Ribon Company, Ltd. – FDA Warning Letter, Feb 20, 2015

On October 5, 2015, the FDA issued a Warning Letter to Ribon Company, Ltd. following an inspection on February 19-20, 2015, in Komaki-shi, Japan. The inspection assessed compliance with the Federal Food, Drug, and Cosmetic Act and regulations for food shipped to the U.S.

The FDA concluded that Ribon Company's "Hokkaido Milk Soft Candy" and "Hello Kitty Milk Flavored Chewy Candy" products were in violation of the Act [21 U.S.C. § 343] and 21 CFR Part 101.

Key violations included: 1. **Misbranding due to undeclared allergen:** "Hello Kitty Milk Flavored Chewy Candy" was misbranded because its label failed to declare wheat, a major food allergen, despite containing wheat protein hydrolysate [Section 403(w)]. 2. **Misbranding due to dual language requirements:** "Hokkaido Milk Soft Candy" was misbranded because it contained Japanese language information, but not all required information (e.g., Nutrition Facts, ingredient statement) was provided in both English and Japanese [Section 403(f), 21 CFR 101.15(c)(2)]. 3. **Misbranding due to undeclared or improperly declared ingredients:** Both products were misbranded as they failed