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WARNING LETTER

Mikakuto Co.,Ltd. Jul 01, 2015

Mikakuto Co.,Ltd. - 07/01/2015


Recipient:
Mikakuto Co.,Ltd.


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 

JULY 1, 2015 

WARNING LETTER 
 
VIA EXPRESS DELIVERY
 
Mr. Hiroyuki Morita, Plant Manager
Mikakuto Co., Ltd.
137-5 Imagou-cho,
Yamatokooriyama-shi, Japan
 
Re: 461446
 
Dear Mr. Morita:
 
The United States Food and Drug Administration (FDA) inspected your facility, Mikakuto Co., Ltd., located in Yamatokooriyama-shi, Japan on January 30 through February 2, 2015. During the inspection, the labels of your “Shuwa Puccho Stick Soda,” “Shuwa Puccho Stick Cola,” “Uha Puccho Stick Grape,” and “Uha Puccho Stick Nama Muscat” candy 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  “Uha Puccho Stick Nama Muscat” candy product is misbranded within the meaning of Section 403(w) of the Act, [21 U.S.C. § 343(w)], in that the finished product label fails to declare the major food allergen, milk, as required by section 403(w)(1) of the Act. Specifically, your product is manufactured using “yogurt,” which contains “milk;” however, you fail to list “milk” on your finished product label.

 
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils as “major food allergens.” A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either: 
  • The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or
  • The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
2.    Your “Shuwa Puccho Stick Soda,” “Shuwa Puccho Stick Cola,” “Uha Puccho Stick Grape,” and “Uha Puccho Stick Nama Muscat” candy products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format. 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) and 101.9(d)(3)(i). The appropriate RACC for “Sugars and Sweets: All other candies,” is 40g. Therefore, all of the nutrient amounts are incorrectly declared.
 
  • The product labels fail to declare percent daily values for total fat, saturated fat, cholesterol, sodium, total carbohydrate, and dietary fiber as required by 21 CFR 101.9(d)(7)(ii).
  • The product labels fail to declare the number of servings per container as required by 21 CFR 101.9(b)(8) and 101.9(d)(3)(ii).
  • The statement of calories is expressed in terms of kcal, which is not in accordance with 21 CFR 101.9(c)(1).
  • The product labels fail to include a footnote as required by 21 CFR 101.9(d)(9). (Percent Daily Values are based on a 2,000 calorie diet. Your Daily Values may be higher or lower depending on your calorie needs.)
 

3.    Your “Uha Puccho Stick Nama Muscat” candy product is misbranded within 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. Specifically, the Uha Puccho Stick Nama Muscat” candy product is manufactured using “yogurt;” however, you fail to list the sub-ingredients on your finished product label.

 
In accordance with 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.
 
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.
 
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 website at: http://www.accessdata.fda.gov/cms_ia/importalert_264.html.
 
For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with Allergen Labeling is Import Alert 99-22. This alert can be found on FDA’s website at: http://www.accessdata.fda.gov/cms_ia/importalert_561.html
 
In addition to the above violations, we also have the following comments about your labels: 
  • The product labels fail to include a street address of the distributor as required by 21 CFR 101.5(d). However, the street address may be omitted if it is shown in a current city directory or telephone directory.
  • The abbreviations declared in the nutrition information does not meet the requirements under 21 CFR 101.9(j)(13)(ii)(B). The product labels declare “Ser.Size; however, the appropriate abbreviation for “Serving size” is “Serv size.”
  • The product labels declare “flavor” in the ingredients statement which is not in accordance with 21 CFR 101.22. The regulations states that such an ingredient may be declared as “artificial flavor.”
  • The product labels misspelled the word “Ingredients” in the ingredient statements.
  • The “Uha Puccho Stick Grape” and “Uha Puccho Stick Nama Muscat” product labels declare “natural colors” which is not consistent with 21 CFR 101.22(k). The regulations states that such ingredients may be declared as “artificial color.”
  • The “Uha Puccho Stick Grape” product label declares “Contain: Orange, Soy;” however, “orange” is not considered a major food allergen under FALCPA.
 
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.
 
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 dehlia.young@fda.hhs.gov.
 
Sincerely,
/S/                                                           
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition