Boulder Files Premarket Tobacco Application with FDA
Boulder International, a manufacturer of high quality, value driven vape devices and e-liquids announced today the filing of their initial Premarket Tobacco Application ("PMTA") submission with the Food and Drug Administration ("FDA"). For almost a decade Boulder International has been committed to the responsible enjoyment of the vaping experience. This recent filing is consistent with the company's belief in the long-term sustainability of this industry, their dedication to manufacturing and delivering best in class products and their determination to comply with all local and federal regulations and guidelines.
According to Robert Heiblim, President of Boulder International USA, "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.”
Boulder's initial filing will include (2) devices, the Boulder Rock and the Aspen Slim and (2) flavors of e-liquid, American Blend and Menthol. 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. 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.”
Boulder executives cited the timing of their PMTA filing as coinciding "nicely" with the company's July announcement that their Boulder Rock devices had exceeded 4M units sold; figures which include the Boulder Viridian, an alternative version of the ROCK designed for plant extracts and distributed through the vape store channels.
Boulder International is based in Boonton, NJ and distributes their products widely to established channels through reputable tobacco distributors and brokers. Boulder International designs, engineers and manufactures devices and e-liquids in their own state-of-the-art facilities. They promote the responsible use of their simple, easy to use vape products.