Sobaek Insam Farming Association · 99-39 · KOREA (THE REPUBLIC OF)
For Sobaek Insam Farming Association · 99-39 · KOREA (THE REPUBLIC OF), import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is KOREA (THE REPUBLIC OF); product is Sobaek Korea Red Ginseng Premium Extract | Sobaek Korea Red Ginseng Premium Extract | Sobaek Korea Red Ginseng Premium Extract | Sobaek Korea Red Ginseng Premium Extract | Sobaek Korea Red Ginseng Premium Extract; product code is 25 M - - 31 Ginseng, Juice or Drink (Root & Tuber Vegetable) | 25 N - - 31 Ginseng, with Sauce (Root & Tuber Vegetable) | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 04/16/2025; address is 2115 Sobaek-Ro , Punggi-Eup , Yeongju, Gyeongsangbuk KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Sobaek Insam Farming Association verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- 2115 Sobaek-Ro , Punggi-Eup , Yeongju, Gyeongsangbuk KOREA (THE REPUBLIC OF) verified
- Date published
- 04/16/2025 verified
- Product code
- 25 M - - 31 Ginseng, Juice or Drink (Root & Tuber Vegetable) | 25 N - - 31 Ginseng, with Sauce (Root & Tuber Vegetable) | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. each item verified
- Product
- Sobaek Korea Red Ginseng Premium Extract | Sobaek Korea Red Ginseng Premium Extract | Sobaek Korea Red Ginseng Premium Extract | Sobaek Korea Red Ginseng Premium Extract | Sobaek Korea Red Ginseng Premium Extract each item verified
- FDA notes
- The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of the following sections: Section 403(f)], the proposed reconditioning LBL contains information in two languages, but it does not repeat all required information in both languages, as per 21 CFR 101.15(c). Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and the proposed reconditioning LBL fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4; Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and it fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4. Section 761, the proposed reconditioning LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of the following sections: Section 403(f)], the proposed reconditioning LBL contains information in two languages, but it does not repeat all required information in both languages, as per 21 CFR 101.15(c). Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and the proposed reconditioning LBL fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4; Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and it fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4. Section 761, the proposed reconditioning LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of the following sections: Section 403(f)], the proposed reconditioning LBL contains information in two languages, but it does not repeat all required information in both languages, as per 21 CFR 101.15(c). Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and the proposed reconditioning LBL fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4; Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and it fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4. Section 761, the proposed reconditioning LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of the following sections: Section 403(f)], the proposed reconditioning LBL contains information in two languages, but it does not repeat all required information in both languages, as per 21 CFR 101.15(c). Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and the proposed reconditioning LBL fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4; Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and it fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4. Section 761, the proposed reconditioning LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of the following sections: Section 403(f)], the proposed reconditioning LBL contains information in two languages, but it does not repeat all required information in both languages, as per 21 CFR 101.15(c). Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and the proposed reconditioning LBL fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4; Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and it fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4. Section 761, the proposed reconditioning LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. each item verified
What the source says
Sobaek Insam Farming Association Date Published : 04/16/2025 2115 Sobaek-Ro , Punggi-Eup , Yeongju, Gyeongsangbuk KOREA (THE REPUBLIC OF) 25 M - - 31 Ginseng, Juice or Drink (Root & Tuber Vegetable) Date Published: 04/16/2025 Desc: Sobaek Korea Red Ginseng Premium Extract Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of the following sections: Section 403(f)], the proposed reconditioning LBL contains information in two languages, but it does not repeat all required information in both languages, as per 21 CFR 101.15(c). Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and the proposed reconditioning LBL fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4; Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and it fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4. Section 761, the proposed reconditioning LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. 25 N - - 31 Ginseng, with Sauce (Root & Tuber Vegetable) Date Published: 04/16/2025 Desc: Sobaek Korea Red Ginseng Premium Extract Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of the following sections: Section 403(f)], the proposed reconditioning LBL contains information in two languages, but it does not repeat all required information in both languages, as per 21 CFR 101.15(c). Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and the proposed reconditioning LBL fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4; Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and it fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4. Section 761, the proposed reconditioning LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 04/16/2025 Desc: Sobaek Korea Red Ginseng Premium Extract Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of the following sections: Section 403(f)], the proposed reconditioning LBL contains information in two languages, but it does not repeat all required information in both languages, as per 21 CFR 101.15(c). Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and the proposed reconditioning LBL fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4; Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and it fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4. Section 761, the proposed reconditioning LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. 54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals Date Published: 04/16/2025 Desc: Sobaek Korea Red Ginseng Premium Extract Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of the following sections: Section 403(f)], the proposed reconditioning LBL contains information in two languages, but it does not repeat all required information in both languages, as per 21 CFR 101.15(c). Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and the proposed reconditioning LBL fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4; Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and it fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4. Section 761, the proposed reconditioning LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 04/16/2025 Desc: Sobaek Korea Red Ginseng Premium Extract Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of the following sections: Section 403(f)], the proposed reconditioning LBL contains information in two languages, but it does not repeat all required information in both languages, as per 21 CFR 101.15(c). Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and the proposed reconditioning LBL fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4; Section 403(q)(5)(F)], the proposed reconditioning LBL fails to declare the serving size in the Supplement Facts label, as per 21 CFR 101.36(b)(1)(i); and it fails to declare all the common or usual names of each ingredient used, as per 21 CFR 101.36 and 21 CFR 101.4. Section 761, the proposed reconditioning LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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