Is the FDA blocking U.S. sales of Joyetech’s new, non-exploding vape pen?
In just a few weeks, the forward-thinking vape company Joyetech is officially releasing a new vaping device specifically designed to prevent explosions, but it won’t be available for purchase in the U.S. Even though UL has pre-certified the new vape pen per its international standards for safety, the U.S. Food and Drug Administration (FDA) is actively blocking American consumers from taking advantage of this remarkable new technology. Meanwhile other countries like Canada, for example, are welcoming the innovative upgrade with open arms.
The UL is a global organization which tests, retests, and certifies thousands of products every year from around the world based on the strictest of safety standards, and California-based Joyetech is the very first American manufacturer to achieve UL-certification for an electronic cigarette. In light of the recent onslaught of negative news stories and press announcements by the FDA over its alleged concerns about vaping, one might assume that the release of a more technologically advanced vaping device that prevents explosive mishaps would be just want the FDA ordered. But there’s a problem.
The FDA deeming regulations prevent product innovation
On May 10, 2016, the FDA published draft guidance or deeming regulations that force vaping companies to submit a Pre-Market Tobacco Application (PMTA) for any product not yet available on the U.S. market prior to August 8, 2016. While the original Joyetech eGo fits this criterion, the FDA considers the upgraded eGo AiO to be a completely new product.
Related Article: New FDA e-cig regulations and the million-dollar PMTA process
Therefore, technically, the company must submit and be approved for an entirely new PMTA. Unfortunately, the process cannot yet be completed and could ultimately take years to complete. Why? Because the FDA has not yet finalized its federal guidelines for the PMTA process. Over two-years later, they still remain in “draft guidance” form.
“Technology innovates in cycles of months, not years, so the products being sold today were first designed almost three years ago…Manufacturers have developed and are selling products in other parts of the world that have safety designs and safety protections in them, but we can’t make any changes to those products here in the U.S. without going through the FDA’s multimillion-dollar multi-year PMTA process.”
-Tony Abboud, executive director of the Vapor Technology Association per interview with NBC News.
The UL is the world’s leading safety review organization for consumer products. Manufacturers who seek and receive UL certification must agree in advance to annual follow-up testing and quarterly inspections of their manufacturing facilities by UL officials. But in America, these same vape companies must also adhere to the FDA’s PMTA process that could cost in upwards of a million dollars per product and take years to complete even after the FDA approval process becomes fully operational.
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By the time that Joyetech would theoretically be granted PMTA approval for its new, non-exploding vape pen, the entire vaping industry will have essentially moved on to even more highly advanced, increasingly safer, technological advancements. It’s a Catch-22.
This conundrum of FDA approval appears – at first glance – to be just another case of slow-moving government regulation gone amuck, but many within the vaping industry are now secretly beginning to wonder. Is this FDA regulation…or extortion?
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