Inspections, Compliance, Enforcement, and Criminal Investigations
Miller's Bakery, inc. 05-Jun-08
Department of Health and Human Services
Public Health Service
Minneapolis District Office
June 5, 2008
RETURN RECEIPT REOUESTED
Refer to MIN 08-13
Brian S. Miller
Miller's Bakery, Inc.
1415 N. Fifth Street
Milwaukee, Wisconsin 53212
Dear Mr. Miller:
An inspection of your facility located at 1415 N. Fifth Street, Milwaukee, Wisconsin, was conducted by an investigator from the Food and Drug Administration (FDA) on December 20, 2007, January 22, 24, and March 3 and 6, 2008. This inspection verified that your firm manufactures and distributes bakery products. During the inspection, we collected samples of labels for your Miller Bakery Stollen, Seedless Rye Bread, and Knot Dinner Rolls. Based on our review of your product labels and other evidence collected during the inspection, these products are misbranded within the meaning of section 403 of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 343]. Regulations implementing the food labeling requirements, of the Act are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). You may find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
The labeling violations are as follows:
1. Your Miller Bakery Stollen product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the label fails to declare the presence of the major food allergen wheat, as required by section 403(w)(l) of the Act. Specifically, your Stollen product is manufactured using bleached enriched bromated flour, which contains wheat flour. However, the label on your product fails to declare the presence of the allergenic ingredient, 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 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)(l)(A) of the Act, 21 U.S.C. 343(w)(l)(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., "enriched 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)(l)(B)of the Act, 21 U.S.C. 343(w)(l)(B)].
2. Your Miller Bakery Stollen, Seedless Rye Bread and Knot Dinner Rolls products 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 but the labels fail to list all sub-ingredients (ingredients of an ingredient in the finished product). For example:
a. Your Stollen and Knot Dinner Rolls products have an ingredient statement that lists unbleached enriched flour." The investigator noted that the label for the bleached enriched flour shows that it is composed of several sub-ingredients (e.g., wheat flour and malted barley flour) that are not included on your label as required by 21 CFR 101.4(b)(2).
b. Your Seedless Rye Bread product has an ingredient statement that lists "unbleached enriched flour" and "white rye flour." The investigator noted that the labels for the unbleached enriched flour and white rye flour show that they are composed of several sub-ingredients that are not included on your label as required by 21 CFR 101.4(b)(2).
c. Your Stollen product has an ingredient statement that lists "shortening" and "margarine." The investigator noted that the labels for the shortening and margarine show they are composed of several sub-ingredients that are not included on your label as required by 21 CFR 101.4(b)(2).
The requirement to list sub-ingredients in the ingredient statement of the finished food may be met either by parenthetically listing the sub-ingredients after the common or usual name of the multi-component ingredient of which they are a part, or by listing the sub-ingredients without listing the multi-component ingredient itself. Under the first alternative, the sub-ingredients must be listed in descending order of predominance within the multi-component ingredient, and under the second alternative, the sub-ingredients must be listed in descending order of predominance in the finished food [21 CFR 101.4(b)(2)].
When you revise the labels of your products to correct the allergen labeling and ingredient labeling violations described above, please bear in mind that each oil present in the product must be declared by its common or usual name in accordance with 21 CFR 101.4(b)(14).
The above violations are not meant to be an all-inclusive list of deficiencies that may exist in any of your products or their labeling. It is your responsibility as top management to ensure that your establishment is in compliance with all requirements of the Act and federal regulations.
In addition to the above violations, we also have the following comments about the labeling on your Stollen, Seedless Rye Bread, and Knot Dinner Rolls products:
• The nutrition labels for these products do not comply with the format requirements in 21 CFR 101.9. For example, your labels do not meet the requirements regarding use of hairlines, bold type, and indentation in the Nutrition Facts panel.
• The net quantity of contents statement on the labels of these products is not located as a distinct item in the bottom 30 percent of the principal display panel, as required by 21 CFR 101.105(f).
We also note that your Stollen product contains margarine, a subcomponent of which is soybean oil. As explained above, soy is a major food allergen and is therefore subject to the allergen source labeling requirements of the Food Allergen Labeling and Consumer Protection Act (FALCPA). Section 201(qq)(2)(A) of the Act provides an exemption for highly refined oils; therefore, highly refined soybean oil would not be subject to the allergen source labeling requirements of Section 403(w). If the soybean oil is not highly refined, however, the product label must declare the presence of soy consistent with section 403(w) of the Act. It is your responsibility to determine whether or not the soybean oil used in your products is highly refined. Additional information about allergen source labeling is available on our website at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
You should notify this office in writing within 15working days of receipt of this letter of any steps you have taken or will take to correct the violations described above. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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.
Failure to promptly correct the violations described above may result in regulatory action without further notice. Such action may include seizure and injunction.
Your reply should be directed to Compliance Officer Jane Nelson at the address indicated on the letterhead.
W. Charles Becoat