Category: Regulation

  • Call for Restrictions

    Call for Restrictions

    Germany’s new drug commissioner, Daniela Ludwig, has called for restrictions on outdoor tobacco and e-cigarette advertising.

    While fewer Germans use cigarettes, vaping is becoming far more popular, especially among young people, according to the 2019 national drug and addiction report

    “We’re seeing that the use of e-cigarettes is clearly increasing, especially among teenagers and young adults,” Ludwig said. “This trend has to be stopped.”

    Ludwig stressed that there needed to be a bigger push to help people with addictions as well as a more open dialogue about drug policy rather than “ideology-based debates.”

  • Promoting Clean Air

    Promoting Clean Air

    Austria banned smoking in bars and restaurants on Friday, bringing the country’s laws into line with other European nations.

    Previously, Austrians were able to light up while drinking and eating inside bars and restaurants larger than 50 square meter, and as long as it was in a separate area.

    Violators will have to pay €1,000 ($1,115), and owners of establishments who allow patrons to smoke will be fined $2,000 rising to €10,000 for repeat offenders.

    Austria has traditionally been more tolerant of smoking than other European countries, earning it a reputation as “the ashtray of Europe” among tobacco critics.

    The debate about the ban has been ongoing for over 10 years, with the far-right Freedom Party—formerly led by a keen smoker—opposing the measure.

    A quarter of Austrians smoke, compared with an average of 18 percent in other EU states.

  • Tackling E-waste

    Tackling E-waste

    The Tobacco Institute of Japan (TIOJ) is set to implement rules for the disposal of heat-not-burn (HnB) products that use lithium-ion batteries, reports The Mainichi.

    The initiative is a response to multiple reports of fire incidents attributed to tobacco cartridges discarded as noncombustible trash.

    Japan requires local governments and electronics manufacturers to collect lithium-ion battery-powered products including smartphones and portable video game consoles.

    However, HnB cartridges are not subject to such requirements. Without clear rules regarding the collection of these products, many local bodies do not accept them as trash.

    Japan Tobacco (JT) launched a pilot program in May to collect used HnB tobacco products at its shops in Tokyo, and the tobacco companies will set rules based on JT’s system.

    HnB products have been on sale in Japan for about five years, sold by TIOJ member companies JT, Philip Morris Japan and British American Tobacco Japan. To date, more than 10 million units have been sold in the country.

  • Preparing for Plain Packs

    Preparing for Plain Packs

    Canada’s plain packaging law will take effect on Nov. 9.

    All packaging will feature the same brown base color, basic gray text and minimalist layout under the new requirements. The measure will also standardize the size and appearance of cigarettes, cigars and other products inside the packages.

    Tobacco companies will have 90 days to offload their branded inventory.

    In 2021, slide-and-shell packages will become mandatory in Canada, providing a wider surface area that will display the largest health warnings in the world, he said.

    “The package designs [are] really amazingly glitzy and very attractive, especially to kids,” said University of Waterloo psychology professor Geoffrey Fong, the founder and chief principal investigator of the International Tobacco Control Policy Evaluation Project.

    “What we’ve found is that plain packaging has tremendous effects on reducing the appeal of these deadly products.”

    Eric Gagnon, head of regulatory affairs at Imperial Tobacco Canada, said plain packaging would boost the illicit sale of tobacco products while disrupting the tobacco supply chain.

    “It’s not like you just turn a key on and off,” he said. “You need to change all your artwork, all your equipment, retool all your machines, so obviously, it’s very costly and a very complex operation.”

  • U.S. Creates Hemp Program

    U.S. Creates Hemp Program

    

    U.S. Secretary of Agriculture Sonny Perdue announced Tuesday the establishment of the U.S. Domestic Hemp Production Program. This program, as required by the 2018 Farm Bill, creates a consistent regulatory framework around hemp production throughout the United States.

    “At [the] USDA [U.S. Department of Agriculture], we are always excited when there are new economic opportunities for our farmers, and we hope the ability to grow hemp will pave the way for new products and markets,” said Perdue.

    “We have had teams operating with all hands on deck to develop a regulatory framework that meets congressional intent while seeking to provide a fair, consistent and science-based process for states, tribes and individual producers who want to participate in this program.”

    Later this week, an interim final rule formalizing the program will be published in the Federal Register that will allow hemp to be grown under federally approved plans and make hemp producers eligible for a number of agricultural programs.

    The rule includes provisions for the USDA to approve hemp production plans developed by states and Indian tribes, including requirements for maintaining information on the land where hemp is produced; testing the levels of delta-9 tetrahydrocannabinol; disposing of plants not meeting necessary requirements; and licensing requirements.

    It also establishes a federal plan for hemp producers in states or territories of Indian tribes that do not have their own approved hemp production plan.

    The interim final rule becomes effective upon publication in the Federal Register. Following publication, the USDA invites public comment on the interim rule and the information collection burden. A preview of the rule is posted on the USDA’s website.

  • Clarifying Expectations

    Clarifying Expectations

    The Food and Drug Administration’s (FDA) Center for Tobacco Products is holding a public meeting today and tomorrow in Silver Spring, Maryland, USA, to provide information on the agency’s expectations for tobacco product applications with a particular focus on deemed tobacco products (e.g., cigars, waterpipes and electronic nicotine-delivery systems including e-liquids and electronic cigarettes) including product review policies, procedures and general scientific principles.

    The information is intended to improve public understanding and assist persons considering submitting marketing applications for tobacco products under the Federal Food, Drug and Cosmetic Act, including pre-market tobacco product applications, substantial equivalence (SE) reports and the exemption from SE.

    Topics to be addressed in the meeting include:

    • Overview of the tobacco product marketing application pathways
    • Information that should be included in a tobacco product marketing application
    • Administrative processes involved in the submission and review of a tobacco product marketing application
    • Other topics relevant to the submission of tobacco product marketing applications, including communications between the FDA and the industry during an application review process, use of tobacco product master files as well as electronic submission resources and tools.

    To view the public meeting online, click here.

  • FDA Warns Eonsmoke

    FDA Warns Eonsmoke

    The U.S. Food and Drug Administration (FDA) has sent a warning letter to Eonsmoke, notifying the company that nearly 100 flavored of its e-cigarette products do not have the required marketing authorization.

    The letter states that the products cannot be legally sold in the United States and rebukes the company for illegally suggesting to consumers that Eonsmoke products are less harmful than other commercially marketed tobacco products, according to an FDA release.

    The FDA’s warning letter additionally cites the company for omitting nicotine warning statements and failing to submit product ingredient information to the agency.

    FDA has requested a written response from Eonsmoke within 15 working days informing the agency of the specific actions taken to address the concerns.

  • MRTP for General Snus

    MRTP for General Snus

    Photo: Swedish Match

    The U.S. Food and Drug Administration (FDA) has authorized Swedish Match U.S. division’s amended modified-risk tobacco product (MRTP) applications for eight varieties of General Snus, making it the first tobacco product to secure the modified-risk designation and right to market the product as a less harmful alternative to cigarettes.

    “Today’s decision is a huge accomplishment for public health in the U.S. and another step toward realizing our vision of a world without cigarettes,” said Gerry Roerty, vice president and general counsel for Swedish Match.

    “There are nearly 35 million adult smokers in the U.S., all of which have been led to believe the only way to reduce tobacco risk is complete abstinence. We now have the opportunity and responsibility to inform cigarette users who cannot abstain that General Snus can be a risk-reducing alternative. If that’s enough to make even a percentage of them switch, we’ve made progress.”

    The modified-risk status classifies General Snus as a tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. The FDA also cleared Swedish Match’s claim that using General Snus instead of cigarettes puts users at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.

    In a statement, Swedish Match said the authorized claim allows it to begin working to reduce misperceptions related to the risk of General Snus. According to the National Young Adult Health Survey, only 10 percent of respondents believed snus was less risky than cigarettes.

    Snus has already been tied to progressing the reduction of cigarette use in other countries. In Sweden, widespread use of snus in place of cigarettes is believed to have helped the country achieve the lowest lung and oral cancer rates in men in Europe. In Norway, snus rates among young women increased to 13 percent since its legalization in 2002. Smoking rates among young women dropped from 30 percent in 2001 to 1 percent in almost the exact same time span.

    In announcing the first-ever modified-risk orders for a tobacco product, the FDA said its decision does not mean General Snus is safe or “FDA approved.” Acting FDA Commissioner Ned Sharpless said, “While we are authorizing these specific modified-risk tobacco products, it’s important for the public to understand that all tobacco products—including these—pose risk.”

    The market authorization is valid for five years and requires Swedish Match to conduct postmarket studies to determine the impact of MRTPs on consumer perception, behavior and health.

    Bonnie Herzog of Wells Fargo Securities described the ability to make a modified-risk claim in tobacco/nicotine as a game changer—”not just from a consumer perception point of view but also in terms of potential tax favorability down the line since it’s logical that a tobacco product that is less harmful to public health should be taxed less onerously than a higher risk product,” she wrote.

    “We view this as very good news for the broader tobacco/nicotine industry as it demonstrates the FDA’s commitment to a ‘continuum of risk’ strategy and provides a viable pathway/process for manufacturers,” she added.

  • Ban Needs Fixing

    Ban Needs Fixing

    A Massachusetts judge on Monday said he would bar the state from enforcing its ban on nicotine vapor product sales unless several defects are addressed.

    While declining to immediately halt the ban as requested by the Vapor Technology Association (VTA), Suffolk County Superior Court Judge Douglas Wilkins said the state must redo the ban and solicit public comment.

    VTA Executive Director Tony Abboud said his organization regretted the ruling and would seek to block the ban, which the group has called an “existential threat” to the state’s $331 million nicotine vapor products sector.

    In its lawsuit challenging the ban, the VTA argued that Baker’s emergency order was an unconstitutional overreach and was arbitrary as it claimed to target youth vaping and the outbreak by banning all sales to anyone in the state regardless of age.

    Baker’s administration has until Oct. 28 to reissue the ban and provide vape shops and members of the public an opportunity to comment.

  • ‘Undermining’ Plain Packs

    ‘Undermining’ Plain Packs

    Tobacco companies have been undermining U.K. plain packaging laws with subtle marketing techniques, according to a report published in BMJ Open. The techniques ensure cigarettes continue to stand out from rival products without breaching regulations.

    Philip Morris International, for example, added beveled edges and a new “pro-seal” closing mechanism to packets of its bestselling Marlboro brand. This made packs “appear more premium and recognizable compared to other brands,” the researchers claimed.

    Tobacco companies have also responded to a ban on taste descriptors by replacing them with names based on color. The researchers said that banning terms such as “smooth” and “light” was meant to dispel the myth that certain types of cigarette are less dangerous but that by teaching customers color codes linked to the old descriptions, “misperceptions are likely to endure.”

    One of the lawmakers who pioneered the legislation said ministers should consider tightening up the rules to eliminate loopholes detailed in the report.

    The U.K. plain packaging law took effect in 2016.