FDA Questions Legality of Over 40 E-Cigarette and ENDS Products

FDA Questions Legality of Over 40 E-Cigarette and ENDS Products

In its latest move impacting the electronic cigarette category, the U.S. Food and Drug Administration (FDA) has sent letters to 21 different manufacturers and importers of different electronic nicotine delivery systems (ENDS) products. These letters question various products that may or may not be promoting a regulated tobacco product in a way that potentially violates the Federal Food, Drug and Cosmetic Act.

Those companies that received letters on Oct. 12, 2018 include:

  • American Vapor, LLC
  • Baton, LLC
  • Black Mountain Fulfillment LLC
  • ECS Global, LLC
  • Eonsmoke, LLC
  • Fontem USA, Inc.
  • Kandypens Inc.
  • Kretek International Inc.
  • Logic Technology Development, LLC
  • Magellan Technology Inc.
  • Maja Flava Vape Den
  • MMS ECVD Distribution, LLC
  • Myle Vape Inc.
  • Reynolds American Inc.
  • Sutra Vape
  • SV3, LLC
  • Vertigo Vapor, LLC
  • VGOD Inc.
  • VMR Products, LLC
  • Xfire Inc.
  • ZLab S.A.

These companies have been asked to provide the FDA with proof that the products in questions meet the deeming rule requirements. These companies have 30 days to respond to these letters with information and evidence that will help the FDA determine whether or not these products have been illegally marketed and made available. It should be noted that these letters do not mean the FDA is considering any enforcement actions, though those could be the result of any cases where deemed products are being illegally sold and marketed.