Category: Regulation

  • Turning Point Submits PMTAs for 250 Products

    Turning Point Submits PMTAs for 250 Products

    Photo: Bacho | Dreamstime

    Turning Point Brands (TPB) has submitted to the U.S. Food and Drug Administration (FDA) premarket tobacco product applications (PMTAs) for 250 products.

    The PMTAs cover a broad assortment of products in the vapor category including multiple proprietary e-liquid offerings in varying nicotine strengths, technologies and sizes. They also include proprietary replacement parts and components of open system tank devices, along with a closed system e-cigarette.

    According to TPB, the filings provide detailed scientific data to demonstrate that the products are “appropriate for the protection of public health,” as required by law.

    The applications are supported by five pharmacokinetics studies, a likelihood-of-use study, and a patterns-of-use study, in addition to a toxicological review. Data throughout the applications underline that TPB products do not appeal to never users, youth or former users; that an extremely small percentage of users are never users, youth, or former users; that a significant majority of users have completely ceased use of combustible cigarettes; that a low percentage of users engage in dual or poly use; and that the products are substantially less harmful than combustible cigarettes and comparable to other products in the vapor category.

    TPB has also provided a detailed marketing plan to illustrate how it will continue to prevent youth exposure to the products.

    “We look forward to engaging with the FDA as it reviews our submissions,” said Larry Wexler, president and CEO of TPB.

    The FDA deadline for submitting PMTAs is today.

  • RAI Concludes PMTA filings for 2020

    RAI Concludes PMTA filings for 2020

    PHoto: RAI

    Reynolds American Inc. (RAI), has filed its final premarket tobacco product application (PMTA) submissions with the U.S. Food and Drug Administration (FDA) to allow its Vuse and Velo brands to remain on the market in the United States.

    Submitted Sept. 4, the filing concludes an 11-month process for RAI. The company has filed six applications for its Vuse Solo, Vuse Ciro and Vuse Vibe vapor products, as well as for its Velo nicotine lozenge and modern oral pouch products. Across the six applications, more than 530,000 pages of scientific data and more than 8,600 scientific documents have been submitted as part of the filings.

    RAI parent company BAT says it is committed to reducing the health impact of its business with a multicategory approach that offers consumers a wide range of enjoyable and lower-risk alternatives to cigarettes. With noncombustible nicotine products now available in more than 40 countries, the group’s ambition is to exceed 50 million noncombustible consumers by 2030.

    Kingsley Wheaton

    “The U.S. is the world’s largest vaping market and so the completion of our PMTA filings is a really important step for us as we transform our organization, drive a step change in our ‘new categories’ business, and increase our non-combustible consumer base and revenues,” said Kingsley Wheaton, chief marketing officer of BAT.

    “Our transformation is progressing very well and in the first six months of 2020 we attracted an additional 2.7 million new noncombustible consumers compared to the same time last year. Globally, we now have nearly 12 million regular noncombustible consumers and the U.S. will play a large part of our ambition to grow this number to at least 50 million by 2030.

    “We remain fully committed to building a better tomorrow and reducing the health impact of our business by offering consumers a range of enjoyable and lower risk products including vapor, tobacco heating and modern oral nicotine products.”

    The FDA’s PMTA deadline is Sept. 9.

  • FDA to List PMTA Applicants

    FDA to List PMTA Applicants

    Mitch Zeller

    The U.S. Food and Drug Administration (FDA) plans to publicly list all e-cigarette manufacturers that want permission to sell their products in the U.S., reports Bloomberg, citing a blog post published on Monday by Mitch Zeller, director of the FDA’s Center for Tobacco Products.

    The move could help consumers and retailers spot illegal products.

    Vapor product manufacturers who want to keep their products on the U.S. market will have to file requests for marketing authorization with the FDA by Sept. 9.

    The FDA has received applications for about 2,000 e-cigarettes and other newly regulated tobacco products already. There are more than 400 million eligible items that would need to apply to stay on the market, according to Zeller.

    Products whose applications were filed on time will have a one-year grace period to stay on the market while the FDA reviews them, unless the agency rejects the request. Large manufacturers, retailers who could be liable for selling illegal products and public-health groups had pushed the FDA to make the process more transparent.

    In a letter to the FDA, several retail associations had asked the agency to release a list of manufacturers that have PMTAs on file so retailers can know what electronic nicotine delivery system (ENDS) brands can remain on store shelves.

     

  • FDA Accepts Vaporesso’s PMTA

    FDA Accepts Vaporesso’s PMTA

    Photo: Bacho | Dreamstime

    Vaporesso received an acceptance letter for its first round of premarket tobacco product applications (PMTAs) from the U.S. Food and Drug Administration (FDA) on Aug. 20, 2020.

    The acceptance letter came three days after the company submitted its PMTAs. The application received positive comments from the FDA on its preparation, according to the company’s U.S. scientific CRO agent.

    “A successful acceptance has boosted the confidence of Smoore to keep investing in bringing more vaping products into PMTA in the future,” the company wrote in its press release. “Our commitment to vapers in the USA remains the same: We will make vaping as easy as possible, and we will consistently provide high-quality vaping experiences for vapers all over the world. So the first round of application accomplished by Smoore is merely the start with more products to come.”

  • Reynolds Submits First Velo PMTA

    Reynolds Submits First Velo PMTA

    Photo: RAI

    Reynolds American Inc. submitted a group of premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking orders authorizing the marketing of Velo dissolvable nicotine lozenges. A grant of these marketing orders would allow these products to remain on the market after the FDA’s Sept. 9, 2020, deadline for PMTAs.
     
    Velo Lozenges—formerly sold under the Revel brand—were reintroduced under the Velo brand in 2020 by Reynolds subsidiary R.J. Reynolds Vapor Company. Velo’s dissolvable oral nicotine lozenge products are available in hard and soft forms and four flavor variants, dark mint, mint, berry and crema. Velo Lozenges are manufactured using tobacco-derived nicotine.
     
    The PMTAs for Velo Lozenges highlight key evidence demonstrating that the continued marketing of these products is appropriate for the protection of the public health. The applications include a range of scientific studies using established methodologies for the comparative assessment of tobacco products and associated health risks, including product analyses, information on human health risks and assessments showing the impact of Velo Lozenges on the health of the population as a whole—including users and nonusers of tobacco products.
     
    “Velo is an award-winning brand bringing consistently innovative products to adult tobacco users, and a potential marketing order for PMTA submission would help to ensure adult tobacco consumers have access to FDA-regulated, consumer-acceptable product alternatives to combustible tobacco,” said James Figlar, Reynolds’ executive vice president and head of scientific and regulatory affairs.

  • Critics Lambast Axing of Public Health England

    Critics Lambast Axing of Public Health England

    The abolition of Public Health England (PHE) puts at risk staff who specialize in tackling alcohol abuse, obesity and smoking, according public health experts.

    Earlier this week, U.K. Health Secretary Matt Hancock announced that PHE was being scrapped and merged into a new National Institute for Health Protection alongside National Health Service Test and Trace and the Joint Biosecurity Centre.

    PHE had come under fire for its performance in the coronavirus crisis, but critics suspect government officials view the agency as a convenient scapegoat for flawed decisionmaking in the early weeks of the coronavirus crisis.

    The timing is also controversial. “It’s an incredibly stupid move,” a health official told The Economist. “We’re in the middle of a pandemic.”

    PHE was created in 2013 with responsibilities including preparing and responding to health-related emergencies, such as pandemics. It currently employs around 5,500 full-time staff made up mostly of scientists, researchers and public health professionals.

    In the nicotine business, PHE is best known for its 2015 assertion that vaping is 95 percent less harmful than smoking. The agency has been credited with Britain’s comparatively pragmatic vapor policies and progressive attitude toward tobacco harm reduction.

  • FDA Accepts Juul Applications

    FDA Accepts Juul Applications

    Photo: Juul Labs

    Juul and Juul pods will now move into the substantive review phase of the premarket tobacco product application (PMTA) process. Juul Labs has received acceptance and filing letters from the U.S. Food and Drug Administration (FDA) for its battery and nicotine cartridges, the company announced Tuesday.

    Joe Murillo

    Juul Labs filed the applications last month and all PMTA applications are due to the FDA by Sept. 9. 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 percent, 3 percent and information on data-driven measures to address underage use of its products.

    “We will continue to follow the PMTA process and look forward to this next step as the FDA commences substantive review of the application,” said Juul Labs Chief Regulatory Officer Joe Murillo in a statement.

  • FDA Accepts Avail Tobacco Application

    FDA Accepts Avail Tobacco Application

    Photo: Bacho | Dreamstime

    Avail Vapor has received its first premarket tobacco product application (PMTA) acceptance from the U.S. Food and Drug Administration (FDA) for its e-liquid nicotine products, reports Vapor Voice.

    Blackbriar Regulatory Services led the highly strategic 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 vapor products are appropriate for the protection of public health.
     

    James Xu

    This is one of numerous applications that Avail plans to file prior to the Sept. 9, 2020 deadline. The products will provide a wide-ranging flavor portfolio to meet the needs of adults seeking alternative choices to combustible tobacco products.
     
    “We started mapping out our regulatory framework and PMTAs in 2015, before nicotine vaping products became subject to the FDA’s tobacco authority,” said James Xu, chairman of Avail.
     
    “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.”

  • Taxpayers’ Group Slams Kiwi Curbs on Flavors

    Taxpayers’ Group Slams Kiwi Curbs on Flavors

    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.

  • Bhutan to Tolerate Tobacco Sales

    Bhutan to Tolerate Tobacco Sales

    Photo: Taco Tuinstra

    The decision by Bhutan’s government to allow the opening of tobacco sale outlets in the country is consistent with the nation’s Tobacco Control Act and constitution, according to the Office of the Attorney General (OAG).
     
    While the Tobacco Control Act of 2010 restricts the domestic sale and purchase of tobacco products, it allows individuals to import tobacco for personal consumption.
     
    Because of the coronavirus crisis, however, Bhutan has closed official border crossings, boosting illegal imports. By allowing limited domestic sales, the government hopes to crack down on smuggling.
     
    Responding to critics who questioned the legality of the measure, the OAG said the extraordinary situation brought about by the coronavirus crisis justified the measure. However, the office insisted that the domestic sales outlets could be tolerated only for the duration of the pandemic.

    Bhutan banned tobacco sales in December 2004. Soon after, Tobacco Reporter visited the Himalayan kingdom to report from the world’s first officially smoke-free nation.