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U.S. Department of Health and Human Services

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Enforcement Actions

Lucky Taco. Inc 4/2/12

  

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

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142

 

                                                                                                         
April 2, 2012
 
 
WARNING LETTER
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED                          
Refer to MIN 12 – 30
 
 
Timothy P. McQuiston
President/Owner
Lucky Taco, Inc.
768 South Lake Street, P.O. Box 112
Hustisford, Wisconsin  53034
 
Dear Mr. McQuiston:
 
The Food and Drug Administration (FDA) conducted an inspection of your facility located at 768 South Lake Street, Hustisford, Wisconsin, on December 19-20, 2011. During the inspection our investigator collected documentary samples of your Lucky Cruncher Cookie (Java Mint Flavored) and Lucky Taco Mexican Fortune Cookie (Strawberry, Lemon, Lime and Mango flavored) fortune cookie products. Our review of your product labels reveals that your Java Mint flavored Lucky Cruncher Cookie and Lucky Taco Mexican Fortune Cookie products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) in that your products are adulterated and misbranded within the meaning of sections 402 and 403 of the Act, 21 U.S.C §§ 342 and 343, and the implementing regulations contained within Title 21, Code of Federal Regulations, Parts 74 and 101 (21 CFR 74 and 101). You may find the Act and the CFR through links on FDA’s home page at www.fda.gov.
 
The violations of concern are as follows:
 
1. Your Java Mint flavored Lucky Cruncher Cookie 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 listing regulation for 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 Java Mint flavored Lucky Cruncher Cookie product is manufactured with coffee liqueur flavor which contains Yellow 5; however, the labels for the finished products fail to declare the presence of Yellow 5 in the ingredient statements.
 
2. Your Lucky Taco Mexican Fortune Cookie products are misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the labels for this product fail to declare the presence of a major food allergen, milk, as required by section 403(w)(1) the Act, 21 U.S.C. § 343(w)(1). Specifically, the ingredient, (b)(4), which contains milk, is used in the manufacture of your Lucky Taco Mexican Fortune Cookie (strawberry, lemon, lime and mango flavored) product. Milk is not declared on the 25 count (4.4 oz.) or single-serving (.28 oz.) labels.
 
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 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 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:
 
i)  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
 
ii) 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. “flour (wheat)”), 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).
 
3. Your Lucky Taco Mexican Fortune Cookie 25 count and Lucky Cruncher Cookie 25 count product labels are misbranded within the meaning of section 403(r)(1)(A) of the Act, 21 U.S.C. § 343(r)(1)(A), because the labels bear nutrient content claims but do not comply with the applicable regulation. Specifically, your 25 count labels for your Lucky Taco Mexican Fortune Cookie and Lucky Cruncher Cookie products bear the implied nutrient content claims “Only 30 Calories per Cookie” and “Only 19 Calories per Cookie,” respectively. Your claims implicitly characterize your products as a low calorie food. A “low calorie” claim may be made if a food with a reference amount customarily consumed (RACC) of 30g or less does not provide more than 40 calories per RACC and, except for sugar substitutes, per 50g. The RACC for cookies is 30g (see 21 CFR 101.12(b), Table 2). Based on your Lucky Taco Mexican Fortune Cookie and Lucky Cruncher Cookie product labels, a 5g serving of these products contain 30 and 19 calories, respectively; this equals about 180 and 114 calories per RACC, and about 300 and 190 calories per 50g, respectively. Therefore, under 21 CFR 101.13(i)(2), the products are required to carry a disclaimer adjacent to the claim, e.g., “Only 30 calories per serving, not a low calorie food.”  Because your products fail to bear the required disclaimer, they are misbranded within the meaning of section 403(r)(1)(A) of the Act.
 
4. Your Lucky Cruncher Cookie 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 Java Mint flavor Lucky Cruncher Cookie is made with coffee liqueur flavor which contains Red 40, Yellow 5, Yellow 6 and Blue 1; however, your 25 count label and single-serving label for the Java Mint flavor cookie fails to declare these colors. According to 21 CFR 101.4(b)(1), the name of an ingredient shall be a specific name and not a collective (generic) name, except that spices, flavorings, colorings and chemical preservatives shall be declared according to the provisions of 21 CFR 101.22. A color additive or the lake of a color additive subject to certification under section 721(c) of the Act shall be declared by the name of the color additive listed in the applicable regulation in Part 74 or Part 82 of this chapter, except that it is not necessary to include the “FD&C” prefix or the term “No.” in the declaration, but the term “Lake” shall be included in the declaration of the lake of the certified color additive (e.g., Blue 1 Lake), 21 CFR 101.22(k)(2).
 
5. Your Lucky Taco Mexican Fortune Cookie 25 count product label is misbranded within the meaning of sections 403(a)(1) and 201(n) of the Act, 21 U.S.C. §§ 343(a)(1) and 321(n), in that the label is false or misleading because it fails to reveal the material fact that the identified flavors are artificially derived. As required by 21 CFR 101.22(i)(2), when a food contains any artificial flavor which simulates, resembles or reinforces the characterizing flavor, the name of the food on the principal display panel or panels of the label shall be accompanied by the common or usual name(s) of the characterizing flavor, in letters not less than one-half the height of the letters used in the name of the food and the name of the characterizing flavor shall be accompanied by the word(s) “artificial” or “artificially flavored,” in letters not less than one-half the height of the letters in the name of the characterizing flavor, e.g., “artificial vanilla,” “artificially flavored strawberry,” or “grape artificially flavored.” Your label bears a declaration of the flavors strawberry, lime, lemon, and mango and your products contain natural and artificial strawberry margarita flavor, natural and artificial lemon juice margarita flavor, natural and artificial lime margarita flavor, and natural and artificial mango flavor. However, the names of these flavors on your label are not accompanied by the word(s) “artificial” or “artificially flavored.” 
 
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. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
 
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 costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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 U.S.C. § 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
 
We also have the following comments about your labels:
  • You use the same label for your Lucky Taco Mexican Fortune Cookie single-serving packages regardless of which flavor is actually contained in the package. The ingredient statement declares Yellow 5, Yellow 6, Blue 1, Red 40, and caramel coloring; however, each flavor of cookie contains different colors. The declaration of specific colors on the label for a product that does not contain those specific colors is a false statement. Specifically,
A. The strawberry flavored cookie does not contain Yellow 5, Yellow 6 or caramel color.
B. The lemon flavored cookie does not contain Yellow 6, Blue 1, Red 40 or caramel color.
C. The lime flavored cookie does not contain Yellow 6, Red 40, or caramel color.
D. The mango flavored cookie does not contain Yellow 5, Blue 1, or caramel color.
  • The declaration of total fat on the Lucky Cruncher Cookie 25 count label is not expressed in the correct increment. In accordance with 21 CFR 101.9(c)(2), if a serving contains less than 0.5g of total fat, the content must be expressed as 0.
  • The declaration of sodium on the Lucky Cruncher Cookie 25 count label is not expressed in the correct increment. In accordance with 21 CFR 101.9(c)(4), if a serving contains less than 5 mg of sodium, the content must be expressed as 0.
  • The Lucky Cruncher Cookie 25 count label appears to have several alternate principal display panels. In accordance with 21 CFR 101.105(e), the net quantity of contents should be duplicated on each principal display panel.
  • The declaration of total fat on the Lucky Taco Mexican Fortune Cookie 25 count and single serving labels is not expressed in the correct increments. In accordance with 21 CFR 101.9(c)(2), if a serving contains less than 0.5g of total fat, the content must be expressed as 0.
  • The declaration of protein on the Lucky Taco Mexican Fortune Cookie 25 count and single serving labels is not expressed in the correct increments. In accordance with 21 CFR 101.9(c)(7), if a serving contains less than 1g of protein, it may be expressed to the nearest gram (1 or 0) or as “less than 1 gram.”
  • The net weight declaration on the Lucky Taco Mexican Fortune Cookie 25 count label does not appear to be sufficiently separated from printed matter above, 21 CFR 101.105(f).
You should respond to this office in writing within 15 working days of receipt of this letter. Your response should outline the specific steps you have taken or will take to correct the noted violations and to prevent their recurrence. You should include in your response documentation, such as verification records and revised labeling, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Your reply should be directed to Compliance Officer Rebecca L. Caulfield at the address indicated on the letterhead.
 
Sincerely,
/S/ 
Joann M. Givens   
Acting Director
Minneapolis District