WOOSHIN LABOTTACH CO.,LTD. · 99-39 · KOREA (THE REPUBLIC OF)
For WOOSHIN LABOTTACH CO.,LTD. · 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 Gut Support with Probiotics | Weight Control | Nerve + Neuropathy Support; product code is 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 10/12/2023; address is # 1907 Daerung P-Toweri , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- WOOSHIN LABOTTACH CO.,LTD. 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
- # 1907 Daerung P-Toweri , Seoul, KOREA (THE REPUBLIC OF) verified
- Date published
- 10/12/2023 verified
- Product code
- 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. each item verified
- Product
- Gut Support with Probiotics | Weight Control | Nerve + Neuropathy Support each item verified
- FDA notes
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(1) of the Act in that they fail to list the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the Act because the labels fail to declare the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(q)(1)(B) of the Act because each product label fails to list the servings per container under the serving size on the left-hand side of the nutrition label (i.e., the Supplement Facts label) or fails to include this information as part of the net quantity of contents declaration (21 CFR 101.36(b)(1)(ii)). Section 403(q)(5)(F) of the Act because the presentation of the nutrition information on the labeling of each product label does not comply with 21 CFR 101.36, 21 CFR 101.4, and 21 CFR 101.9. Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. 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. Section 403(s)(2)(C) of the Act because each product label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(1) of the Act in that they fail to list the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the Act because the labels fail to declare the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(q)(1)(B) of the Act because each product label fails to list the servings per container under the serving size on the left-hand side of the nutrition label (i.e., the Supplement Facts label) or fails to include this information as part of the net quantity of contents declaration (21 CFR 101.36(b)(1)(ii)). Section 403(q)(5)(F) of the Act because the presentation of the nutrition information on the labeling of each product label does not comply with 21 CFR 101.36, 21 CFR 101.4, and 21 CFR 101.9. Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. 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. Section 403(s)(2)(C) of the Act because each product label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, (21 CFR 101.4(h)(1)). Section 403(i)(2) of the Act because each product label fails to declare all the common or usual names of each ingredient used (21 CFR 101.36 and 21 CFR 101.4(a) and (g)). | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(1) of the Act in that they fail to list the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5) Section 403(e)(2) of the Act because the labels fail to declare the net quantity of contents on the principal display panel (21 CFR 101.7} Section 403(q)(1)(B) of the Act because each product label fails to list the servings per container under the serving size on the left-hand side of the nutrition label (i.e., the Supplement Facts label) or fails to include this information as part of the net quantity of contents declaration (21 CFR 101.36(b)(1)(ii)). Section 403(q)(5)(F) of the Act because the presentation of the nutrition information on the labeling of each product label does not comply with 21 CFR 101.36, 21 CFR 101.4, and 21 CFR 101.9). Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. 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. Section 403(s)(2)(C) of the Act because each product label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Section 403(i)(2) of the Act because each product label fails to declare all the common or usual names of each ingredient used (21 CFR 101.36 and 21 CFR 101.4(a) and (g)). each item verified
What the source says
WOOSHIN LABOTTACH CO.,LTD. Date Published : 10/12/2023 # 1907 Daerung P-Toweri , Seoul, KOREA (THE REPUBLIC OF) 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 10/12/2023 Desc: Gut Support with Probiotics Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(1) of the Act in that they fail to list the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the Act because the labels fail to declare the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(q)(1)(B) of the Act because each product label fails to list the servings per container under the serving size on the left-hand side of the nutrition label (i.e., the Supplement Facts label) or fails to include this information as part of the net quantity of contents declaration (21 CFR 101.36(b)(1)(ii)). Section 403(q)(5)(F) of the Act because the presentation of the nutrition information on the labeling of each product label does not comply with 21 CFR 101.36, 21 CFR 101.4, and 21 CFR 101.9. Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. 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. Section 403(s)(2)(C) of the Act because each product label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 10/12/2023 Desc: Weight Control Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(1) of the Act in that they fail to list the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the Act because the labels fail to declare the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(q)(1)(B) of the Act because each product label fails to list the servings per container under the serving size on the left-hand side of the nutrition label (i.e., the Supplement Facts label) or fails to include this information as part of the net quantity of contents declaration (21 CFR 101.36(b)(1)(ii)). Section 403(q)(5)(F) of the Act because the presentation of the nutrition information on the labeling of each product label does not comply with 21 CFR 101.36, 21 CFR 101.4, and 21 CFR 101.9. Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. 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. Section 403(s)(2)(C) of the Act because each product label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, (21 CFR 101.4(h)(1)). Section 403(i)(2) of the Act because each product label fails to declare all the common or usual names of each ingredient used (21 CFR 101.36 and 21 CFR 101.4(a) and (g)). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 10/12/2023 Desc: Nerve + Neuropathy Support Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(1) of the Act in that they fail to list the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5) Section 403(e)(2) of the Act because the labels fail to declare the net quantity of contents on the principal display panel (21 CFR 101.7} Section 403(q)(1)(B) of the Act because each product label fails to list the servings per container under the serving size on the left-hand side of the nutrition label (i.e., the Supplement Facts label) or fails to include this information as part of the net quantity of contents declaration (21 CFR 101.36(b)(1)(ii)). Section 403(q)(5)(F) of the Act because the presentation of the nutrition information on the labeling of each product label does not comply with 21 CFR 101.36, 21 CFR 101.4, and 21 CFR 101.9). Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. 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. Section 403(s)(2)(C) of the Act because each product label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Section 403(i)(2) of the Act because each product label fails to declare all the common or usual names of each ingredient used (21 CFR 101.36 and 21 CFR 101.4(a) and (g)).
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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