Category: Regulation

  • New PMTA Finish Date is June 30: FDA Status Report

    New PMTA Finish Date is June 30: FDA Status Report

    Credit: Postmodern Studio

    The U.S. Food and Drug Administration now states that it will complete all covered marketing applications by June 30. In its latest court-ordered status report, the agency stated that continued review is
    necessary in light of recent judicial decisions, including the D.C. Circuit’s decision in Fontem US.

    “Further, several of these remaining applications present complex scientific issues that require careful review and consideration.

    In the Fontem case, the court’s unanimous decision in Fontem US v. FDA upheld the regulatory agency’s denial of Fontem’s application to market flavored vaping products, in line with prior D.C. Circuit precedent but rejected the FDA’s denial of Fontem’s applications for unflavored products.

    The agency stated that it was also facing challenges from manufacturers that filed premarket tobacco product applications (PMTAs) that made amendments to their applications after several legal decisions were handed down by courts.

    “Many of these amendments contain substantial data and scientific explanation,” the agency wrote. “The amendments range from a few pages to hundreds of pages and were received on a rolling basis, with the most recent 2023 amendment being filed in December 2023.”

    Also, on Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) 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.

    The regulatory agency is under court order to file regular status reports on the agency’s review of pending PMTAs for new tobacco products that were on the market as of Aug. 8, 2016.

    For such new tobacco products to be lawfully marketed in the United States, the Family Smoking Prevention and Tobacco Control Act requires the FDA to complete a substantive review of the PMTA for each new tobacco product and issue a marketing granted order authorizing the sale of the product.

    The court order stems from litigation filed by health groups against the FDA seeking a court-imposed deadline for finalizing the review of the PMTAs that were filed with the agency by Sept. 9, 2020.

    The court-imposed deadline to complete the agency’s review was originally Sept. 9, 2021, which the FDA could not meet due to the extremely large number of PMTAs filed by manufacturers.

    The most recent and FDA’s seventh status report was filed on Oct. 23, 2023. Specifically, in these reports, the FDA provides an update on the progress to finalize the agency’s review of pending PMTA “covered applications.”

    A “covered application” is for new electronic cigarette/vapor products that were on the market as of Aug. 8, 2016, which had a PMTA filed with the FDA by Sept. 9, 2020, are sold under the brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin, or Puff Bar, and reach 2 percent or more of the total retail sales volume in NielsenIQ’s various retail e-cigarette sales reports.

    The agency also stated that it now expects to take action on 94 percent of covered applications by March 31. The FDA stated that it would file another status report on or before April 22.

  • UK Delegation to Push Vapes for Cessation at COP10

    UK Delegation to Push Vapes for Cessation at COP10

    Photo: IRStone

    The U.K. government believes that vapes comprise an important tool for helping adults quit tobacco smoking, a position its delegation will put forward during COP10, according to Dame Andrea Leadsom, the parliamentary under-secretary of state for health and social care.

    Leadsom was speaking on Jan. 18 at Westminster during a backbench debate organised by MP Andrew Lewer and aimed at uncovering what stance the government would take at COP10, the 10th Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control, which is due to be held in Panama on Feb. 5-10.

    Lewer, and others who spoke during the debate, were concerned that COP10 might resolve to establish equivalence in the regulation of combustible cigarettes and reduced-risk products, thus undermining the U.K.’s successful strategy of using vapes to help smokers quit their habit. Their concerns had been inflamed because previously they had been unable to wring from the government information about who would go to Panama as part of the U.K.’s delegation and what positions they would take.

    Leadsom said the U.K. delegation would be led by the U.K.’s deputy chief medical officer, Jeanelle de Gruchy, but gave only a rough overview of the U.K.’s position. Referring to the discussions that would take place about progress on tobacco control worldwide, she said the U.K. was an outlier on the topic of vapes, and would be putting forward its position that vapes were a very important tool for helping adults to quit. The U.K. government would welcome other parties going further on tobacco control, but it would be monitoring the negotiations to ensure that “nothing becomes mandatory.”

    On novel and emerging tobacco products, said Leadsom, different parties took different approaches. Currently, the U.K. was still looking at issues around heated tobacco, so the U.K. delegation would be in listening mode in this respect.

    She said the U.K. had no plans to implement further restrictions on advertising and sponsorship, and she said that it would be pressing for no increase to be made in assessed FCTC contributions.

    This last point was likely to have been in response to concerns expressed by some during the debate that while the U.K. was a major contributor to the FCTC, it seemed diffident in its approach to tobacco COPs. It was suggested that U.K. taxpayers might end up paying for policies that ran counter to their interests.

    This was perhaps something of a concern because the debate never got to grips with the issues of how COP proposals could be blocked by individual parties, and, if they were not blocked, whether they were binding on all parties. The latter issue would not be so worrisome currently because the U.K. government has shown itself to be relaxed in its approach to complying with international agreements and laws, but it might become more of an issue if the current government is replaced in this election year.–George Gay

  • 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.

  • 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.

  • 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.”

  • Tobacco Tax Not a Factor in Singapore’s Vaping Ban

    Tobacco Tax Not a Factor in Singapore’s Vaping Ban

    Credit: Andreykr

    The Singapore government said that the potential loss in revenue from tobacco tax was not a factor in its decision to ban the use of e-cigarettes in 2018.

    In his reply to a question by a Workers’ Party and Sengkang Member of Parliament, Deputy Prime Minister Lawrence Wong, who is also the Minister for Finance, said, “The Government’s decision to ban the use of e-cigarettes in 2018 was based on public health considerations, to protect our population from the harms of these products. The potential loss in tobacco tax revenue from the reduced consumption of tobacco products was not a factor in this decision.”

    … our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans.”

     

    Lawrence Wong

    Wong added that if the government were to legalize and tax e-cigarettes “the challenges would be similar to those we encounter for cigarettes and other tobacco products today.

    “In any case, the government has no plans to change our current approach, as our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans.”

  • Durbin Decries FDA Vape Failures From Senate Floor

    Durbin Decries FDA Vape Failures From Senate Floor

    Senator Dick Durbin
    Credit: Dick Durbin

    U.S. Senate Majority Whip Dick Durbin has again decried the Food and Drug Administration on its unacceptable failure to “protect children from the dangers of vaping” as the agency continues to miss and delay critical deadlines.

    In a press release, Durbin stated that he has repeatedly criticized the FDA for its long-overdue review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers, which originally had a federal court deadline of September 9, 2021.

    FDA has missed that court-ordered deadline by 28 months as unauthorized e-cigarettes flood the market.

    During his speech, Durbin also called on the Biden Administration to swiftly implement a proposed public health rule to prohibit the production and retail sale of menthol cigarettes and flavored cigars.

    “I know this President cares deeply about the toll of cancer. It has touched his family personally, as it has mine,” the Senator said. “If we want to make a difference in the health of Americans—and set a legacy for future generations—then the Administration must finalize this public health measure to end Big Tobacco’s predatory promotion of menthol cigarettes. Lives hang in the balance.”

    The FDA stated in prior status reports for PMTAs that the agency would complete a review of 100 percent of the applications by the end of 2023. The agency is now estimating that completion of the reviews may be delayed as the FDA considers the D.C. Circuit’s opinion in Fontem US v. FDA, affirming in part and vacating and remanding in part marketing denial orders for certain vaping products.