| 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 |
Department of Health and Human ServicesJuly 22, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 – 39
Barry L. Berman
President/Owner
Bagels Forever, Inc.
2947 University Avenue, P.O. Box 5547
Madison, Wisconsin 53705-0547
Dear Mr. Berman:
The Food and Drug Administration (FDA) inspected your processing facility located at 2947 University Avenue, Madison, Wisconsin, on April 13, 14 and 21, 2011. The inspection found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulation in manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations cause the foods manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C § 342(a)(4), in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. Further, FDA conducted a review of your labeling for several of your bagel products and found significant violations of the labeling regulations for foods, 21 CFR 101. These violations cause your products, Bagels Forever® “Bluebarry” bagels and 1st National Bagel Co.® Blueberry bagels, to be misbranded within the meaning of section 403 of the Act, 21 U.S.C. § 343. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
Adulterated Food
Specifically, our inspection of your facility revealed the following CGMP violations:
1. In order to comply with 21 CFR 110.35(d), all food contact surfaces, including utensils and food contact surfaces of equipment, must be cleaned as frequently as necessary to protect against the contamination of food.
Our inspection revealed that your firm only scraped or brushed readily-available food contact surfaces at the end of the production day and that the food contact surfaces were not cleaned during production. These methods of cleaning left a significant amount of product in and on the equipment. Specifically, the mixers, dough formers, separators, and canvas conveyor belts had dough stuck to their respective food contact surfaces. Moreover, chunks of raw dough were stuck to the food contact surfaces of the dough forming machines.
2. In order to comply with 21 CFR 110.80(b)(7), all reasonable precautions must be taken to ensure that production procedures do not contribute to contamination from any source. Therefore, equipment, containers, and utensils used to convey, hold, or store raw work materials, work-in-process, re-work or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination.
Our inspection revealed that your firm processes all of your 26 different varieties of bagels on one bagel manufacturing line without cleaning the equipment between bagel varieties that contain different ingredients. Specifically, there was crusted dough, dough residue, and chunks of dough on the separators, bagel formers, and mixers, which were not cleaned between the manufacturing of different bagel varieties.
Moreover, the production procedures your firm uses in cleaning equipment and the sequencing of production are not adequate to ensure that preceding products do not contaminate subsequent products. This is of particular concern when allergenic ingredients are used to produce preceding products and not subsequent products.
Misbranded Food
Specifically, our inspection of your labels revealed that your products are misbranded as follows:
1. Your Bagels Forever® “Bluebarry” bagel product is misbranded within the meaning of section 403(a)(1) of the Act, 21 U.S.C. § 343(a)(1), in that the label uses the terms “All Natural” and “No Preservatives” in a manner that is false and misleading. FDA considers use of the term “natural” on a food label to be truthful and non-misleading only when nothing artificial or synthetic has been included in, or has been added to, a food that would not normally be expected to be in the food (58 FR 2302, 2407, January 6, 1993; 21 CFR 101.22). Your product is manufactured with infused wild dry blueberries that contain potassium sorbate, which is listed in 21 CFR 182.3640 as a chemical preservative; therefore, your product may not make the claims “All Natural” and “No Preservatives.”
2. Your Bagels Forever® “Bluebarry” and the 1st National Bagel Company® Blueberry bagels are misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), because these foods are fabricated from two or more ingredients, but the labels fail to bear the common or usual name of each ingredient. Specifically, your products are made with infused wild dry blueberries, a multi-ingredient food, but your labels fail to declare the sub-ingredients of this food. According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or “sub-ingredients”) may be met by either (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 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 1st National Bagel Company® Blueberry bagel product is misbranded within the meaning of section 403(e)(1) of the Act, 21 U.S.C. § 343(e)(1), because the label fails to bear the name and place of business of the manufacturer, packer, or distributor. According to 21 CFR 101.5(b), the requirement for declaration of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. Your label states “1st National Bagel Company®;” however, your corporate name is Bagels Forever®, Inc. In addition, 21 CFR 101.5(d) states that the statement of the place of business shall include the street address, city, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. Your label declares only a P.O. Box located in Minneapolis, Minnesota, whereas your place of business is Madison, Wisconsin.
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 statues 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.
In addition, we have the following comments:
1. We note that your website, www.bagelsforever.com, contains ingredients statements for each of your Bagels Forever® bagel varieties. These ingredients statements fail to identify the major food allergen wheat in accordance with section 403(w)(1) of the Act, 21 U.S.C. § 343(w)(1).
2. We note that your 1st National Bagel Company® Tomato Basil Bagels and Bagels Forever® Pumpernickel Bagels are made with ingredients (sun-dried tomatoes and caramel color, respectively) that contain sulfites; however, your labels fail to include sulfites as an ingredient. Under 21 CFR 101.4(a)(1), ingredients required to be declared on the label or labeling of a food, except those ingredients exempted by 101.100, shall be listed by their common or usual name. Therefore, unless the sulfiting agent included in your bagel varieties has no technical effect in this food and is present at less than 10 ppm in the finished food, you must declare its presence on your labels in accordance with 21 CFR 101.4. See 21 CFR 101.100(a)(4).
3. When allergens that are not specifically formulated in a food are identified as likely to occur in the food because of manufacturing practices, the manufacturer should identify and implement controls to reduce or prevent allergen cross-contact. Examples of preventive measures include production scheduling and dedicated equipment for production runs of products for which cross-contact is a concern, and proper cleaning. For more information, see CPG Sec. 555.250 http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074552.htm
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. 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 Tyra S. Wisecup at the address indicated on the letterhead.
Sincerely,
/s/
Gerald J. Berg
Director
Minneapolis District
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