Category: Regulation

  • Alarm over smoking bans

    Alarm over smoking bans

    Extreme smoking bans undermine social inclusiveness without benefitting public health, according to a report published today by the smokers’ campaign group Forest EU.

    The new report includes the Smoking in Society Index, the most comprehensive, up-to-date public table of smoking and vaping regulations in the 28 EU member states.

    Slovenia is the worst EU country to smoke in, followed by Bulgaria, Finland, Hungary, Ireland and Poland,

    Forest describes the extent of the new smoking and vaping prohibitions as worrying, with many member states enacting restrictions that go beyond the 2009 EU Recommendation on smoke-free environments.

    “The prohibition of smoking in the open air and the extension of smoking bans to vaping represent a betrayal of the 2009 EU Recommendation on smoke-free environments,” said Guillaume Périgois, director of Forest EU.

    “Reaching into smokers’ homes takes tobacco control in a new and rather sinister direction.”

    Périgois called on the European Commission to denounce the marginalization of smokers and vapers and reaffirm the principles of the 2009 EU Recommendation.

  • Malaysia mulls vapor ban

    Malaysia mulls vapor ban

    Malaysia is considering a ban on vapor products following an outbreak of vaping-related deaths and illnesses in the United States, reports Reuters.

    “A detailed study is required to review the need for enforcing a total ban on the sale of electronic cigarettes and vapes,” Health Minister Dzulkefly Ahmad told Parliament.

    Tobacco products in Malaysia are currently regulated under the Food Act while the sale of vaporizer liquids containing nicotine has been banned since 2015.

    The country is finalizing a law that would ban the use of all smoking products, including electronic cigarettes and vaporizers, among minors and prohibit their promotion and advertising.

    As of Friday, U.S. authorities had reported 29 deaths and 1,299 cases of respiratory illnesses linked to the use of vapor products.

  • PMTA filed for Vuse

    PMTA filed for Vuse

    Reynolds American Inc. (RAI) on Oct. 11 submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA) seeking permission to market its Vuse vapor products.

    RAI is among the first in the vapor industry to file a PMTA, according to its parent company, British American Tobacco (BAT). To remain on the U.S. market, all vapor products must be submitted for FDA review by May 11, 2020.

    RAI’s submission includes more than 150,000 pages of documentation intended to demonstrate that the continued marketing of Vuse is “appropriate for the protection of the public health,” as required by the FDA.

    “Today’s application marks the culmination of years of hard work across multiple teams involving more than 100 individuals, including dozens of Ph.D. team members collaborating every day, with a substantial financial investment,” said James Figlar, executive vice president of scientific and regulatory affairs at RAI.

    “We have long worked to build a broad portfolio of competitive options for the adult tobacco consumer, and today’s application is a strong next step for us in that journey,” said Ricardo Oberlander, CEO of RAI.

    RAI previously submitted a regulatory application for Camel Snus. The company intends to submit additional applications for products in its “new oral” portfolio, such as Velo.

  • Capping nicotine

    Capping nicotine

    U.S. Congressman Raja Krishnamoorthi is introducing a bill that would limit the amount of nicotine in e-cigarettes to 20 mg per ml.  

     While other countries around the world regulate the amount of nicotine in e-cigarettes, the U.S. does not currently have any restrictions. Krishnamoorthi said nicotine caps enacted in the European Union, United Kingdom and Israel have limited use among young people in those countries.

     A standard Juul pod sold in the U.S. contains 59 mg of nicotine per ml.  

     The proposed law would allow the Food and Drug Administration to lower the cap even more to make e-cigarettes minimally addictive or not addictive at all. 

    Supporters say the punch that Juul pods packs helps smokers transition from combustible cigarettes. Critics say it makes Juul extremely addictive, especially for teenagers. 

  • Juul withdraws from ballot

    Juul withdraws from ballot

    Juul Labs will end its support for a ballot measure that would roll back San Francisco, California’s, ban on e-cigarettes.

    In a statement released on Monday, Juul Labs said it “recently announced a broad review of the company’s policies in order to responsibly lead the industry.”

    “As we continue that review, the company announced it will cease active support of Prop C in San Francisco.”

    Prop C would repeal the e-cigarette sales restrictions that were passed unanimously by the city’s board of supervisors.

    In June, San Francisco became the first U.S. city to ban e-cigarettes in response to what officials described as an “epidemic” of youth e-cigarette use. The ordinance prohibits the sale and distribution of e-cigarettes in San Francisco unless that product has undergone premarket review by the U.S. Food and Drug Administration.

    No e-cigarette has done so yet.

    Juul Labs’ announcement follows a leadership change. Last week, the company named K.C. Crosthwaite as its new CEO, replacing Kevin Burns.

    Previously, Crosthwaite was chief growth officer at Altria, which owns 35 percent of Juul Labs.

  • Flavor ban upheld

    Flavor ban upheld

    A court has denied a request by the vapor industry to delay New York’s emergency ban on flavored e-cigarettes sales.

    Acting state Supreme Court Justice Gerald Connolly on Friday refused to issue a temporary restraining order on the regulations approved on Sept. 17 by Governor Andrew Cuomo.

    The 90-day emergency regulations ban possession, manufacturing, distribution and sale of all vape flavors except tobacco and menthol.

    The temporary injunction had been requested by the Vapor Technology Association and two retailers.

  • Washington bans flavors

    Washington bans flavors

    Washington state Governor Jay Inslee has ordered state officials to impose an emergency ban on flavored vapor products, reports The Seattle TImes.

    The move comes in response to the mysterious lung illnesses that have rippled the United States.

    As of Sept. 30, the U.S. Centers for Disease Control and Prevention had recorded 805 lung injury cases and 12 deaths.

    If adopted during the health board’s Oct. 9 meeting, Washington state’s ban would go into effect the next day, last 120 days and could be renewed.

    Michigan and New York have also banned flavored vapor products. Massachusetts has banned all vapor products until Jan. 25, 2020.

  • Merger plan abandoned

    Merger plan abandoned

    Philip Morris International (PMI) and Altria have called off talks to reunite their businesses in the face of investor pushback and a regulatory crackdown on vaping in the United States.

    Altria’s $12.8 billion investment in e-cigarette manufacturer Juul has soured as regulators in the United States and other markets have started restricting flavored vapor products in response to a series of vaping-related deaths and hospitalizations and concerns about increased youth vaping.

    Walmart, the world’s largest retailer, announced last week it would stop carrying e-cigarettes altogether.

    “While we believed the creation of a new merged company had the potential to create incremental revenue and cost synergies, we could not reach agreement,” said Howard Willard, Altria’s chairman and CEO.

    “After much deliberation, the companies have agreed to focus on launching IQOS in the U.S. as part of their mutual interest to achieve a smoke-free future,” said PMI CEO Andre Calantzopoulos.

    IQOS is the only heated tobacco product with premarket authorization from the U.S. Food and Drug Administration (FDA). PMI has also submitted a modified risk tobacco product application for IQOS, which the agency is still reviewing.

    Global data, based on four years of use, show that IQOS is not significantly appealing to youth or to nonsmokers, according to PMI.

    The potential for Juul and iQOS to dominate the world’s biggest vapor markets was seen as central rationale of a deal when the merger talks were announced last month. It would have created an industry heavyweight with a combined market value of $187 billion, triple its closest rival, British American Tobacco.

    However, some investors were skeptical of the synergies the deal would generate and a steady rise in number of vaping-related deaths and illnesses reported in the U.S. may also have changed the companies’ thinking.

    “It appears that both management teams clearly listened to shareholder feedback and certainly couldn’t ignore the barrage of negative headlines,” wrote Bonnie Herzog, managing director of equity research at Wells Fargo.

    Philip Morris’ stock jumped more than 6 percent after the merger talks were canceled, bringing its market value to about $118 billion. Shares of Altria were down 2.4 percent Wednesday afternoon, valuing the company at around $74 billion.

    Altria spun PMI off in 2008, remaining focused mostly in the U.S. through its Marlboro cigarettes, while PMI has focused on selling cigarettes outside the U.S.

  • Consultation urged

    Consultation urged

    British American Tobacco (BAT) Malaysia managing director Erik Stoel said that the tobacco product manufacturer supports the Malaysian government’s plans to introduce legislation to regulate vapor products and asks that the industry be consulted to ensure that “robust quality and safety standards requirements were considered” in their rulemaking.

    Stoel added, “Banning e-cigarettes will only encourage consumers to continue buying unregulated products. Already, Malaysian law enforcement agencies are facing a huge task of clamping down on illegal cigarettes. The last thing Malaysia needs to deal with is another illegal product boosting an already thriving black economy. It is disappointing that up until today, we have not been consulted on these new regulations, especially at a time when effective regulations and policies are required to ensure that vaping products are safe and not sold to the underaged.”

    Stoel cited the news concerning deaths arising from vapor use in the U.S. as to why it is necessary to have “effective regulations and enforcement to ensure product safety and to prevent youth access.”

    BAT Malaysia currently does not sell vapor products in Malaysia.

  • Vapor ban boosts demand

    Vapor ban boosts demand

    India’s recent decision to ban e-cigarettes has triggered a run on the devices.

    The union government on Sept. 18 issued an ordinance to prohibit production, manufacturing, import, export, transport, sale, distribution, storage and advertisement of e-cigarettes.

    “After the decision was announced, customers wanted to stock the product,” an unidentified shop owner told The Hindu. “When we shut down our store, thousands of people called asking for e-cigarettes or liquid cartridges.”

    The Association of Vapers India is exploring legal options to contest the decision, saying that the government appears more concerned about protecting the combustible cigarette industry than protecting consumers’ health.