Category: Regulation

  • Avail Earns PMTA Acceptance Letter From FDA for E-liquids

    Avail Earns PMTA Acceptance Letter From FDA for E-liquids

    Credit: Avail

    Avail Vapor announced today that it has received its first premarket tobacco product application (PMTA) acceptance letter from the U.S. Food and Drug Administration (FDA) for its e-liquid nicotine products. While the company would not say what flavors or how many flavors, it was confirmed that the mixed-berry flavored Mardi Gras was a submitted flavor.

    Blackbriar Regulatory Services led the regulatory process for Avail’s submission. The application now moves to the substantive scientific review where the FDA will determine if Avail has scientifically proven that its nicotine vaping products are appropriate for the protection of public health.

    This is one of numerous applications that Avail plans to file prior to the September 9, 2020 deadline which will provide a wide-ranging flavor portfolio to meet the needs of adults seeking alternative choices to combustible tobacco products, according to James Xu, chairman of Avail.

    James Xu

    “We started mapping out our regulatory framework and PMTAs in 2015, before nicotine vaping products became subject to the FDA’s tobacco authority,” said Xu. “We couldn’t be more pleased that the years of hard work, investment and dedication have gotten us to this point. Our end goal is to seek an FDA marketing order which would allow us to continue to keep our products on the market for those adult smokers looking for alternatives to traditional tobacco products.”

    In order for nicotine vaping products to remain on the market after the FDA’s September 9, 2020 PMTA submission deadline, companies must submit a viable PMTA with the intent of seeking an FDA marketing order. A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health.

  • Myanmar Makes Vaping Illegal After 5-Month Debate

    Myanmar Makes Vaping Illegal After 5-Month Debate

    Credit: Bill Oxford

    The government of Myanmar has approved a complete ban on vapor products. Experts now say consumers will be forced to look towards the black market or return to combustible cigarettes.

    The bill to ban e-cigarettes and shisha won cabinet approval and unanimous support in the lower house five months after it was proposed by by San Shwe Win, a physician representing Yegyi in Ayeyarwady region, according to a story on coconuts.co.

    “Today, e-cigarettes and shishas are easily accessible at most bars, nightclubs, [karaoke clubs] and other modern tea shops, restaurants and stores in Myanmar – for all ages and genders. It has become even more popular, and that’s a threat for all the young people out there,” San Shwe Win said at a government meeting.

    Vaping has been popular in Myanmar since around 2017, where it has been falsely promoted as a means to quit smoking tobacco. Vape shops have proliferated in Yangon, and smoking pens have become stylish accessories.

    Last month, a Myanmar Custom Department petitioned to approve the import of e-cigarettes but was rejected by the Ministry of Health and Sports.

  • Still No House Vote on Bill Ending Online Youth Sales

    Still No House Vote on Bill Ending Online Youth Sales

    Credit: Succo

    The U.S. House of Representatives has not yet voted on a bill that would end online sales of vapor products to minors. The bill has been “held at desk” for nearly a month. No announcement has been made for when the House would bring the bill to the floor.

    On July 1, the U.S. Senate passed the Preventing Online Sales of E-Cigarettes to Children Act (S.1253) by unanimous consent. The legislation aims end online e-cigarette sales to minors by applying the same measures that are required when traditional cigarettes are purchased online.

    The National Association of Convenience Stores (NACS) said it strongly supports S. 1253, which “ensures responsible retailing of e-cigarettes and age verification across all channels. The legislation would require online sellers of e-cigarettes to ensure the delivery carrier verifies the age of the recipient upon delivery. It would also require online sellers to collect and remit the appropriate state and local taxes,” according to a story on the NACS website.

    These rules are already in place for cigarettes and smokeless tobacco products purchased over the internet after Congress passes the Prevent All Cigarette Trafficking (PACT) Act, in 2010. Language for vapor products was not included in the law.

    The House passed its version of the bill (H.R. 3942) on suspension. Given that the Senate bill is slightly different than the House version, the House will need to pass the Senate’s version before it can become law, according to NACS.

  • Taiwan Health Organization Seeking to Ban Vapor Products

    Taiwan Health Organization Seeking to Ban Vapor Products

    city in Taiwan
    Credit Remi Yuan

    The director of Taiwan’s top health organization said his agency was seeking to amend the Tobacco Hazard Prevention and Control Act to ban the import and sale of heated tobacco products and e-cigarettes.

    During the two-month preview period for the draft amendments, which ended at the end of last month, the Health Promotion Administration (HPA) received more than 4,000 letters from members of the public expressing conflicting opinions on the proposed bans, according to Deputy Director-General Wu Chao-chun yesterday .

    Letters from tobacco companies mostly criticized proposals to enlarge the warnings printed on cigarette packages to 85 percent of the front surface area and to raise the legal age for smoking from 18 to 20, Wu said, according to a story in the Taipei Times..

    The HPA hopes to submit the draft amendments to the Ministry of Health and Welfare at the end of this month, which would forward them to the Executive Yuan next month for review, he said.

  • Taxpayers’ Group Slams Kiwi Curbs on Flavors

    Taxpayers’ Group Slams Kiwi Curbs on Flavors

    Photo: Duh84bk – Dreamstime.com

    New Zealand will enact flavor restrictions and ban vapor product advertising in November, reports the New Zealand Herald.

    The country’s House of Representatives passed the Smokefree Environments and Regulated Products Vaping Amendment Bill on Aug. 5—just before the final sitting day in this term of government.

    Associate Health Minister Jenny Salesa promised to regulate the industry in November 2018 but didn’t introduced the bill until this year. She described the legislation as the most significant change to the Smokefree Act.

    The new law will:

    • Ban the sale of vaping products to those under the age of 18.
    • Prohibit advertising the products and encouraging people to buy them in-store.
    • Limit the sale of all flavors to specialist stores, including online retailers, with shops Like dairies, supermarkets and petrol stations restricted to mint, menthol and tobacco.
    • Allow specialty stores to continue offering loyalty points and discounts.
    • Ban vaping in cars with children.
    • Enable all retailers to display products in-store.
    • Provide a framework for regulations to be set where people can vape in or outside premises.
    • Introduce a safety system which would allow the Ministry of Health to recall products, suspend them and issue warnings.

    Critics said the new rules are too restrictive and could prompt people using vaping as a smoking-cessation tool to turn back to cigarettes.

    “The vaping regulations rushed through under urgency are an absolute boon for the tobacco industry,” said Jordan Williams, spokesman of the New Zealand Taxpayers’ Union. “Decreasing the availability of appealing alternatives to cigarettes will keep disproportionately poor New Zealanders on the durries, paying a massive price in excise tax and devastating health outcomes.

    “The range of appealing flavors is one of the key attractors for smokers transitioning off cigarettes,” he said. “When someone walks into a convenience store and is denied access to flavored vape liquid but can still buy their favorite cigarette brand, they’re at risk of falling off the wagon. And a complete ban on advertising for vaping products will prevent these brands from appealing to smokers to make the switch,” said Williams.

  • U.S. House Votes to Protect States With Legal Marijuana

    U.S. House Votes to Protect States With Legal Marijuana

    Credit: Louis Velazquez

    An amendment to protect all U.S. state-run marijuana programs from federal interference passed the U.S. he House of Representatives on Thursday. The bill passed in a 254-163 vote on the floor. Earlier in the day, it had been approved in an initial voice vote.

    If enacted, the measure would prevent the Department of Justice (DOJ) from using its funds to impede states from implementing cannabis legalization laws. The bipartisan effort was led by Reps. Earl Blumenauer, Tom McClintock, Eleanor Holmes Norton and Barbara Lee.

    The amendment builds on an existing provision that only protects state medical cannabis laws from DOJ intervention that has been enacted through appropriations legislation each year since 2014.

    As a growing number of states have legalized marijuana for medical or recreational purposes, “we’ve watched across the country shifting attitudes,” Blumenauer said in the floor debate prior to the vote, according to marijuanamoment.net, a cannabis advocacy group. “The federal government, sadly, is still trapped by the dead hand of Richard Nixon’s war on drugs, declaring cannabis a schedule I controlled substance.”

    The congressman also talked about separate House-passed legislation to protect banks that service the marijuana industry and another standalone bill to federally deschedule cannabis.

  • Juul Labs Submits its PMTA to U.S. FDA

    Juul Labs Submits its PMTA to U.S. FDA

    Neon Juul sign
    Photo: Jordan Whitfield

    Juul Labs has submitted a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) for the company’s Juul system, an electronic nicotine delivery system (ENDS) product. The company’s submission includes comprehensive scientific evidence for the Juul device and Juul pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5.0 percent and 3.0 percent, as well as information on its data-driven measures to address underage use of its products.

    With its PMTA submission, Juul Labs has provided a scientific foundation for the FDA to evaluate whether these products are “appropriate for the protection of the public health” with respect to the risks and benefits to the population as a whole. The application includes detailed scientific data from over 110 studies totaling more than 125,000 pages evaluating the product’s impact on both current users of tobacco products and nonusers, including those who are underage.

    As part of the PMTA process, Juul Labs has built a comprehensive research program focused on examining the public health impact of the Juul system. This includes research addressing the harm reduction potential of the product, including its ability to convert adult smokers from combustible cigarettes. This research is supplemented with information on the controlled design and repeatable manufacturing processes associated with the Juul system, as well as data-driven measures to limit unintended consequences to the overall population, including initiation among nonusers.

    “In order to earn a license to operate in society, we need to be a science and evidence-based company, engage in open and transparent dialogue with our stakeholders, and take methodical and responsible actions to advance the potential for harm reduction for adult smokers while combating underage use. Our PMTA submission is a key part of that approach,” said Juul Labs CEO K.C. Crosthwaite.

    “Juul Labs has committed all necessary resources to deliver the best possible PMTA based on rigorous scientific research and data-driven measures to address underage use,” said Joe Murillo, chief regulatory officer at Juul Labs. “We respect the PMTA process and believe it is the right forum to determine the role ENDS products can play in transitioning and completely switching adult smokers from combustible cigarettes to potentially less harmful alternative products while combating underage use.”

    Late last year, the company, under Crosthwaite’s leadership, committed to resetting the vapor category and seeking to work cooperatively with regulators, legislators, attorneys general, public health officials, and other stakeholders to combat underage use and transition adult smokers from combustible cigarettes. As part of that process, the company reduced its product portfolio, halted television, print, and digital product advertising, built up its science and evidence-based capabilities, and supported the U.S. Administration’s final flavor policy for ENDS products, while taking a methodical approach to its global presence.

    Juul Labs has built up its science and evidence-based capabilities and will use its research and data to explore additional pathways in other countries. The company will continue to share its research with regulators and the public health community globally through peer-reviewed journals, conferences, and one-on-one meetings.

  • Melbourne City Council: Make Vaping Same as Smoking

    Melbourne City Council: Make Vaping Same as Smoking

    Credit: VapeClubMY

    Vaping is on the verge of being banned in Melbourne’s CBD as the council votes on whether to redefine e-cigarettes as ‘smoking’, angering civil libertarians. The City of Melbourne Council will decide on Tuesday whether to ban vaping from all of council’s existing smoke-free zones, according to an article in the Daily Mail.

    Melbourne city centre (also known colloquially as simply “The City” or “The CBD” is the central built up area of the city of Melbourne, Victoria, Australia, centred on the Hoddle Grid, the oldest part of the city laid out in 1837, and includes its fringes. It is not to be confused with the larger local government area of the City of Melbourne which includes this area and the inner suburbs around it, according to wikipedia.

    A total of 11 smoke-free zones in the CBD and surrounds including the Bourke Street Mall would be covered by the ban. The popular Tan running track which loops around Kings Domain and the Royal Botanical Gardens, south-east of the CBD, would be off-limits to vapers if the motion passes the council vote.

  • Minnesota Law Banning Under 21 Vape Sales Starts Saturday

    Minnesota Law Banning Under 21 Vape Sales Starts Saturday

    Credit: Bao Chau

    Anyone who is younger than 21 will be prohibited from buying tobacco products in Minnesota beginning Saturday, Aug. 1.

    A new statute is set to take effect that day, squaring state law with a federal measure that outlaws purchases of tobacco and e-cigarette products to those younger than 21, according to an article in the Duluth News Tribune. Under the law, those under 21 would also be prohibited from entering tobacco or vape shops.

    Businesses that sell tobacco products to those younger than 21 would face a $300 penalty after the first offense with higher fees on subsequent offenses. And anyone under 21 found buying tobacco products would face license suspensions and adults who furnish the products to them would face a $50 fine, the story states.

    The federal government has hiked the minimum age of sale of tobacco products from 18 to 21, and local governments around the state have enacted similar ordinances in their communities. But state lawmakers and advocates aiming to prevent tobacco addiction in young people said the measures weren’t being enforced evenly across the state.

  • Russia Adopts Bill to Restrict Vapor Products

    Russia Adopts Bill to Restrict Vapor Products

    Credit: Alexander Smagin

    The State Duma MPs in Russia have adopted a bill restricting the use of electronic cigarettes and hookahs.

    According to a statement from the lawmaking authority, the measure sets restrictions on the use of electronic nicotine delivery systems (ENDS) and hookahs inside certain territories, premises and objects; issues requirements for demonstration of electronic smoking articles in audiovisual works for minors and adults.

    Moreover, the document restricts the sale of vapor products and bans their sale to minors and involvement of children in the use of them, according to a Russian state information agency.

    There is also a proposal to introduce administrative fines for violations of the imposed restrictions.