Yamashin Company, Ltd. – FDA Warning Letter, Sep 9, 2014

The FDA inspected Yamashin Company, Ltd. in Hekinan City, Japan, on September 8-9, 2014. The inspection and subsequent label review of their Yamashin Shiro Shoyu (soy sauce) product revealed violations of the Federal Food, Drug, and Cosmetic Act and food labeling regulations (21 CFR 101).

The Yamashin Shiro Shoyu product is misbranded under Section 403(q) because its Nutrition Facts Panel is incorrectly formatted. Specifically, the serving size is declared as 180mL, not the required 1 tablespoon (15 ml) based on the Reference Amount Customarily Consumed (RACC) for soy sauce (21 CFR 101.9, 101.12(b)).

Additionally, the product is misbranded under Section 403(i)(2) because it fails to declare all ingredients on the label, as required by 21 CFR 101.4. Ingredients like "defatted soy flour," "water," "alcohol," and "Kabinain T6 (Vitamin B1)" are used but not listed. Furthermore, "Kabinain T6," a multi-component ingredient, does not have its sub-ingredients declared, violating 21 CFR 101.4(b)(2).

The FDA also noted concerns regarding the accuracy of nutrition information (0 calories