Inspections, Compliance, Enforcement, and Criminal Investigations
Nissin Foods Co Inc. USA 9/13/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
September 13, 2010
RETURN RECEIPT REQUESTED
Mr. Ken Sasahara, President
Nissin Foods (USA) Co., Inc.
2001 W. Rosecrans Ave.
Gardena, California 90249
Dear Mr. Sasahara:
The Food and Drug Administration (FDA) has reviewed the label for your “Cup Noodles® With Shrimp” product. Based on our review, we have concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find copies of the Act and these regulations through links in FDA’s home page at http://www.fda.gov.
Your “Cup Noodles® With Shrimp” product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim but does not meet the requirements to make the claim. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation promulgated by the Secretary (or by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient in the labeling of a food without complying with the applicable nutrient content claim requirements misbrands the product under section 403(r)(1)(A) of the Act.
Your “Cup Noodles® With Shrimp” product bears the phrase “0 g Trans Fat,” a nutrient content claim, on the principal display panel of the product label, but fails to bear the disclosure statement required by 21 CFR 101.13(h). The phrase “0 g Trans Fat” meets the definition of a nutrient content claim because it characterizes the product’s level of trans fat, which is a nutrient of the type required to be in nutrition labeling (21 CFR 101.13(b)). The Nutrition Facts panel of your product declares the nutrient values of 7 g saturated fat and 1180 mg sodium per serving. A food that bears a nutrient content claim that contains more than 4 g of saturated fat and 480 mg of sodium per labeled serving must bear a disclosure statement (immediately adjacent to the claim) referring the consumer to nutrition information for saturated fat and sodium, e.g., “See nutrition information for saturated fat and sodium content,” as required by 21 CFR 101.13(h)(1). The label of your product fails to bear the required disclosure statement.
This letter is not intended to be an all-inclusive review of your products and their labeling. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations. You should take prompt action to correct this violation. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct this violation and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
Your written response should be sent to Latasha Robinson, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions please contact Ms. Robinson at 301-436-1890.
Office of Compliance
Center for Food Safety
and Applied Nutrition