Tag: Vapor Station

  • Firms Embrace Synthetic Nicotine After FDA Rejections

    Firms Embrace Synthetic Nicotine After FDA Rejections

    Photo: Martinmark – Dreamstime.com

    Vapor Salon will be switching to synthetic nicotine, the company wrote in a public Facebook post dated Aug. 26.

    The post was published on the same day that the U.S. Food and Drug Administration denied some 55,000 marketing applications by Vapor Salon and two other companies on the ground that they “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by well-documented, alarming levels of youth use of such products,” according to an FDA press release.

    “VaporSalon is switching to TOBACCO FREE NICOTINE on Friday, 8/27/2021,” the Facebook post reads. “The main purpose of this is to be outside of the FDA’s regulations with their hefty PMTA requirement which takes full effect on Sept 9th 2021 with needing an approved PMTA, or your product can no longer be sold. There has been 0 approved PMTA’s for anything ENDS related to-date.”

    According to Filter, more manufacturers have begun looking at the possibility of synthetic nicotine as a way to avoid having to comply with FDA regulations.

    The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”

    Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, said that, in response to such moves by vapor companies, the FDA could either assert jurisdiction over synthetic nicotine as tobacco product or push for synthetic nicotine to be regulated like any other drug.

    Because synthetic nicotine is more expensive than the natural variety, a switch would likely result in higher prices for consumers. Vapor Salon indicated that many of its redesigned products will now have “an upcharge,” according to Filter.

  • Jarvis Vaping Supply Receives PMTA Acceptance Letter

    Jarvis Vaping Supply Receives PMTA Acceptance Letter

    Jarvis Vaping Supply (JVS), parent to four of 21 Ohio-based Vapor Station vape shops, announced that its premarket tobacco product application (PMTA) has been accepted by the U.S. Food and Drug Administration (FDA). James Jarvis, co-owner of JVS with his wife Gerri, announced the receipt of the acceptance letter on his Facebook page. The acceptance includes all 998 SKUs submitted to the FDA for authorization, James confirmed in a text.

    “I’m so proud of my wife … she spent so many late nights, so many hours, frustration, stress and a lot of patience went into this,” James wrote. “She helped many others once she finished ours on top of this.”

    JVS is a wholesale vaping supply store. Alongside the four Vapor Station retail stores in and around Columbus, Ohio, James also serves as president of the Ohio Vapor Trade Association, and both Gerri and James are avid advocates of the vapor industry.

    Gerri and James Jarvis

    While James continued to run the business, Gerri worked day and night over six months to fill out PMTAs for 998 products (SKUs). In the end, she dumped roughly 3 million pages off at the FDA. With just the help of a Facebook group called PMTA Sharing, Gerri was able to climb the PMTA mountain without any help from firms experienced in submitting PMTAs. The Jarvis’ were among 1,600 vapor company representatives who joined this and other private groups to help them navigate the PMTA process.

    “With Covid-19 hitting right in the thick of the PMTA process, money was so tight that we needed to be careful with spending. Thanks to the help of the Facebook group, we were confident that we could turn something in to the FDA,” Gerri said in a recent interview with Vapor Voice.

    After submitting JVS PMTAs, Gerri then went on to help her friend Jason Gang of Westside Vapor as well as several other small companies negotiate the PMTA process, including Dripology, Vapor Generation, KL Labs and E Cig Cafe. Gerri said Westside Vapor’s PMTAs for its 1,800 products totaled over 6 million pages. Westside Vapor also received an acceptance letter according to James, but that has not yet been verified.