Food additive legislation in Food Drug and Cosmetic Act

The 1938 Food, Drug and Cosmetic Act 1938 is the basis of modern food law; it gives the Food and Drug Administration (FDA) authority over food and food ingredients.

In 1958, Congress passed the Food Additives Amendment to the FD&C Act. The Food Additives Amendment describes the types of data necessary to evaluate the safety of a food additive and it provides the criteria for determining the safety of a food additive.

In United States, the risks or benefits of food additive and ingredients must be clearly displayed for consumers. The FD&C Act requires, in virtually all cases, a complete of all the ingredients of a food. 

Under the FD&C Act definition, a food additive is a substance which, through is intended use, may reasonably be expected (directly or indirectly) to become a component or affect the characteristics of any food.

The FD&C Act requires premarket approval of any additive regardless of the technique used to add it to food.

Thus, substances introduced into food are either new food additives that require premarket approval by FDA, or GRAS and are therefore exempt from the requirement for premarket review. Manufacturers must prove an additive’s safety by conducting research and presenting the scientific safety data to the FDA.

The Food Additives Amendment has a significant effect. It establishes that a food additive must be shown to be safe before it can be added to food. It also establishes the criterion of relatively safety rather than absolute safety for substances added to food.
Food additive legislation in Food Drug and Cosmetic Act