Inspections, Compliance, Enforcement, and Criminal Investigations

Main Street Cafe Bloomer, LLC 8/18/15

  

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

 

August 18, 2015
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                           
Refer to MIN 15 - 15
 
 
Donald D. Stoik
Owner
Main Street Cafe Bloomer, LLC
1418 Main Street
Bloomer, Wisconsin 54724
 
Dear Mr. Stoik:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 1418 Main Street, Bloomer, Wisconsin, on April 17 and 29, 2015. We reviewed your product labels and find that your labels cause your products to be adulterated and misbranded within the meaning of sections 402 and 403, 21 U.S.C. § 342 and 343, of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulations under Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
 
Adulterated Food
 
Your 10” M&M pie 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. § 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 10” M&M pie product is manufactured with FD&C Yellow No. 5 (as an ingredient of the M&Ms); however, the label for this product fails to declare FD&C Yellow No. 5 in the ingredient statement.
 
Misbranded Food
 
1.    Your 10” M&M, 10” Butterfinger pie and 3” Tart Pie Peanut Butter Heath products are misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the finished product labels fail to declare the major food allergen, wheat, as required by section 403(w)(1) of the Act. Specifically, your 10” M&M, 10” Butterfinger pie, and 3” Tart Pie Peanut Butter Heath products are manufactured using “Oreo Crumb” that contains wheat. 
 
Your 10” Butterfinger pie product is further misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the finished product label fails to declare the major food allergen, egg, as required by section 403(w)(1) of the Act. Specifically, your 10” Butterfinger pie product is manufactured using “Vanilla Silk” that contains egg. 
 
Your 3” Tart Pie Peanut Butter Heath product is further misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the finished product label fails to declare the major food allergens, egg, almonds, soy, and milk, as required by section 403(w)(1) of the Act. Specifically, your 3” Tart Pie Peanut Butter Heath product is manufactured using the following ingredients, which contain major food allergens:
  • “Vanilla Silk” which contains egg;
  • “Chopped Heath English Toffee” which contains almonds, soy and milk;
  • “Graham Cracker Tart shells” which contain wheat (previously mentioned) and soy. 
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines 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, as “major food allergens.” 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:
  • 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 (e.g., “Whey (Milk)”), 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 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).
2.    Your 10” M&M, 10” Butterfinger pie and 3” Tart Pie Peanut Butter Heath products are misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4.  For example:
  • Your 10” M&M pie product is manufactured using the ingredient “M&M,” which is a multi-component ingredient in that it contains two or more ingredients; however, you fail to list all its sub-ingredients on your finished product label.
  • Your 10” M&M pie product is manufactured using the ingredient “Cream Cheese,” which is a multi-component ingredient in that it contains two or more ingredients; however, you fail to list all its sub-ingredients on your finished product label.
  • Your 10” M&M pie product is manufactured using the ingredient “Oreo Crumb,” which is a multi-component ingredient in that it contains two or more ingredients; however, you fail to list all its sub-ingredients, specifically flour, on your finished product label.
  • Your 10” Butterfinger pie product is manufactured using the ingredient “Vanilla Silk,” which is a multi-component ingredient in that it contains two or more ingredients; however, you fail to list all its sub-ingredients on your finished product label.
  • Your 10” Butterfinger pie product is manufactured using the ingredient “Oreo Crumb,” which is a multi-component ingredient in that it contains two or more ingredients; however, you fail to list all its sub-ingredients, specifically flour, on your finished product label.
  • Your 3” Tart Pie Peanut Butter Heath product is manufactured using “English Toffee” and “Graham Crumbs,” which are multi-component ingredients; however, you fail to list all of the sub-ingredients on your finished product label. 
According to 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, 21 CFR 101.4(b)(2)(i), or by listing the component ingredients without listing the ingredient itself, 21 CFR 101.4(b)(2)(ii). 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.
 
3.    Your 10” M&M pie and 10” Butterfinger pie products are misbranded within the meaning of section 403(i)(1) of the Act, 21 U.S.C. § 343(i)(1), in that the product labels fail to bear the common or usual name of the food.  For example, the product label fails to declare a statement of identity of the food (pie) on the principal display panel as required by 21 CFR 101.3.
 
4.    Your 10” M&M pie 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.  Your 10” M&M pie product is manufactured with “M&M” ingredient containing certified color additives FD&C Blue 1, FD&C Blue No. 1 Lake, FD&C Blue No. 2, FD&C Blue No. 2 Lake, FD&C Red No. 40, FD&C Red No. 40 Lake, FD&C Yellow No. 5, FD&C Yellow No. 5 Lake, FD&C Yellow No. 6, and FD&C Yellow No. 6 Lake; however, the product does not bear 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).
 
5.    Your 3” Tart Pie Peanut Butter Heath product is misbranded within the meaning of section 403(e)(1) of the Act, 21 U.S.C. § 343(e)(1), in that the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).
 
You indicated to the investigator that you would be providing a response to the labeling deviations discussed at the close-out of the inspection. To date, we have not received a written response. 
 
The violations cited in this letter are not intended to be an all-inclusive statement of labeling violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complieswith all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
In addition to violations cited above, we have the following comment:
  • If the “Peanut Butter” and “Whipped Topping” used in the manufacture of your 3” Tart Pie Peanut Butter Heath product are also multi-component ingredients, you need to declare the sub-ingredients as well as those previously identified. 
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 re-inspection-related costs. 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 re-inspection-related costs.
 
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
 
Your response should be addressed to Compliance Officer Dianna C. Sonnenburg at the address indicated on the letterhead. 
 
Sincerely,
/S/
Michael Dutcher, DVM
Director
Minneapolis District

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