FDA WARNING_LETTER - Suzukatsu Co., Ltd - September 12, 2014

On September 11-12, 2014, the FDA inspected Suzukatsu Co., Ltd. in Shizuoka, Japan, and found violations of the Federal Food, Drug, and Cosmetic Act, specifically section 403, and 21 CFR Part 101, regarding food labeling.

The "Eel Grilling Sauce Unagi Kabaya No Tare Regular" product was misbranded because its label failed to declare all ingredients as required by 21 CFR 101.4. Specifically, "corn syrup" was listed but not in the formulation, and sub-ingredients of "glucose syrup" (sweet potato starch, potato starch, corn starch) were not listed.

Both "Eel Grilling Sauce Unagi Kabaya No Tare Thick Type Koikuchi" and "Eel Grilling Sauce Unagi Kabaya No Tare Regular" products were misbranded under Section 403(q) because their Nutrition Facts Panels were incorrectly formatted per 21 CFR 101.9. The declared serving sizes (1 tablespoon) were not based on the appropriate Reference Amount Customarily Consumed (RACC) of 2 tablespoons (30mL) for sauces.

The FDA also noted additional labeling issues: the "Contains" statement was not in the required FALCPA format, the street address was omitted from the manufacturer's information without justification, and not all required label information was repeated in both