The FDA issued a new warning letter to EVO Brands, LLC and PVG2, LLC, who are doing business as Puff Bar. The Puff Bar products that subject to this waring letter are non-tobacco nicotine (NTN) products. The FDA was granted regulatory power over NTN and synthetic nicotine products by a federal law passed by Congress earlier in 2022. The warning letter accuses the companies of receiving and delivering e-cigarettes in the U.S. without a marketing authorization order. Both companies have 15 working days from receiving the letter to detail how they intend to address the FDA’s concerns, including the dates that they discontinued the sale and/or distribution of these tobacco products.
The FDA also revealed that it has issued marketing denial orders (MDO) for premarket tobacco applications that were submitted by Magellan Technology, Inc. for 32 Hyde e-cigarettes.
“In conducting its scientific review, the FDA determined that the applications lacked sufficient evidence demonstrating that these flavored e-cigarettes would provide a benefit to adult users that would be adequate to outweigh the risks to youth. Therefore, the FDA has determined that permitting the marketing of these products would not be appropriate for the protection of the public health. The company must stop selling and distributing these products, and those currently on the market must be removed or risk enforcement action. No Hyde products have received marketing authorization orders from the FDA,” the agency wrote in a press release.
You can read the full press release on the 2022 National Youth Tobacco Survey and its recent warning letter and MDO issuing by clicking here.
For all the latest news from the FDA, visit fda.gov.
