Category: Regulation

  • California Becomes Second State to Ban Flavored Vapor

    California Becomes Second State to Ban Flavored Vapor

    Finding a flavored vapor product in California is now an illegal act. The Golden State’s governor, Gavin Newsom, signed SB793 into law on Friday. His signed the bill after California’s Senate unanimously approved (34-0) an amended version of the bill returned by the Assembly. The law does not apply to online sales.

    The bill prohibits a Vape shop owner or tobacco retailer, or any of those entities retailer’s agents or employees, from selling, offering for sale, or possessing with the intent to sell or offer for sale, a flavored tobacco product or a tobacco product flavor enhancer, subjecting them to a fine of $250 for each violation. It also allows local governments to impose greater restrictions on the access to tobacco products than the bill imposes.

    California joins Massachusetts as the two states having flavored vaping bans, though each have unique exemptions to the laws. In Massachusetts, businesses defined as “smoking bars” are still able to sell flavored vaping and tobacco products.

    In California, premium cigars and shisha/hookah products are exempt. The law also does not include the possession or use of flavored tobacco products.

    The ban goes into effect on Jan. 1, 2021.

  • MIchigan City Restricts Outdoor THC and Vapor Use

    MIchigan City Restricts Outdoor THC and Vapor Use

    The Saginaw City Council adopted two ordinance changes on Monday, Aug. 24, as the city moves towards legalizing recreational marijuana within city limits. The move comes after the council previously approved other ordinance changes relating to issues such as recreational marijuana facility licensing and zoning issues on Aug. 11.

    The first ordinance prohibits the consuming of marijuana products in any manner or form in public places within city limits or smoking marijuana in a private place where prohibited by the property owner, according to an article on Mlive.com.

    “Violations of this chapter shall be deemed a public nuisance in accordance with chapter 94 of this code of ordinances, and any person who violates this chapter is responsible for a class C municipal civil infraction,” reads the newly approved ordinance.

    Meanwhile, the second ordinance focuses on the consumption of tobacco products as well as marijuana products and sets the groundwork for regulations in city parks, according to the article.

    The ordinance reads, “For purposes of this section, smoke or smoking means possessing a cigarette, e-cigarette, cigar, hookah, or pipe that contains tobacco, marijuana, or any other product that is lit or burning; lighting a cigarette, e-cigarette, cigar, hookah, or pipe that contains tobacco or any other product; or exhaling smoke from burning tobacco or any other burning product that is contained in a hookah, pipe, cigar, cigarette and/or e-cigarette.”

    According to the ordinance, no individual is allowed to engage in any of the aforementioned activities and smoking in any city park, including, any playground, tennis court, community center or outdoor athletic complex owned by Saginaw, according to the article.

    Violating the ordinance could result in a fine of $50, according to the ordinance, and community service may be ordered in lieu of a fine.

    Both ordinances will become effective as of Sept. 3, and changes were unanimously approved by the City Council, with no discussion or objections.

  • Vaporesso PMTA Quickly Accepted by the U.S. FDA

    Vaporesso PMTA Quickly Accepted by the U.S. FDA

    Credit: Vaporesso

    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 Application

    Reynolds Submits First Velo PMTA Application

    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.

  • British Columbia’s Vaping Rules May Breach Charter Rights

    British Columbia’s Vaping Rules May Breach Charter Rights

    Credit: Obi Onyeador

    There are potential constitutional issues arising from the recently announced amendments to British Columbia’s (B.C.) vaping regulations, states the Canadian Constitution Foundation.

    The new vaping legislation, which amends B.C.’s Public Health Act and the Tobacco and Vapour Products Control Regulation, will impose a limit on nicotine concentrations to 20mg/ml for products sold in retail locations, will call for plain packaging for vaping substances, will ban the sale of flavoured vapour products except in age-restricted specialty stores, will restrict advertising in spaces where youth may be present and will require vaping substances for sale to be packaged with a skull-and-crossbones health hazard symbol and a health warning.

    The CCF said that the new vaping regulations may violate s. 7 of the Canadian Charter of Rights and Freedoms, which safeguards the right to life, liberty and the security of the person, because the nicotine ceiling and flavour restriction may potentially make vaping products a less attractive or effective quit-aid for smokers, according to Canadian Lawyer magazine.

    FLSC commits to framework promoting reconciliation with Indigenous peoples
    The CCF also said that the new legislation may breach s. 2(b) of the Charter, which protects the right to freedom of expression, in light of the imposition of plain packaging, with no images or text allowed beyond the brand name and regulatory text. The CCF argued that the new regulations extensively limit the packaging and display of vaping products, in violation of the requirement for restrictions on free speech to be no greater than is reasonably necessary.

    Moreover, the requirement of plain packaging may prevent smokers who may benefit from a switch to vaping products from being exposed to such products or lessen the opportunity for exposure, said the CCF.

    “Rules that confine the sale of vaping products to shops that sell them exclusively will result in fewer smokers being exposed to them in convenience stores, where they likely already shop for their cigarettes,” the CCF further said.

    The CCF cited a February 2020 report written by Leonid Sirota, senior lecturer at the Auckland University of Technology’s Law School, wherein Sirota emphasized the rights of current smokers who are seeking to quit, according to the article.

    “The conflation of vaping and smoking within the law runs contrary to the best available evidence and risks conveying to smokers the impression that vaping is not meaningfully different and better than smoking, discouraging them from trying what may be the best harm-reduction method available,” said Sirota.

  • Critics Harshly Criticize Axing of Public Health England

    Critics Harshly Criticize Axing of Public Health England

    Photo: Chris Dorney – Dreamstime.com

    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 credit with Britain’s comparatively pragmatic vapor policies and progressive attitude toward tobacco harm reduction.

  • Juul and Juul Pods PMTA Moves to Substantive Review

    Juul and Juul Pods PMTA Moves to Substantive Review

    Juul starter kit

    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.

    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.

  • ARVIA: Legal Tasmanian Vapor Would Add Jobs, Save Costs

    ARVIA: Legal Tasmanian Vapor Would Add Jobs, Save Costs

    Credit: Vaporesso

    Tasmanian smokers and the health system would save big dollars if vaping using nicotine was legalized, according to The Australian Retail Vaping Industry Association (ARVIA). The group has also suggested Tasmania could gain new businesses and jobs if it was the first jurisdiction to make the move, with much of an estimated $438 million per year spent overseas by Australian vapers being spent in Tasmania.

    ARVIA said member surveys showed at least 70 per cent of Australian vape businesses would consider establishing in Tasmania and creating new jobs if the state was “first mover”.

    “Legalising vaping would be a win-win-win for Tasmania’s health, jobs and economy,” ARVIA spokesman Russell Zimmerman said, according to an article in The Examiner. “With the second highest smoking rate in Australia … every measure which helps Tasmanians give up traditional cigarettes offers significant health benefits.”Zimmerman said research had shown vaping was up to 95 per cent less harmful than smoking.

    He said that had led to many developed nations legalising and regulating it as a proven way to help people quit cigarettes. “Studies from New Zealand forecast the country is set to see health system savings of $720 per citizen from their liberalised approach to vaping, savings which I’m sure most would agree would be very welcome in Tasmania,” Zimmerman said.

  • 511 Solutions Receives PMTA Acceptance for Prism Brand

    511 Solutions Receives PMTA Acceptance for Prism Brand

    Credit: Priam E-liquids

    The owner of the Prism e-liquid brand, 511 Solutions, announced today that it has filed its first premarket tobacco product application (PMTA) with the U.S. Food and Drug Administration (FDA). The application was accepted by the FDA and has now moved to the substantive scientific review phase.

    All Prism e-liquids are manufactured by Blackbriar Regulatory Services (BRS) in an ISO class 6 cleanroom, tested in an ISO 17025 laboratory, according to a press release. In compliance with FDA guidelines, Prism e-liquids will be allowed to remain on the market during the FDA review process while waiting for a marketing order.

    “When 511 Solutions created this e-liquid line, their goal was to create something really special and to do it right the first time,” said Don Hashagen, sales agent for Prism e-liquids. “They invested an enormous amount of resources into creating high-quality nicotine products for adult smokers looking for alternatives. And, partnering with BRS was a natural choice. Having the ability to streamline the manufacturing, distribution and regulatory needs all under one roof has been a huge win for 511.”

    The PRISM brand represents three unique, high-quality e-liquid lines with a total of 19 flavors going through the PMTA process, according to the release. The flavor profiles range from tobacco, menthol, fruits and bakery in a variety of nicotine strengths.

  • Montana Lawmakers to be Polled on Flavored Vaping Ban

    Montana Lawmakers to be Polled on Flavored Vaping Ban

    Lawmakers in Montana legislature will be polled on a proposed ban of flavored vaping products. The decision comes after numerous Republican lawmakers opposed the rule advanced by the Montana Department of Health and Human Services.

    Montana law dictates that a poll of the legislature is required when 20 or more legislators object to a proposed administrative rule, according to an article on flatheadbeacon.com.

    Thirteen Montana senators and seven representatives, all Republicans, signed letters last month opposing the rule, stating that the health department does not have the authority to implement such a ban. If passed, the rule would prohibit all sales, distribution and marketing of electronic smoking devices in Montana. The health department proposed the rule on June 16, citing increased use of flavored vaping products by Montana youth.

    Numerous health officials spoke Wednesday in favor of the proposed ban during a special meeting of the legislative Children, Families, Health and Human Services Committee.

    The committee, which has jurisdiction over the health department, determined that Montana’s 50 senators and 100 house members will be polled on whether the rule is “consistent with the intent of the legislature.”

    Supporters of the ban cited a study conducted by Stanford researchers and released earlier this week, which linked vaping with a substantially increased risk of COVID-19 in youth. The research found that those who used vaping products were five to seven times more likely to be infected with the respiratory virus than those who did not use e-cigarettes.

    Sen. Jason Ellsworth, R-Hamilton, was one of the 20 legislators who opposed the rule. He spoke during the committee meeting Wednesday, stating the health department was “circumventing the legislative process by trying to create law within rule.”

    “We have three branches in our government,” Ellsworth said. “We do not have a fourth branch, we do not have a branch called the Department of Health and Human Services, or any other department that can create law.”

    Polling ballots will be sent to Montana legislators by next week, and must be postmarked by Sept. 8. Poll results will be provided to the Montana secretary of state for publication.