Public Health Service Food and Drug Administration
College Park, MD 20740
MAR 10, 2015
VIA EXPRESS DELIVERY
Mr. Shinichi Okajima, President
Yamashin Company, Ltd.
Hekinan City, Aichi Japan
Dear Mr. Okajima:
The United States Food and Drug Administration (FDA) inspected your facility, Yamashin Company, Ltd. located in Hekinan City, Japan on September 8-9, 2014. During the inspection, the label of your Yamashin Shiro Shoyu (soy sauce) product was collected for review. FDA has reviewed the labeling for this product and, based on our review, we have concluded that this product is in violation of section 403 of Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 343], and the food labeling regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and these regulations through links in FDA’s home page at www.fda.gov.
Your significant violations are as follows:
Your Yamashin Shiro Shoyu (soy sauce) product is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format, as required by 21 CFR 101.9. For example, the product label fails to declare a serving size based on the reference amount customarily consumed (RACC) [21 CFR 101.12(b), Table 2] and in a common household measure [21 CFR 101.9(b)(5)]. The product label declares 180mL; however, the appropriate format based on the RACC for Sauces, Dips, Gravies, and Condiments: Major Condiments, e.g., soy sauce is 1 tablespoon (15 ml).
Your Yamashin Shiro Shoyu (soy sauce) product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For example, according to your formulation sheet:
· Your product is manufactured using “defatted soy flour,” “water,” “alcohol,” and “Kabinain T6 (Vitamin B1);” however, you fail to declare these ingredients on your finished product label.
·Your product is manufactured using the ingredient “Kabinain T6,” which is a multicomponent ingredient in that it contains two or more ingredients; however, you fail to list all sub-ingredients on your finished product label.
According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
The above violations are not meant to be an all-inclusive list of violations that exist in connection with your products and labeling. It is your responsibility to ensure that the products you market are in compliance with the Act and all applicable regulations.
You should notify this office, in writing, within 15 working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. You should include in your response documentation and other useful information that would assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may refuse admission of your imported products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the Nutritional Labeling and Education Act (NLEA) is Import Alert #99-20. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/importalert_264.html.
In addition to the above violations, we also have the following comments about your labels:
·We question the accuracy of the nutrition information in the Nutrition Facts label. We note that the serving size is declared as “180ml,” which is grossly larger than the RACC of 15 ml and the calories declared is 0, although the Nutrition Facts label declares 2g of total carbohydrates.
The net quantity of contents statement is missing from the principal display panel, as required by 21 CFR 101.105(a).
The product label fails to include the street address in the statement of the place of business, as required by 21 CFR 101.5(d). The street address may be omitted if it is shown in a current city directory or telephone directory.
You should direct your written reply to: Marjorie Davis, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions regarding any issues in this letter you may contact Ms. Davis via email at Marjorie.Davis@fda.hhs.gov.