| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT 900 U.S. Customhouse |
Department of Health and Human Services
WARNING LETTER
11-PHI-12
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
May 20, 2011
Anthony Vitaletti, President
National Bakery Inc.
1100 Capouse Ave.
Scranton, PA 18509
Dear Mr. Vitaletti:
We inspected your food manufacturing facility located at 1100 Capouse Ave, Scranton, PA, on February 8, 2011 through February 10, 2011. A review of your product labels revealed violations that cause several of your products to be misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (CFR) Part 101. You may find the Act and the Food Labeling Regulations through links in the FDA’s home page at www.fda.gov.
The labeling violations are as follows:
1. Your Pumpernickel Bread and Seedless Rye Bread 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 namely, wheat.
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 containing proteins 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, 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)].
2. Your products Pumpernickel Bread and Seedless Rye Bread are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients and the label fails to bear the common or usual name of each ingredient in accordance with 21 CFR 101.4(a)(1). For examples:
a. The Certificate of Analysis (COA) from (b)(4) indicated the following ingredients which are not on your product label: bleached wheat flour, malted barley flour, niacin, reduced iron, potassium bromate, thiamine mononitrate, riboflavin, folic acid.
For ingredients that are themselves composed of two or more ingredients, (e.g., mayonnaise), the requirement to list the 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 [21 CFR 101.4(b)(2)(i)], or (2) 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. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
3. Your Bakery Cinnamon Raisin Bagels are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] because the product label fails to declare trans fat on the nutrition facts information panel in accordance with 21 CFR 101.9(c)(2)(ii).
We also note that your Pumpernickel Bread fails to declare the appropriate household measure of the product. The Nutrition Facts panel declares "Serving Size 1 1/20 oz (30g)". We do not know if this product is sold as a loaf of bread or as slices. Therefore, an appropriate label statement for the product would be "___piece(s) (__g)" for sliced bread or "2 oz (56g/___inch slice)" for unsliced bread (21 CFR 101.9(b)(5) and 101.12(b)).
The above violations are not meant to be an all-inclusive list of deficiencies in your product labeling. You should take prompt action to correct the violations described above. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
We also have the following comments for your information when revising your labeling:
- The net weight declaration for your cinnamon Raisin Bagel is not expressed in pounds as required by 21 CFR 101.105(j)(l).
- The UPC code and recycling symbol on your Pumpernickel and Seedless Rye Breads are intervening material in accordance with 21 CFR 101.2(e).
- The footnote is missing from your Pumpernickel and Seedless Rye Breads as required by 21 CFR 101.9(d)(9).
You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You are also responsible for ensuring that all of your products and their labeling are in compliance with the laws and regulations enforced by FDA. In addition to consulting the Act and Title 21 of the CFR, you may find it useful to visit our website at http://www.cfsan.fda.gov when reviewing your labels.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Your response should be sent to Yvette Johnson, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Johnson can be reached at 215-717-3077 or Yvette.Johnson@fda.hhs.gov.
Sincerely,
/S/
Kirk Sooter
District Director
Philadelphia District
cc:
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Assistant Director
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