Lakeland Bakery, Inc. 11/8/11

Department of Health and Human Services	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

November 8, 2011

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED 

Refer to MIN 12 - 04

Richard D. Savoy, President/Co-Owner
Adrienne Savoy, Co-Owner
Lakeland Bakery, Inc.
421 N. Wisconsin Street
Elkhorn, Wisconsin  53121-1317 

Dear Mr. and Ms. Savoy:

The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 421 N. Wisconsin Street, Elkhorn, Wisconsin, on July 6 and 7, 2011. As part of the inspection, FDA collected product labels for some of your products. A review of these labels revealed that your Wheat Hamburger Buns (1/2 dozen) product is 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’s regulations through links on FDA’s home page at www.fda.gov.

1. Your Wheat Hamburger Buns (1/2 dozen) product is misbranded within the meaning of section 403(a)(1) of the Act, 21 U.S.C. § 343(a)(1), in that its product label is false or misleading.  Specifically, the label declares butter as an ingredient.  However, according to your formulation sheet, also collected during the inspection, butter is not an ingredient in this product.

2. Your Wheat Hamburger Buns (1/2 dozen) 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 a major food allergen, egg, as required by section 403(w)(1) of the Act. 

Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines 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, as “major food allergens.”  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 ingredient, 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).

3. Your Wheat Hamburger Buns (1/2 dozen) product is also misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that it is fabricated from two or more ingredients, but the label fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4.  For example:

• Your product is manufactured with Wheat Flour and Milk Powder. However, you fail to list the sub-ingredients of these ingredients on the finished product label.
• According to your formulation sheet, (b)(4) Flour, Sugar, Eggs and Yeast, are ingredients in your product. However, you fail to declare them on your finished product label. 

The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component 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, 21 CFR 101.4(b)(2).

This letter may not list all the violations at your facility. You are responsible for ensuring that your firm and your products are in compliance with the Act and all applicable regulations, including the food labeling regulations (21 CFR Part 101). 

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.

In addition, we note that you do not declare the net quantity of content in the bottom one-third of the label as required in 21 CFR 101.105(f).

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations.  Please 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, please 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. If you have questions regarding this letter, please contact Ms. Wisecup at (612) 758-7114.

Sincerely, 

/s/

Gerald J. Berg
Director
Minneapolis District