GRAS List and Delaney Clause

2 GRAS List Generally Recognized as Safe (GRAS) List 1958 Food additives that have a long history of common usage in food with no known negative health effects. Over 600 additives on list -- eventually had to be tested 1969 GRAS substances are re-examined Potentially hazardous items were removed from list After being re-examined, the GRAS List was divided into five classifications.

3 Class 1 Ingredients safe at present and anticipated levels of use. Class 2 Ingredients safe at current usages, however, need more study to see if higher level usage could be hazardous Class 3 Ingredients that have restricted use. Further research needed. GRAS List Classifications

4 Class 4 Ingredients that the FDA needs to establish stricter guidelines. Class 5 Ingredients recommended to be removed from the GRAS List.

5 The Delaney Clause Food, Drug, and Cosmetic Act set of laws giving authority to the FDA to oversee the safety of food, drugs, and cosmetics. Delaney Clause, which is in the Food, Drug, and Cosmetic Act, states: No additive may be permitted in food if the additive at any level can produce cancer when fed to man or animals or can be shown to be carcinogenic by any other appropriate test.

Delaney Clause Controversy Problem Some harmless and common substances possibly induce cancer in one animal or another under special conditions that have little to do with normal food consumption Examples – saccharin, pepper, charred meat Possible modification Modify definition of “safe” in regard to foods and use informed scientific judgments to make regulatory decisions.