Tag: news

Triton Distro FDA Lawsuit Decision Expected This Week
Triton Distribution filed a motion to stay the U.S. Food and Drug Administration’s decision to issue the company marketing denial orders (MDOs) for its premarket tobacco product applications (PMTAs). The company requested a decision from the judge by Oct. 15.
“Black-letter rules of administrative law prevent an agency from retroactively changing legal requirements and from doing so without accounting for reliance interests. FDA failed to satisfy these requirements when it executed an about-face on the evidence it required to support a premarket tobacco product application (“PMTA”) for a marketing order for flavored electronic nicotine delivery system (“ENDS”) products almost a year after such applications were due,” the motion states. “FDA also acted arbitrarily and capriciously by ignoring relevant evidence found in Petitioner Wages and White Lion Investments, LLC d/b/a Triton Distributions (“Triton”) PMTA and applying a double standard to its consideration of that evidence when it issued Triton a marketing denial order (“MDO”). Further, by imposing a new, across-the-board requirement that flavored ENDS products be demonstrably more effective at promoting smoking cessation than otherwise identical tobacco-flavored products, FDA acted contrary to its authority under Section 910 of the Food, Drug and Cosmetic Act (“FDCA), 21 U.S.C. § 387j, and not in accordance with law.”
Triton states that it has been irreparably harmed as a result of the FDA’s actions and faces an imminent shutdown of its business in approximately two weeks. This is why Triton entered an emergency stay of the “FDA’s MDO for Triton’s products by October 15, 2021, and order expedited merits briefing. Respondent FDA consents to the proposed expedited merits briefing schedule but opposes a stay.”
At least six companies have filed lawsuits challenging the agency’s decision to make the companies remove their products from the market. Last week, the FDA rescinded the MDO issued to Turning Point Brands (TPB) and the company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s premarket tobacco product application (PMTA).
The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads the FDA letter to TPB. “Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”
October 11, 2021
FDA Admits Error, Rescinds Turning Point Brands MDOs
Turning Point Brands (TPB) has had its marketing denial orders (MDOs) rescinded by the U.S. Food and Drug Administration. The company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s premarket tobacco product application (PMTA).
“We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said Larry Wexler, president and CEO, Turning Point Brands. “It is important that the PMTA process is transparent, purposeful, and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance. We remain hopeful that the depth and range of our studies and data will persuade the FDA that the continued marketing of our vapor products is appropriate for the protection of the public health and that the agency will ultimately preserve a diverse vapor market for the more than 30 million American adult smokers who may wish to transition from combustible cigarettes to lower risk alternatives.”
Credit: Momius
The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads the FDA letter to TPB. “Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”
The letter comes after TPB filed a petition with the court that forced the FDA to provide an administrative record for its decisions on PMTAs. TPB sells various flavored e-liquids marketed under the Solace, VaporFi and Vapor Shark brands. TPB then filed a stay motion asking the the court to review the FDA order “on the grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.”
Avail Vapor and several other companies that received MDOs have also now filed petitions for information related to their PMTA reviews. After the FDA rescinded TPB’s MDOs, the company dropped its lawsuit against the regulatory agency.
“In light of the unusual circumstances,” the FDA’s Center for Tobacco Products (CTP) Director Matt Holman stated in the letter. “FDA has no intention of initiating an enforcement action” against TPB’s products that had previously received an MDO.
October 9, 2021
Study Claims Many Unknown Chemicals In E-Cigarettes

Photo: pavelkant
E-cigarettes and other vapor products contain thousands of unknown chemicals and substances not disclosed by manufacturers, according to a study published on Oct. 6 by Chemical Research in Toxicology.
The authors noted that the aerosols produced by vapor products contain more than 2,000 chemicals, the vast majority of which are unidentified. The researchers, who are from Johns Hopkins University, reported that the findings suggest people who vape are using a product whose risks have yet to be fully determined and could be exposing themselves to chemicals with adverse health effects.
The researchers used a chemical fingerprinting technique based on liquid chromatography and high-resolution mass spectrometry, which can identify organic compounds in wastewater, food and blood. The team evaluated four popular products: Mi-Salt, Vuse, Juul and Blu, testing only tobacco-flavored products.
The examined e-liquids contained hydrocarbon-like compounds, typically associated with combustion, which manufacturers claim are not produced during vaping. “More and more young people are using these e-cigarettes, and they need to know what they’re being exposed to,” study co-author Carsten Prasse was quoted as saying by Johns Hopkins Magazine. “E-cigarette aerosols contain other completely uncharacterized chemicals that might have health risks that we don’t yet know about. People just need to know that they’re inhaling a very complex mixture of chemicals when they vape. And for a lot of these compounds, we have no idea what they actually are.”
October 8, 2021
FDA Issues First Warning Letters for MDO Violations
The U.S Food and Drug Administration today issued warning letters to 20 companies for unlawfully continuing to market electronic nicotine-delivery system (ENDS) products that are the subject of marketing denial orders (MDOs).
These are the first warning letters issued for the marketing of products subject to MDO determinations on their premarket tobacco product applications (PMTAs), according to an FDA statement. The FDA has also issued warning letters for the unlawful marketing of tobacco products to one company that received Refuse to File (RTF) determinations on their PMTA, one company that received both RTF and MDO determinations on their PMTA, and six companies that did not submit any premarket applications.
“Collectively, these 28 companies have listed a combined total of more than 600,000 products with the FDA. All new tobacco products sold, distributed, or imported in the United States without FDA authorization are marketed unlawfully and risk FDA enforcement,” the statement reads. “On FDA’s Warning Letters page, you can find all of these warning letters by entering “Center for Tobacco Products” in the “Issuing Office” box in the “Filter by” section of the search tool.”
Products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement.
Companies receiving these MDOs may have submitted premarket applications for other products (such as ENDS devices, tobacco-flavored ENDS or menthol-flavored ENDS), and those products, if still pending, remain under review at FDA.
October 7, 2021
Costa Rica Readies to Ban Vaping in Public Spaces
Costa Rican lawmakers this week approved in a second debate a bill that will the ban the use of vaping products such as e-cigarettes in public spaces. The bill, Project 21.658, passed with 33 votes in favor and seven against. Seventeen deputies did not participate in the vote and the bill must still be signed into law and published in La Gaceta before it takes effect, according to the Tico Times.
Credit: Zerophoto
In addition to banning vaping in most public spaces, the bill also sets the grounds for the country to implement a tax on vaping devices and accessories, such as coils and e-liquids. The Health Ministry endorses the bill, which was first introduced prior to the coronavirus pandemic.
“I think this project is extremely important for the country. It has the full support of the Ministry of Health,” a lawmaker supporting the bill said. “It is completely in line with the health alert we already issued regarding the use of vaping devices, where we have even been very clear that there is no study that can show e-cigarettes are a smoking cessation therapy. On the contrary, we have to disincentivize the use of cigarettes and the use of vaporizers.”
The taxes would be allocated to the Costa Rican Social Security Fund (CCSS) and be earmarked for the treatment of diseases related to tobacco consumption.
The Red Nacional Antitabaco (RENATA) – National Anti-Smoking Network – expressed its satisfaction with the approval of the law. Nydia Amador, president of that organization, assured that the new regulations will give substantial support to the Ley de Control de Tabaco (Tobacco Control Law).
“It is important to consider the vulnerability of all consumers of tobacco products, including electronic devices or vapers, to any disease of the respiratory system, since the first studies on the effects of the use of vaporizers and heated tobacco products show negative consequences for the lungs and the immune and cardiovascular systems,” said Amador.
RENATA also stated that vaping advocates “tried to confuse public opinion by claiming that vaping is 95 percent less harmful than tobacco use.”
Many organizations such as the United Kingdom’s Royal College of Physicians and Public Health England (PHE) have released studies that show vapor products have been scientifically proven to be 95 percent less harmful than cigarettes and related tobacco products. This is supported by the U.S. Academies of Science which has also found that e-cigarettes have a lower harm profile compared to their combustible competition.
October 7, 2021
E-cigarette Market To Reach $84.43 Billion by 2025

Photo: lezinav
The global e-cigarette market is expected to reach $84.43 billion in 2025, progressing at a compound annual growth rate (CAGR) of 17.65 percent over the period 2021–2025, according to a new report in Research and Markets.
Growth in the e-cigarette market has accrued due to the changing consumer perception toward combustible cigarettes, upsurge in working population, decline in consumption of cigarettes, mounting-up prices of tobacco cigarettes and peer influence on youth.
The market is anticipated to experience certain trends like upswing in Gen Z income, emergence of flavored e-cigarettes, increasing influence of social media and rise in technological developments by e-cigarette manufacturers. However, the growth of the market would be challenged by stringent regulations, nicotine exposure in e-cigarettes and surging concerns over side effects of e-cigarettes and vapor products.
The fastest-growing regional market is the U.S. due to increasing awareness of safer tobacco alternatives, continuous efforts of anti-smoking organizations shifting the tobacco consumers to alternative forms, i.e., e-cigarettes and increased customer acceptance due to cost-efficiency of these devices.
Further, the sudden outbreak of Covid-19 is causing an adverse disruption on the overall economy through halted production and logistics activities, affecting the demand and supply of e-cigarettes across the world.

October 7, 2021
Fierce Opposition to Legalizing E-Cigarettes in Thailand

Photo: 1STunningART
A proposal to legalize e-cigarettes in Thailand has run into fierce opposition, reports the Bangkok Post
Digital Economy and Society Minister Chaiwut Thanakamanusorn said on Tuesday he is exploring ways to permit the sale of e-cigarettes, citing their potential to help people quit smoking and economic opportunities.
At least 67 countries have approved e-cigarettes as a less harmful alternative to smoking, while Thailand still refuses to accept them, Chaiwut noted. More importantly, if it is possible to turn tobacco grown in Thailand into e-cigarette products and export them, both the Tobacco Authority of Thailand and tobacco growers will benefit, he said.
The National Alliance for a Tobacco-Free Thailand (NATFT) responded by calling on the government to increase efforts to protect the public from all forms of tobacco products. “Various elements of society, both government and non-government, have been working hard to reduce the number of smokers, so legalizing e-cigarettes will only exacerbate the situation,” said NATFT chairwoman Somsri Pausawasdi.
E-cigarettes are not safer choices for people who want to quit smoking while knowledge about their long-term effects on health remains limited for now, echoed Ronnachai Kongsakon, director of Tobacco Control Research and Knowledge Management Center.
The Medical Association of Thailand too has come out strongly against Chaiwut’s proposal.
The organization sent an open letter to Prime Minister Prayut Chan-o-cha asking him to caution the minister. The letter was signed by Amorn Leelarasamee, president of the Medical Association of Thailand, and supported by heads of other organizations, including 14 royal colleges and the National Alliance for Tobacco-Free Thailand.
The president of the Royal College of Surgeons of Thailand, Pramuk Mutirangkura, also voiced his opposition.
Responding to the minister’s assertion that at least 67 countries had approved e-cigarettes as being less harmful than smoking tobacco, Pramuk said that each of those countries had allowed the sale with conditions attached. They were not sold without restrictions, he noted.
Many other countries still banned e-cigarettes because they wanted to protect the people’s health, preferring the “prevention is better than cure” principle, he added.
There are at least 10 million smokers in Thailand.

October 7, 2021
EU Taxation Consultation Split Over Vapor Issues

Image: mazhor
Participants in the public consultation organized by the European Commission on the review of the Tobacco Taxation Directive are split on many questions relating to e-cigarettes and e-liquids, according to the Independent European Vape Alliance (IEVA).
Following the publication of the raw data by the European Commission, the IEVA conducted a preliminary analysis of the first results.
According to the group, the participation rate to this public consultation was higher than usual. The survey gathered 7,262 answers, 89.2 percent originating from EU citizens, 6 percent from companies and business organization and 1.1 percent from business associations.
Most active respondents were based in France (26.9 percent), Greece (23.2 percent), Germany (7.9 percent), Poland (6.5 percent), Italy (5.8 percent), Romania (5 percent) and Spain (4.3 percent).
Regarding specific questions on e-cigarettes and e-liquids, the results provide some light trends but the answers remain overall even split:
Harmonization of tax rules for e-liquids containing nicotine:
45.6 percent against, 44.8 percent in favor, almost 10 percent undecided
Harmonization of tax rules for e-liquids that do not contain nicotine:
50.8 percent against, 40 percent in favor, almost 10 percent undecided
Establishment of a minimum tax on e-cigarettes:
46.7 percent answered “none,” 41.6 percent answered “€0.10/ml,” 5.6 percent answered “€0.30/ml,” 6.1 percent said either “don’t know” or provided no answer.
According to the IEVA, The main question to be answered now is how the Commission will interpret the 10 percent indecisive parties for the first and the second question, as those 10 percent could tilt the balance in a way or another.
Following the closure of the public consultation, the European Commission may now complete drafting of the proposal to revise the tobacco taxation directive. The IEVA expects the document to be presented in the fourth quarter of 2021 or the first quarter of 2022.
October 6, 2021
Kate Wang Resigns from RLX Audit Committee

Photo: RLX Technology
RLX Technology founder Ying (Kate) Wang has resigned as a member of the audit committee of the company’s board of directors to help the RLX comply with the relevant New York Stock Exchange’s listing requirements on audit committee’s independence.
Going forward, the audit committee will be composed entirely of independent directors—Zhenjing Zhu and Youmin Xi—RLX technology announced in press note.
October 5, 2021
U.S. FDA Issues Two Final Rules for PMTAs and SEs
The U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information on the requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports—two of the most commonly used pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.
According to the agency, the finalization of these rules helps ensure that all future submissions contain the basic information needed to determine whether the new tobacco products meet the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. It also formalizes the general procedures the FDA follows when evaluating PMTAs, including application acceptance, application filing and inspections.
It also outlines, among other things, requirements for submitting application amendments, the time for review, withdrawal of applications, postmarket reporting requirements for applicants that receive marketing granted orders, the FDA’s communications with an applicant and the FDA’s disclosure procedures and electronic submission requirements. It also allows for a supplemental PMTA as opposed to a new submission in cases such as authorization for a modified version of a tobacco product for which they have already received a PMTA marketing granted order.
“These final rules are important components of the FDA’s comprehensive approach to tobacco product regulation, which includes premarket application review, science-based use of the product standard authority and prioritized compliance and enforcement actions,” said acting FDA Commissioner Janet Woodcock, in a statement. “The FDA is committed to protecting Americans from tobacco-related disease and death by ensuring that new tobacco products undergo appropriate regulatory review to determine if they meet the public health standards set by law. If new tobacco products do not meet the standards for these pathways, they cannot be marketed or sold in the United States.”
“Conducting review of new tobacco products before they can be legally marketed is a critical responsibility of the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency in review of new tobacco products by describing information that any company must provide if they seek to market a new tobacco product in this country.”
On Jan. 19, 2021, the PMTA and SE final rules were displayed in the Federal Register but did not publish. On Jan. 20, 2021, a memo from the White House Chief of Staff ordered the withdrawal of any rules that did not publish in the Federal Register by noon on that day. Therefore, these final rules were withdrawn at that time. The rules displaying today reflect clarifying changes made from the previous versions, but no significant substantive changes. Both final rules will publish on Oct. 5 and are effective Nov. 4. Beginning on the effective date, applications submitted through these pathways must meet the requirements described in these final rules.
October 4, 2021