Reference Source

Pharmtech Korea · 99-39 · KOREA (THE REPUBLIC OF)

For Pharmtech Korea · 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 IMPERIAL BE COLLAGEN | IMPERIAL BE COLLAGEN; product code is 53 P D - 02 Collagen (Cosmetic Raw Material), Liquid, Lotion | 54 G - - 99 Animal By-Products and Extracts, N.E.C; date published is 03/30/2020; address is #59 Road,Munmak Industrial Complex , Munmak-Eup , Wonju-City, KANGWON KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

Firm
Pharmtech Korea 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
#59 Road,Munmak Industrial Complex , Munmak-Eup , Wonju-City, KANGWON KOREA (THE REPUBLIC OF) verified
Date published
03/30/2020 verified
Product code
53 P D - 02 Collagen (Cosmetic Raw Material), Liquid, Lotion | 54 G - - 99 Animal By-Products and Extracts, N.E.C. each item verified
Product
IMPERIAL BE COLLAGEN | IMPERIAL BE COLLAGEN each item verified
FDA notes
• The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(a). Specifically, the principal display panel does not bear an appropriate statement of identity. The principal display panel (PDP) lists fish collagen; however, the bottom of the box label bears the product description as "mixed drinks." • The article is subject to refusal of admission pursuant to section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the ingredients are not listed in descending order of predominance as required by 21 CFR 101.4(a)(2) and because the ingredients do not appear to be appropriate common or usual names of the ingredients as required by 21 CFR 101.4(a)(1). For example: o The product label fails to deciare the specific common or usual name of the fish species o "Seven berry" does not appear to be a common or usual name of an ingredient. o "Pomegranate (flavor)" ingredient is not declared in accordance with 21 CFR 101.22(h). o "Vitamin B1" and Vitamin B2" are not declared by their common or usual name as required by 21 CFR 101.9(c)(8)(iv). | • The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(a). Specifically, the principal display panel does not bear an appropriate statement of identity. The principal display panel (PDP) lists fish collagen; however, the bottom of the box label bears the product description as "mixed drinks." • The article is subject to refusal of admission pursuant to section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the ingredients are not listed in descending order of predominance as required by 21 CFR 101.4(a)(2) and because the ingredients do not appear to be appropriate common or usual names of the ingredients as required by 21 CFR 101.4(a)(1). For example: o The product label fails to deciare the specific common or usual name of the fish species o "Seven berry" does not appear to be a common or usual name of an ingredient. o "Pomegranate (flavor)" ingredient is not declared in accordance with 21 CFR 101.22(h). o "Vitamin B1" and Vitamin B2" are not declared by their common or usual name as required by 21 CFR 101.9(c)(8)(iv). each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Pharmtech Korea Date Published : 03/30/2020 #59 Road,Munmak Industrial Complex , Munmak-Eup , Wonju-City, KANGWON KOREA (THE REPUBLIC OF) 53 P D - 02 Collagen (Cosmetic Raw Material), Liquid, Lotion Date Published: 03/30/2020 Desc: IMPERIAL BE COLLAGEN Notes: • The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(a). Specifically, the principal display panel does not bear an appropriate statement of identity. The principal display panel (PDP) lists fish collagen; however, the bottom of the box label bears the product description as "mixed drinks." • The article is subject to refusal of admission pursuant to section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the ingredients are not listed in descending order of predominance as required by 21 CFR 101.4(a)(2) and because the ingredients do not appear to be appropriate common or usual names of the ingredients as required by 21 CFR 101.4(a)(1). For example: o The product label fails to deciare the specific common or usual name of the fish species o "Seven berry" does not appear to be a common or usual name of an ingredient. o "Pomegranate (flavor)" ingredient is not declared in accordance with 21 CFR 101.22(h). o "Vitamin B1" and Vitamin B2" are not declared by their common or usual name as required by 21 CFR 101.9(c)(8)(iv). 54 G - - 99 Animal By-Products and Extracts, N.E.C. Date Published: 03/30/2020 Desc: IMPERIAL BE COLLAGEN Notes: • The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(a). Specifically, the principal display panel does not bear an appropriate statement of identity. The principal display panel (PDP) lists fish collagen; however, the bottom of the box label bears the product description as "mixed drinks." • The article is subject to refusal of admission pursuant to section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the ingredients are not listed in descending order of predominance as required by 21 CFR 101.4(a)(2) and because the ingredients do not appear to be appropriate common or usual names of the ingredients as required by 21 CFR 101.4(a)(1). For example: o The product label fails to deciare the specific common or usual name of the fish species o "Seven berry" does not appear to be a common or usual name of an ingredient. o "Pomegranate (flavor)" ingredient is not declared in accordance with 21 CFR 101.22(h). o "Vitamin B1" and Vitamin B2" are not declared by their common or usual name as required by 21 CFR 101.9(c)(8)(iv).

accessdata.fda.gov, retrieved 2026-09-15

Source

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