The U.S. Food and Drug Administration has accepted all of Nicopure Labs’ Halo products’ premarket tobacco product applications (PMTA) for the substantive scientific review phase.
Just over six months after submission, Nicopure Labs’ PMTAs for Halo Turkish Tobacco E-liquid, Halo Triton II Starter Kit, Halo ZERO Starter Kit and all supporting consumable components have been accepted and advanced to the final phase, substantive scientific review, by the FDA. Halo FDA accepted premarket tobacco product applications include:
Halo Tribeca Tobacco e-liquid
Halo SubZero Menthol e-liquid
Halo Turkish Tobacco e-liquid
Halo Fusion Unflavored Tobacco e-liquid
Halo Triton II Starter Kit (and supporting consumable components)
Halo ZERO Starter Kit (and supporting consumable components)
“Halo’s more than 12 years of commitment to producing the highest quality vaping products available for adult consumers has been our organization’s mission for more than a decade,” said Jeffrey Stamler, co-founder of Nicopure Labs, in a statement. “We believe in science, and we believe in transparency; we are honored to continue to work with the FDA, and as always, in the best interest of the industry and the most important thing of them all, our loyal customers.”
The global e-liquid market is growing quickly. New data suggests that the market could reach $3.3 billion by 2027. According to a new study by Grand View Research, the market is expected to expand at a CAGR of 13.4 percent from 2021 to 2027.
Credit: Vaporesso
“The advent of e-cigarette products such as squonk mods and pod systems has increased its popularity and adoption in recent years. The rising demand for these products globally is expected to drive the market over the forecast period,” a press release states. “In addition, the general presumption that these products can reduce the risk of lung disorders is fueling the market. Moreover, the absence of the tobacco burning process that is often found in conventional smoking products is expected to drive the market in the near future.”
In terms of flavor, the menthol segment is anticipated to register the highest growth rate over the forecast period owing to increasing adoption among young people, especially in students, coupled with its availability at affordable prices, according to the report.
“In terms of type, the bottled segment is expected to register growth at a significant pace from 2021 to 2027. This can be attributed to the fact that bottles allow users to make their own e-juice by adding two or more e-liquids,” the report states. “In terms of distribution channel, the online segment is anticipated to register a significant growth rate over the forecast period as it provides customers with a wide variety of e-liquids.”
Regionally, Europe is anticipated to register notable market growth from 2021 to 2027. This can be attributed to rising awareness among individuals about the tobacco-free formulation of e-liquids, according to the report.
“Market players are focusing on mergers and acquisitions, collaborations, and partnerships in order to expand their distribution networks and build an international presence for their brands,” the reportstates. “For instance, in January 2018, Nicopure, a manufacturer of e-cigarette and e-liquid, announced a partnership with Vapоr Ltd., a distributor of e-cigarette and e-liquid in Bulgaria. Nicopure appointed Vapоr Ltd. as one of its distributors in Bulgaria. The partnership allowed the former to expand its brand presence in Bulgaria.”
Key players are increasingly investing in the marketing and distribution of their products owing to rising competition in the market. For instance, in July 2019, Turning Point Brands, Inc., a manufacturer, and distributor of consumer products, invested $3.0 million in the Canadian distribution firm ReCreation Marketing. Through the ReCreation Marketing platform, the company launched RipTide, an e-liquid vape technology, and a variety of Nu-X products in Canada.
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.”
