FDA WARNING_LETTER - Nissin Food Co Inc. USA

On September 13, 2010, the FDA issued a Warning Letter to Nissin Foods (USA) Co., Inc. regarding their "Cup Noodles® With Shrimp" product. The FDA's review of the product label concluded that it violates the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101.

The product is deemed misbranded under section 403(r)(1)(A) of the Act because it bears a nutrient content claim, "0 g Trans Fat," on the principal display panel but fails to meet the required disclosure statement under 21 CFR 101.13(h). The "0 g Trans Fat" claim characterizes the product's trans fat level, a nutrient required in nutrition labeling. However, the Nutrition Facts panel declares 7g saturated fat and 1180mg sodium per serving. Since the product contains more than 4g saturated fat and 480mg sodium per serving, it must include a disclosure statement, such as "See nutrition information for saturated fat and sodium content," immediately adjacent to the claim, as per 21 CFR 101.13(h)(1). The product label lacks this required statement.

Nissin Foods is instructed to take prompt action to correct this violation. Failure to do so may result in regulatory action, including seizure or injunction, without further notice. A written response