Lucky Taco. Inc – FDA Warning Letter, Dec 20, 2011

On April 2, 2012, the FDA issued a Warning Letter to Lucky Taco, Inc., following an inspection on December 19-20, 2011, at their Hustisford, Wisconsin facility. The inspection revealed that Lucky Taco's "Lucky Cruncher Cookie (Java Mint Flavored)" and "Lucky Taco Mexican Fortune Cookie (Strawberry, Lemon, Lime and Mango flavored)" products were adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Adulteration (Lucky Cruncher Cookie - Java Mint):** The product contains Yellow 5, but the label fails to declare it, violating 21 U.S.C. § 342(c) and 21 CFR 74.705(d)(2). 2. **Misbranding (Lucky Taco Mexican Fortune Cookie):** Labels fail to declare milk, a major food allergen, which is present in an ingredient, violating 21 U.S.C. § 343(w). 3. **Misbranding (Nutrient Content Claims):** Both 25-count products bear implied "low calorie" claims ("Only 30 Calories per Cookie," "Only 19 Calories per Cookie") but exceed the calorie threshold for such claims without the required disclaimer, violating 21 U.S.C. § 3