Violation Code: 2300
FDA Violation
Charge Code: DIETARYLBL
Violation Details
- Violation Code (ASC ID)
- 2300
- Charge Code
- DIETARYLBL
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
- Legal Section
- 403(s)(2)(B), 801(a)(3), misbranded
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Equisalud S.L.U. | Huarte, SPAIN | 42 |
| 2 | Swiss Natural Sources | Richmond Hill, CANADA | 39 |
| 3 | PHARMA GREEN S.R.L. | Falciano, ITALY | 34 |
| 4 | Dana Ya | Kyiv, UKRAINE | 29 |
| 5 | ZooScape Corporation | Brampton, CANADA | 25 |
| 6 | Webber | Burnaby, CANADA | 25 |
| 7 | Nelikunnath Arya Vaidya Sala | Kerala, INDIA | 21 |
| 8 | REMEDI WELLNESS AND SPA | Burnaby, CANADA | 20 |
| 9 | Canadian Forest Tree Essences Inc | Aylmer, CANADA | 19 |
| 10 | Herb-Xtra | Ste-Julie, CANADA | 18 |
| 11 | Gladys Saldana Mieres | Santiago, CHILE | 18 |
| 12 | Interactive Nutrition | Ottawa, CANADA | 16 |
| 13 | KITCHEN XPRESS OVERSEAS LTD | Gujarat, INDIA | 16 |
| 14 | OKONET EUROPE KERESKEDELMI ES | Dabas, HUNGARY | 16 |
| 15 | UAB "EKV Logistik | Kovno, LITHUANIA | 15 |
| 16 | Wn Pharmaceuticals | Coquitlam, CANADA | 15 |
| 17 | Omega Alpha Pharmaceuticals | Scarborough, CANADA | 14 |
| 18 | Vitaquest International LLC d/b/a State Nutritionals, Inc. | West Caldwell, UNITED STA | 14 |
| 19 | 7567600 Canada Inc | Quebec, CANADA | 14 |
| 20 | HAMSOA PHARMACEUTICAL CO., LTD. | Seoul, SOUTH KORE | 14 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/3/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCY99 | |
| 12/3/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCY99 | Sheth BrothersINDIA |
| 12/3/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCY99 | Sheth BrothersINDIA |
| 11/5/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | |
| 10/27/2025 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BYY99 | GLOBAL FASHIONVIETNAM |
| 10/18/2025 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | KHBO VITA, OOORUSSIA |
| 9/26/2025 | CYPROHEPTADINE HCL (ANTI-HISTAMINIC) 61XCK14 | New GPC Inc.GUYANA |
| 9/26/2025 | FERRIC CITRATE (PHOSPHATE BINDER) 63LCK01 | New GPC Inc.GUYANA |
| 9/23/2025 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | WOOLTARI KOREASOUTH KORE |
| 9/23/2025 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BYY99 | WOOLTARI KOREASOUTH KORE |
| 9/19/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Jamieson LaboratoriesCANADA |
| 9/19/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Jamieson LaboratoriesCANADA |
| 9/19/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Jamieson LaboratoriesCANADA |
| 8/21/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | JEEVITHA ENTERPRISESINDIA |
| 7/29/2025 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BGT99 | COLOMBIAN ROOTS COMPANY SASCOLOMBIA |
Frequently Asked Questions
What is FDA violation code 2300?
2300 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 in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.". This violation is based on 403(s)(2)(B), 801(a)(3), misbranded of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2300?
According to FDA Import Refusal data, there have been 2597 import refusals issued for violation code 2300, affecting 1112 unique firms.
When was the most recent refusal for violation 2300?
The most recent import refusal for violation 2300 was on December 3, 2025.
What products are commonly refused for violation 2300?
Products commonly refused under violation 2300 include: HERBALS & BOTANICALS (NOT TEAS), N.E.C., VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C., FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2300?
Violation code 2300 is based on 403(s)(2)(B), 801(a)(3), misbranded 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.