FDA, DOJ Seek Permanent Injunction Against E-Cigarette Manufacturer

From FDA, full article here:  https://www.fda.gov/tobacco-products/ctp-newsroom/fda-doj-seek-permanent-injunction-against-e-cigarette-manufacturer

On December 4, the U.S. Department of Justice (DOJ), on behalf of FDA, filed a complaint for a permanent injunction against Jessica M. Fitzgerald and Michelle L. Allen doing business as Vape Junkie Ejuice (Vape Junkie Ejuice) for manufacturing, selling, and distributing unauthorized e-cigarette products.  This case represents the seventh time FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for new tobacco products.

Vape Junkie Ejuice was previously warned by FDA that they were in violation of the FD&C Act’s premarket review requirements for new tobacco products by manufacturing, selling, and distributin new tobacco products without first obtaining marketing authorization from FDA.  FDA’s warning noted that continued violations could lead to further action, including injunction.  However, Vape Junkie Ejuice continued to manufacture, sell, and distribute unauthorized e-cigarette products to consumers.

This action is part of FDA’s comprehensive approach to enforcing the law and its commitment to work with federal partners.  Other recent enforcement actions include:

  • On November 16, FDA issued warning letters to seven online retailers for selling and/or distributing unauthorized e-cigarettes.  The unauthorized e-cigarettes are packaged to look like youth-appealing toys and drink containers, including milk cartons (pictured below), soft drink bottles, and slushies.
  • On November 9, FDA issued warning letters to seven online retailers for selling unauthorized e-cigarette products.  The warning letters cite the sale of popular and youth-appealing disposable e-cigarette products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars, and Lava.
  • On November 7, FDA issued a warning letter to Nic Nac Naturals, LLC for the marketing of their unauthorized dissolvable nicotine products, which the company describes as “nicotine mints” and resemble a pack of mints (pictured below).  These products are of particular concern because of their resemblance to popular candies and the potential to cause severe nicotine toxicity or even death if accidentally ingested by younger children.

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