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More Vaping Brands File PMTA With FDA
USA Vape Lab, the maker of the popular Naked 100 e-juice brand, is one of the vaping companies to announce recently that it has successfully filed its PMTAs with the FDA. In June 2019, manufacturers of vaping products were given ten months to submit their PMTAs, and that window expired on September 9th.
In a statement, USA Vape Labs said it had received a letter from the FDA indicating that the PMTA for its Naked 100 e-liquids is complete. The next step is for the FDA to review the data and scientific information submitted by USA Vape Labs. After the review process, Naked 100 e-liquids could receive the FDA’s approval to market its products to the public. This would potentially make Naked 100 the very first brand in the vaping industry to receive the FDA’s stamp of approval.
The PMTA allows the FDA to determine which nicotine products can be marketed to the public. Many pundits in the vaping industry voiced disapproval after the FDA announced in 2016 that manufacturers of vaping products would be required to submit PMTAs for their products. According to critics, cigarettes have never been subjected to the same level of scrutiny. Also, filing PMTAs is an expensive and complicated process. There were concerns that the high cost of filing may force many small-scale vaping brands out of business.
However, the FDA was adamant on its stand in a bit to regulate vape products and combat the disturbing trend of vaping among teens.
“The FDA’s ongoing oversight of e-cigarettes and other ENDS products is critical to our public health mission and, especially, to protect kids from the dangers of nicotine and tobacco-related disease and death. The FDA is committed to providing a solid, science-based regulatory foundation to ensure that ENDS products authorized for marketing are appropriate for the protection of public health,” Acting FDA Commissioner Ned Sharpless M.D. said in a statement last year.
The CEO of USA Vape Lab, Huy Nguyen, expressed optimism that the FDA would approve the company’s PMTAs.
“Our team has dedicated time and resources to ensure we have the data, research, and necessary components needed for our applications. We are optimistic that our applications will continue to advance and result in the FDA granting USA Vape Lab with marketing orders,” Nguyen said in a statement.
USA Vape Lab is not the only company to announce that it has received a letter from the FDA indicating that the FDA’s PTMA filing met its requirements. Air Factory, Vaporesso, Bad Drip Labs Inc., Halo, and many other brands have also had their PTMAs officially accepted by the FDA. Some brands are still waiting for the agency to confirm that their filings meet its requirements.
As part of the PMTA, vaping companies have to provide scientific data to show that their products are not harmful to public health. They would also need to demonstrate how their products may potentially help people quit smoking tobacco cigarettes, how their products are manufactured and packed as well as how their ingredients are sourced.
Kyle Godfrey, the CEO of My Vape Order, Inc (the parent company of Air Factory), expanded a bit on what will happen after the company submitted its PMTAs for Air Factory products.
“In this critical phase, FDA will review the extensive scientific data and research submitted with the Air Factory PMTA to determine whether the Air Factory products consumers know and love are ‘appropriate for the protection of public health’ – the standard that FDA considers when deciding which products to allow for sale,” Godfrey said. “The Air Factory PMTA was the culmination of years of planning and extensive toxicological testing and scientific research. We look forward to working with the FDA on its review of the Air Factory products, with the ultimate goal of obtaining FDA marketing orders for the products.
“We are confident that with all the comprehensive studies, the [sic] vapers will be well protected. American vapers would continue its [sic] vaping journey with rigorously tested devices and e-liquid options,” said Eve Wang, Shenzhen Smoore Technology Limited (the company behind the Vaporesso brand).
In a bid to keep vapers updated about the status of the PMTA filings of the top vape brands, a physician has launched a website called PMTAfiled.com. The goal is to become a dependable online platform for everyone to find information about the PMTA status of different vaping brands.
“AT PMTA Verified, we stand for every Small Business Owner’s right to make decisions regarding their business without the fear of fines, unsafe products, or a devastating loss in income due to confiscated inventory,” Laura Tobin, the press manager of PMTA Verified, said.
At Ejuice Deals, we are closely following all the developments in the vaping industry, and we are committed to providing you with safe, high-quality vaping products.