4 PMTA Updates From Manufacturers

CHICAGO — E-cigarette and vapor companies are continuing to publicize what products they’ve submitted premarket tobacco applications (PMTA) for.

And while the U.S. Food and Drug Administration has a year from the Sept. 9 deadline to review these products, some have already reached the step of substantive review. If successful, this phase results in the FDA granting marketing orders to authorize the continued marketing of the submitted products.

Here is what MNGO, ZLab, Bantam Vape LLC and Humble Juice Co. submitted so far:

The FDA moved disposable vaping product maker MNGO’s application to the filing stage of the PMTA process, according to the company. The product now moves into the substantive review phase.

"Our goal has always been to provide adults with the highest quality alternative products that are affordable and taste great," the company said. "While 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.”

Flavors submitted in applications included Strawberry Mango, Tobacco, Mint, Blueberry Mango, Watermelon Freeze and more. In all, 13 flavors across five nicotine levels, including a zero nicotine option, were included.

MNGO products have been on the United States market since 2015, and the Chicago-based company is preparing further PMTAs for new products in early 2021.

PMTAs for Shenzhen Yibo Technology Co Limited’s ZLab products—a brand of pods, disposable sticks and e-juice bottles—moved onto the substantive review phase.

ZLab’s product applications cover six nicotine strengths, including a 0% nicotine option, and 13 flavors including Berry Mix, Mint, Strawberry Lemonade and Banana Pineapple.

ZLab, San Francisco, has offices in 12 countries and revenues close to $300 million a year, the company said. It is planning to submit 120 more PMTAs in 2021, including an application for their new pod system.

Bantam Vape, Morrisville, N.C., submitted its PMTA to the FDA, it announced in October. The e-liquid company submitted its application on Sept. 2, it said. In preparation for the submission, Bantam worked with labs to conduct the in-depth testing needed including storage and stability testing, toxicity testing and pharmacokinetic and topography studies.

"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," Bantam spokesperson Anthony Dillon said. "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."

Humble Juice, Thousand Oaks, Calif., said its PMTA submitted on Sept. 3 for its e-liquids has advanced to the substantive review phase.

The company submitted its PMTA for 84 e-liquid products in various flavors, nicotine levels and sizes. Its products include 30 milliliter salts and 60 milliliter e-liquids.

“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,” Humble CEO Daniel Clark said.