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WARNING LETTER
•Liquid Nics LLC•October 7, 2021

Liquid Nics LLC – FDA Warning Letter, Oct 7, 2021

Record Details

The FDA issued a Warning Letter to Liquid Nics LLC, identifying that their e-liquid products, specifically "95% VG Haze Purple Haze 3mg 60ml e-liquid," are tobacco products subject to FDA jurisdiction. The letter states that this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act.

Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided. The failure to provide such a report is a prohibited act under section 301(p).

Liquid Nics LLC is a registered manufacturer with over 7,500 products listed. Their Premarket Tobacco Product Application (PMTA), STN PM0001943, submitted on September 9, 2020, received a Marketing Denial Order on September 7, 2021, covering 3,105 products. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement, with products lacking pending

Company
Liquid Nics LLC
Inspection date
October 7, 2021
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
View Company Profile

ID · 56c83cc9-68c1-4c44-9fd0-51fbe62cb8e3

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)21 U.S.C. 387b(6)(A)21 U.S.C. 387c(a)(6)

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