Inspections, Compliance, Enforcement, and Criminal Investigations
Yon's Foods LLC 8/26/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-41424
August 26, 2009
RETURN RECEIPT REQUESTED
Yon's Foods LLC
4706 Cedar Avenue South
Minneapolis, Minnesota 55407
Refer to MIN 09 - 22
Dear Ms. Quinlan:
An inspection of your facility located at 4706 Cedar Avenue South, Minneapolis, Minnesota, was conducted by investigators from the Food and Drug Administration (FDA) on May 29 and June 5, 2009. This inspection verified that your firm manufactures and distributes Kimchi, a food product. Our review of your product label reveals that your Kimchi product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA's labeling regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). As a result of these violations, your product is misbranded within the meaning of sections 403(w) and 403(i)(2) of the Act [21 U.S.C. §§ 343(w) and 343(i)(2)]. You may find the Act and the CFR through links in FDA's home page at www.fda.qov.
Your Kimchi product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)]. The label fails to completely or accurately declare all major food allergens in the product, as required by section 403(w)(1) of the Act [21 U.S.C. § 343 (w)(1)].
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines as major food allergens: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans; as well as any food ingredient containing proteins derived from one of these foods with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient bearing or containing, 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, 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 appearing 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, your Kimchi product is labeled to contain the ingredient "fish sauce" but fails to declare the species of fish, i.e., anchovy, on its label as specified in the Act.
Your product is further misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that declared ingredients are fabricated from two or more ingredients but the label fails to declare the common or usual name of each sub-ingredient as required by 21 CFR 101.4(b)(2). The label of your Kimchi product declares fish sauce in the ingredient statement but does not list all of the sub-ingredients for this ingredient.
The requirement to list the 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 (21 CFR 101.4(b)(2)(i)), e.g., "Fish Sauce (anchovy extract, salt, vinegar)." Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food (21 CFR 101.4(b)(2)(ii), e.g., listing "anchovy extract", "salt" and "vinegar" in the list of ingredients in descending order of predominance in the finished food.
We request that you notify this office in writing within 15 working days of receipt of this letter stating the actions you will take to correct the violations discussed above and to prevent their recurrence. Include documentation that illustrates these corrections, if applicable. If corrective action cannot be completed within 15 working days, state the reason for the delay and a reasonable time within which the corrections will be completed.
In addition to the above violations, we also have the following comment about your Kimchi product labeling:
We question the use of Kimchi as a common or usual name. As stated in 21 CFR 102.5(a) the common or usual name of a food, which may be a coined term, shall accurately identify or describe in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The name shall be uniform among all identical or similar products and may not be confusingly similar to the name of any other food that is not reasonably encompassed within the same name. A search on the internet has resulted in finding other "Kimchi"products containing a descriptive phrase directly below the name "Kimchi." A descriptive phrase such as "Pickled Chinese Cabbage" or "Pickled Spicy Korean Cabbage" would serve as a simple description as the term for and basic nature of the food. In addition, the statement of Net Weight on your product labeling is not in accordance with 21 CFR 101.105(j)(1) in that the label declares 32 oz. only. As required by the regulation a correct statement of net weight would be 32 oz. (2lbs).
Failure to make prompt corrections may result in enforcement action, including seizure and/or injunction being initiated by the Food and Drug Administration (FDA). This letter does not represent a comprehensive review of all of the products distributed by your firm. As president, it is your responsibility to ensure that all products distributed by your firm are in compliance with the Act and its implementing regulations.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated in the letterhead. Ms. Wisecup may be reached at (612) 758-7114.
W. Charles Becoat