FDA WARNING_LETTER - Juice Co. - June 03, 2025
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On May 30, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Vapejuice.com after reviewing their website and determining that electronic nicotine delivery system (ENDS) products were offered for sale or distribution in the U.S. These products are considered tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.
The FDA identified two specific ENDS products, "Raz LTX 25K Disposable Vape - 25,000 Puffs – Triple Berry Gush" and "Hyppe Max-Air 5000 Puff 13ml Disposable Vape – Mega Mint," as "new tobacco products" that lack the required premarket authorization order. These products were not commercially marketed in the U.S. as of February 15, 2007, and do not have FDA marketing authorization or an exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.
The letter requires a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales/distribution and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure,
ID · a405a89f-75f1-46db-821d-d0654f5c0c37
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