Category: Regulation

  • New Zealand Urged to Rethink Closed-System Ban

    New Zealand Urged to Rethink Closed-System Ban

    Photo: Evgeniy Vershinin

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) is urging New Zealand to reconsider its proposed vaping regulations, which include a ban on closed systems, tighter limits on displays in retail shops and new flavor restrictions.

    “This amendment will make it more difficult for adults who smoke to access vaping products, potentially pushing them back to smoking,” said CAPHRA Executive Coordinator Nancy Loucas. “It’s a step backwards in our journey towards a smoke-free New Zealand.

    The CAPHRA submission highlights several concerns. According to the advocacy group, the ban disproportionately affects older adults and those with dexterity issues who rely on simpler closed systems. The proposed display restrictions, says CAPHRA, may deter smokers from switching to less harmful alternatives. Meanwhile, the focus on further display restrictions in retail shops ignores the real issue of social supply to youth, according to the organization, while flavor restrictions could hinder successful smoking cessation efforts.

    “Consumers have the right to make informed choices about their health. This amendment proposes to restrict consumer autonomy and may hinder harm reduction efforts,” said Loucas. 

    “Even the Ministry of Health suggested that the regulations, as they are, are fit for purpose and the ASH Year 10 survey has shown that youth vaping has declined from the peak a couple of years ago.

    “CAPHRA calls for a more balanced approach, focusing on education and transparent risk communication. By highlighting the facts about vaping, who it is for, and what it is, we can combat misinformation and support public health,” said Loucas.

  • Korea Urged to Regulate Vapes Same as Tobacco

    Korea Urged to Regulate Vapes Same as Tobacco

    Photo: Teo

    Health advocates are calling on South Korea to regulate e-cigarettes as tobacco products, reports the Maeil Business Newspaper

    The current law does not classify vapes as cigarettes, which means they are exempt from many of the regulations that apply to tobacco products. For example, vaping companies do not have to print graphic health warnings on their products or charge their customers tobacco consumption tax.

    Article 2 of the Tobacco Business Act, defines “cigarettes” as products suitable for smoking, sucking, inhaling, chewing or smelling.

    The calls for expanding the legal definition come follow concern about the growth of unmanned e-cigarette stores in Seoul, which are said to have inadequate age-verification procedures.

    A survey by the Seoul metropolitan government revealed that the number of unmanned e-cigarette stores has quadrupled since April.

    According to data from the Korea Centers for Disease Control and Prevention, three out of 10 youth smokers started smoking e-cigarettes from 2019 to 2023. Six out of 10 teenagers who started with e-cigarettes are currently smoking regular cigarettes, the centers said.

    Bills to regulate e-cigarettes were tabled in the 20th and 21st National Assembly, but failed to cross the plenary session threshold in each instance.

  • FDA Warns 6 Companies for Trade Show Sales

    FDA Warns 6 Companies for Trade Show Sales

    Credit: Mr. Fog

    The U.S. Food and Drug Administration has issued six warning letters to manufacturers and retailers for selling or distributing unauthorized e-cigarette products promoted at an industry trade show.

    After observations made by Center for Tobacco Products (CTP) staff attending the trade show, the FDA conducted investigations and issued warning letters to six retailers and manufacturers for selling or distributing unauthorized e-cigarette products.

    Regulated entities must comply with all applicable requirements under the Federal Food, Drug, and Cosmetic Act. Under these requirements, the sale and distribution of unauthorized tobacco products is illegal, including at industry events such as trade shows or expos, according to the FDA.

    “Regulated industry should be aware that CTP obtains leads that inform investigations from many sources, including trade shows,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “We remain committed to identifying and taking action against those breaking the law, including at these events.”

    FDA also announced the issuance of warning letters to five online retailers for selling unauthorized e-cigarette products popular with youth, including products marketed under the brand names Breeze, Mr. Fog, and Raz.

    “Results from the recently released 2024 National Youth Tobacco Survey found that Breeze and Mr. Fog were among the top five most commonly used brands among youth who use e-cigarettes,” an FDA release states. “Additionally, Raz was identified as a popular brand through routine surveillance, with youth-appealing flavors such as sour mango pineapple and razzle-dazzle.”

    The companies receiving these warning letters sold or distributed e-cigarette products without marketing authorization from the FDA. Warning letter recipients are given 15 working days to respond with the steps they will take to address the violations 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.

    The trade show was not named in the FDA release.

  • Lawmakers Blast FDA for Rise of Illegal Vapes

    Lawmakers Blast FDA for Rise of Illegal Vapes

    The agency is struggling to justify the need for additional resources to combat illegal vape products.

    A bipartisan group of powerful House lawmakers are doubtful of the Food and Drug Administration’s proposal to begin collecting fees from e-cigarette companies, akin to how the agency charges fees to tobacco firms.

    FDA officials say that the fees would give regulators resources to tackle the thousands of illegal vapes lining store shelves.

    Lawmakers on the House Energy & Commerce Committee questioned whether the FDA’s Center for Tobacco Products (CTP), which has struggled for years to police the vaping industry, is capable of effectively using allocated funds.

    The agency is caught in a Catch-22 situation. Some lawmakers are demanding that the FDA crackdown on illegal e-cigarettes before receiving more funding, but the FDA argues that it needs additional funding to boost its enforcement efforts.

    Brian King

    CTP Director Brian King attempted to persuade lawmakers that the agency has taken significant action against vape companies selling illegal products. This includes imposing fines on retailers, seizing products at the border, and filing injunctions against manufacturers in federal courts. Lawmakers from both sides questioned if the agency was taking sufficient action.

    New Jersey Rep. Frank Pallone said that while he hopes e-cigarette user fees would “make a difference,” he was skeptical of whether the FDA would be able to rein in the illegal vape market. “I hate to say it but you just make it seem hopeless to me,” he said.

    Tony Abboud, executive director of the Vapor Technology Association (VTA), said the FDA’s Center for Tobacco Products (CTP) created a flawed and broken premarket tobacco product application (PMTA) process. He explained that the House committee hearing revealed that, under King’s leadership, CTP continues to approve combustible cigarettes while also denying millions of e-cigarette PMTAs at a 91:1 ratio.

    “Director King’s statement that there is ‘no safe harbor’ for companies with pending applications clearly demonstrates that CTP continues to move the scientific goalpost and is not truly committed to harm reduction for Americans who smoke,” said Abboud. “Cigarette smoking continues to be the leading cause of preventable death and disease in the U.S., yet Director King calls for more money to remove less harmful products from the market.

    “The CTP must acknowledge the undisputed smoking cessation benefits of e-cigarettes, authorize a diverse marketplace of flavored nicotine alternatives to cigarettes, and stop approving new cigarettes.”

    House Energy and Commerce Committee Chair Cathy McMorris Rodgers said that out of more than 26 million applications for electronic nicotine delivery systems (ENDS) products and has authorized fewer than 50 products.

    “However, according to recent market data, those products only account for about 10 percent of sales, showing how behind the FDA is with keeping up with the demand,” she said. “The lack of clear enforcement policy and authorized products leaves tobacco users, distributors, and convenience stores in the dark on what products they can use and sell to those that are looking for alternatives to traditional cigarettes.

    “Companies need clear guidelines on what is required to meet the standard for authorization and what changes to products require new applications.”

    The CTP currently collects user fees from cigarette and cigar companies. However, it requires Congressional approval to begin collecting user fees from vaping product manufacturers. The agency has been advocating for this change for some time. This change is estimated to increase CTP’s budget by approximately $114 million from its current budget of over $700 million.

    Half of this additional funding would be allocated to increasing enforcement efforts, according to STAT News.

    The hearing, titled “Evaluating FDA Human Foods and Tobacco Programs,” was House lawmakers’ first chance to question both King and Jim Jones, the FDA’s deputy commissioner for Human Foods. King joined the agency in July 2022. Jones joined last September.

  • Frustration Voiced at FDA House Committee Hearing

    Frustration Voiced at FDA House Committee Hearing

    Photo courtesy of Plus PR

    U.S. lawmakers and advocacy groups expressed concern about the Food and Drug Administration’s regulation of smokefree products during a Sept. 10 House of Representatives’ Energy and Commerce Subcommittee hearing.

    Health Subcommittee Chair Brett Guthrie criticized FDA delays and what he viewed as a lack of transparency. “Manufacturers filing premarket tobacco product applications [PMTAs] with the goal of meeting the standard of an ‘appropriate protection of public health,’ still have no clear guidance and are waiting for hundreds of days for outreach on their applications,” he said.

    “More importantly, these products pending at FDA could present an opportunity to improve public health by providing less harmful alternatives to traditional cigarettes. This lack of transparency has consequences.”

    Full Committee Chair Cathy McMorris Rodgers highlighted the massive backlog of product applications at the FDA’s Center for Tobacco Products (CTP). “Out of the over 26 million applications for electronic nicotine delivery systems, or ENDS products, the center has authorized fewer than 50 products,” he said.

    “However, according to recent market data, those products only account for about 10 percent of sales, showing how behind the FDA is in keeping up with demand.”

    Representative Richard Hudson blamed the CTP for the increase in illegal products on the U.S. market from abroad. “Millions of illegal products are on the market targeting our youth while some legitimate companies have been waiting for years for review or even hear a word from FDA about their application,” he said.

    “The illicit market has been enabled by the Center for Tobacco Products’ lack of action … the fact is, the inefficiency of CTP has driven an illicit market that has been filled by China.”

    In a separate statement, Philip Morris said the hearing put a bright bi-partisan spotlight on the fact that the agency is neglecting millions of adult smokers by failing to authorize scientifically-substantiated, smoke-free nicotine products that are better alternatives to combustible cigarettes.

    “More than 26 million premarket tobacco product applications have been submitted to the FDA for review, but the agency has authorized only several dozens of those applications, and none within the 180-day deadline set by Congress,” said PMI Director for Regulatory Communications Matthew Sheaff.

    “FDA’s goal to strike ‘an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes’ is far from the reality of its actions. It is our hope the FDA will fully embrace the tobacco harm reduction principles enshrined in the Tobacco Control Act and more importantly provide the millions of adult smokers in the United States access to better alternatives to combustible cigarettes.”

    The Taxpayers Protection Alliance (TPA) criticized the FDA’s authorization process and noted the low rate of youth e-cigarette use. “The PMTA costs to manufacturers are astronomical, while the regulatory requirements are obscure at best,” Lindsey Stroud wrote on the TPA’s website.

    “To date, the FDA has only authorized 56 products under the PMTA pathway. Given the current low rate of youth e-cigarette use and the high number of adults using novel tobacco products, there is a pressing need for the FDA to adapt its authorization strategies to better serve adults seeking to quit smoking through these alternatives. Lawmakers are urged to advocate for this necessary shift in FDA policy.”

    Americans For Tax Reform (ATR) called on the FDA to educate the public about the continuum of risk for nicotine products. “The agency’s failures to educate the public about the continuum of risk in nicotine products—despite their own internal documents demanding the need to do so—has meant that 75 percent of Americans inaccurately believe vaping is equal to or worse than smoking,” Tim Andrews wrote on ATR’s website.

    “The fact that the agency’s leadership continues to ignore its own comprehensive plan for tobacco and nicotine, where harm reduction is supposed to play a central role in the FDA’s tobacco control plan, is a downright scandal.”

  • South Africa Moves Closer to Vape Regulations

    South Africa Moves Closer to Vape Regulations

    Credit: Sharaf Maksumov

    The South African government plans to enforce stricter smoking and vaping regulations.

    The Tobacco Products and Electronic Delivery Systems Control Bill is currently under review. It aims to overhaul how tobacco products are marketed, sold, and consumed.

    The proposed legislation tightens restrictions on where people can smoke, with hefty fines and even potential jail time for those who break the rules.

    It also introduces stringent regulations for vaping and electronic nicotine delivery systems (ENDS), which are currently not addressed by existing laws, according to media reports.

    There is significant opposition from the business and labor sectors.

    Critics argue that the new restrictions could adversely affect the tobacco industry, including farmers and retailers.

    This move is part of South Africa’s broader effort to align its tobacco policies with international standards, particularly those set by the World Health Organization’s (WHO) Framework Convention on Tobacco Control.

  • Vapes Major Cause of Aviation Battery Incidents

    Vapes Major Cause of Aviation Battery Incidents

    Image generated with Adobe Firefly

    The rate of “battery thermal Runaway incidents”—instances of lithium-ion batteries overheating on passenger planes—hit a five-year peak last year, with e-cigarettes being the biggest culprit, according to a report from UL Standards & Engagement (ULSE), a nonprofit organization focused on safety standards.

    The data comes from ULSE’s Thermal Runaway Incident Program (TRIP), a voluntary lithium-ion battery incident reporting system. TRIP comprises 35 passenger and cargo airline participants. The program was designed with the aviation industry to better understand the extent of thermal runaway incidents caused by lithium-ion batteries onboard aircraft and how to prepare for, or ideally prevent, future incidents.

    “Passengers are often unaware that many devices they bring on board are powered by lithium-ion batteries, let alone the risks they carry, and it’s much harder to solve a problem that they do not know exists,” said David Wroth, director of technology and systems at ULSE and the leader of TRIP, in a statement. “Thermal runaway incidents on board aircraft are largely preventable but admittedly more difficult to contend with at 40,000 feet. TRIP provides a unique opportunity for the aviation industry to come together to find strategies to mitigate the risk of these incidents.” 

    As technology evolves and more products rely on rechargeable power, lithium-ion batteries are getting more powerful and in some cases larger, further complicating the thermal runaway threat. Damaged, substandard, or counterfeit batteries run the greatest risk of going into thermal runway, presenting serious consequences in flight.

    Key takeaways from the report include:

    • Incidents are at the highest point in five years of data collection, rising 28 percent from 2019-2023. There are an average of two thermal runaway incidents reported in the TRIP database each week. While on the rise, with approximately 180,000 flights in U.S. airspace per week, it is still highly unlikely to experience a thermal runaway incident.
    • The average passenger brings four rechargeable devices on board. Most common items include smartphones (82 percent), laptops (41 percent), wireless headphones (39 percent), and tablets (36 percent). E-cigarettes were responsible for the most incidents in 2023, with 35 percent of reported incidents attributed to vaping devices on passenger flights, followed by power banks, representing another 16 percent of incidents.
    • Most incidents happen on the aircraft with devices that are stored near the passenger’s seat. Almost nine out of 10 (87 percent) incidents are reported on the aircraft, with the remaining 13 percent occurring when baggage and personal items are on the move. On the aircraft, thermal runaway incidents occur in or around the passenger’s seat nearly 60 percent of the time.
    • The vast majority of incidents are addressed before reaching the fire or explosion stage of thermal runaway. Most (85 percent) incidents in 2023 were addressed when batteries showed warning signs such as overheating and smoking prior to entering full thermal runaway. While only 15 percent of incidents resulted in fire or explosion, the speed in which thermal runaway can develop means that the events in the majority could have been more serious had the issue not been addressed quickly.
    • Rechargeable devices are being packed in checked luggage. The devices that were most cited in thermal runaway incidents in 2023 were also the two most frequently put in checked luggage, according to passengers surveyed. More than a quarter (27 percent) of travelers reported checking portable chargers, and another 27 percent said they checked e-cigarettes. Devices that enter thermal runaway in checked baggage cannot be accessed by crew while in flight, and fires may not be detected as quickly in the cargo hold as they would be in the cabin.

    “Our research highlights several trouble spots that need to be addressed, from passengers missing warnings about lithium-ion batteries to packing rechargeable devices out of reach,” said Lesley Rohrbaugh, head of insights and policy analysis for ULSE. “But we also see clear opportunities to reduce the risk and that’s where we’re focused.” 

    Through additional passenger and cabin crew focus groups and interviews conducted by ULSE and data from TRIP, strategies to reduce these risks include passenger education, cabin crew training, and standards for aircraft baggage handling.

  • Mixed Feelings for Four-Year Anniversary of PMTAs

    Mixed Feelings for Four-Year Anniversary of PMTAs

    Credit: Asier Romero

    Representatives of the U.S. vapor industry expressed mixed feelings at the four-year anniversary of the filing of the first premarket tobacco product applications (PMTAs).

    Since the Sept. 9, 2020, deadline, the Food and Drug Administration’s Center for Tobacco Products (CTP) has received applications for 26 million novel tobacco products, mostly electronic cigarettes or e-cigarettes.

    However, despite its acknowledgement that e-cigarettes overall are less harmful and less toxic than combustible cigarettes, the agency has rejected more than 99 percent of PMTAs for these products.

    At the same time, the FDA has authorized 6,670 new combustible tobacco products to be sold in the U.S., including 3,232 new cigars, 1,291 new pipe tobacco products,1,073 new hookah tobacco products and 973 new cigarettes.

    According to the Vapor Technology Association (VTA), current CTP Director Brian King has authorized only four vaping devices as alternatives to cigarettes, compared with 1,270 combustible products.

    Director King has justified his refusal to authorize flavored e-cigarettes that are widely used by American adults with the need to protect youth. Yet the most recent National Youth Tobacco Survey revealed that the youth vaping rate—the share of users who say they’ve used an e-cigarettes at least once in the past 30 days—has declined to 5.9 percent, the lowest level in more than a decade.

    “Since Sep. 9, 2020, 1.93 million Americans have died from smoking cigarettes (480,000 each year), and approximately 64 million Americans suffered from smoking-related disease (16 million each year), according to the CDC, at a cost of hundreds of billions of dollars to the U.S. health care system and gross domestic product,” the VTA wrote in a statement.

    “In this time, the FDA has only allowed the purveyors of these deadly combustible products to strengthen their grip on the market. Meanwhile, more and more Americans die from smoking, making this anything but a happy anniversary.”

  • Philippines Bans 5 Vaping Products for Violations

    Philippines Bans 5 Vaping Products for Violations

    Credit: Adobe Photo

    The Department of Trade and Industry (DTI) in the Philippines on Saturday said it removed five vape brands from shelves pending an investigation into alleged violations of the law.

    The DTI identified the brands Shft, Dr. Freeze, Areogin, Don Bars and Chillax as the subjects under the order.

    “The trade suspension, effective immediately, is in accordance with section 11 of Executive Order No. 913 (1983) and will remain in place pending resolution of the formal charges,” the DTI said in a statement.

    The government agency cited that the trade suspension was in response to the formal charges filed against the said brands for violating Section 4(d) of Republic Act No. 11900, or the Vaporized Nicotine and Non-Nicotine Products Regulation Act.

    In addition to the trade suspension, the DTI said it has suspended the Philippine Standard licenses for the same brands.

  • Accorto Joins Global Institute for Novel Nicotine

    Accorto Joins Global Institute for Novel Nicotine

    Accorto Regulatory Solutions has joined the Global Institute for Novel Nicotine (GINN), an organization dedicated to advancing tobacco harm reduction through supporting the research and development of non-vaporized tobacco alternatives for adult smokers. The GINN also promotes compliance standards, focusing on youth access prevention, responsible marketing and product quality.

    Accorto Chief Scientific Officer Vince Angelico will join the GINN’s science and standards committee, which helps shape regulatory recommendations for the industry.

    “Becoming a member of GINN is a pivotal move in our ongoing commitment to advancing public health through robust, evidence-based regulation,” said Accorto Regulatory Solutions CEO Tom Beaudet in a statement. “GINN’s dedication to upholding industry integrity and prioritizing consumer safety mirrors our own values. We are eager to collaborate with fellow members to drive impactful progress in the tobacco harm reduction space.”

    Through this collaboration, Accorto Regulatory Solutions aims to contribute to the development of comprehensive, science-driven regulations that will enhance public health outcomes and promote responsible industry practices. Additionally, Accorto says it is dedicated to helping GINN members with novel, science-backed reduced-risk products fortify their regulatory applications, enabling these products to reach the market.

    “Accorto Regulatory Solutions joining GINN marks a significant step forward in our shared mission to advance tobacco harm reduction through evidence-based regulation,” said GINN Director Shem Baldeosingh. “Accorto’s deep expertise in regulatory compliance and their commitment to public health align perfectly with GINN’s core values. We are particularly excited about Dr. Vince Angelico’s involvement in our science and standards committee, as it will further enhance our ability to develop comprehensive, science-driven regulatory frameworks that support the safe and responsible marketing of reduced-risk nicotine products.”