Ogura Shokuhin Co Ltd · 99-39 · JAPAN

Product code, Product and FDA notes

16 A - - -- Fish Date Published: 08/21/2024 Desc: Seasoned Alaska Pollock Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) because the product label is false or misleading. Section 403(i)(1) because Seasoned Alaska Pollock Powder product is not an appropriate name for a product that is 80% sugar colored with cochineal and 20% cod flakes. Section 403(i)(2) in that the product label fails to declare the common or usual name of each ingredient used as required by section 21 CFR 101.4, for example, the product label lists Alaska Pollock in the ingredients statement, but Denbu is made from Cod. Section 403(q)(1)(A) for failing to declare the nutrition information in accordance with 21 CFR 101.9. 16 A - - -- Fish Date Published: 08/21/2024 Desc: Dried Sardine Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q)(1)(A) because the serving size declared on the label is not based on the appropriate Reference Amounts Customarily Consumed Per Eating Occasion (RACC) as required by 21 CFR 101.9(b)(2) and CFR 101.12(b) Table 2. 16 A - - -- Fish Date Published: 08/21/2024 Desc: Dried Prepared Sardine products Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q)(1)(A) because the serving size declared on the label is not based on the appropriate Reference Amounts Customarily Consumed Per Eating Occasion (RACC) as required by 21 CFR 101.9(b)(2) and CFR 101.12(b) Table 2.