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WARNING LETTER
•Eliquidstop LLC•April 21, 2020

Eliquidstop LLC – FDA Warning Letter, Apr 21, 2020

Record Details

The FDA Center for Tobacco Products issued a Warning Letter to Eliquidstop.com after reviewing its website and finding that it offers electronic nicotine delivery system (ENDS) products for sale in the United States without required marketing authorization. The identified products, including Mango – EonSmoke Pods, Peach Madness – 4X Pods, and Pineapple Lemon – PUFF Pods, are considered "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack necessary FDA marketing authorization orders or exemptions. Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) due to the absence of required notice under section 905(j). The company is responsible for ensuring all tobacco products and related advertising comply with the FD&C Act and FDA regulations. Eliquidstop.com must promptly correct these violations, cease the sale and distribution of the non-compliant products, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may result in enforcement actions such as civil money penalties, seizure, or injunction.

Company
Eliquidstop LLC
Inspection date
April 21, 2020
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
View Company Profile

ID · 22f728b6-e57b-4614-8fbc-6a5397da9ce6

Violation Codes10
21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 CFR 1100.121 U.S.C. 387j(a)21 U.S.C. 387j(c)(1)(A)(i)21 U.S.C. 387e(j)21 U.S.C. 387e(j)(1)(A)(ii)21 U.S.C. 387e(j)(3)FD&C Act 910(a)(2)(A)FD&C Act 902(6)(A)

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