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Violation Code: 3854

FDA Violation

Charge Code: TPLKUSSLLB

6,831
Total Refusals
266
Affected Firms
1/21/2026
Latest Case
3/16/2020
First Case

Violation Details

Violation Code (ASC ID)
3854
Charge Code
TPLKUSSLLB
Description
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.
Legal Section
903(a)(2)(D); 801(a)(3); MISBRANDING

Most Affected Firms

#Firm NameLocationCases
1Swedish Match AbStockholm, SWEDEN2246
2XQS INTERNATIONAL ABBorlange, SWEDEN786
3NGP TOBACCO APSNorager, DENMARK363
4Swedish Match AbStockholm, DENMARK346
5Swedish Match North EuropeStockholm, SWEDEN308
6CBI SROTeplice, CZECH REPU277
7Gn Tobacco Sweden AbBispgarden, SWEDEN170
8Fiedler & Lundgren AbMalmo, SWEDEN165
9Skruf Snus AbStockholm, SWEDEN158
10APRES NICOTINE ABVetlanda, SWEDEN138
11NGP TOBACCOAalborg Sv, DENMARK96
12BRITISH AMERICAN TOBACCOMalmo, SWEDEN80
13CHAINPOP ABGoteborg, SWEDEN71
14LIW INNOVATION ABHokerum, SWEDEN67
15YOIK ABGemla, SWEDEN67
16HELIX SWEDEN ABHelsingborg, SWEDEN61
17ACTIV SP ZOOWarsaw, POLAND57
18Dongguan Xingda Electronic Technology, Co., LTDDongguan, CHINA56
19GLOBAL SNUS UABVilnius, LITHUANIA48
20THE SNUS BROTHERSOdeshog, SWEDEN44

Recent Import Refusals

DateProductFirm
1/21/2026
NICOTINE POUCH
98NCA11
Swedish Match AbDENMARK
1/20/2026
NICOTINE POUCH
98NCA11
Swedish Match AbDENMARK
1/15/2026
NICOTINE POUCH
98NAA11
NGP TOBACCO APSDENMARK
1/15/2026
NICOTINE POUCH
98NAA11
NGP TOBACCO APSDENMARK
1/15/2026
NICOTINE POUCH
98NAA11
NGP TOBACCO APSDENMARK
1/15/2026
NICOTINE POUCH
98NAA11
NGP TOBACCO APSDENMARK
1/15/2026
NICOTINE POUCH
98NAA11
NGP TOBACCO APSDENMARK
1/15/2026
NICOTINE POUCH
98NAA11
NGP TOBACCO APSDENMARK
1/15/2026
NICOTINE POUCH
98NAA11
NGP TOBACCO APSDENMARK
1/15/2026
NICOTINE POUCH
98NAA11
NGP TOBACCO APSDENMARK
1/15/2026
NICOTINE POUCH
98NAA11
NGP TOBACCO APSDENMARK
1/15/2026
NICOTINE POUCH
98NAA11
NGP TOBACCO APSDENMARK
1/15/2026
NICOTINE POUCH
98NAA11
NGP TOBACCO APSDENMARK
1/14/2026
NICOTINE DELIVERY PRODUCT, NEC
98NCA99
Swedish Match AbDENMARK
1/14/2026
NICOTINE POUCH
98NCA11
Skruf Snus AbSWEDEN

Frequently Asked Questions

What is FDA violation code 3854?

3854 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.". This violation is based on 903(a)(2)(D); 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 3854?

According to FDA Import Refusal data, there have been 6831 import refusals issued for violation code 3854, affecting 266 unique firms.

When was the most recent refusal for violation 3854?

The most recent import refusal for violation 3854 was on January 21, 2026.

What products are commonly refused for violation 3854?

Products commonly refused under violation 3854 include: NICOTINE POUCH. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 3854?

Violation code 3854 is based on 903(a)(2)(D); 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.