FDA WARNING_LETTER - Food For Life Baking Company, Inc. - December 04, 2007

The FDA conducted an inspection of Food For Life Baking Company, Inc. from November 27 to December 4, 2007. The inspection revealed that the company's "Food For Life Spelt Bread" product is misbranded under the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to declare wheat allergen:** The product contains spelt, which is a species of wheat (Triticum spelta L.), but the labels do not list "wheat" as a major food allergen as required by section 403(w) of the Act [21 U.S.C. 343(w)]. Two different labels were in use, neither declaring wheat. The FDA noted that only a small number of labels at the facility had a sticker declaring wheat. 2. **False or misleading labeling:** Statements like "Wheat-Alternative Spelt Bread" and "This unique bread is designed for those looking for an alternative to wheat" on outer cartons and labels are misleading because spelt is a type of wheat, violating section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)]. 3. **Failure to declare trans fat:** The label for "Food For Life Wheat Alternative Fruit Juice Sweetened Spelt Bread" fails to declare trans fat as required by 21 CFR 101.9(