FDA kbjr6

FDA Warns Uwell to Delist Caliburn

FDA kbjr6

The US Food and Drug Administration (FDA) issued a new round of warning letters to e-cigarette manufacturers and retailers this week, asking them to remove some e-cigarette products.

Shenzhen Uwell Technology Co., Ltd. received a warning letter and the FDA asked Uwell to withdraw Caliburn and three other products from the market. Because these products violate the 2009 Tobacco Control Act and the 2016 Deeming Rule. All products launched after August 8, 2016, must be approved by the FDA, otherwise, they will face the same product removal warning.

The Uwell Caliburn is a very popular refillable pod vape that began selling at the end of 2018. Its taste, capacity, and ability to charge quickly have been favored by users, and it has become a best-selling product in vape stores and online retailers.

Juul vaping lawsuits | Insurancejournal

The manufacturers and retailers mentioned in the warning letter also include:
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)

FDA requires manufacturers and retailers who receive the warning letter to respond within two weeks and inform them of the corrective actions they have taken. Besides, imports of products launched after August 8, 2016, that have not been approved by the FDA will also need to stop importing, otherwise, they will face, including but not limited to, civil fines, seizures, or injunctions. Although the FDA has never continued to follow up on these warnings.

Most of the 89 violations listed in the warning letter are convenience stores, tobacco shops, or gas stations, and only 2 to 3 are vape stores. None of the 16 offenders announced last month were vape stores.

This article is issued by vaping360, Jim McDonald. For further information, please check out vaping360.


Share on facebook
Share on twitter
Share on tumblr
Share on reddit
Share on linkedin
Share on telegram