FD&C Act Section 402 - Adulterated Food

What it says

Food is considered adulterated if, among other circumstances, it contains a poisonous or deleterious substance that may render it injurious to health, consists of filthy or decomposed material, or has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health, and the Act also treats food not manufactured under CGMP-based requirements as adulterated.

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

What it means in practice

• This statute is the legal foundation behind food GMP requirements, because a failure in sanitation can make food adulterated even where no contamination was found in the product.
• Insanitary conditions are judged by the conditions of the facility, so pests, residue and poor maintenance can support an adulteration finding.
• It links the regulations, such as 21 CFR Part 117, to enforcement outcomes like seizure, injunction and recall.

What FDA inspectors look for

• Whether conditions in the facility could allow food to become contaminated.
• Whether pest activity, residue or structural problems are controlled.
• Whether the facility's records show it detects and corrects these conditions.

Related regulations