Fiber Foods, Incorporated 5/13/14
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
May 13, 2014
Return Receipt Requested
Mr. Greg Xia, Owner
Fiber Foods, Inc.
2400 Florida Avenue
Norfolk, VA 23513
Dear Mr. Xia:
The Food and Drug Administration (FDA) inspected your processing facility located at 2400 Florida Avenue, Norfolk, VA from March 31, 2014 through April 2, 2014.
During the inspection, FDA collected labels for several of your products. Based on our review, we have concluded that these products are adulterated and misbranded within the meaning of sections 402 and 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342; 21 U.S.C. § 343], and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov
1. Your Yellow Wonton Wrapper and Egg Noodle products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. 342(c)] because the products bear or contain a color additive which is unsafe within the meaning of section 721(a) of the Act [21 USC 379e(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive listing regulation. Specifically, the listing regulation for FD&C Yellow No.5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use [21 CFR 74.705(d)(2)]. Your Yellow Wonton Wrapper and Egg Noodle products are manufactured with “(b)(4)” ingredient, which contains FD&C Yellow No.5; however, the labels for these products fail to declare the presence of FD&C Yellow No.5 in the ingredient statements.
2. Your Yellow Wonton Wrapper and Egg Noodle products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)] because the products bear or contain 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. Your Yellow Wonton Wrapper and Egg Noodle products are manufactured with “(b)(4)” ingredient containing certified color additives FD&C Yellow No.5 and FD&C Yellow No.6; however, neither product bears a label identifying the presence of these color additives. Under 21 CFR 101.22(k)(l ), certified colors must be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter. The common or usual name may be abbreviated to omit the "FD&C" prefix and the term "No." (e.g., Yellow 5).
3. Your Yellow Wonton Wrapper, Egg Roll Wrapper, Egg Noodle, and Chinese Yock-A-Mein Wheat Noodle products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] because the label fails to declare the presence of egg and wheat, major food allergens, as required by section 403(w)(1) of the Act. Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as 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 certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded 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 is 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, except that 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)].
Specifically, our investigators observed a series of products being manufactured and scraps from each product being reworked into the subsequent product. For example, the first product, wonton wrappers was made with egg and this was reworked into egg roll wrappers. The scrap from the previous batch of egg roll wrappers was reworked into yellow egg noodles. Then the scrap from the previous batch of yellow egg noodle was reworked into the wheat noodles. Since the rework was intentionally added to each of the foods made after the wonton wrappers, the ingredients in the rework are considered ingredients in any foods made from them. Therefore the major food allergens eggs, and wheat must be declared on the labels of your Yellow Wonton Wrapper, Egg Roll Wrapper, Egg Noodle, and Chinese Yock-A-Mein Wheat Noodle products.
4. Your Yellow Wonton Wrapper and Egg Noodle products are misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], because they are fabricated from two or more ingredients but the labels fail to bear the common or usual name of each ingredient. Specifically, you fail to list the following ingredients on theouter containers used during product distribution:
o You failed to declare, salt, egg, benzoate, and egg color;
o You declare “selected flour” as an ingredient, however this is not an appropriate common or usual name. “Flour” may be an appropriate name depending on the actual ingredient used (See 21 CFR 137.105), or the name of the specific type of flour may be used.
o You failed to declare, salt, corn starch, benzoate, and egg color
The requirement to list 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.
5. Your Yellow Wonton Wrapper, Yellow Egg Roll Wrapper, and Egg Noodle products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because your bulk product container fails to declare the common or usual name of the food in accordance with 21 CFR 101.3.
6. Your dried Chinese Yock-A-Mein Wheat Noodles (2 lb.) 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 as defined in 21 CFR 101.9. For example:
- Trans fat content is not declared as required by 21 CFR 101.9(c)(2)(ii).
- Polyunsaturated and Monounsaturated fat are not declared as required by 21 CFR 101.9(c)(2)(iii) and (iv). The label bears a claim about cholesterol content; therefore, these nutrients must be declared.
7. Your Yellow Wonton Wrapper, Bulk fresh Chinese Yock-A-Mein Wheat Noodles, and Egg Noodle products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the bulk product container fails to declare the net quantity of contents, as required under 21 CFR 101.105.
Section 743 of the Act (21 USC 379j-31) authorizes FDA to assess and collect fees to cover FDA’s cost for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection which identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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 re-inspection-related costs.
The deviations identified above are not intended to be an all-inclusive list of deficiencies at your establishment. It is your responsibility to ensure that all products marketed by your firm comply with the FD&C Act and its implementing regulations. You must take prompt action to correct these violations. Failure to promptly correct these deviations may result in administrative and/or regulatory action without further notice including, but not limited to, seizure, injunction, and/or prosecution.
We also offer the following comments regarding your product labeling:
- Based on the production process that our investigators observed, any ingredients in the scrap used to make a particular food must be declared as ingredients, unless they are incidental additives under 21 CFR 101.100(a)(3). Not only would the ingredients of scrap A need to be declared, but if the food that scrap A came from was made with scrap B, the ingredients of scrap B would also need to be declared, and so forth, unless as stated previously, they qualify as incidental additives. Based on what our investigators observed these ingredients may include egg shade (including sub-ingredients), salt, benzoate (which is not an appropriate common or usual name in accordance with 21 CFR 101.4(a)(l)), corn starch, other types of flour and eggs.
- Your Dried Chinese Yock-A-Mein Wheat Noodle (2 lb.) label bears the statement "Processed in a facility that uses egg." We note that an advisory statement cannot be used in lieu of including an accurate declaration of allergens. Based on the observations of our investigators, this product does contain the allergen egg due to the addition of rework.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Ms. Cherlita Honeycutt, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Ms. Honeycutt at (410) 779-5412 or via e-mail at Cherlita.Honeycutt@fda.hhs.gov
Pamela W. Miles
Virginia Department of Agriculture and Consumer Services
Food Safety and Security Program
102 Governor Street, Suite 349
Richmond, VA 23219