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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Herman's Bakery 2/22/12

  

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

 

February 22, 2012
 
 
WARNING LETTER
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED                          
Refer to MIN 12 – 25
 
 
Herman A. Oestreich
Owner
Herman’s Bakery
130 Main Street South
Cambridge, Minnesota  55008-1621
 
Dear Mr. Oestreich:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 130 Main Street South, Cambridge, Minnesota, on September 14-15, 21-22, 27 and 29, 2011.  During the inspection, product labels were collected. Our review of your product labels reveals that your Long Johns, Raspberry Bismarks, Snowballs, and Glazed Raised Donuts products are misbranded within the meaning of section 403, 21 U.S.C. § 343, of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and the referenced CFR regulations through links on FDA’s internet home page at www.fda.gov.
 
The significant violations are as follows:
 
1.     Your Long Johns, Raspberry Bismarks, Snowballs and Glazed Raised Donuts are misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the labels for these products fail to declare the known major food allergens, wheat and soy, as specified by the Act.
 
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 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:
 
  • 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. “(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).
 
Your Long Johns, Raspberry Bismarks, Snowballs and Glazed Raised Donuts product formulations reveal that (b)(4) Flour and (b)(4) milk powder, which contain bleached wheat flour and defatted soy flour, respectively, are used in the manufacturing process. However, your finished product labels fail to declare the presence of the major food allergens wheat and soy. 
 
Additionally, your Long Johns product label includes a “With Nuts” statement which does not properly identify the type of tree nut in the product, as required under section 403(w)(2). During the inspection it was determined that the Long Johns that are filled with Bavarian Crème filling do not contain nuts and the Long Johns that are not filled with Bavarian Crème filling have nuts sprinkled on top of them. The nuts you sprinkle on your non-crème-filled Long Johns are ground peanuts; however, the ingredient “peanuts” is not declared as a major food allergen on your finished product label.  
 
Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
 
2.     Your Long Johns, Raspberry Bismarks, Snowballs and Glazed Raised Donuts products are misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that they are fabricated from two or more ingredients, but the finished product labels fail to list the component ingredients of all of their ingredients, as required by 21 CFR 101.4(b)(2). Specifically:
 
  • Your product formulation for the Long Johns, Raspberry Bismarks, Snowballs and Glazed Raised Donuts products include the ingredients (b)(4) Flour and (b)(4) milk powder; however, all of the ingredients in the premium bakers flour and milk powder are not declared on your product labels. For example, the ingredient statement for the premium flour reads:  “Bleached Wheat Flour, Malted Barley Flour, Niacin, Reduced Iron, Potassium Bromate, Thiamine Mononitrate, Riboflavin, Folic Acid.” Additionally, the ingredient statement for the non-fat dry milk powder reads:  “Whey, defatted soy flour, soybean oil, Contains 2% or less of each of the following: sodium caseinate.” 
  • Your Long Johns product contains Bavarian Creme filling and your Raspberry Bismarks product contains Apple-Black Raspberry Pastry filling. However, based on the product labels collected during the inspection, the Bavarian Creme and Apple-Black Raspberry Pastry fillings contain sub-ingredients which are not declared on your finished product labels.
  • The nuts you sprinkle on your non-creme-filled Long Johns are ground peanuts; however, the ingredient “peanuts” is not declared on your finished product label as required by 21 CFR 101.4(a)(1).  
 
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. 
 
3.     Your Long Johns (Cream Filled) and Raspberry Bismarks 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 artificial coloring but fail to bear labeling stating that fact. In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added must declare the coloring in the statement of ingredients. For example:
 
  • 317502 Bavarian Creme filling is used in the manufacture of your Long Johns (Cream Filled) product. However, ingredients used in the manufacture of the Bavarian Creme, specifically, the artificial color additive Yellow 6, is not declared on the finished product label.
  • 302102 Apple-Black Raspberry Pastry Filling is used in the manufacture of your Raspberry Bismarks product. However, ingredients used in the manufacture of the Apple-Black Raspberry filling, specifically, the artificial color additives Blue 1 and Red 40, are not declared on the finished product label. 
 
4.     Your Long Johns (Cream Filled) product is further misbranded within the meaning of section 403(k) of the Act, 21 U.S.C. § 343(k), because the product bears or contains artificial flavors but fails to bear labeling stating that fact. In accordance with 21 CFR 101.22(h), the label of a food to which any flavoring has been added must declare the flavor in the statement of ingredients. The Bavarian Creme filling is used in the manufacture of your Long Johns (Cream Filled) product. The statement of ingredients for your Long Johns (Cream Filled) product does not list all of the Bavarian Creme sub-ingredients as ingredients. These sub-ingredients contain artificial flavors, which are not declared on the finished product label.
 
5.     Your Raspberry Bismarks product is further misbranded within the meaning of section 403(k) of the Act, 21 U.S.C. § 343(k), because the product bears or contains a chemical preservative(s) but fails to bear labeling stating that fact. In accordance with 21 CFR 101.22(j), the label of a food to which a chemical preservative(s) is added shall bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor” or “to promote color retention.” The Apple-Black Raspberry Pastry Filling is used in the manufacture of your Raspberry Bismarks product. However, ingredients used in the manufacture of the Apple-Black Raspberry Pastry Filling, specifically, Potassium Sorbate, Sodium Propionate, and Sodium Benzoate, are not declared on the finished product label with a separate description of their function as required.
 
This letter is not meant to be an all-inclusive list of deficiencies that may exist in any of your product labeling. You are responsible for ensuring that your facility operates in compliance with the Act and the Food Labeling regulations (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction.
 
As you may recall, many violations of the Current Good Manufacturing Practice (GMP) regulation for foods, 21 CFR 110, were brought to your attention during the previous FDA inspection conducted on September 30, October 5 and 13, 2010. These same violations were documented during the most recent inspection conducted on September 14-15, 21-22, 27 and 29, 2011. Also, samples of rye flour, and caked and spilled product/debris from various areas of the bakery were analyzed for pests. Analytical results documented larvae, larval cast skins, pupa, and adult Red Flour Beetles, and adult Merchant Grain Beetles in the food products. 
 
We acknowledge the corrective actions you took during the most recent inspection and your destruction of the insect-infested food ingredients. On October 24, 2011, we received your letter responding to FDA-483 Inspectional Observations issued on September 29, 2011, at the conclusion of the most recent inspection of your firm.  You are responsible for ensuring that your facility operates in compliance with the Act and the Current Good Manufacturing Practice regulations (21 CFR 110). We recommend you implement a sanitation program at your facility. 
 
We also note the following labeling comments:
 
  • Your Long Johns, Raspberry Bismarks, Snowballs and Glazed Raised Donuts products fail to provide the ZIP code on your product labels in accordance with 21 CFR 101.5(d).
  • The net quantity of contents for your Long Johns, Raspberry Bismarks, Snowballs and Glazed Raised Donuts bakery products must be declared by numerical count and net weight.
  • Your Raspberry Bismarks, Snowballs and Glazed Raised Donuts product labels contain the statement “may contain FD&C yellow #5” within the ingredient declaration. The ingredient statement should only include those ingredients used in the manufacture of the finished product. Statements such as “may contain ______” should not be included in an ingredient declaration, nor should such a statement be used in lieu of good manufacturing practices (GMPs).  
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation 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.
 
Please send your reply to the Food and Drug Administration, Attention: Rebecca L. Caulfield, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612) 758-7194.
 
                                                         
Sincerely,
/S/
Joann M. Givens
Acting Director
Minneapolis District Office