Lena's Lefse, Inc. 3/28/11

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

March 28, 2011

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 11 - 19

Douglas T. Lindsay
Susan Lindsay
Co-owners
Lena's Lefse, Inc.
325 First Street SW, P.O. Box 328
Ulen, Minnesota 56585-0328

Dear Mr. and Ms. Lindsay:

FDA conducted an inspection of your food manufacturing facility located at 3212 Highway 32 South, Ulen, Minnesota, on October 29-November 2, 2010. During the inspection our investigators collected samples of your "Lena's Lefse" product label. Our review of this product label reveals that your Lena's Lefse product is misbranded within the meaning of section 403 of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 343. You may find the Act and related regulations through links on FDA's home page at www.fda.gov.

Specifically, your Lena's Lefse product is misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that its label fails to declare the presence of wheat, a major food allergen present in the product, as required by section 403(w)(1) of the Act.

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)(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 product label for your Lena's Lefse product declares as an ingredient bleached enriched flour. Enriched flour contains wheat. However, your product label does not declare the presence of wheat, which is a major food allergen.

This letter is not meant to be an all-inclusive list of violations that may exist at your facility or 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 have the following comments regarding your Lena's Lefse product label:

1. The label fails to declare the product ingredients that contain two or more ingredients in accordance with Title 21, Code of Federal Regulations (21 CFR) 101.4(b)(2). For example:

• The label declares as an ingredient "bleached enriched flour" and lists the following component ingredients in accordance with 21 CFR 101.4(b)(2)(i): malted barley, flour, niacin, iron, thiamine, mononitrate, riboflavin, and folic acid. However, the product label for the bleached enriched flour used in your Lena's Lefse product declares several ingredients (bleached wheat flour and potassium bromate) that are not declared on your label.

• The label also declares soybean oil as an ingredient. However, you informed our investigators that the product actually contains shortening. The product label for the shortening declares as its ingredients partially hydrogenated soybean and cottonseed oils. To comply with 21 CFR 101.4(b)(2), the Lena's Lefse product label should declare all of these component ingredients.

The requirement to list these component ingredients (or "subingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or 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, 21 CFR 101.4(b)(2).
 

2. In accordance with 21 CFR 101.105(f), the net weight declaration must be placed within the bottom 30 percent of the principal display panel.

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.

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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