A company can decide on its own that a new food ingredient is safe, put it into products sold nationwide, and never tell the Food and Drug Administration it exists. That is not a violation of the rules. It is the rules.
The mechanism is called self-affirmed GRAS, short for generally recognized as safe. Under current regulations, a company can convene a panel of experts, conclude an ingredient meets the safety standard, and market it without notifying the agency. There is no requirement to submit anything and no public database of self-affirmed ingredients.
