Tag: regulation

  • VTA: CTP Continues ‘De-Facto’ Flavor Ban With MDOs

    VTA: CTP Continues ‘De-Facto’ Flavor Ban With MDOs

    Tony Abboud
    Tony Abboud, director of the Vapor Technology Association.

    When the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued marketing denial orders (MDOs) for Suorin and Blu PLUS+ e-cigarette products, Tony Abboud, executive director of the Vapor Technology Association (VTA), said the decision was just the latest installment of the FDA and CTP’s efforts to implement its de-facto ban on e-cigarettes in the U.S.

    “The constant refrain from CTP is that e-cigarette manufacturers are not providing ‘sufficient scientific evidence’ in their PMTAs, yet CTP refused to answer the Reagan-Udall Foundation’s most fundamental criticism of CTP’s entire regulatory process: that CTP has not clearly articulated what is required to prove what is appropriate for the protection of the public health (APPH) or how it is interpreting what is APPH,” Abboud stated in a release.

    He stated that the FDA has failed to objectively define the APPH standard while simultaneously using it to deny marketing authorization to critical smoking cessation and harm-reduction products, which is a “gross overreach” for any governmental institution whose mandate is to follow the science.

    “Courts have found that the process has become ‘arbitrary and capricious’ in practice, with CTP leadership choosing on a case-by-case basis how the standard ought to be defined,” he stated. “Meanwhile, companies are simply trying to do the right thing by complying with and adhering to the PMTA process set forth by the FDA.”

    Abboud stated that the actions of the FDA and CTP do nothing to protect public health or help Americans who smoke. “VTA once again calls on CTP to reverse course on its misguided actions and restore scientific integrity to its regulatory and decision-making process. Enough is enough,” he wrote.

  • SMOK Files Appeal of FDA’s Marketing Denial Orders

    SMOK Files Appeal of FDA’s Marketing Denial Orders

    SMOK’s factory

    One of the oldest MOD makers in the vaping industry has filed an appeal of the U.S. Food and Drug Administration’s marketing denial orders for six of the company’s open-system vaping devices.

    China-based Shenzhen IVPS, the parent to SMOK brand vaping devices, filed the appeal after with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit, and was joined in the suit by a Dallas, Texas-based distributor of the SMOK products that were denied marketing.

    The FDA claimed that it had issued the MDOs for the premarket tobacco product applications (PMTAs) for the SMOK products because the applications “failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.” The agency also stated that SMOK failed to provide a specific e-liquid and consumers could use any e-liquid in the devices.

    Shenzhen IVPS strongly challenges those assertions, as the company “invested more than $30 million in its applications, which totaled well over 600,000 pages in all, and collaborated with the world’s leading laboratories to conduct robust harmful and potentially harmful constituent aerosol testing, in vitro toxicology testing and toxicological analysis, accelerated and 24-month storage and stability testing, and rigorous clinical pharmacokinetic studies to test the products’ potential abuse liability profiles,” according to a press release.

    Welfer Ouyang, Shenzhen IVPS CEO, said he was “very concerned” that the agency issued marketing denial orders on open-system devices that are sold without any nicotine-containing e-liquid.

    “FDA is using isolated data from testing of the devices with e-liquid formulations that the products’ instruction manuals specifically warn are not compatible with these devices, and ignoring the overwhelmingly positive toxicological and safety profile of these products,” said Ouyang.

    On Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting PMTAs of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.

    The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.

    The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.

  • Khyber Pakhtunkhwa Bans Vapes Provisionally

    Khyber Pakhtunkhwa Bans Vapes Provisionally

    Photo: SakhanPhotography

    The government of Pakistan’s Khyber Pakhtunkhwa province has banned the storage, sale and use of e-cigarettes for 60 days, according to the Associated Press of Pakistan.

    All deputy commissioners have been directed to impose a complete ban on the sale of e-cigarettes and vapes to those under age 21 and its sale and storage within a 50-meter radius of all educational institutions in the province.

    Those caught violating these orders will face legal consequences under Section 188 of the Pakistan Penal Code.

    The interim ban follows a series of meetings with the Provincial Alliance for Sustainable Tobacco Control, Blue Veins and KPTCC focused on the dangers of e-cigarettes and vapes and that examined global legislative and policy practices regarding the products’ sale and storage.

    “The decision has been taken in wake of alarming increase in use of electronic cigarettes (e-cigarettes) and vaping devices particularly among children and youth in the province,” said an official notification by the Home and Tribal Affairs Department of Khyber Pakhtukhwa, according to the Pakistan Observer.

    “This interim ban is a commendable step by the KP government, reflecting its proactive approach to public health,” said Qamar Naseem, civil society activist. “However, we must solidify this progress through comprehensive provincial legislation to ensure a permanent solution to this growing health concern.”

    “This ban is a significant victory for the health and well-being of our children and youth,” said Sana Ahmad, coordinator of the Child Rights Movement KP. “It prevents easy access to addictive substances and protects our future generations from the allure of harmful vaping products.”

    “We, the healthcare providers, appreciate the governor and chief secretary of Khyber Pakhtunkhwa for this decisive ban,” said Qazi Shahbaz, president of the Provincial Doctors Association. “It’s a step forward in the right direction, and we now urge the government to enact comprehensive legislation for a complete ban. This is not just a win for public health but a strong message that the health and safety of our citizens, especially our youth, are of paramount importance.”

  • FDA Denies Marketing of Suorin, Blu Plus+ Products

    FDA Denies Marketing of Suorin, Blu Plus+ Products

    The U.S. Food and Drug Administration has issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products. It also issued Fontem US, LLC MDOs for its Blu PLUS+ brand e-cigarette products.

    “Thorough scientific review of tobacco products applications is a key pillar of FDA’s comprehensive regulatory approach,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “It is the applicant’s responsibility to ensure that sufficient scientific evidence is included in an application to meet the necessary public health standard required by law. In these cases, such evidence was lacking.”

    The companies must not market or distribute these products in the United States or they risk FDA enforcement action. The companies may submit new applications for the products that are subject to these MDOs, according to an agency press release.

    The FDA denied Suorin Air refillable vaporizers in various colors and an empty refillable cartridge. The FDA stated that Suorin Air’s empty cartridges would allow consumers to fill the cartridge with an e-liquid purchased separately.

    “The applications submitted by Shenzhen Youme Information Technology Co. Ltd. lacked sufficient evidence regarding abuse liability, which is the ability of a tobacco product to promote continued use and the development of addiction and dependence,” the release states.

    SMOK recently had 22 products denied, including devices, pods, atomizers, and cartridges. It was the first time the agency has denied strictly hardware products from one company en mass. The products were denied because they were submitted without a specific e-liquid to be used with the devices, according to the FDA. 

    The denied Blu PLUS+ products include a battery and several prefilled e-liquid pods:   

    • blu PLUS+ Battery  
    • blu PLUS+ Carolina Bold 2.0%  
    • blu PLUS+ Classic Tobacco 1.2%  
    • blu PLUS+ Classic Tobacco 2.4%  
    • blu PLUS+ Gold Leaf 1.2%  
    • blu PLUS+ Gold Leaf 2.4%  
    • blu PLUS+ Menthol 1.2%  
    • blu PLUS+ Menthol 2.4%

    “Among other deficiencies in their applications, Fontem US, LLC failed to include sufficient ingredient information, harmful and potentially harmful constituent (HPHC) yield quantities, and abuse liability information.,” the FDA stated. “In addition, the applicant did not provide sufficient evidence demonstrating that the flavored new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth.

    The FDA also issued MDOs for additional blu PLUS+ products not listed above. The regulatory only publicly names products that the FDA or the manufacturer has confirmed to be currently marketed to avoid the release of confidential commercial information.

  • RLX Releases Corporate Sustainability Report

    RLX Releases Corporate Sustainability Report

    RLX Technology presented its “Corporate Social Responsibility Report.” The report outlines the firm’s annual progress in fulfilling various corporate social responsibilities, including rural revitalization, product-related responsibility, corporate governance, environmental responsibility and employee responsibility.

    According to the report, as of 2023, RLX has invested a total of CNY44.3 million ($6.2 million) in areas such as biodiversity conservation and rural revitalization. By the end of April 2023, RLX had effectively generated approximately 120,000 employment opportunities along the supply chain and accumulated research and development investments totaling CNY800 million.

    Navigating the delicate balance between compliance and innovation is the most crucial challenge for RLX, according to a company press release. In pursuit of a first-class user experience, the company says it not only strictly adheres to regulatory requirements by developing products in line with national standards to ensure quality and safety but is also comprehensively upgrading its research and development system. This involves establishing eight major laboratory matrices and rigorous factory quality control to enhance product innovation. The report reveals that as of April 2023, RLX has applied for nearly 900 patents globally.

    From child-proof locks to anti-dry burn functions, each of the eight laboratories plays a specific role in developing products that meet both regulatory requirements and user-experience expectations. The Innovation Lab, for example, focuses on material purification and flavor perception, significantly reducing the risk of alterations to product taste and flavor. The Quality and Safety Lab conducts tests such as drop and negative pressure tests to ensure product stability in extreme environments. This lab has received accreditation from China National Accreditation Service for Conformity Assessment.

    Since outlining its “1+4” scientific research path in 2020, RLX has initiated nearly 50 research projects to fill the gaps in the field of vape science. The report highlights several breakthrough achievements from the past year. In November 2022, the first domestic clinical study on electronic cigarettes initiated by RLX was published in the medical SCI journal Nicotine and Tobacco Research. By the end of April 2023, RLX had conducted 17 collaborative research projects, publishing 11 research papers in authoritative journals.

    “From 2022 to 2023, whether in the Chinese e-cigarette industry or at RLX Technology, it has been an extremely important period. We wholeheartedly respond to policies and actively address various changes, not only fulfilling strict compliance and providing reassuring products as ‘required actions’ but also contributing our modest efforts in ‘voluntary actions’ such as wildlife protection and rural revitalization to enhance social well-being,” said Kate Wang, founder and CEO of RLX.

  • Florida Bill Would Ban Vapes at State Parks, Beaches

    Florida Bill Would Ban Vapes at State Parks, Beaches

    Credit: Aleksandr Kondratov

    A Florida Senate panel approved a proposal to ban smoking and vaping in state parks and beaches.

    The Environment and Natural Resources Committee backed a measure (SB 1576), filed by Chair Ana Maria Rodriguez, that would lead to fines for smoking and vaping in state parks.

    Fines would start at $100 for the first violation and jump to $500 for each subsequent offense, according to media reports.

    The state park system mostly follows the Florida Clean Indoor Air Act, which bars smoking inside buildings. The exception is Ellie Schiller Homosassa Springs Wildlife State Park, where smoking is prohibited. The park is deemed a “congested area” because of its layout and many visitors.

    While he supported the bill, Sen. Jonathan Martin suggested including an exemption for areas where people stay overnight.

    “I know a lot of state parks do allow for camping and RVs, enclosed containers where individuals might pay 30 bucks a night to stay there. Perhaps there could be a carve-out for that,” Martin said.

    The bill next goes to the Appropriations Committee on Agriculture, Environment and General Government.

    A similar House bill (HB 495) has not been heard in committees.

    In 2022, lawmakers passed a measure that allows cities and counties to restrict smoking at beaches and parks that they own.

  • US Tourist Fined for Vaping During Flight to Caymans

    US Tourist Fined for Vaping During Flight to Caymans

    Credit: S. Tratong

    In what is believed to be the first case of its kind before a Cayman Islands court, an American tourist has been fined KYD$1,000 ($1,219) for vaping inside an airplane bathroom.

    Brendan Joseph Fallon, a US Navy veteran, vaped to try to calm his nerves as the United Airlines jet from Newark, New Jersey, was preparing to land at Owen Roberts International Airport in Grand Cayman on Wednesday, 10 Jan., according to court records.

    While e-cigarettes are not illegal, their use in public places is prohibited; the Cayman Islands is still developing additional regulations for vaping products.

  • U.S. FDA Denies 22 SMOK Vape Hardware PMTAs

    U.S. FDA Denies 22 SMOK Vape Hardware PMTAs

    SMOK Osub One 50W AOI

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Shenzhen IVPS Technology Co., Ltd for 22 SMOK vaping hardware products.

    The denied products include devices, pods, atomizers, and cartridges. It’s the first time the agency has denied strictly hardware products from one company en mass.

    The products were denied because they were submitted without a specific e-liquid to be used with the devices, according to the FDA. “The denied SMOK e-cigarette products are not sold with an e-liquid. A consumer instead adds their separately purchased e-liquid into the device,” the agency wrote. “Therefore, these SMOK products have the potential to be used with any e-liquid on the market and available to the consumer, which could include tobacco-flavored and non-tobacco-flavored e-liquids.”

    The products receiving MODOs include:

    • SMOK OSUB ONE Device
    • SMOK OSUB ONE RPM Cartridge
    • SMOK RPM DC 0.8 Ω MTL Atomizer
    • SMOK OSUB ONE RPM Cartridge 3 Pack
    • SMOK RPM DC 0.8 Ω MTL Atomizer 5 Pack
    • SMOK Nfix Device
    • Nfix DC 0.8 Ω MTL Pod
    • SMOK POZZ Device
    • SMOK POZZ DC 0.8 Ω Pod
    • SMOK RPM 40 Device
    • SMOK RPM Empty Standard Cartridge
    • SMOK RPM Empty Nord Cartridge
    • SMOK RPM Mesh 0.4 Ω Atomizer
    • SMOK Nord DC 0.8 Ω MTL Atomizer
    • SMOK SCAR-P3 Device
    • SMOK SCAR-P3 Empty RPM 2 Cartridge
    • SMOK SCAR-P3 Empty RPM Cartridge
    • SMOK PRM 2 Mesh 0.16 Ω Atomizer
    • SMOK RPM Mesh 0.4 Ω Atomizer
    • SMOK Nord 2 Device
    • SMOK Nord 2 RPM Cartridge
    • SMOK Nord 2 Nord Cartridge

    After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. More specifically, the applicant failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.

    “Science is a cornerstone of FDA’s tobacco product review process, and CTP remains committed to evaluating applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of FDA’s Center for Tobacco Products. “It is the applicant’s responsibility to provide sufficient scientific evidence to demonstrate that marketing a new tobacco product is appropriate for the protection of the public health. In this case, the applicant failed to provide this evidence.”

  • Spain Bans Flavors for Heated Tobacco Products

    Spain Bans Flavors for Heated Tobacco Products

    Credit: Weyo

    The government in Spain has approved a decree that equates the regulation of heated tobacco products with that of traditional cigarettes, prohibiting products with flavorings. The rules do not apply to all vaping products, such as e-cigarettes.

    In addition, it will now be mandatory for labels to contain warnings for heated tobacco products that they products are harmful to health, according to Catalan News.

    The Ministry of Health is considering further regulations.

    “The ban will cover tobacco products with an aroma or flavor in their components (such as filters, papers, packaging, or capsules) or any other technique that allows modifying the smell or taste of the products or intensify the smoke. Filters, papers and capsules cannot contain tobacco or nicotine,” the report states.

    Heated tobacco products must include the following informative message on their outer packaging: “Tobacco smoke contains more than 70 carcinogenic substances,” with relevant accompanying photographs.

    This decree will enter into force three months after its publication in the official state gazette (Boletín Oficial del Estado).

  • WVA: EU Harm Reduction Approach ‘Out of Touch’

    WVA: EU Harm Reduction Approach ‘Out of Touch’

    Vapor Voice Archive

    The European Commission’s approach to tobacco harm reduction is out of touch with EU citizens’ views, according to the World Vapers’ Alliance (WVA)

    A recent public consultation on the EU Tobacco Products Directive (TPD), analyzed by Snusforumet, reveals a substantial consensus among citizens, NGOs and scientific institutions on the effectiveness of harm-reduction products in assisting smokers to quit.

    A striking 77 percent of respondents recognize these products as helpful smoking cessation tools, while a mere 9 percent of EU citizens disagree. Furthermore, an overwhelming 82 percent of respondents refute the notion that new nicotine alternatives pose a risk to public health, with only 6 percent perceiving them as a threat.

    “The EU Commission’s current stance on harm reduction is not just out of touch; it’s a blatant disregard for consumer opinions and scientific evidence,” said WVA Director Michael Landl in a statement. “It’s high time the Commission responds to the reality that harm-reduction products are not the enemy but a vital ally in the fight against smoking.”

    According to the WVA, countries like Sweden serve as living proof of the success of a consumer-friendly harm reduction approach, significantly outpacing the EU in reducing smoking rates. The EU Commission’s reluctance to embrace this approach is not only perplexing but also detrimental to public health efforts, the organization says.

    “Sweden’s success story is a testament to what can be achieved with a sensible harm reduction policy,” said Landl. “It’s baffling and frankly irresponsible for the EU Commission to continue its hostile approach towards these life-saving products. The Commission needs to align its policies with the clear evidence and public opinion, rather than clinging to outdated and ineffective methods.”