Consumer Lawyers

Herman’s Bakery 2/22/12 Warning Letter

In Uncategorized on February 29, 2012 at 2:13 am
 
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. 
 
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