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FDA Continues Enforcement with More Letters

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Twenty-one unlucky vaping importers and sellers have been sent letters from the Food and Drug Administration asking for “evidence that some of their products were on the market” before the Aug. 8, 2016 deeming rule date, as reported on by Vaping360.

As most of us know, the rule prohibits new products from entering into the market after that date without a review from the FDA. Vaping360 says that after two years, no product has been submitted for review, spawning this round of letters. Companies and their products who were sent letters stating they were in violation of the Food, Drug and Cosmetic Act (FDCA) are:

  • Suorin Vagon (American Vapor LLC)
  • Baton Nicotine Salts and Baton Pods (Baton LLC)
  • Nicosurge Nicotine Inhaler (Black Mountain Fulfillment, LLC)
  • PHIX Pods (ECS Global LLC)
  • JUUL Compatible Pod System and other devices and pods (Eonsmoke LLC)
  • myblu Starter Kit (Fontem USA Inc.)
  • RUBI (Kandypens Inc.)
  • PIXL (Kretek International, Inc.)
  • Vapeleaf (Logic Technology Development, LLC)
  • Juno E-Vapor Battery and other Juno products (Magellan Technology Inc.)
  • Maja Flavor Eliquids and Maja Flava Salty Crystal Starter Kit (Maja Flava Vape Den)
  • Bo One, Bo Plus, bo CAPS (MMS ECVD Distribution, LLC)
  • MYLE Devices, MYLE Pods, MYLE Starter Kits (Myle Vape Inc.)
  • Vuse Alto (Reynolds American Inc.)
  • Sutra Dash POD Vaporizer (Sutra Vape)
  • Mi-Pod, Smoking Vapor E-Liquids (SV3 LLC)
  • Vertipod Device, Vertipod Starter Kit (Vertigo Vapor LLC)
  • STIG Disposable Pod Devices (VGOD Inc.)
  • ALD POD Systems (VMR Products LLC)
  • Xfire E-Cigarette Pen, Xfire Starter Kits (Xfire Inc.)
  • Ziip Pods, Zpods (ZLab S.A.)

Vaping360 notes that most of the devices listed are pods and mini vapes, which along with the Juul have been in the news in rapid fire form as of recent. Vaping360 says these products are the subject “of a coordinated campaign of misinformation in an attempt to portray vaping in general and JUUL specifically as deliberately trying to lure teenagers into nicotine use.” Additionally, some of the products in the list were on the market before the 2016 deeming date, so it seems odd that they were included.

FDA Commissioner Scott Gottlieb has said that his latest crusade against vaping is due to youth vaping in what he calls an “epidemic.” Vaping360 also says that anti-vaping groups who are accusing manufacturers of breaking protocol after the deadline were part of what prompted the FDA to send this group of letters, “although the agency certainly must be aware that there are thousands of non-compliant products on the market.” Instead, the FDA may be sending these letters to appease the youth “epidemic” lot’s concerns. “The agency wants the public to believe that pointless sanctions on fringe elements of the Chinese vaping industry represent meaningful enforcement actions.

Finally, Gottlieb has promised to put a number on how many youth are vaping each product, which seems like a tall order due to the timing of these letters two years later. Only time will tell if this round of letters are due to political pressure or a true concern for our youth.