Inspections, Compliance, Enforcement, and Criminal Investigations
Minnesota Smoothies And More, LLC. 11/5/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7194
FAX: (612) 334-4142
November 5, 2010
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 05
Dodie M. Green
Co-Owner/Chief Financial Officer
Minnesota Smoothies and More, LLC
dba Saint Paul Bagelry
1702 Lexington Avenue North
Roseville, Minnesota 55113-6514
Dear Ms. Green:
The United States Food and Drug Administration (FDA) conducted several inspections of your facility located at 1702 Lexington Avenue North, Roseville, Minnesota, with the most recent being on June 8, 2010. These inspections verified that your firm manufactures and distributes ready-to-eat bagel products. Our review of product labels collected during these inspections reveals that your Everything, Blueberry, Jalapeno Cheese, Poppy seed, Sesame, Whole Wheat, Multi Grain, Garlic, Asiago Cheese, Plain, Cinnamon Raisin, Onion, and Pumpernickel bagel products ("your bagel products") are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343], and the implementing regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and related regulations through links on FDA's internet home page at http://www.fda.gov.
1. Your Asiago Cheese bagel and Jalapeno Cheese bagel products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare all major food allergens present in the products.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines "major food allergens" 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:
• 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., "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)]).
The ingredient statements for the Asiago Cheese bagel and Jalapeno Cheese bagel declare "Asiago cheese" and "Pepper jack cheese" as ingredients in each of the products, respectively. Both Asiago cheese and Pepper Jack cheese contain milk. However, these product labels fail to declare the presence of milk, which is a major food allergen.
2. Your bagel 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 labels fail to bear the common or usual name of each ingredient in the products in accordance with 21 CFR 101.4(a)(1) and 101.4(b)(2).
Specifically, under 21 CFR 101.4(a)(1), ingredients required to be declared on the label or labeling of a food shall be listed by common or usual name. However, your bagel products fail to list each ingredient by its common or usual name. For example, your bagel products list the ingredient "Natural bagel base." However, "Natural bagel base" is not an appropriate common or usual name for this ingredient. The appropriate common or usual name is "bagel base."
Furthermore, under 21 CFR 101.4(b)(2), an ingredient which itself contains two or more ingredients may be designated in the statement of ingredients by either of the following alternatives: (1) parenthetically listing the component ingredients after the common or usual name of the main ingredient, or (2) 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 multicomponent ingredient. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food. However, the labels for your bagel products do not declare all of the sub-ingredients for each product. For example:
• The Asiago Cheese bagel (square) label declares: "Hi Gluten Flour, Water, Natural bagel base, (sugar, sea salt, malt, yeast, molasses, 2% or less honey, enzyme, ascorbic acid, cultured wheat starch, soy oil), Vital wheat gluten, Asiago cheese, Rosemary, Yeast." However, the ingredients Hi Gluten Flour and Asiago cheese contain sub-ingredients which are not declared on the product label. In addition, there appears to be more than one shape of label (square and circular) for your bagel products that necessitate the listing of sub-ingredients.
• The Jalapeno Cheese bagel (square or circular) label declares: "Flour, Water, Natural bagel base, Vital wheat gluten, Jalapeno pepperss [sic], Mild salsa, Pepper jack cheese, Yeast." However, the ingredients Flour, Natural bagel base, mild salsa, and Pepper jack cheese contain subingredients which are not declared on the product label.
3. Your bagel products are misbranded within the meaning of section 403(q)(1) of the Act [21 U.S.C. § 343(q)(1)] because the labels fail to bear nutrition information as required by 21 CFR 101.9, and your firm is not currently exempt from the nutrition labeling requirements under section 403(q)(5)(D) of the Act [21 U.S.C. § 343(q)(5)(D)].
Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemptions in 21 CFR 101.9(j)(18), or see
http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRequlatorylnformation/SmallBusinessNutritionLabelingExemption/default.htm for information on filing for an annual exemption. The application may be submitted online at: https://infol.cfsan.fda.gov/nle/client/login.cfm.
This letter is not meant to be an all-inclusive list of deficiencies in your product labeling. It is your responsibility to ensure that your establishment is in compliance with the Act and all applicable Federal regulations.
You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in additional regulatory action without further notice, such as seizure and/or injunction.
We also note that your bagel product labels declare "Hi Gluten Flour" which, according to information collected during the inspection, contains enriched bleached wheat flour. Enriched flour is a food for which a standard of identity has
been established in 21 CFR 137.165 and contains wheat flour, niacin, iron, thiamin mononitrate, riboflavin, and folic acid. A few of those components are not listed on the ingredient statement of the "Hi Gluten Flour" used in your production. If your products contain enriched flour, you must declare all of the ingredients in the enriched flour. This may require you to contact your third party provider and have them verify the formulation of the "Hi Gluten Flour" to reassure it meets the standard of identity.
Further, we note that your bagel product labels include the statement "May contain wheat." However, as several of the ingredients used in the production of your bagels are, or contain, wheat, your bagel products do in fact contain wheat and this claim appears redundant. Please see section 403(w) of the Act, discussed above, for the proper use of a "Contains" statement to indicate the presence of a major allergen in a product.
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. Please include copies of any available documentation demonstrating that corrections have been made.
Your reply should be directed to Compliance Officer Rebecca L. Caulfield at the address indicated on the letterhead. If you have questions regarding this letter, please contact Ms. Caulfield at (612) 758-7194.
Gerald J. Berg