Adulteration and misbranding

The act's main regulatory tool is prohibition of "adulteration and misbranding". The FDA interprets these words to require agency approval before a company can market regulated direct or indirect food additives, and certain food, drug and medical device products.

Use of an unapproved direct or indirect food additive as an ingredient in a food product or in a food contact product renders the product adulterated and thus illegal.

The term "misbranded" refers to false or misleading labeling statements, designs or pictures, or to omission of required statements.

Page glossary

  • FDA
  • Labeling