FD&C Act Section 403 - Misbranded Food

What it says

Food is considered misbranded if its labeling is false or misleading, or if it fails to carry required information, such as the name, quantity of contents and the ingredient list, and, under the allergen labeling provisions, if it contains an ingredient that is or contains a major food allergen without declaring it as required. The major food allergens are milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans and sesame.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Allergen labeling errors are among the most common causes of food recalls, so label control carries weight in a food GMP program.
• Cross-contact can create an undeclared allergen even where the allergen is not an intended ingredient, which links labeling to sanitation and changeover controls.
• A formulation or supplier change can introduce a new allergen, so label review should be part of change control.

What FDA inspectors look for

• Whether labels match the actual formulation, including all major allergens.
• Whether label control prevents the wrong label being applied to a product.
• Whether supplier or formulation changes trigger a label review.

Related regulations