Category: Regulation

  • U.S. FDA Sends 3 Enforcement Letters for Illegal Sales

    U.S. FDA Sends 3 Enforcement Letters for Illegal Sales

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    On the same day premarket tobacco applications (PMTAs) were due, the U.S. Food and Drug Administration (FDA) issued warning letters notifying three companies who sell or distribute unauthorized electronic nicotine delivery system (ENDS) products to remove those products from the market.

    The FDA issued a warning letter to XL Vape LLC (doing business as Stig Inc.) warning the company to remove their disposable e-cigarettes from the market because they do not have the required premarket authorization. Additional warning letters were issued to Flavour Warehouse LTD (doing business as Vampire Vape) and Pretty Women UK LTD (T/A Coil2oil and Mad Kingdom Liquids) for illegally marketing unauthorized menthol-flavored e-liquids.

    The labeling and/or advertising of these products also features cartoon images, such as vampires and kings, that are commonly marketed and/or appeal to youth.

    The FDA stated in a release that it will be prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a PMTA. “The warning letters issued today underscore our concern with the rise in youth use of disposable e-cigarettes and the notable use of menthol-flavored e-cigarettes,” thr release states. “As we have said many times, the FDA will take action against any ENDS product—regardless of whether it is cartridge-based, disposable, flavored, or otherwise—if it is targeted to kids, if its marketing is likely to promote use by minors, or if the manufacturer fails to take adequate measures to prevent youth access.”

  • CDC Study: Youth E-cigarette Use Sees Significant Drop

    CDC Study: Youth E-cigarette Use Sees Significant Drop

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    The overall use of e-cigarettes by youth dropped from 28 percent to 20 percent among high schoolers, according to the latest data. The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) released the 2020 National Youth Tobacco Survey (NYTS), which show 1.8 million fewer U.S. youth are currently using e-cigarettes compared to 2019.

    “After two years of disturbing increases in youth e-cigarette use, we are 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.”

    The 2020 NYTS data also showed an uptick in the youth use of disposable e-cigarettes. Disposable products were reportedly used by 26.5 percent of high school e-cigarette users (up from 2.4 percent in 2019) and 15.2 percent of middle school e-cigarette users (up from 3 percent in 2019).

    A rise in the youth use of flavors prompted the FDA to remove all flavored prefilled pods from the market. However, consistent with 2019, prefilled pods or cartridges were the most commonly used device type in 2020, the report states. “The use of disposable e-cigarettes surged among both high school and middle school students,” the FDA statement noted.

    The NYTS was released on the same day that premarket tobacco product applications (PMTAs) were due to the FDA. Companies must demonstrate that each product meets the applicable statutory criteria for receiving marketing authorization, such as whether marketing the product is appropriate for the protection of the public health.

  • Beard Vape Company Submits PMTAs for E-liquid Brands

    Beard Vape Company Submits PMTAs for E-liquid Brands

    Beard Vape Co. has officially submitted premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA). The company announced that it submitted data for 10 flavors, including five each from both its Beard and The One e-liquid brands.

    “We, like many in the industry, disagree with the PMTA process. However, we will be submitting our PMTA in September. This is a major step for a small company that
    began serving customers in a small shop in California,” a representative wrote in an email. “To shops, distributors, and customers. We hope that you will join us in the next chapter of the industry we have built together. We are grateful for all of your support over the years and plan to continue to serve you for as long as possible. To our international accounts, we will continue to serve you as well.”

  • AMV Holdings Receives First PMTA Acceptance Letter

    AMV Holdings Receives First PMTA Acceptance Letter

    AMV Holdings has received its first premarket tobacco product application (PMTA) from the U.S. Food and Drug Administration (FDA). AMV has filed an additional 104 PMTA submissions accounting for over 5,000 SKUs. All of these submissions reflect the same file and information structure as the PMTA for which AMV received the acceptance letter, according to a press release.

    Acceptance of a PMTA is the first step in a long approval process that, if positive, will end in a marketing order. AMV’s first PMTA will now be on to the substantive review phase to determine if the product is beneficial to public health.

    “We are proud of our team and their achievement in completing a significant step in a rigorous regulatory process and look forward to the FDA’s review of all our products,” said Mark Kehaya, chairman of AMV Holdings. “We view this multi-year effort as another milestone in leading with science and quality in the vapor industry. We hope that the FDA’s PMTA process will increase consumers’ trust in the industry and the products we offer give combustible tobacco users a reliable alternative.”

    AMV Holdings, which includes the brands Alohma, Kure, Madvapes, ELB Labs, and Wholesale Vaping Supply, is a manufacturer and retailer of electronic nicotine delivery systems (ENDS) products in the U.S. and Europe. AMV currently operates 113 retail locations in the U.S. through a combination of corporate-owned, franchised and licensed stores. The company also has seven stores in Germany and Ireland.

    “It’s exciting to know that we will be able to continue to offer our guests PRIME e-liquids in all our retail locations,” said Sam Salaymeh, president of AMV Holdings. “The process with the FDA has enabled us to document our philosophy of providing high-quality standards and superior chemistry of our PRIME e-liquid line, that is something we are all proud of. We look forward to providing our guests with the best service and products in the industry for many years to come.”

  • Final Countdown: PMTAs Due to the FDA by 4pm Today

    Final Countdown: PMTAs Due to the FDA by 4pm Today

    The vapor industry is expected to look vastly different tomorrow. At 4pm today, all premarket tobacco product applications (PMTA) must be submitted to the U.S. Food and Drug Administration (FDA). Many industry players say that the regulatory rule will force more than 10,000 businesses to close and cause more than 100,000 jobs to be lost. It could also force millions of vapers back to smoking deadly combustible cigarettes.

    The vapor industry is not dead, however, as several manufacturers have announced that their PMTA submissions have been accepted and filed by the FDA. This allows those products to remain on the market while the FDA conducts its substantive review phase of the PMTA. During this period, the FDA will evaluate whether marketing a specific electronic nicotine delivery system (ENDS) product is appropriate for the protection of public health.

    If a company does not submit a PMTA by 4pm today, it must remove its products from the market. If the product was “verifiably” on the market prior to Aug. 8, 2016 (the FDA’s cutoff for new products) and submitted a PMTA application before Sept. 9 at 4pm, the product can stay on the market for up to a year or until the FDA approves or denies the PMTA. For any PMTA submitted after today’s deadline, a product may not be marketed until the FDA grants a marketing order, according to the FDA.

    The FDA has said that it will release a list of products that can legally remain on the market, although no timeframe was established for when that list would be available to retailers. Beyond all the major tobacco companies, which all have submitted PMTAs for vapor products, only a few other companies have publicly announced PMTA submissions to the FDA for their products.

    As of Aug. 31, the FDA had received applications for around 2,000 deemed products, of which around 40 percent have been resolved, according to Mitch Zeller, director of the agency’s Center for Tobacco Products. Only two brands have ever had a PMTA application approved, Swedish Match’s General snus products and Philip Morris International’s IQOS, HeatSticks and charger.

    AMV Holdings (Madvapes, Kure, Aloma), Avail Vapor, Beard Vape Co., Charlie’s Chalk Dust, Bidi Stick, E-Alternative Solutions (Leap, Leap Go), Innoken, Jarvis Vaping Supply, KangerTech, Nicopure Labs, Prism (511 Solutions), Smok, Smoore/Vaporesso, Turning Point Brands and Voom are just some of the vapor manufacturers that are not affiliated with a major tobacco company that have filed PMTAs. It is expected that this list will grow exponentially throughout the day as companies submit applications before the deadline. Several companies have said they have submitted PMTAs already but are waiting for acceptance letters from the FDA before making the announcement public.

    “We feel that we have met all documentation requirements in our over 3-million-page submission thus far,” wrote James Jarvis of Jarvis Vaping Supply in a press release. “We excited about the future opportunity to work with [the] FDA and the industry to achieve final authorization in the coming months.”

    Receiving a marketing authorization to sell vapor products isn’t the end of the process for manufacturers. The FDA requires companies to conduct post-market surveillance and studies to determine the impact of the marketing orders on consumer perception, behavior and health, and to enable the FDA to review the accuracy of the determinations upon which the orders were based.

    These post-market requirements include a rigorous toxicity study using computer models to help predict potential adverse effects in users. The orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the product does not have unintended consequences for youth use.

  • Florida Governor Vetoes Flavor Ban Bill

    Florida Governor Vetoes Flavor Ban Bill

    Credit: Juan Pablo

    Florida’s Governor Ron DeSantis vetoed a bill that would have raised the legal age to buy vapor and other tobacco products to 21 and banned flavored nicotine products.

    DeSantis vetoed the vape and tobacco bill (SB 810), arguing it was, in part, redundant and also detrimental to smoking cessation efforts, as reported on floridapolitics.com.

    “While originally conceived as a bill to rate the legal age to buy tobacco to 21, (which is superfluous given this is already mandated by federal law) … SB 810 effectively bans tobacco-free vaping flavors used by hundreds of thousands of Floridians as a reduced-risk alternative to cigarettes, which are more dangerous,” DeSantis wrote in his veto transmission letter.

    Raising the age to 21 would have helped the state comply with new federal regulations. The bill would have also banned all vape flavors other than menthol and tobacco until they receive approval from the U.S. Food and Drug Administration.

    “Governor DeSantis has shown true leadership and understanding in his decision to veto SB 810,” said Tony Abboud, Executive Director of the Vapor Technology Association (VTA). “On behalf of all the vapor companies, large and small, and the more than one million vapers in the state of Florida, VTA thanks Governor DeSantis for his bold decision to protect Florida’s public health and economy, which comes at a time of great uncertainty for many. This is the positive reinforcement the industry and the people of Florida need.”

    The VTA worked closely with the Florida Smoke Free Association, a VTA member association, to educate legislators throughout the legislative session and had moved a meaningful regulatory bill that would have provided real solutions to the core issue of youth access and/or appeal. However, that effort was tossed in favor of an unnecessary and last minute flavor ban, disguised as a bill that would merely raise the age to 21.

    The legislature delayed sending the bill, as well as others, to DeSantis’ desk to give him time to respond to the COVID-19 pandemic. Lawmakers sent the bill to his desk last week.

    Republican Sen. David Simmons ran the bill in the Senate while Reps. Jackie Toledo and Ray Rodrigues made changes delaying the start date of the age hike three months to the start of 2021, ensuring permitted store employees younger than 21 years old can sell tobacco and vape products and clarifying that vape product permits don’t carry a $50 fee, a previous provision removed that would have accessed product license fees.

    “This legislation would almost assuredly lead more people to resume smoking cigarettes, and it would drive others to the hazardous black market,” DeSantis wrote. “The latter consequence is especially significant because the much-publicized cases of lung injury associated with vaping in recent years have been traced to illegal, or black market, vape cartridges containing THC, not the types of legal vaping products that this bill would abolish.”

    DeSantis added, “reducing the use of all nicotine-related products, including vaping among our youth, is an important goal, but this will not be achieved by eliminating legal products for adults and by devastating the small businesses who provide these adults with reduced-risk alternatives to cigarettes.”

    In addition to the vape flavor ban and increased tobacco sales age, foods like tomatoes and potatoes, which contain trace nicotine, were carved out of the bill in a clarification.

    Democratic Senator Randolph Bracy, who said he accidentally voted yes the first time around, called the measure a terrible bill.

    “It will destroy an entire industry that actually helps people as a way to decrease the amount of nicotine they use,” he said.

    Republican Rep. Anthony Sabatini said banning those flavors would create a black market for flavored vape liquids. Off-market liquids and vapes have reportedly been tied to vaping-related deaths.

    “If you look at the history of this country’s war on drugs, I believe it’s been an epic failure,” he said. “The only historic simile is probably Pickett’s Charge. It was an absolute failure.

  • Turning Point Brands Submits PMTAs for 250 Products

    Turning Point Brands 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.

  • Bidi Stick Disposable Vape Submits PMTA to U.S. FDA

    Bidi Stick Disposable Vape Submits PMTA to U.S. FDA

    Bidi Vapor, the manufacturer of the disposable vape pen Bidi Stick, has submitted its Premarket Tobacco Product application (PMTA) to the U.S. Food and Drug Administration (FDA). The announcement was made by Kaival Brands Innovations Group, a company focused on growing and incubating innovative and profitable products into mature, dominant brands, in a press release.

    “We are confident that, upon review, the FDA will authorize Bidi Vapor’s Bidi™ Stick for continued marketing in the United States,” said Niraj Patel, president and CEO of Kaival Brands. “It is a premium-quality product that adult smokers have discovered can be a viable alternative to combustible tobacco, and we look forward to meeting the increasing market demand for the innovative Bidi Stick.”

    The application detailed 11 flavored varieties with nicotine concentrations of 6 percent weight/volume. The Bidi Stick is a disposable pod system, similar to Juul. “Starting from a science-based foundation, Bidi Vapor has engineered its electronic nicotine-delivery system (ENDS) products using its own patented technology, ensuring quality control and assurance from the raw chemicals and components purchased through to the manufacturing process in a cGMP (current Good Manufacturing Practice) facility,” the release states.

    Bidi states that its product went through various in-vitro and in-vivo toxicity testing (including genotoxicity tests) at a GLP (Good Laboratory Practice) approved lab, as well as HPHC (Harmful and Potentially Harmful Constituents) analysis of both the aerosol and e-liquid in ISO 17025 certified labs. Also included in its PMTA submission, Bidi Vapor conducted three independent surveys and one “combined” consumer survey of people aged 21 and over.

    Bidi Vapor’s application was more than 285,000 pages, according to the release. “Both Kaival Brands and Bidi Vapor fully support proper regulation of the category so that all ENDS products meet the highest manufacturing, safety and marketing standards for adult smokers, with the ultimate goal of improving the public health,” said Patel. “We look forward to working with Bidi Vapor as they work with the FDA to construct its regulatory policy based on science and facts.”

  • New Regulations are Restricting the Russian Vapor Market

    New Regulations are Restricting the Russian Vapor Market

    Russia
    Credit: Jaunt and Joy

    Since Russia’s anti-smoking legislative campaign began in 2013 by restricting smoking in public places and banning tobacco advertising, promotions, and sponsorships, the Russian government has been tightening its grip on tobacco manufacturing, sales, and permitted consumption. Vapor products are the latest next-generation tobacco product to catch the ire of regulators.

    On July 31, 2020, Russian Federation President, Vladimir Putin, approved new amendments to the country’s Tobacco Control Law that was initiated by Russia’s Parliament. The main thrust of the new amendments is to unify the regulation of tobacco and other nicotine products, especially e-cigarettes.

    The amendments introduce a new category of “nicotine-containing products” (NCPs) which includes heated tobacco products, solutions, liquids and gels containing nicotine, according to an article on mondaq.com, an information platform. NCPs, like vapor products, are now subject to the same restrictions and prohibitions imposed upon traditional cigarettes.

    The new law also introduces a definition of “devices for consumption of nicotine-containing products” which includes electronic nicotine delivery systems (ENDS) and heated tobacco devices (heat-not-burn) except for those registered as medical devices and medicines.

    The new law prohibits:

    • The sale of NCPs, hookahs and devices for NCPs consumption to persons under the age of 18.
    • The sale of NCPs via vending machines and the Internet, as well as open displays in stores.
    • The sale of a new NCP in the absence of specific regulations and requirements.
    • The consumption of NCPs in restaurants and commercial facilities.
    • The advertising, promotion, sponsorship by and demonstration of NCPs, hookahs and devices for NCPs consumption and their trademarks, including the use of such trademarks for other goods.

    Adults are allowed to purchase and use NCPs only in locations where the sale and smoking of cigarettes is already permitted, according to the story

    The sale of chewing, sucking and snuffing NCPs is now prohibited. The law also forbids any food products containing nicotine except for food products containing nicotine in natural form. The law establishes the maximum nicotine content at 20mg per 1 ml in liquids used in ENDS products. However, if such e-liquid contains zero nicotine, it will still be classified as a nicotine containing product.

    The government is planning to amend the existing technical regulations on tobacco products to address the sale and use of NCPs.

    The new law came into effect on July 31, 2020, save for certain rules that provide for a transition period. The prohibition against use of NCPs in restaurants and cafes enters into effect on October 30, 2020, while the restrictions on retail sales and the prohibitions regarding advertising, promotion and sponsorship of NCPs, hookahs and devices for NCPs consumption become effective on January 28, 2021.

  • Nicopure Labs has First PMTAs Accepted Quickly by US FDA

    Nicopure Labs has First PMTAs Accepted Quickly by US FDA

    Credit: Nicopure Labs

    The U.S. Food and Drug Administration has accepted Nicopure Labs first round of premarket tobacco product applications (PMTA). The application will now move into the substantive scientific review phase of the process, according to a press release.

    “I am extremely proud of all the hard work and dedication from the Nicopure Team that’s been put forth into our first round of applications. Over the next few days we will be filing additional applications and are very optimistic about Halo’s future,” said Jeffrey Stamler, CEO of Nicopure Labs. “Halo e-liquid flavors have been chosen by millions of vapors around the world as the Tobacco and Menthol e-liquids that vapers prefer.”

    The regulatory agency took just three day to accept and file the submissions for Tampa-based Nicopure Labs’ Halo Tribeca Tobacco e-liquid, Halo SubZero Menthol e-liquid and Halo Fusion e-liquid.

    “Halo’s 10-year history as a prominent brand, specializing in the tobacco-flavored e-liquid space has positioned the brand well for what is likely to come for the vaping industry. With California and New York becoming tobacco flavor-only markets, it is expected that more states will follow suit and Halo will be well-prepared with their award-winning tobacco flavors,” the release states. “Once accepted for filing, the final phase of the PMTA review process will be the FDA’s comprehensive evaluation of the scientific data supplied in the (PMTA) After all information has been fully evaluated and inspected, the FDA will make their final approval decision.”