Inspections, Compliance, Enforcement, and Criminal Investigations

Ribon Company, Ltd. 10/5/15

  

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

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

WARNING LETTER

OCT 5, 2015
 
VIA EXPRESS DELIVERY
 
Mr. Ken Tsubouchi, President
Ribon Company, Ltd.
48 Koki 1 Chome
Komaki-shi, Japan
 
Re: 472107
 
Dear Mr. Ken Tsubouchi:
 
The United States Food and Drug Administration (FDA) inspected your facility, Ribon Company, Ltd., located in Komaki-shi, Japan, on February 19-20, 2015.  The inspection was conducted to determine your compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and regulations that apply to the food you ship to the United States. Based on our review, we have concluded that your Hokkaido Milk Soft Candy and Hello Kitty Milk Flavored Chewy Candy products are in violation of the Act [21 U.S.C. § 343] 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 Hello Kitty Milk Flavored Chewy 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, wheat, as required by section 403(w)(1) of the Act. Specifically, your Hello Kitty Milk Flavored Chewy Candy product is manufactured using Wheat protein hydrolysate that contains wheat.
 
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 Hokkaido Milk Soft Candy product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains 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 Nutrition Facts panel and ingredient statement must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).
 
3.    Your Hokkaido Milk Soft Candy and Hello Kitty Milk Flavored Chewy Candy products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are 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:
  • Your Hokkaido Milk Soft Candy product is manufactured using Wheat protein hydrolysate; however, you fail to declare this ingredient on your finished product label by its common or usual name “wheat protein hydrolysate” or “hydrolyzed wheat protein.” Your Hello Kitty Milk Flavored Chewy Candy product does not declare this ingredient on its label.
  • The Hokkaido label lists “gelatin” as an ingredient. The Hello Kitty candy lists “millet jelly” as an ingredient.
  • The Hokkaido label lists “artificial flavor.” The Hello Kitty candy lists “flavor.”
  • Coconut oil is identified in the formulation sheet and does not appear on either label.
  • We are not familiar with the ingredients declared on the label of the Hokkaido candy as “milk processed product” and “milk calcium.” There is no calcium ingredient declared on the Hello Kitty candy label.
  • The formulation list identifies an ingredient as “sweetened condensed milk,” a multicomponent ingredient. This ingredient appears to be declared on the two labels simply as “condensed milk.” 
According to the investigation the products are the same formulation. Based on this finding, all of the ingredients in the formulation list are not declared on the Hello Kitty candy product.
 
4.    Your Hokkaido Milk Soft Candy and Hello Kitty Milk Flavored Chewy 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 based on an appropriate serving size determined from the Reference Amounts Customarily Consumed Per Eating Occasion (RACC).   Hokkaido Milk Soft Candy declares a serving size of 3 pieces (18g). The Hello Kitty Milk Flavored Chewy Candy declares a serving size of 2 candies (12g). Under current regulations, for products in discrete units where the individual unit weights less than 50 percent of the established RACC, the serving size is the number of units that most closely approximates the RACC. The RACC for this type of candy is 40 grams (21 CFR 101.12(b), Table 2, “Sugars and Sweets: All other candies”). According to the nutrition labels, one piece of candy weighs 6 g. We calculate that seven pieces of candy would weigh 42 grams. The weight of seven pieces of candy is the number of units that most closely approximates the 40 g RACC.   Accordingly, the nutrition information on the packages of these products is not based on an appropriate serving size.
 
5.    The Hokkaido Milk Soft Candy product is misbranded within the meaning of section 403(r)(1)(A) of the Act in that the label bears the claim “…calcium enriched soft candy…healthy and tasty” but the product does not meet the requirements for the nutrient content claim “enriched” (in accordance with 21 CFR 101.54(e)) or “healthy” (in accordance with 21 CFR 101.65(d)(2)). According to the declared nutrition information, the product contains 4% Daily Value per 18 g (the label also declares 230 mg calcium per 100 g) of product which equates to 8.88% of the DV of calcium per 40 g RACC. The product does not meet the requirements of 21 CFR 101.54(e) in that it does not contain at least 10 % more of the DV of an appropriate reference food.  We also note that the label does not identify (1) the reference food, (2) the percent or fraction that the food is greater relative to the RDI, and (3) quantitative information comparing the level of the nutrient in the product per labeled serving with that of the reference food that it replaces. In addition, the enriched claim is based, at least in part, on the addition of calcium and the addition of calcium to this food is not in accordance with the fortification policy because the food is a candy.
 
The product does not meet the requirements to make a “healthy” claim under 21 CFR 101.65(d)(2), in part, because the food does not meet the definition for low in saturated fat as defined in 101.62(c)(2) (i.e., 1 g or less of saturated fatty acids per RACC and not more than 15 percent of calories from saturated fatty acids) and does not contain at least 10 % of the RDI or the DRV per RACC of one or more of vitamin A, vitamin C, calcium, iron, protein or fiber.  The product contains about 3.3 g saturated fat per 40 gram RACC. In addition, the definition for “healthy” requires that if you add a nutrient to the food to meet the 10 percent requirement, that addition must be in accordance with the fortification policy for foods in 21 CFR 104.20 of this chapter. The fortification of snack foods such as candy is not consistent with this fortification policy. Even with the calcium fortification, your product still does not contain at least 10% of the RDI of calcium.
 
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 candy 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 allergen labeling requirements is 99-22 while the Import Alerts that convey information specific to foreign firms that are not in compliance with nutritional labeling and other labeling requirements are 99-20 and 99-39, respectively. You may view these alerts 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 also have the following comments about your Hokkaido Milk Soft Candy label:
  • The manufacturer information on the Hokkaido Milk Soft Candy label is located on a panel other than the principal display panel or on the information panel. (21 CFR 101.2(b))
  • We note that your Hokkaido Milk Soft Candy product bears the label claims of “Modern people lack calcium and this provides 230 mg of calcium” and “230 mg of calcium per 100g.” However, the serving size is listed as 18 grams, therefore one serving would only provide 41 mg of calcium. The intent of your claims may not be clear to consumers and may mislead those who are seeking products that are high in calcium. We recommend that you clarify your claims.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs.  A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)].  For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any reinspection-related costs.  Please consider providing a copy of this letter to your U.S. Agent.
 
We request that you respond to 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, your response should state the reason for the delay and the time within which corrections will be completed.
 
You should direct your written reply to: Tyra Wisecup, 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. Wisecup via email at tyra.wisecup@fda.hhs.gov.
 
Sincerely,
/S/                                                           
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
       and Applied Nutrition

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