Category: Regulation

  • Shenzhen Shuns Vapor Product Sales Near Schools

    Shenzhen Shuns Vapor Product Sales Near Schools

    One of China’s most adamantly anti-smoking cities has vowed to stop selling e-cigarettes near schools and reduce children’s exposure to secondhand smoke at home as part of a new “smoke-free communities” campaign.

    In a more focused update to its “smoke-free city” campaign launched in 2018, the southern metropolis of Shenzhen pledged Saturday to strictly prohibit the sale of not only tobacco products but also e-cigarettes within 50 meters of primary and middle schools, according to Sixth Tone’s sister publication The Paper.

    The city is also aiming to reduce primary and middle schoolers’ exposure to secondhand smoke at home to below 20% while raising the proportion of “smoke-free families” to at least 50% in three years — though it’s unclear how the success rates will be measured. Some doctors believe that, because secondhand smoke can cause a variety of diseases in children, from asthma and pneumonia to lung cancer and sudden infant death syndrome, it is equivalent to child abuse.

    The smoke-free communities campaign, jointly announced by Shenzhen’s civilization and tobacco control offices, will be enforced alongside the city’s official smoking control regulation, last updated in July 2019. While other Chinese cities have also taken steps to curb smoking and vaping, Shenzhen’s are widely regarded as the most comprehensive in the country.

  • Humble Juice Co. Receives Filing Letter for PMTA

    Humble Juice Co. Receives Filing Letter for PMTA

    The Humble Juice Co. is moving on to the scientific review stage of its premarket tobacco product application (PMTA). The leading e-liquid company with a humble beginning, announced that it had received a filing letter from the U.S. Food and Drug Administration (FDA). The letter indicates the FDA has completed its preliminary review of Humble’s PMTA, advancing the brand’s application forward in the review process.

    Humble submitted its PMTA to the FDA on Sept. 3.

    “We were excited to receive a filing letter from the FDA just days after being notified of our PMTA’s acceptance,” said Humble CEO Daniel Clark. “To my knowledge, there are a limited number of e-liquid companies that have moved forward to this phase of the PMTA process thus far. We hope our application continues to advance in a timely manner and we remain committed to working with the FDA in order to achieve this.”

    A filing letter from the FDA is a result of a preliminary scientific review of a PMTA. This review ensures an application includes the necessary components and scientific analyses. FDA will now conduct a Substantive Review of Humble’s application to evaluate the scientific information and data submitted within its PMTA. If successful, this phase will result in the FDA granting marketing orders, authorizing the continued marketing and sale of Humble’s products.”

  • Bantam E-Liquids Garners Acceptance Letter for PMTA

    Bantam E-Liquids Garners Acceptance Letter for PMTA

    The legal e-liquid market continues to grow. Bantam Vape announced yesterday that it had received an acceptance letter for its premarket tobacco product application (PMTA) from the U.S. Food and Drug Administration (FDA). The brand’s application now moves to the next step in the PMTA process—a preliminary scientific review to ensure the application contains all required items to permit a substantive review by the FDA.

    Bantam submitted its application to the FDA on Sept. 2.

    “Bantam has been anticipating and planning for these regulations since entering the e-liquids category,” said Bantam spokesperson Anthony Dillon. “The receipt of this acceptance letter is a significant milestone for Bantam. It reiterates a commitment to providing adult-use consumers with high-quality, science-based and compliant e-liquid products that can be enjoyed for years to come.”

    In preparation for its submission, Bantam worked with highly-qualified labs to conduct the in-depth product-specific and non-product specific testing needed for its PMTA, including: storage and stability testing; toxicity testing; and pharmacokinetic and topography studies. Bantam also submitted an extensive review of available literature on electronic nicotine delivery systems (ENDS) products.

    “Bantam has always supported the need for science-based regulation for the e-liquids industry. And while the PMTA process is complex and resource intensive, it is necessary to establish much needed standards and oversight across the board,” said Dillon. “Bantam is confident in the content and quality of materials prepared by its hardworking team of experts, and remains committed to working with the FDA throughout the PMTA process.”

  • Bulgarian MEPs Ban Sale of E-Cigarettes for Under 18

    Bulgarian MEPs Ban Sale of E-Cigarettes for Under 18

    Credit: Alexandr Bormotin

    MEPs in Bulgaria have banned the sale of hookahs, e-cigarettes and other non-tobacco products for people under 18 years of age.

    The amendments to the Child Protection Act, introduced by the VOLIA party, were supported at first reading by 98 votes to 2, with 1 abstention, according to Novinite.com.

    According to the petitioners, the legislative initiative meets the need to protect the health of children under 18 years of age.

    The Republic of Bulgaria is a country in Southeast Europe. It is bordered by Romania to the north, Serbia and North Macedonia to the west, Greece and Turkey to the south, and the Black Sea to the east. The capital and largest city is Sofia; other major cities are Plovdiv, Varna and Burgas, according to wikipedia.

  • PMTA Filing Letter Received for Disposable MNGO

    PMTA Filing Letter Received for Disposable MNGO

    Credit MNGO

    The makers of the disposable MNGO e-cigarettes and disposables announced today that it has advanced received a filing letter for its premarket tobacco product application (PMTA). The U.S. Food and Drug Administration will now conduct a scientific review.

    “Our goal has always been to provide adults with the highest quality alternative products that are affordable and taste great,” said a spokesperson for the company. “While [the] PMTA represents a major investment of time and resources for MNGO, we actually welcome the work. We want the industry to comprise of only companies that respect quality and customer safety as much as we do. We believe that the PMTA process is an important regulatory step for the vapor industry, and we are committed to working together with the FDA and remain optimistic about receiving a marketing order.”

    MNGO states that its PMTA was a global effort, with teams working around the world to support the document-intensive application. The submission included thousands of pages of scientific research and other supporting data.

    “We believe our products are appropriate for the protection of public health,” the spokesperson added. “We have always been committed to creating products for adult smokers seeking an alternative to combustible cigarette smoking and hold ourselves to higher standards.”

    MNGO, which has been on the US market since 2015, is already preparing further PMTAs for new products in early 2021 as part of an effort of sustainability within an ever-changing and advancing industry, according to a press release.

  • Zlab Receives PMTA Filing Letter for 78 Products

    Zlab Receives PMTA Filing Letter for 78 Products

    Credit: Zlab

    Shenzhen Yibo Technology Co. has received a filing letter from the U.S. Food and Drug Administration (FDA) for its premarket tobacco product application (PMTA). The company submitted the PMTA before the Sept. 9 deadline.

    The company is now allowed to market its ZLab brand of pods, disposable e-cigarettes and e-juice for up to 1 year or until the FDA takes action on its PMTA submission. On the market since 2015, Zlab’s PMTA includes 13 flavors in six different nicotine strengths totalizing 78 different SKUs, according to a press release.

    ZLab has over 20,000 points of sale in the US market. They currently have offices in 12 countries with revenues close to $300 million a year, according to the release. ZLab states that it is planning to submit 120 more PMTA applications in 2021, including an application for a new pod system, which should be launched at the beginning of 2022.

  • Air Factory Receives PMTA Acceptance for 72 Flavors

    Air Factory Receives PMTA Acceptance for 72 Flavors

    Credit: MVS

    My Vape Order (MVO) received its premarket tobacco product application acceptance letter, yesterday, Oct. 2. The company announced that the letter from the U.S. Food and Drug Administration (FDA) for its 72 bundled Air Factory e-liquids meets the statutory and regulatory requirements for a PMTA submission.

    MVO submitted its Air Factory PMTA on Sept. 3.

    “MVO looks forward to working with FDA on its review of the … PMTA, which covers a suite of 72 Air Factory products, including both freebase and salt nicotine formulations in a variety of nicotine strengths tailored to meet the needs of our Air Factory consumers,” wrote MVO CEO Kyle Godfrey on the Air Factory website. “The PMTA is supported by robust scientific data, including independently-conducted toxicological risk assessment data for the submitted products, and thorough research establishing the products to be appropriate for the protection of public health. MVO is committed to working with FDA through the entire PMTA review process as expeditiously as possible.”

    The company will continue to provide PMTA and product updates at www.airfactoryeliquid.com.

  • Boulder Intl. Receives PMTA Acceptance Letter From FDA

    Boulder Intl. Receives PMTA Acceptance Letter From FDA

    Boulder
    Credit: Boulder

    Boulder International announced its premarket tobacco product application (PMTA) has been accepted by the U.S. the Food and Drug Administration (FDA). Boulder’s initial filing will include two devices, the Boulder Rock and the Aspen Slim and two flavors of e-liquid, American Blend and Menthol.

    “Since the beginning, it’s been quite clear to us that the only road to long term success in this industry is through a socially responsible strategy that extends through all aspects of our business; from product conception through production and marketing,” Robert Heiblim, president of Boulder International USA, wrote on the company’s website.

    Each e-liquid will be available in four strengths. All products covered in the initial filing were introduced to the market prior to the August 8, 2016 deeming date, according to Boulder, adding the company has new devices currently under development which they intend to submit in future applications.

    “We welcome the introduction of formal policy and agency oversight to ensure the safe enjoyment of our products; and all vape products,” Heiblim added. “In our opinion it is fitting and proper that consistent and sustainable measures be observed as our industry matures. PMTA submissions not only enhance the profile and position of companies who possess the resources to file but also benefit the industry as a whole while improving the user experience for consumers.”

  • Health Institute Says Belgium’s Vaping Law ‘Too Vague’

    Health Institute Says Belgium’s Vaping Law ‘Too Vague’

    Credit: Carius Badstuber

    The Belgian law regulating the use of e-cigarettes and vaping products is still too vague, the Sciensano Public Health Institute said Thursday. The institute claims the law imposes restrictions only on the presence of nicotines in e-liquids. Other substances are not explicitly banned and therefore we still often find them.

    “These are nicotine impurities, volatile organic compounds and diacetyl and acetyl propionyl flavour enhancers. The latter are safe in food but can be harmful when inhaled over long periods of time,” said Sophia Barhdadi, a researcher at Sciensano, based on sample analyses.

    In total, the institute analysed 246 e-liquids dating from before (2013-2016) and after (2017-2018) the revised European Tobacco Product Directive (TPD) and its implementation in the Royal Decree (RD) of 28 October 2016, according to an article in The Brussels Times.

    The institute also claims that there were “more impurities in e-liquids sold online. The e-liquids that we bought in official vape shops were of better quality,” Barhdadi said.

    Sciensano pointed out, however, that the 2016 Royal Decree has improved the quality of e-liquids, including more correct nicotine information on labels, the absence of volatile organic compounds (VOCs) (up from 10 percent in 2016) and a reduction in caffeine and flavor enhancers.

  • County in Washington State Seeks Comments on Vaping

    County in Washington State Seeks Comments on Vaping

    Credit Stephanie Bergeron

    A public hearing on a proposed county ordinance prohibiting vaping at indoor public places, places of work and certain youth-oriented outdoor spaces has been scheduled for Tuesday, Oct. 13.

    The meeting will be hosted at 5 p.m. in Thurston County Courthouse, Building 1, Room 280. Members may attend in person or call in at 360-252-9020.

    “We are committed to putting police in place to support the health of our community, with a strong focus on the health of our youth,” Thurston County Board of Health Chair Tye Menser said in a statement in a county news release. “The use of vaping products among Thurston County youth is rising at an alarming rate.”

    According to a news release from the county, the draft ordinance includes local adoption of the statewide Smoking in Public Places law.

    “It would apply the same 25-feet rule from doors and other air intakes for indoor spaces for vaping as is true for smoking,” the news release reads. “It would also require signage about the rule at public places and places of employment. It employs the standard approach to enforcement, specifying what constitutes a civil infraction and penalties. The draft includes a rebuttal process for reducing the 25-feet rule.”

    Additional information on the proposal can be found on the Thurston County Board of Health’s website: https://www.thurstoncountywa.gov/phss/Pages/smoking-vipp-sepa.aspx.