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WARNING LETTER
•bongsociety.com•December 1, 2025

bongsociety.com – FDA Warning Letter, Dec 1, 2025

Record Details

On December 30, 2025, the FDA"s Center for Tobacco Products issued a Warning Letter to bongsociety.com for marketing unapproved nicotine pouch products. The agency reviewed the company"s website and found nicotine pouch products, including "ON! Plus Nicotine Pouches Raspberry Lemon - 5 Pack 6mg," "ON! Plus Nicotine Pouches Citrus - 5 Pack 6mg," and "ON! Plus Nicotine Pouches Berry - 5 Pack 6mg," offered for sale to U.S. customers. These products are considered "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially marketed in the U.S. as of February 15, 2007, and contain nicotine from any source, falling under expanded FDA jurisdiction. The main violation is the sale of these products without the required premarket authorization order, rendering them unlawfully marketed, adulterated, and misbranded. The FDA requires bongsociety.com to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing sales and outlining a plan for future compliance with the FD&C Act and its implementing regulations. Failure to comply could lead to further enforcement actions, such as civil money penalties, product seizure, or injunction.

Company
bongsociety.com
Inspection date
December 1, 2025
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • John E. Verbeten (Director)
View Company Profile

ID · fe4f8e59-2302-4e81-99fd-b28529aa732f

Violation Codes10
FD&C Act 201(rr)21 U.S.C. 321(rr)FD&C Act 901(b)21 U.S.C. 387a(b)21 CFR 1100.1FD&C Act 910(a21 U.S.C. 387j(a)FD&C Act 910(c}(1)(A)(i)21 U.S.C. 387j(c)(1)(A)(i)FD&C Act 905(j)

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