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WARNING LETTER

Fu Fa Flour Food Enterprise Co., Ltd. MARCS-CMS 493377 — 09/05/2016

Fu Fa Flour Food Enterprise Co., Ltd. - 493377 - 05/09/2016


Recipient:
Fu Fa Flour Food Enterprise 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 

 

WARNING LETTER
MAY 9, 2016
 
VIA EXPRESS DELIVERY
 
Xidum Li, CEO
Fu Fa Flour Food Enterprise Co., Ltd.
No.21, Houhu, Xinwu Township
Taoyuan 327, Taiwan
Reference No. # 493377
 
Dear Mr. Li:
 
The United States Food and Drug Administration (FDA) inspected your facility Fu Fa Flour Food Enterprise Co., Ltd., located in Xinwu Township, Taoyuan Taiwan on September 14-15, 2015. During the inspection, the label for your “Dry Noodle Spinach Favour” product was collected. FDA has reviewed the labeling for this product and, based on our review, we have concluded that this product is in violation of the food labeling regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).  These violations cause the product to be adulterated within of section 402 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342] and misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act. You may find the Act and these regulations through links in FDA’s home page at www.fda.gov.
 
We acknowledge receipt of your firm’s January 28, February 2, February 5, February 10, and March 15, 2016 email responses. We have evaluated the corrections that were made to the labeling that was collected at the time of the inspection and the color certification information that was submitted by the manufacturer Kiriya Chemical Co. Ltd. We have found the corrections to the labeling and the batch certification information provided inadequate to bring your product into compliance.
 
We found the following significant deviations:
 
1.    Your “Dry Noodle Spinach Favour” product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the product bears or contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive's listing regulation. Specifically, the product label declared Sunset Yellow FCF and Brilliant Blue FCF, which were not certified as FD&C Yellow No. 6 and FD&C Blue No. 1, respectively.
 
2.    Your “Dry Noodle Spinach Favour” product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product bears or contains an artificial flavoring, coloring, or chemical preservative.  In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients. Specifically, FD&C Yellow No. 6 and FD&C Blue No. 1 are not declared by their listed names or appropriate abbreviations.
 
3.    Your “Dry Noodle Spinach Favour” 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, but the label fails to bear the common or usual name of each ingredient. Specifically, your product is composed of artificial colors that are not declared in accordance with 21 CFR 101.22(k)(1).
 
4.    Your “Dry Noodle Spinach Favour” product is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format. For example:
  • The serving size is not based on the Reference Amount Customarily Consumed (RACC) or this noodle product in accordance with 21 CFR 101.9(b)(2). The RACC for pastas, plain, dry is 55 grams (21 CFR 101.12(b)(Table2)); however, the serving size declared on the label is 100 g. Therefore, all of the nutrient information is incorrect.
  • The serving size is not declared in a common or household measure as required in 21 CFR 101.9(b)(7) and (d)(3)(i).
  • The vitamins and minerals (vitamins A & C, calcium and iron) are not declared in accordance with 21 CFR 101.9 (c)(8). Vitamins and minerals must be expressed only as percent of Daily Value. There is no provision for declaring the amounts in mg or IU within the nutrition label.
  • Calories from fat not expressed to the nearest 5-calorie increment 21 CFR 101.9(c)(1)(ii).
  • The quantitative amount for Sodium is not rounded in accordance with 21 CFR 101.9(c)(4).
  • The statement of calories on the product labels are expressed in terms of kcal, which is not in accordance with 21 CFR 101.9(c)(1).
  • The nutrition labels do not include the full footnote required in 21 CFR 101.9(d)(9).
  • The nutrition label presented in the foreign language must include all required information and must meet all formatting requirements (21 CFR 101.9(d)(14) and 101.15(c)(2)).
  • We note numerous formatting deviations such as lack of bolding for headings, and the names of some of the nutrients, indentations, bars, and hairlines (21 CFR 101.9(d)).
5.    Your “Dry Noodle Spinach Favour”  product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the net quantity of contents in terms of weight, measure, or numerical count is not listed on the principal display panel of the label as required by 21 CFR 101.105(a). The net quantity statement must be accurate. There are no provisions for the use of “+/-” (plus or minus) amounts in the net quantity declaration.
 
The above violations are not meant to be an all-inclusive list of violations that exist in connection with your product and labeling.  It is your responsibility to ensure that the products you market are in compliance with the Act and all applicable regulations.
 
In addition to the above violations, we also have the following comments about your labels:
  • If you choose to use a separate allergen statement it must be in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the statement must declare the common or usual name in English of all major food allergens intentionally added to the product.
  • The label information which is required on the information panel is declared on the same panel without intervening material in accordance with 21 CFR 101.2(d)(1) and (e). Bar codes, “QR codes,” “valid date,” and expiration dates are not required label information and as such, are intervening.
  • We question whether the statement of identity, “Dry Noodle, Spinach Favour” should be “Dry Noodle, Spinach Flavor.”
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 color additive regulations is Import Alert #45-02. An example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the basic labeling requirements is 99-39. You may view these alerts at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
 
Please send your reply to the Food and Drug Administration, Attention:  Alex Brown, 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. Please identify your response with CMS #493377. You may send any questions you may have regarding this letter to Mr. Brown via email at alexander.brown@fda.hhs.gov.
 
 
Sincerely,
/S/ 
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition

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