K & B Manufacturing · 99-39 · INDIA

Product code, Product and FDA notes

09 A - - 02 Butter Oil Date Published: 09/01/2022 Desc: VEGETABLE COOKING OIL 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(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)). 26 B - - 99 Vegetable Oil Seed Stock, N.E.C. Date Published: 09/01/2022 Desc: VEGETABLE COOKING OIL 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(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)). 26 C - - 06 Peanut Oil, Refined, Single Ingredient Date Published: 09/01/2022 Desc: VEGETABLE COOKING OIL 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(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)). 26 C - - 15 Sunflower Oil, Single Ingredient Date Published: 09/01/2022 Desc: VEGETABLE COOKING OIL 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(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)). 26 Y - - 01 Vegetable Oil with Dried Herbs Date Published: 09/01/2022 Desc: VEGETABLE COOKING OIL 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(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)). 26 Y - - 02 Vegetable Oil with Fresh Herbs Date Published: 09/01/2022 Desc: VEGETABLE COOKING OIL 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(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)). 26 Y - - 99 Vegetable Oils Not Mentioned Elsewhere, N.E.C. Date Published: 09/01/2022 Desc: VEGETABLE COOKING OIL 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(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)). 27 Y - - 99 Condiments, N.E.C. Date Published: 09/01/2022 Desc: VEGETABLE COOKING OIL 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(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)). 30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C. Date Published: 09/01/2022 Desc: VEGETABLE COOKING OIL 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(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).