Lena's Lefse, Inc. – FDA Warning Letter, Nov 2, 2010

On October 29-November 2, 2010, the FDA inspected Lena's Lefse, Inc.'s food manufacturing facility in Ulen, Minnesota. The inspection revealed that the "Lena's Lefse" product is misbranded under section 403(w) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 343(w).

Specifically, the product label fails to declare wheat as a major food allergen, despite "bleached enriched flour" being an ingredient, which contains wheat. The Act requires major food allergens to be declared either immediately after or adjacent to the ingredient list with "Contains," or by parenthetically listing the food source in the ingredient list (e.g., "flour (wheat)").

Additionally, the product label has further deficiencies: 1. It fails to declare all component ingredients of multi-component ingredients as per 21 CFR 101.4(b)(2). For example, "bleached enriched flour" contains undeclared ingredients like bleached wheat flour and potassium bromate. Also, "soybean oil" is declared, but the product contains shortening with partially hydrogenated soybean and cottonseed oils, which are not fully declared. 2. The net weight declaration is not placed within the bottom 30 percent of the principal display panel, violating 21 CFR 101.10