- Suzukatsu Co., Ltd
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
FEB 13, 2015
Mr. Yoshihiko Suzuki, President
Suzukatsu Co., Ltd.
Yaizu, Shizuoka 421-0211 Japan
Dear Mr. Suzuki:
The United States Food and Drug Administration (FDA) inspected your facility, Suzukatsu Co., Ltd. located in Shizuoka 421-0211 Japan on September 11-12, 2014. During the inspection, labels of your Eel Grilling Sauce Unagi Kabaya No Tare Thick Type Koikuchi and Eel Grilling Sauce Unagi Kabaya No Tare Regular products were collected for review. FDA has reviewed the labeling for these products and, based on our review, we have concluded that these products are 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 were as follows:
1. Your Eel Grilling Sauce Unagi Kabaya No Tare Regular product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. For example:
· The product label declares “corn syrup;” however, this ingredient is not in the product formulation.
· The product is manufactured using glucose syrup; however, it fails to list the sub-ingredients “sweet potato starch,” “potato starch,” and “corn starch” on the 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, or by listing the component ingredients without listing the ingredient itself. 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.
2. Your Eel Grilling Sauce Unagi Kabaya No Tare Thick Type Koikuchi and Eel Grilling Sauce Unagi Kabaya No Tare Regular products are 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 labels fail to declare a serving size based on the reference amount customarily consumed (RACC) and in a common household measure as required by 21 CFR 101.9(b)(7) & 101.9(d)(3)(i). Specifically,
· The Eel Grilling Sauce Unagi Kabaya No Tare Thick Type Koikuchi product label declares 1 tablespoon (25g); however, the appropriate RACC for Sauces, Dips, Gravies, and Condiments is 2 tablespoons (30mL).
· The Eel Grilling Sauce Unagi Kabaya No Tare Regular product label declares 1 tablespoon (21g); however, the appropriate RACC for Sauces, Dips, Gravies, and Condiments is 2 tablespoons (30mL).
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:
· The “Contains” statement on these product labels is not provided in the format required by the Food Allergen Labeling and Consumer Protection Act (FALCPA). A “Contains” statement must appear on the label immediately after or adjacent to the ingredient statement in the same type as that used for the ingredient list.
· The statement of the name and place of business of the manufacturer, packer, or distributor does not contain the street address. The street address may be omitted if it is shown in a current city directory or telephone directory (21 CFR 101.5(d)).
· The product labels contain information in two languages but do not repeat all the required label information in both languages. As required by 21 CFR 101.15(c)(1), all information required to appear on the label must appear in English. Where a product label contains any representation in a foreign language or in foreign characters, under 21 CFR 101.15(c)(2) all words, statements, and other information required to appear on the label must appear in the foreign language.
You should direct your written reply to: Dehlia Young, 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. Young via email at firstname.lastname@example.org.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition
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