Dhariwal Industries PVT. LTD · 99-39 · INDIA

Product code, Product and FDA notes

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C. Date Published: 12/06/2022 Desc: Pan Masala RMD 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(f) of the Act because outer box and sachet contain information in a second language. All required information must be in both languages (i.e., the English language as well as the foreign language) [21 CFR 101.15(c)(2)]. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (outer box and sachet), (21 CFR 101.4). “Condiments”, “Natural Flavors” and “Herbs” are not the common or usual names for any ingredient. 21 CFR 101.4(b) does not permit the use of the collective terms “condiments” and “herbs” in the ingredient statement. Each ingredient must be listed separately in descending order of predominance by weight. “Contains Added” term is not part of the ingredient name and needs to be removed. Spices, condiments, and herbs are not considered “natural flavors” under 21 CFR 101.22. “Flavours” (sic) is not the U.S. spellings for flavors. Section 403(q) of the FD&C Act in that the nutrition facts information is not as defined in 21 CFR 101.9. The sachets do not include a Nutrition Facts label. The outer box lists nutrients that are not in the correct increments: Calories, Total Fat, Saturated Fat, Polyunsaturated Fat, Monounsaturated Fat, Total Sugars, Added Sugars, Protein, Calcium, Iron, and Potassium declarations are not expressed in the appropriate increments [21 CFR 101.9(c)]. 54 K - - 11 Betel Nut (Herbal and Botanicals, not Teas II) Date Published: 12/06/2022 Desc: Pan Masala RMD 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(f) of the Act because outer box and sachet contain information in a second language. All required information must be in both languages (i.e., the English language as well as the foreign language) [21 CFR 101.15(c)(2)]. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (outer box and sachet), (21 CFR 101.4). “Condiments”, “Natural Flavors” and “Herbs” are not the common or usual names for any ingredient. 21 CFR 101.4(b) does not permit the use of the collective terms “condiments” and “herbs” in the ingredient statement. Each ingredient must be listed separately in descending order of predominance by weight. “Contains Added” term is not part of the ingredient name and needs to be removed. Spices, condiments, and herbs are not considered “natural flavors” under 21 CFR 101.22. “Flavours” (sic) is not the U.S. spellings for flavors. Section 403(q) of the FD&C Act in that the nutrition facts information is not as defined in 21 CFR 101.9. The sachets do not include a Nutrition Facts label. The outer box lists nutrients that are not in the correct increments: Calories, Total Fat, Saturated Fat, Polyunsaturated Fat, Monounsaturated Fat, Total Sugars, Added Sugars, Protein, Calcium, Iron, and Potassium declarations are not expressed in the appropriate increments [21 CFR 101.9(c)].