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WARNING LETTER
•vprsupplyco.com•July 29, 2025

vprsupplyco.com – FDA Warning Letter, Jul 29, 2025

Record Details

The U.S. Food and Drug Administration (FDA) issued a warning letter on July 15, 2025, to VPR Supply Co., located at 3355 S Wadsworth Blvd, Lakewood, CO, for violations related to the sale and distribution of e-liquid products. The FDA"s Center for Tobacco Products identified that VPR Supply Co. was offering e-liquid products, such as Vapergate - Hyper Drive, Vapergate Cafe - MFPB, and Vapergate - Player One, without the necessary premarket authorization, which is required under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The inspection revealed that these products are classified as "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required marketing authorization order. Consequently, these products are considered adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act.

The FDA requires VPR Supply Co. to take immediate action to address these violations. The company must submit a written response within 15 working days detailing the steps taken to bring their products into compliance, including ceasing the sale and distribution of the violative products. Failure to comply may result in regulatory actions such as civil penalties, product seizure, or injunctions.

VPR Supply Co. is advised to ensure all tobacco products sold and advertised comply with the FD&C Act and FDA regulations. The company is also encouraged to consult the FDA"s Searchable Tobacco Products Database for authorized products. The letter serves as a formal notification and opportunity for the company to rectify the identified issues.

Company
vprsupplyco.com
Inspection date
July 29, 2025
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • John E. Verbeten (Director)
View Company Profile

ID · 65b90216-dfcf-43af-8a8a-9e297bd9aedd

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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