Kugi Foods Co., Ltd. · 99-39 · TAIWAN

Product code, Product and FDA notes

14 B - - 06 Imitation Milk, Dried Milk Type Product Date Published: 03/22/2019 Desc: HOKKAIDE FLAVOR POWDER 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)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. The product was analyzed to contain milk, but the label does not appear to declare milk or milk-containing ingredient. Further, the ingredient "glucose" is not a recognized common or usual name of an ingredient in the U.S. in accordance with 21 CFR 101.4(a)(1). If the ingredient is one of the standardized foods, Glucose Sirup (21 CFR 168.120) or Dried Glucose Sirup, it must be declared in accordance with the applicable standard. - Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(a). -Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). For example, the statement of identity, ingredients, nutrition facts label, and net quantity of content must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).