FDA Tells Uwell to Remove the Caliburn from the Market

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The FDA announced Monday a new round of warning letters to vaping manufacturers and retailers, demanding that some vaping products be removed from the market. Most of the items named are niche products, but one is a very popular refillable pod vape, the Uwell Caliburn.

According to the warning letter to Shenzhen Uwell Technology Co., Ltd., the Caliburn and three other Uwell products violate rules in the 2009 Tobacco Control Act and the 2016 Deeming Rule, including the requirement that any products introduced after Aug. 8, 2016 must first receive marketing approval by the FDA. All products introduced after that date are subject to the same enforcement.

The Uwell Caliburn was introduced in late 2018, and quickly became among the most popular refillable pod vapes. Users appreciate its flavor, capacity and fast charging capability. After some initial quality control problems with replacement pods, the device took off and became a best seller in vape shops and at online retailers.

The other Uwell products cited by the FDA are:

  • Uwell Amulet Watch Pod System
  • Uwell Caliburn KOKO Kit
  • Uwell Yearn Pod System

The agency noted that the Amulet Watch product was “likely to appeal to children because it is designed to conceal a tobacco product from parents, teachers, or other adults,” and that it “contains features that resemble smartwatches that are commonly worn by children.” The FDA illustrates the point with an image of the Uwell watch next to an Apple Watch.

Other products cited in Monday’s warning letters include e-liquid with cartoon and candy-inspired labels, another wristwatch mod, VOOPOO’s fidget spinner pod vape, a mod that resembles a Nintendo Game Boy, and a hoodie and backpack designed to allow stealth vaping through hidden hoses. The manufacturers and retailers are:

  • Vaprwear Gear, LLC (manufacturer, online retailer)
  • Vapewear, LLC (manufacturer, online retailer)
  • Wizman Limited (manufacturer, online retailer)
  • EightCig, LLC (online retailer)
  • Ejuicepack, LLC (online retailer)
  • Vape Royalty, LLC (online retailer)
  • VapeCentric, Inc. (online retailer)
  • Dukhan Store (online retailer)
  • VapeSourcing (online retailer)

Manufacturers and retailers that receive warning letters are expected to reply to the FDA within 15 working days, describing what corrective actions they’ve taken, or alternatively, disputing the agency’s accusations. In the case of products that were not marketed before the August 2016 cutoff date, a manufacturer is theoretically expected to stop importing the product or face additional FDA sanctions, “including, but not limited to, civil money penalties, seizure, and/or injunction.” In reality, the FDA may never even follow up on the warning.

The agency also released a list of retailers who received warning letters for individual violations of the FDA’s January enforcement guidance that bans sales of prefilled pod- and cartridge-based vapes in flavors other than tobacco and menthol.

Of the 89 violations on the list, just two or three appear to be from vape shops. Most of the violators were convenience or tobacco stores, or gas stations. (In March, the FDA announced that 16 retailers had received warning letters. None were vape shops.)

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Source: Vaping360