Inspections, Compliance, Enforcement, and Criminal Investigations
Country Maid, Inc. 02-Nov-06
Department of Health and Human Services
Public Health Service
Minneapolis District Office
November 2, 2006
RETURN RECEIPT REQUESTED
Refer to MIN 07 - 05
Wayne T. Becker
Country Maid, Inc.
1919 S. Kinnickinnic Avenue
Milwaukee, Wisconsin 53204-4030
Dear Mr . Becker:
On September 12, 2006, an investigator from the Food and Drug Administration (FDA), conducted an inspection of your facility located at 1919 S. Kinnickinnic Avenue, Milwaukee, Wisconsin. During this inspection, the investigator collected labels from several of your ready-to-eat food products. Our review of your product labels reveals that several of your products violate the Federal Food, Drug, and Cosmetic Act (the Act) in that they are misbranded within the meaning of sections 403(a)(1), 403(i) and 403(w) of the Act [21 U.S.C § 343(a)(1), 343(i) and (w)] and the regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and the CFR through links in FDA's home page at www.fda.gov.
Your Seafood Fettuccini is misbranded within the meaning of section 403(i)(2) of the Act in that it is fabricated from two or more ingredients but all of the ingredients are not declared on the label. The product is labeled to contain, in part: ". . .EGG NOODLES. . . ." The label for the ingredient egg noodles shows it is comprised of several sub-ingredients which are not included on your label, including durum wheat semolina and durum wheat flour [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.
Your Seafood Fettuccini is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the label fails to declare all major food allergens present in those products, as required by section 403(w)(1). 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 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 that bears or contains, a major food allergen, unless either:
1. 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 ingredient, [section 403(w)(1)(A) of the Act, 21 U.S.C. 343(w)(1)(A)],
2. 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)].
For tree nuts, fish, or Crustacean shellfish, the term "name of the food sources from which the major food allergen is derived" means the name of the specific type of nut or species of fish or Crustacean shellfish [section 403(w)(2), 21 U.S.C. 343(w)(2)].
Guidance on the allergen labeling requirements in section 403(w) may be found on FDA's website at www.fda.gov.
Specifically, your Seafood Fettuccine is misbranded under section 403(w) in that the product fails to declare the major food allergen wheat, which is a subcomponent of the egg noodles, as specified by the Act.
Under section 403(w)(1)(A) of the Act [21 U.S.C. 343(w)] when a "Contains" statement is used to identify the presence of major food allergens, each of the major food allergens in the product must be listed after the word "Contains." Not all of your products comply with this requirement; for example:
The label for your Shrimp Pasta Salad product lists shrimp in the ingredient statement, but does not list shrimp in the "Contains" statement.
The label for your Tuna Pasta Salad product lists tuna in the ingredient statement, but does not list tuna in the "Contains" statement.
The label for your Crabmeat Topper lists soy protein in the ingredient statement, but does not list soy in the "Contains" statement.
The label for your Seafood Delight includes a statement, "Contains Fish, Shellfish . . . ." The label for your Crabmeat Topper includes a statement, "Contains . . . Fish . . . ." As noted, FALCPA requires the declaration of the name of the food source from which each major food allergen is derived. For fish and Crustacean shellfish, the term "name of the food source from which the major food allergen is derived" means the name of the species of fish or Crustacean shellfish [section 403(w)(2), 21 U.S.C. 343(w)(2)]. Thus, for each fish and Crustacean shellfish ingredient in your products, the species of fish or shellfish must be declared in the "Contains" statement if you choose to use such a statement to comply with section 403(w)(1). The species of fish or shellfish may be identified by using the acceptable market name provided in FDA's Seafood List. FDA's Seafood List is a compilation of existing acceptable market names for imported and domestically available seafood. The list is available at http://www.cfsan.fda.gov/~frf/seaintro.html.
False or misleading label
Your Crabmeat Topper product is misbranded under section 403(a)(1), in that the label is false or misleading. The product name on the label is Crabmeat Topper; however, according to the product label, the product contains less than 2% snow crabmeat and the primary seafood ingredient in the product is surimi, which is made from Pollock.
This letter is not meant to be an all-inclusive list of deficiencies that may exist in any of your product labeling. It is your responsibility as top management to ensure that your establishment complies with all requirements of the Federal regulations.
You should notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. 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.
Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and injunction.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.
W. Charles Becoat