The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires that any FDA-regulated packaged food that contains a major food allergen must declare it on the label. Wheat is one of the nine major allergens covered under FALCPA, alongside milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, soy, and sesame.
In practice, this means that when a manufacturer uses a wheat-derived ingredient, one of two things must appear on the label:
The ingredient list must use the common or usual name of the food source (e.g., "flour (wheat)" or "wheat gluten"), or A "Contains: Wheat" statement must appear immediately following or adjacent to the ingredient list.
Both approaches are compliant. Either gives you notice that the product contains a wheat-derived ingredient.
The FALCPA Loophole for Highly Processed Wheat Derivatives
FALCPA contains a specific exemption for highly processed wheat derivatives. The law states that wheat that has been processed to remove gluten, such as wheat starch or wheat-derived glucose syrup, may be exempt from the allergen declaration if the FDA determines that the ingredient no longer contains allergenic protein.
In practice, this means that some products may contain wheat-derived ingredients without declaring wheat on the label. This is a significant loophole for individuals with wheat allergy. The FDA has issued guidance on this exemption, but the rules are complex and not always clear to consumers.
The 2025 FDA Guidance Update
In January 2025, the FDA published the 5th edition of its Food Allergen Labeling Guidance. The update clarified that the wheat allergen declaration applies to all wheat-derived ingredients, including those that have been highly processed. However, the exemption for certain wheat derivatives remains in place, creating ongoing confusion.
For individuals with wheat allergy, the safest approach is to avoid all wheat-derived ingredients, even those that may be exempt from the allergen declaration. This includes wheat starch, wheat-derived glucose syrup, and other highly processed wheat derivatives.
Where FALCPA Does Not Apply
FALCPA applies to packaged foods regulated by the FDA. It does not apply to:
Restaurant food and foodservice. No federal law requires restaurants to label allergens. Some states have their own requirements, but at the federal level, you must ask directly. USDA-regulated products. Most meat, poultry, and egg products fall under USDA jurisdiction rather than FDA. These are not covered by FALCPA, though USDA has its own allergen labeling guidance. Alcohol. Beverages regulated by the TTB have separate labeling rules. Some beers and malt beverages contain wheat. Non-packaged foods. Foods sold loose, in bulk, or without standard packaging may not carry ingredient labels at all.