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WARNING LETTER
•mohawksmoke.com

mohawksmoke.com – FDA Warning Letter

Record Details

On April 3, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to the online retailer mohawksmoke.com for distributing unauthorized tobacco products. Following a review of the website, the FDA identified that the company offered nicotine pouches, specifically "Zyn Nicotine Pouches 11mg" in Apple Mint and Strawberry Cake flavors, for sale in the United States without the required legal permissions. Under the Federal Food, Drug, and Cosmetic Act, any tobacco product introduced or modified after February 15, 2007, is considered a "new tobacco product" and requires a premarket authorization order to be legally marketed. Because these specific nicotine pouches lack such authorization, the FDA has classified them as both adulterated and misbranded. The agency emphasized that selling these products violates federal law and may result in enforcement actions, such as civil money penalties, product seizures, or injunctions. To address these violations, mohawksmoke.com must submit a written response to the FDA within 15 working days. This response must detail the actions taken to stop the illegal sale and distribution of the products and provide a plan for ensuring future compliance with tobacco regulations.

Company
mohawksmoke.com
Product type
tobacco
Office
Office of Compliance and Enforcement
Person
  • Ele Ibarra-Pratt (Acting Director)
View Company Profile

ID · 7280b3df-2768-4f45-90f7-9fab3dc64f66

Violation Codes10
FD&C Act 910(a)(2)(A)21 U.S.C. 387b(6)(A)FD&C Act 905(j)(3)21 U.S.C. 387j(a)21 CFR 114321 U.S.C. 387a(b)FD&C Act 905(j)(1)(A)(ii)FD&C Act 901(b)21 U.S.C. 387e(j)(3)21 U.S.C. 387e(j)

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