Regulation of Added Substances in the Food Supply by the Food and Drug Administration Human Foods Program

The US food supply is increasingly associated with diet-related diseases, toxicity, cancer, and other health harms. These public health concerns are partly attributable to a loophole in federal law. The Food and Drug Administration (FDA) evaluates the premarket safety of ingredients regulated as food additives but allows the food industry to self-regulate and determine which substances to classify as generally recognized as safe (GRAS) based on undisclosed data and conclusions that the FDA never sees. Furthermore, the FDA lacks a formal approach for reviewing food additives and GRAS substances already found in the food supply. Substances in the food supply thus include innocuous ingredients (e.g., black pepper), those that are harmful at high levels (e.g., salt), those that are of questionable safety (e.g., potassium bromate), and those that are unknown to the FDA and the public. A recent court decision codified these gaps in the FDA’s current approach, leaving states to try to fill the regulatory void. The FDA and Congress should consider several policy options to ensure that the FDA is meeting its mission to ensure a safe food supply.