Category: U.S. FDA

FDA Restates Enforcement Policy for E-Cigarettes
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.”
September 21, 2020
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.
September 18, 2020
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.
September 16, 2020
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.
September 15, 2020
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.
September 12, 2020
U.S. FDA Sends 3 Enforcement Letters for Illegal Sales

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.”
September 10, 2020
CDC Study: Youth E-cigarette Use Sees Significant Drop

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.
September 10, 2020
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.”
September 9, 2020
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.”
September 9, 2020
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.
September 9, 2020