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WARNING LETTER
•VapeCentric, Inc.•April 27, 2020

VapeCentric, Inc. – FDA Warning Letter, Apr 27, 2020

Record Details

The FDA Center for Tobacco Products issued a Warning Letter to Michael Daneshrad regarding the sale of an e-liquid product, "Pink Sticks," on vapecentric.com. The FDA determined this e-liquid is a tobacco product under section 201(rr) of the FD&C Act and is subject to FDA regulation.

The "Pink Sticks" e-liquid is identified as a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. It lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making it adulterated under section 902(6)(A). Furthermore, it is misbranded under section 903(a)(6) because required notice or information under section 905(j) was not provided.

The FDA expressed particular concern that the "Pink Sticks" packaging imitates food products, specifically Pocky Strawberry biscuit sticks, which are typically marketed to children. This raises concerns about enticing minors to use tobacco products and potentially encouraging unlawful sales to youth.

The letter mandates prompt corrective actions, including discontinuing the violative sale and advertising. A written response detailing corrective actions and a plan for compliance must be submitted within 15 working days. Failure to comply may result in civil money penalties, seizure, and/or injunction.

Company
VapeCentric, Inc.
Inspection date
April 27, 2020
Product type
Tobacco
Office
Center for Tobacco Products
People
  • Ann Simoneau (Director)
  • Michael Daneshrad
View Company Profile

ID · 14701248-391c-4446-b8cc-47103b7b076d

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 902(6)(A)FD&C Act 903(a)(6)

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