KUKJE CONFECTIONERY CO.,LTD/ · 99-39 · KOREA (THE REPUBLIC OF)

Product code, Product and FDA notes

33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate) Date Published: 11/15/2016 Desc: Fruit Stick Candy (Suckers) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) for the following: It appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, the ingredients "blue color AC5113/gardenia blue," "shade lemon yellow/safflower color," "acidity regulator," "color preparation/cochineal color," and "shade strawberry red P(red cabbage [sic]" are not appropriate common or usual names for the subject ingredients. It appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. For example: "Calories from Fat" fails to be declared in accordance with 21 CFR 101.9(c)(1)(ii); the amount of dietary fiber fails to be declared in accordance with 21 CFR 101.9(c)(6)(i); the product does not contain a statement of the amount per serving of the vitamins and minerals, calculated as a percent of the Reference Daily Intake (RDI) and expressed as percent of Daily value, as required by 21 CFR 101.9(c)(iii).; the declaration of nutrients is not in the order as described in 21 CFR 101.9(c).; the bilingual format does not appear to meet the requirements in 21 CFR 101.9(d)(14) because the foreign language must follow English.; calorie content does not appear to be declared in accordance with 21 CFR 101.9(c)(1) because there is no provision for declaring calories as "kcal"; the label format does not appear to meet the requirements for bolding of certain nutrients and bars in 21 CFR 101.9(d).