Category: Regulation

  • New Vaping Index Grades States Based on Regulations

    New Vaping Index Grades States Based on Regulations

    California is the “worst state for vaping.” A new index ranks New York, California, New Jersey, Massachusetts and Rhode Island as the top states having the least consumer-friendly regulatory approach to vaping. The states of Virginia, Colorado, Texas and Maryland each received “A” scores.

    The findings come from a report by the Consumer Choice Center, which ranks each state “based on its consumer-friendly regulatory approach to vaping products.”

    David Clement and Yaël Ossowski, North American Affairs manager and deputy director of the Consumer Choice Center, the study’s authors, wrote in a press release that recent legislative actions on flavored vaping products including restrictions, taxation, and online sales prohibitions were key to each state’s score (graded A, C, or F).

    “The worst states … are far behind all the other states because of flavor bans, exorbitant taxation on vaping products, and restrictions on online sales,” said Clement, North American Affairs Manager at the Consumer Choice Center. “Our research indicates these states go above and beyond to deter adult smokers from switching to vaping, which could vastly improve and prolong their lives.”

    Credit: Consumer Choice Center

  • Australia: Vapor by Prescription Only Starts Mid-2021

    Australia: Vapor by Prescription Only Starts Mid-2021

    Credit: Tom Claes

    Vapor products such as e-cigarettes will become available only by a doctor’s prescription, Australia’s drug regulator said on Wednesday.

    The Therapeutic Goods Administration (TGA) announced its interim decision to reclassify nicotine as a prescription-only medication, meaning nicotine for use in e-cigarettes, and e-juice containing nicotine, would become prescription-only from June 2021, according to the guardian.com.

    The changes would also effect heat-not-burn tobacco products, chewing tobacco, snuff and other novel nicotine products. The decision is open for consultation until Nov. 6.

    Existing state and territory laws make the sale of nicotine e-cigarettes and e-juice illegal throughout Australia and its possession illegal everywhere but in South Australia.

    In a statement, the TGA said the proposed changes meant that “while you would still be able to use the ‘personal importation scheme’ under the Therapeutic Goods Act 1989 to order online from your usual supplier … it would be clear that you would be required to have a prescription”.

    “You would also be able to fill your prescription at your local community pharmacy, however your pharmacy may have to order it in for you,” the statement said.

  • Humble Juice Co. Receives PMTA Acceptance Letter

    Humble Juice Co. Receives PMTA Acceptance Letter

    Humble Juice Co. announced today that the company had received an acceptance letter for its premarket tobacco product application (PMTA) from the U.S. Food and Drug Administration (FDA). Humble submitted its application to the FDA on Sept. 3.

    “Since starting Humble in 2015, we’ve grown more than I could have ever imagined. During that time, we’ve expanded the business while being mindful of future regulation of the e-liquids industry,” said Humble CEO Daniel Clark. “For the past several months, the Humble team has dedicated time and resources to compiling the necessary materials for our PMTA. We are confident in our submission and look forward to providing our customers with flavor-filled, affordable and compliant e-juice long into the future.”

    Humble’s PMTA submission includes product-specific details, consumer survey data, and scientific studies and analyses, as well as risk assessments. Its application specifically pursues marketing orders for 84 e-liquid products in various flavors, nicotine levels and sizes.

    “Our long-term strategy will include the release of additional flavors and nicotine levels,” said Clark. “In the near term, we are focused on working with the FDA to obtain marketing orders for the products submitted in our initial PMTA.”

    Clark added that the Humble team looks forward to the next step in the PMTA journey: the preliminary scientific review of its application.

  • FDA Restates Enforcement Policy for E-Cigarettes

    FDA Restates Enforcement Policy for E-Cigarettes

    Mitch Zeller
    Mitch Zeller, former director of the FDA’s Center for Tobacco Products

    The U.S. Food and Drug Administration (FDA) stated today that it still intends to prioritize enforcement against any electronic nicotine delivery system (ENDS) product that continues to be sold and for which the agency has not received a premarket submission as indicated in FDA’s enforcement priorities guidance.

    “Now that the deadline has passed, and the submissions are with FDA, many may be wondering about the upcoming steps for both submitters and the Agency,” the agency wrote in today’s release. “As Mitch Zeller, CTP Director, stated in a recent perspective piece, FDA strives to be as transparent as possible with regards to the status of these submissions and plans to provide regular updates to the public over the course of the next year.”

    The factors behind enforcing  a device will include several factors, including the likelihood of youth use or initiation. The regulatory agency stated that it will make the best use of agency resources to enforce against any other deemed new tobacco product that does not have the required premarket authorization (PMTA).

    in January of this year, the agency did not mention prioritizing open-systems. The three urgencies that earned a bullet-point were:

    • “Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
    • “All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
    • “Any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors.”

    “New data, such as that from the 2020 National Youth Tobacco Survey (NYTS), will also inform the FDA’s enforcement and other actions, and flavored disposable ENDS will be an enforcement priority for the agency,” according to today’s agency release.

    The 2020 NYTS showed a large decrease in youth vaping. On Sept. 10, the FDA announced that after two years of disturbing increases in youth e-cigarette use, the agency was “encouraged by the overall significant decline reported in 2020,” the FDA stated in a release. “This is good news; however, the FDA remains very concerned about the 3.6 million U.S. youth who currently use e-cigarettes and we acknowledge there is work that still needs to be done to curb youth use.”

    Complicating matters, while the FDA has said that it plans to post a list of the deemed new tobacco products that were on the market in the U.S. as of Aug. 8, 2016, are still on the market now, and for which a premarket submission was made by Sept. 9, 2020, that list may not be available for many weeks or even months.

    “Before making such a list available, FDA needs to ensure that publishing any such information complies with federal disclosure laws and regulations,” the FDA wrote. “For example, before FDA can include a specific product on this public list, the Agency may need to verify with companies, on a case-by-case basis, the current marketing status of a product and whether it was on the market as of Aug. 8, 2016.”

  • U.K.-Based Riot Labs Earns PMTA Acceptance for E-liquids

    U.K.-Based Riot Labs Earns PMTA Acceptance for E-liquids

    Credit: Riot Labs

    Riot Labs, a UK-based e-liquid manufacturer has received an acceptance letter from the U.S. Food and Drug Administration (FDA) for its premarket tobacco product application (PMTA). The company is now authorized to sell seven flavors of e-liquids in the United States:

    ● Pink Grenade

    ● Sub Lime

    ● Tropical Fury

    ● Blue Burst

    ● Cherry Fizzle

    ● Rich Black Grape

    ● Ultra peach Tea

    The flavors can be found in 0mg, 3mg and 6mg in freebase nicotine, 20mg and 40mg in nicotine salt. “The PTMA submissions are a key milestone in Riot Labs journey which started back in 2016 to produce viable alternatives to combustible tobacco,” a press release states. “The PMTA submissions conclude a process which has taken over 2 years, with 7 applications and over 1.8 million pages of scientific data submitted as part of the submissions.”

    Riot Labs has one year or until the FDA acts on its application to market the products in the U.S.

    “We are delighted to announce that our first-round of PMTA applications have been accepted”, said CEO for Ben Johnson Riot Labs. “We pride ourselves on producing the highest quality products. We have been working on our submissions since 2018. Everyone at Riot Labs is fully committed to offering better alternatives to combustible tobacco products.”

    Riot Labs was established in 2016 by Johnson who has an extensive background in pharmaceuticals. He set out to build ‘Riot Squad’ into an innovative brand, with safety and sustainability at the forefront of the company’s values, according to the release. By 2019 Riot Squad had moved into the international market, and it’s products were available in over 86 countries.

  • New York Lawmaker Wants 25 as Age to Purchase Vapor

    New York Lawmaker Wants 25 as Age to Purchase Vapor

    A legislator in Long Island legislator introduced a bill that would raise the age for vaping and smoking cigarettes from 21 to 25 in in Suffolk County.

    The legal age to smoke statewide is 21. But localities have the option to raise it higher. New York City’s smoking age is 21, according to a story in the New York Post.

    The author of the proposed law, Suffolk County Legislator Sam Gonzalez, said boosting the age to 25 will save thousands of lives by discouraging and preventing young people from smoking. Smoking will be less alluring to a more mature 25-year-old, said Gonzalez, who kicked the habit 27 years ago, around the time his daughter was born.

    “I was a two-pack-a-day smoker,” Gonzalez, 59, said. “The raise-the-age law will stop the younger kids from smoking. There is a big difference between the age of 21 and 25.”

    He said having an age 25 smoking law will “absolutely” make Suffolk a more attractive place to live.

    “God willing. Everyone should follow us,” Gonzalez said.

    But he also pointed to scientific studies that show that the “rational part” of the human brain is not fully developed until the age of 25.

    “The smoking age should be increased in order to protect Suffolk County’s young people from making such a significant decision until such time as their brains are fully developed,” he said. “I’m expecting pushback. I’m hearing whispers of, ‘Are you crazy?’ ”

  • Air Factory Submits PMTA for 72 Flavors to FDA

    Air Factory Submits PMTA for 72 Flavors to FDA

    Credit: MVS

    My Vape Order, parent to the Air Factory e-liquid brand, has announced its submission of a bundled premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA). The PMTA was for the company’s suite of 72 Air Factory flavors. The products include both freebase and salt nicotine formulations in a variety of nicotine strengths.

    “Submission of the Air Factory PMTA marked the culmination of years of planning and hard work for the MVO team and our valued partners,” said MVO’s CEO Kyle Godfrey. “MVO is honored to be a leader in the vape industry, and is proud to provide consumers of tobacco and nicotine products a quality line of e-liquids that consumers can trust and enjoy.”

    The PMTA submission was electronically filed with FDA on September 3, 2020. Included with the application were robust scientific data including independently-conducted toxicological risk assessments for the submitted products, as well as thorough research findings intended to establish the AIR FACTORY® products as appropriate for the protection of public health, according to a press release. T

    The company’s PMTA filing coincides with the launch of redesigned product packaging for the Air Factory brand and the implementation of additional safeguards through the company’s B2B and B2C websites to further the company’s commitment to preventing youth exposure to tobacco and nicotine products.

  • Fresh Farms E-liquid Confirms PMTA Submission to FDA

    Fresh Farms E-liquid Confirms PMTA Submission to FDA

    Fresh Farms E-Liquid has confirmed it submitted a premarket tobacco product application (PMTA) on Sept. 6 to the U.S. Food and Drug Administartion (FDA)

    Working with key scientific partners to ensure the highest standards of analysis as well as the world-class legal team at Keller and Heckman, Fresh Farms fully expects its submission to be accepted and move on to the substantive scientific review phase with the FDA, a press release states.

    “The Fresh Farms submission encompasses dozens of products as it seeks FDA approval to continue offering its extensive portfolio, which company leaders believe is perfectly suited to the needs of adults looking for alternatives to traditional, combustible tobacco products,” the release states. During the PMTA review, the FDA will evaluate whether there is sufficient scientific data demonstrating a net-positive public health result by allowing the product submissions to be sold as alternative options to traditional tobacco products.

    “From day one, we have sought to be the best,” said Fresh Farms CEO and co-Founder Tony Devincentis. “From our branding, our messaging, our team and the quality of our products – our commitment to the PMTA process has been no exception. We have spent years and countless hours evaluating our products, preparing for this moment, and the preliminary results have been phenomenal. Ultimately, our goal is to receive a marketing granted order from the FDA and begin postmarket reporting to them immediately. We plan on being a leader in our industry for years to come.”

    In addition to rigorous adherence to FDA regulations and filing PMTAs, Southern California-basedFresh Farms E-Liquid has proactively led the way for safer packaging with additional warning labels, launching a “No2Minors” campaign to build additional awareness and reduce underage sales to minors. Avail Vapor partnered with Fresh Farms E-liquids, the parent company of Fruitia, in July.

    “We could not be more pleased that Fresh Farms submitted PMTAs for their highly sought-after e-liquid products,” said James Xu, chairman of AVAIL.  “Our customers truly love the Fruitia brand, and we look forward to continuing our shared missions by providing adult smokers with high-quality alternatives to deadly cigarettes.” 

    As of September 9, only those products submitted to the FDA according to their PMTA guidelines will be permitted to remain on the market in the United States.

  • Fliq Vapor Receives PMTA Acceptance Letter From FDA

    Fliq Vapor Receives PMTA Acceptance Letter From FDA

    Fliq Vapor has received and acceptance and filing letter for its premarket tobacco product application (PMTA). The company submitted the PMTA to the U.S. Food and Drug Administration (FDA) for its Fliq XL prefilled disposable system with PachaMama e-liquids.

    In an email to Vapor Voice, Fliq Vapor CEO Jimmy Arazi wrote that Fliq Vapor “has indeed submitted a compliant PMTA along with the associated Tobacco Master File (TPMF) files in a timely manner prior to the September 9, 2020 deadline.” The application was more than 75,000 pages.  

    “Fliq Vapor has retained an FDA registered analytical laboratory, who have performed a complete analysis on the Fliq XL product(s) and will secure the required laboratory testing, including for pharmacokinetics, harmful and potentially harmful constituents (HPHC), and product stability and provide the results to Fliq Vapor and the FDA,” he wrote.

    Fliq submitted the PMTAs for eight flavors of prefilled disposable devices with Pachamama e-liquid brand that is owned by Charlie’s Chalk Dust. Manufactured in the U.S., Charlies also submitted PMTAs for PachaMama e-liquids. The flavors include: Ice cherry limeade, Ice peach, Ice blue razz, Ice kool melon, ice pear apple, Grapple berry, tobacco And menthol.

  • EAS Offers Free Webinar on PMTA Site Inspections

    EAS Offers Free Webinar on PMTA Site Inspections

    Tara Lin Couch and Andrew Mooney

    The EAS Consulting Group is offering a webinar on how to prepare for premarket tobacco product application pre-approval inspections of manufacturing facilities by the U.S. Food and Drug Administration (FDA).

    EAS Consulting Group’s senior director for dietary supplement and tobacco services, Tara Lin Couch, and LabStat’s Andrew Mooney will help participants understand the requirements.

    The webinar is free of charge and will take place Sept. 15, 2020, at 11 a.m. Eastern time. Participants can register here.

    On Nov. 9 2020, E-liquid manufacturer Purilum has entered into an exclusive, long-term supply agreement with E-Alternative Solutions (EAS), the manufacturer and supplier of Leap Vapor products.The Leap products containing e-liquids provided by Purilum have been on the market since prior to August 8, 2016, and are currently under review by the U.S. Food and Drug Administration (FDA).