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WARNING LETTER

Marumi


Recipient:
Marumi


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

DEC 23, 2014

WARNING LETTER

VIA EXPRESS DELIVERY
 
Mr. Kiyoshi Kashimoto, President
Marumi Co., Ltd.
1-19-16, Shinimazato, Ikuno-ku
Osaka-shi, Osaka 544-0001, Japan
 
Re: 444514
 
Dear Mr. Mr. Kiyoshi Kashimoto:
 
The United States Food and Drug Administration (FDA) inspected your facility, Zdenka d.d located in Veliki Zdenci, Croatia, on July 16, 2014 through July 17, 2014. The inspection was conducted to determine compliance with the Federal, Food, Drug, and Cosmetic Act (the Act) and regulations that apply to the food that you ship to the United States. Based on our review, we have concluded that your dumpling wrapper products (Frozen Shumai Skin, Frozen Wonton Pi Shell, Frozen Wontan Skin, Gyoza Skin, and Shumai Skin) are in violation of 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 www.fda.gov.
 
1.    Your Frozen Shumai Skin, Frozen Wonton Pi Shell, Frozen Wontan Skin, Gyoza Skin, and Shumai Skin products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label does not meet the requirements of 21 CFR 101.9. For example:
 
  • The serving size is not based on an appropriate “reference amount customarily consumed” (RACC) that is appropriate to the food as defined within 21 CFR 101.12; and therefore, all the nutritional information is declared incorrectly. The appropriate RACC for Wrappers for egg rolls, dumplings, wontons, or potstickers is 60g.
  • The Gyoza Skin and Shumai Skin product labels fail to declare saturated fat as required by 21 CFR 101.9(c)(2)(i).
  • The Frozen Shaumai Skin and Frozen Wontan Skin % Daily Value declaration for calcium and iron are not in accordance with 21 CFR 101.9(c)(8)(iii).
  • The Gyoza Skin product label fails to declare calories to the nearest 5 calorie increment in accordance with 21 CFR 101.9(c)(1).
 
2.    Your Frozen Shumai Skin, Frozen Wonton Pi Shell, Frozen Wontan Skin, Gyoza Skin, and Shumai Skin products are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are 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 Gyoza Skin and Frozen Shumai Skin product labels fail to declare “sucrose esters of fatty acids” by its common or usual name.
  • The Gyoza Skin and Shumai Skin product labels declare “sorbit” in the ingredient statements; however, “sorbitol” is the common or usual name of this ingredient.
  • The Frozen Shumai Skin, Frozen Wonton Pi Shell, Frozen Wontan Skin product labels declare “alcohol” in the ingredient statement; however, “alcohol” is not an ingredient in the product.
  • The Gyoza Skin and Shumai Skin product labels declare “citric acid” in the ingredient statement; however, “citric acid” is not an ingredient in the product.
  • The Frozen Shumai Skin, Frozen Wonton Pi Shell, Frozen Wontan Skin are manufactured using “sake lees;” however, the product labels fail to declare “sake lees” in the statement of ingredients.
  • The Frozen Wonton Pi Shell is manufactured using “sodium lactate;” however, the product label fails to declare “sodium lactate” in the statement of ingredients.
  • The Gyoza Skin and Shumai Skin are manufactured using “lactic acid” and “sodium lactate;” however, the product labels fail to declare “lactic acid” and “sodium lactate” in the statement of ingredients.
  • The Frozen Wonton Pi Shell product label declares “soybean” in the contains statements; however, the product label fails to list “soybean” in the statement of ingredients.
3.    Your Frozen Shumai Skin, Frozen Wonton Pi Shell, Frozen Wontan Skin, Gyoza Skin, and Shumai Skin products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because they contain information in a second language, Japanese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). For example, the statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).
 
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported dumpling wrapper 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 food labeling requirements is 99-20. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. 
 
We offer the following additional labeling comment:
 
Your Frozen Wontan Skin product declares the allergy statement, “Allergy Information: Wheat, Soybean.” However, according to the evidence, there are no soy ingredients used in the formulation of the product. Only those major food allergens that are used to manufacture the product should be declared on the product label in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). Further, the allergen statement required by FALCPA requires the term “Contains” before the declaration of the major food allergens that are present in the food.
 
We request that you notify this office in writing, within (15) working days of receipt of this letter. Your response should include the specific steps you have taken to correct the violations. If you cannot complete all of the corrections within (15) working days, state the reason for the delay and the time within which corrections will be completed.
 
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 this letter you may contact Ms. Young via email at dehlia.young@fda.hhs.gov. 
 
Sincerely,
/S/                                                           
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition

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