Violation Code: 3140
FDA Violation
Charge Code: SBGINSENG
Violation Details
- Violation Code (ASC ID)
- 3140
- Charge Code
- SBGINSENG
- Description
- The article is subject to refusal of admission in that it appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are not an herb or herbal ingredient derived from a plant classified within the genus Panax.
- Legal Section
- 801(a)(3); 403(u) Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Top Shelf Food and Beverage Corp | Scarborough, CANADA | 47 |
| 2 | BELIEVE SUPPLEMENTS | Blainville, CANADA | 21 |
| 3 | Lifestyles Global Network | Vaughan, CANADA | 9 |
| 4 | 7338457 Canada Inc dba Karma Nutritionals | Langley, CANADA | 9 |
| 5 | Believe Supplements | Blainville, CANADA | 6 |
| 6 | Terra Botanica Products Ltd. | Nakusp, CANADA | 4 |
| 7 | Advanced Orthomolecular Research Inc | Calgary, CANADA | 4 |
| 8 | MP KSS SRL | Chisinau, MOLDOVA | 4 |
| 9 | Nutri-Nation Functional Foods | Port Coquitlam, CANADA | 3 |
| 10 | 1965599 ONTARIO LTD | Windsor, CANADA | 3 |
| 11 | Naka Sales Ltd | Etobicoke, CANADA | 3 |
| 12 | Cactus Botanics Limited | Shanghai, CHINA | 2 |
| 13 | Biotanico, Inc. | Tainan City, TAIWAN | 2 |
| 14 | Naturex | Avignon Cedex 9, FRANCE | 2 |
| 15 | Min Tong Pharmaceutical Company | Taichung, TAIWAN | 2 |
| 16 | GFR PHARMA | Maple Ridge, CANADA | 2 |
| 17 | Huisong Pharmaceuticals | Hangzhou, CHINA | 2 |
| 18 | Cognis Iberia S.L. | Castellbisbal, SPAIN | 2 |
| 19 | A.G.M. Foods Pty Ltd | Wynnum, AUSTRALIA | 2 |
| 20 | Karma Nutritionals | Pitt Meadowspitt Meadows, CANADA | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/8/2025 | GINSENG (HERBAL & BOTANICALS, NOT TEAS) 54FCY12 | MP KSS SRLMOLDOVA |
| 12/8/2025 | GINSENG (HERBAL & BOTANICALS, NOT TEAS) 54FCY12 | MP KSS SRLMOLDOVA |
| 11/20/2025 | GINSENG (HERBAL & BOTANICALS, NOT TEAS) 54FCY12 | MP KSS SRLMOLDOVA |
| 11/20/2025 | GINSENG (HERBAL & BOTANICALS, NOT TEAS) 54FCY12 | MP KSS SRLMOLDOVA |
| 8/2/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCE99 | 1965599 ONTARIO LTDCANADA |
| 8/2/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCE99 | 1965599 ONTARIO LTDCANADA |
| 8/2/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCE99 | 1965599 ONTARIO LTDCANADA |
| 7/17/2024 | GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS 54YCI04 | Vitamin-One FormulasCANADA |
| 11/16/2023 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | Believe SupplementsCANADA |
| 11/16/2023 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | Believe SupplementsCANADA |
| 11/16/2023 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | Believe SupplementsCANADA |
| 11/16/2023 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | Believe SupplementsCANADA |
| 10/20/2023 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | BELIEVE SUPPLEMENTSCANADA |
| 8/29/2023 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCY99 | |
| 8/28/2023 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YYY99 | BELIEVE SUPPLEMENTSCANADA |
Frequently Asked Questions
What is FDA violation code 3140?
3140 is an FDA violation code that indicates: "The article is subject to refusal of admission in that it appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are not an herb or herbal ingredient derived from a plant classified within the genus Panax.". This violation is based on 801(a)(3); 403(u) Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3140?
According to FDA Import Refusal data, there have been 189 import refusals issued for violation code 3140, affecting 78 unique firms.
When was the most recent refusal for violation 3140?
The most recent import refusal for violation 3140 was on December 8, 2025.
What products are commonly refused for violation 3140?
Products commonly refused under violation 3140 include: GINSENG (HERBAL & BOTANICALS, NOT TEAS), VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3140?
Violation code 3140 is based on 801(a)(3); 403(u) 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.