Category: U.S. FDA

U.S. Senator Asks FDA to Release List of PMTA Filers

Credit: Durbin.gov
U.S. Senator Dick Durbin urged the U.S. Food and Drug Administration (FDA) to strongly enforce its own regulations “to protect kids from addictive e-cigarettes” by publishing a list of products that submitted premarket tobacco product applications (PMTAs). The Illinois senator wants to remove products that did not submit PMTAs from store shelves.
“After years of delayed regulatory oversight, which fueled the explosion in youth e-cigarette use, FDA finally required e-cigarette PMTAs to be submitted for review on September 9. It has now been more than one month, and the agency has yet to publish a comprehensive list of products that submitted applications,” according to a press release.
Durbin said he was concerned that the delay to publish the list of products that have submitted applications will allow products that remain out of compliance and illegally on the market to proliferate.
“In order to protect public health and uphold the duty to enforce against products on the market that are out of compliance, I urge FDA to immediately publish a comprehensive product listing of all relevant e-cigarette applications received by FDA. While I appreciate the sheer volume of applications submitted to FDA, and the agency’s intention to prioritize review of those with the greatest market share and public health impact, we know from recent years that youth shift patterns of e-cigarette use based upon what products are available to them,” Durbin wrote in a letter to FDA Commissioner Dr. Stephen Hahn.
Vapor and e-cigarette products can remain on the market while the FDA determines whether to approve or reject PMTA applications. The agency has up to one year to make these determinations.
October 20, 2020
USA Vape Lab Gets Filing Letter From FDA for PMTA

Credit: Naked 100
USA Vape Lab, one of the largest e-liquid manufacturers in the world, announced that it received its filing letter from the U.S. Food and Drug Administration (FDA). The filing letter acknowledges that the company’s premarket tobacco product applications (PMTAs) for their Naked 100 products are sufficiently complete, advancing the brand’s application forward to the substantive review phase.
During the substantive review phase, the FDA evaluates the scientific studies and data presented in the applications submitted to ensure that the products are appropriate for the protection of the public health (APPH).
“We are excited to be advancing further through the PMTA process. Our team has dedicated time and resources to ensure we have the data, research, and necessary components needed for our applications,” said Huy Nguyen, CEO of USA Vape Lab. “We are optimistic that our applications will continue to advance and result in the FDA granting USA Vape Lab with marketing orders.”
The company says it continues to maintain the highest standards of regulatory compliance and is committed to working with the FDA as its applications undergo review.
October 20, 2020
Air Factory, Charlie’s Chalk Dust Get PMTA Filing Letters

My Vape Order, Inc. (MVO) announced that on October 9, 2020, the U.S. Food and Drug Administration (FDA) issued a Filing Letter notifying MVO that the Air Factory’s premarket tobacco product application (PMTA) met the FDA’s requirements and was moving forward into the regulatory agency’s substantive scientific review phase.
Charlie’s Chalk Dust e-liquids have also received a filing letter and moved on to substantive review. “It is with great pleasure that we can announce to our customers that the FDA’s Center for Tobacco Products has informed us that our PMTA is sufficiently complete to enter the Substantive Review phase of the process,” wrote Brandon Stump, CEO of Charlie’s Chalk Dust. “This news is worthy of celebration as it highlights our progress towards achieving full regulatory compliance and providing our customers with a trusted product portfolio. It is a reflection of our relentless hard work and meticulousness in the pursuit of precision. We are confident that during the Substantive Review process the FDA will recognize that our submission is both distinguished and suitable for approval.”
Kyle Godfrey, MVO’s CEO, said the FDA will review the extensive scientific data and research submitted with the PMTA to determine whether the Air Factory products are appropriate for the protection of public health. “The Air Factory PMTA was the culmination of years of planning and extensive toxicological testing and scientific research,” he said. “We look forward to working with FDA on its review of the Air Factory products, with the ultimate goal of obtaining FDA marketing orders for the products.”
October 16, 2020
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.”
October 9, 2020
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