Tag: FDA

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.”
October 9, 2020
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.
October 7, 2020
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.
October 5, 2020
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.
October 3, 2020
Boulder Intl. Receives PMTA Acceptance Letter From FDA

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.”
October 3, 2020
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.
September 22, 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
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
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).

September 10, 2020