why age of asthma onset rather than whether they developed asthma at all?” says Selya. “Often, I read a study and think, did you look at these other related outcomes? If so, why weren’t they published?” This issue of results that may exist but aren’t reported are known as the “file drawer problem.” Preregistering study plans would avoid this issue.
Researchers, Meet Users
Before I dove deeply into tobacco harm reduction, my research focused on the effects of violent video games on youth. Finding discrepancies between research reports and what teens told me, I realized that many of the field’s most-cited “experts” had never actually played or even observed the games they studied.
Similarly, many nicotine researchers seem to have never held or used the noncombusted products they study. This leads to findings that don’t reflect real-world situations. One example is an article by Sebastien Soulet and Roberto Sussman on metal contents of e-cigarette aerosols. They found that researchers were overheating tank vaping devices, generating aerosols that would be “likely repellent to human users.”
“I think there’s a big disconnect and abysmally low involvement of actual consumers, the people affected by policies,” says Selya. Partnering with people who actually know and use novel nicotine products would be a giant step toward improved research quality.

References
Foxon F. (2023). Discordant device/brand reporting among adolescents who used e-cigarettes in the National Youth Tobacco Survey. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntad228
Joelving F. (2024). Prescription for controversy. Science. https://www.science.org/content/article/questionable-firms-tempt-young-doctors-with-easy-publications
Selya A, Ruggieri M, Polosa R. (2024). Measures of youth e-cigarette use: strengths, weaknesses and recommendations. Frontiers in Public Health. https://doi.org/10.3389/fpubh.2024.1412406
Soulet S, Sussman RA. (2022). A critical review of recent literature on metal contents in e-cigarette aerosol. Toxics. https://www.mdpi.com/2305-6304/10/9/510
Vansickel A et al. (2022). Human abuse liability assessment of tobacco and nicotine products: approaches for meeting current regulatory recommendations. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntab183
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.

August 1, 2024
Age to Purchase Nicotine Raised to 21 in Indonesia

Vapor Voice Archives
Indonesia raised the minimum age limit for purchasing cigarettes and vaping products to 21 from 18 as part of a series of changes to health regulations intended to curb nicotine use in a country with one of the world’s highest smoking rates.
A country of 270 million people, Indonesia is one of the world’s top producers of tobacco, and there are about 70 million adult smokers there, according to a 2021 World Health Organization survey, a media outlet states.
In a government regulation signed by President Joko Widodo last week, Indonesia raised the minimum age for people wanting to buy cigarettes to 21. It also banned the sale of a single cigarette.
The regulation is intended to “lower the prevalence of smokers and prevent early-age smokers.” Among the provisions is banning the sale of cigarettes within 200 meters (656 feet) of schools and playgrounds.
The regulation took effect immediately.
The new regulation also bans conventional and e-cigarette sales on “commercial electronic applications” and social media sites. It also bans advertising cigarettes on social media. Penalties for violations range from a written reprimand to a temporary ban on advertising cigarettes.
The new provisions on advertising will come into force in two years.
July 31, 2024
California County Shutters Shop for Illegal Sales

Credit: Wesnice
A county district attorney in California wants to keep vapes, tobacco products and other prohibited items off of store shelves out of the hands of children.
Monterey County is handing down civil penalties to Rubystar Gems and Gifts, a local business accused of doing just that. The Monterey County District Attorney’s Office says they received word in late 2023 from the Monterey Police Department and Monterey Sheriff’s Department about complaints against the store for selling tobacco products to minors.
The store was also allegedly selling flavored tobacco products, which are illegal in California, hallucinogenic mushroom gummies containing a substance that is illegal to sell in California and illegal weapons like “metal knuckles.”
The mushroom gummies contain psilocybin, which is a hallucinogenic controlled substance that is illegal to sell in California. The packaging was counterfeit and did not indicate the actual product and its true manufacturer on the label, according to media reports.
The store’s owner agreed to a civil settlement and has to pay a $25,000 penalty for the violations. In 2022 and 2023, two sales clerks were prosecuted in a criminal court for selling tobacco products to minors. Continued complaints prompted the Monterey District Attorney’s Office to investigate further.
The store is currently closed, but Emily Hickok, a chief deputy district attorney at the Monterey County District Attorney’s Office, says it can legally continue to operate. The store owner didn’t want to go on camera but did say the store is closed because of personal health reasons and that he is retiring.
July 31, 2024
Top Court Upholds Philippines FDA Vapes Authority

Photo: natatravel
The Supreme Court of the Philippines upheld its 2021 decision to grant the country’s Food and Drug Administration regulatory authority over the health aspects of tobacco products, reports the Inquirer.
“All products affecting health, including tobacco products, are covered by the FDA’s mandate to ensure the safety, efficacy, purity, and quality of health products,” the Supreme Court said.
“Thus, the inclusion of tobacco products in the implementing rules of the FDA Act is in accordance with the law,” it added.
The case stemmed from an attempt to stop the enforcement of the FDA implementing rules and regulations. In a case filed in 2011 before the Regional Trial Court of Las Pinas City, the Philippine Tobacco Institute (PTI) alleged that those rules improperly expanded Republic Act No. 9711 by classifying tobacco products as health products.
The PTI argued that under the Tobacco Regulation Act of 2003, the Inter-Agency Committee on Tobacco (IACT) had exclusive jurisdiction over tobacco products.
In 2012, the Las Pinas court ruled in favor of PTI and nullified the provisions of the FDA implementing rules and regulations relating to tobacco.
The Department of Health and the FDA then petitioned the Supreme Court for review, which overturned the Las Pinas court decision in 2021. The PTI then challenged the high tribunal’s ruling, but was rebuffed.
The denial of the motions for consideration means the IACT and the FDA will continue to share authority over tobacco, with each overseeing different aspects of the trade.
Under the Tobacco Regulation Act, the IACT is chaired by the trade secretary with the health secretary as vice chair and includes a representative of the tobacco industry as a member. The PTI previously held the position of representing the tobacco industry in the committee.
July 31, 2024
Nebraska Lawmaker Introduces Vaping Tax Bill
Credit: Mandritoiu
Lawmakers in Nebraska have introduced legislation to increase the tax on vaping products.
The tax on electronic nicotine delivery system (ENDS) products will be 40 percent of the purchase price of the device if the bill becomes law.
The tax is to be paid by the first owner or at a price at which the first owner who made, manufactured, or fabricated the ENDS product sells the item to others, the proposed bill states.
For ENDS products in the possession of retail dealers for which tax has not been paid, the bill states that the tax shall be imposed at the earliest time the retail dealer “brings or causes to be brought into the state” any ENDS device for sale.
The bill is currently with the Revenue Committee in Nebraska’s House of Representatives.
July 30, 2024
Vaporesso to Celebrate 9th Anniversary in Vaping

A legendary brand in the vaping industry announced its 9th anniversary, which will be celebrated with special events. Vaporesso invites its community to participate in “exciting activities that embody the spirit of competition and achievement.”
According to a press release, on Aug. 18, Vaporesso will hold a music party featuring extreme sports in Nice, France. Bringing together top athletes from the sea (surfing), land (BMX), and air (paragliding).
“Inspiring to ‘Push the Envelope,’ vapers are encouraged to share their personal ‘Championship Moments’ in the comments section of the Vaporesso website for our community to celebrate together,” a press release states. “Share the moments when our vapers took up the challenge to try to break through their upper limits. Let’s celebrate victories, big or small, and inspire one another to reach new heights. Anyone has the right to become their own champion through determination and resilience.”
For a chance to win prizes, including a grand prize of a round-trip flight ticket to Paris, visitors can participate in a trivia game to learn facts about the three showcased extreme sports: BMX, paragliding, and surfing.
“Our 9th anniversary is a testament to the passion and dedication of our team and the unwavering support of our fans. We hope that through the anniversary celebration, everyone can learn about meaning behind Vaporesso’s ‘Move Beyond Ordinary.’ Our spirit of continuous breakthroughs and challenging limits will continue to be reflected in Vaporesso’s business,” said Jimmy Hu, VP at Vaporesso. “We also hope to give back to our community with prizes that represent our spirit. A thank you for 9 years of companionship in the vaping journey.”
July 30, 2024
Taiwan: No Approved Vape, Heated Tobacco Devices

Vapor Voice Archives
Taiwan’s Health Promotion Administration (HPA) has reminded suppliers and consumers that it has not approved any e-cigarettes or tobacco heating products (HTPs), reports the Taipei Times.
The warning came after security footage showed a lawmaker using a THP in the legislature’s corridors.
Novel tobacco and nicotine products require government approval in Taiwan. To date, the HPA has received applications for authorization for HTPs from 12 companies. It has rejected the applications of eight, while two of the remaining four have been asked to furnish additional information.
The HPA has a panel of toxicology, public health and addiction experts to assess requests for authorized use of THPs. The panel has so far convened 30 meetings.
Taiwanese law punishes the manufacture, import, sale, supply, display or advertisement of unauthorized novel tobacco products by a maximum penalty of TWD5 million ($152,263), while users may be fined TWD10,000.
July 30, 2024
CAPHRA: Vape Misinformation is ‘Propaganda’

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The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) is denouncing the widespread misinformation surrounding tobacco harm reduction as biased propaganda perpetuated by “certain factions” within the tobacco control community.
These factions refuse to accept the proven role of reduced-risk products in helping people quit smoking, thereby undermining public health efforts.
Recent commentary and reports have highlighted a disturbing trend of disinformation about safer nicotine products, according to an emailed CAPHRA press release.
“It is spread by those who are ideologically opposed to harm reduction strategies, despite mounting evidence that safer nicotine products (SNPs) can significantly reduce smoking rates and associated health risks,” said Nancy Loucas, executive coordinator of CAPHRA. “The quantity and depth of this campaign makes it clear that certain factions within the tobacco control community are more interested in maintaining their prohibitionist stance than in embracing evidence-based harm reduction strategies that can save lives.”
Studies have consistently shown that vaping and other SNPs are far less harmful than smoking combustible tobacco.
Furthermore, countries that have adopted harm reduction strategies, such as the UK and New Zealand, have seen significant declines in smoking rates.
“The refusal to acknowledge the benefits of SNPs is not just misguided; it is dangerous. By spreading disinformation, these groups are effectively discouraging people who smoke from switching to less harmful alternatives, thereby perpetuating the smoking epidemic,” said Loucas.
CAPHRA is calling on governments and public health bodies to promote accurate information, ensure that public health messaging about SNPs is based on the best available scientific evidence, and embrace harm reduction strategies as a key component of tobacco control policies.
July 30, 2024