UHA Mikakuto Co.,Ltd. – FDA Warning Letter, Feb 2, 2015

The FDA inspected Mikakuto Co., Ltd. in Yamatokooriyama-shi, Japan, from January 30 to February 2, 2015. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act and food labeling regulations (21 CFR 101) concerning their "Shuwa Puccho Stick Soda," "Shuwa Puccho Stick Cola," "Uha Puccho Stick Grape," and "Uha Puccho Stick Nama Muscat" candy products.

Key violations include: 1. **Misbranding due to undeclared allergen:** The "Uha Puccho Stick Nama Muscat" product is misbranded because its label fails to declare milk, a major food allergen, despite containing "yogurt" which contains milk, violating Section 403(w) of the Act. 2. **Misbranding due to incorrect nutrition information format:** All four candy products are misbranded under Section 403(q) of the Act because their nutrition information is improperly formatted. Deficiencies include: * Failure to declare serving size based on the Reference Amount Customarily Consumed (RACC) and in a common household measure (21 CFR 101.9(b)(7), 101.9(d)(3)(i)). * Failure to declare percent daily values for total fat, saturated fat, cholesterol, sodium,