Reference Source

DR.BAELTZ CO.,LTD · 99-39 · JAPAN

For DR.BAELTZ CO.,LTD · 99-39 · JAPAN, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is JAPAN; product is Puerafica Anti-Aging Supplement; product code is 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 10/02/2015; address is 2 Chome 3-23 , Senzui , Asaka, Saitama JAPAN, verified against its source on 2026-09-16.

Firm
DR.BAELTZ CO.,LTD verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
JAPAN verified
Address
2 Chome 3-23 , Senzui , Asaka, Saitama JAPAN verified
Date published
10/02/2015 verified
Product code
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. verified
Product
Puerafica Anti-Aging Supplement verified
FDA notes
VIOLATION (IN NOTES): 1. 403(q) ; 403(i)(2) 1. 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(q) of the Act [21 U.S.C. § 343(q)] because the label fails to bear nutrition labeling (Supplement Facts panel) in the proper format, which is required under 21 CFR 101.36. For example: The caloric content is expressed in kcal rather than Calories. The Percent Daily Value for dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) are not declared. Specifically, the product does not list the percent daily values for Vitamin A, Vitamin C, Vitamin D, Vitamin E, thiamin(Vitamin B1), niacin (Vitamin B3), folate (folic acid), Vitamin B12, pantothenic acid as required by 21 CFR 101.36(b)(2)(iii). The quantitative amount by weight per serving for each dietary ingredient are not declared as required by 21 CFR 101.36(b)(2) and 101.36(b)(3). The correct nomenclature for some of the dietary ingredients is not declared, as required by 21 CFR 101.36(b)(2)(B). For example, niacin is incorrectly listed as nicotinamide. The dietary ingredients are not listed in the proper order. Specifically, Vitamin B6, Vitamin E, sodium, Vitamin C, niacin, pantothenic acid, thiamin, folic acid, Vitamin B12, Vitamin A, and Vitamin Dare not in the correct order, as required by 21 CFR 10 1.36(b )(2)(i)(B). verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

DR.BAELTZ CO.,LTD Date Published : 10/02/2015 2 Chome 3-23 , Senzui , Asaka, Saitama JAPAN 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 10/02/2015 Desc: Puerafica Anti-Aging Supplement Notes: VIOLATION (IN NOTES): 1. 403(q) ; 403(i)(2) 1. 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(q) of the Act [21 U.S.C. § 343(q)] because the label fails to bear nutrition labeling (Supplement Facts panel) in the proper format, which is required under 21 CFR 101.36. For example: The caloric content is expressed in kcal rather than Calories. The Percent Daily Value for dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) are not declared. Specifically, the product does not list the percent daily values for Vitamin A, Vitamin C, Vitamin D, Vitamin E, thiamin(Vitamin B1), niacin (Vitamin B3), folate (folic acid), Vitamin B12, pantothenic acid as required by 21 CFR 101.36(b)(2)(iii). The quantitative amount by weight per serving for each dietary ingredient are not declared as required by 21 CFR 101.36(b)(2) and 101.36(b)(3). The correct nomenclature for some of the dietary ingredients is not declared, as required by 21 CFR 101.36(b)(2)(B). For example, niacin is incorrectly listed as nicotinamide. The dietary ingredients are not listed in the proper order. Specifically, Vitamin B6, Vitamin E, sodium, Vitamin C, niacin, pantothenic acid, thiamin, folic acid, Vitamin B12, Vitamin A, and Vitamin Dare not in the correct order, as required by 21 CFR 10 1.36(b )(2)(i)(B).

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

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