1. Regulating Food Additives

2. Food and Drug Administration (FDA) 1938 – Federal Food, Drug, and Cosmetics Act Authority over food and food ingredients Defined “truthful labeling of ingredients” requirements Branch of the Dept. of Health and Human Services Regulate all foods except meat, poultry and eggs Supervise the use of additives Set manufacturers guidelines

3. Additive Guidelines Food Additives Amendment -1958 “No additive can be used in foods unless the FDA is convinced its safety” Additive manufactures must provide proof additive is safe Based on thorough scientific study Food additive approval steps Page 461 of textbook, table 16-2

4. Additive Guidelines cont….. Additive is “Hazardous” if it causes injury under certain use Margins of safety Zone between normal use concentration and hazardous level Salt 1/5 Most at risk additives are 1/100 Law also requires that an additive: Must perform useful function Can’t be used to deceive consumer or cover up manufacturing practices Can’t cause substantial loss of nutritive value Cant be substitute for good manufacturing practices Method for analyzing presence of additive must exist

5. The GRAS list Generally Recognized as Safe list Additives widely used with no known hazards Over 600 on list in1958 Would still need testing Manufacturers could legally use until test prove hazards Table 16-2 page 462

6. The Delaney Clause Bars the approval of any additive found to cause cancer In animals or humans Good clause – a few problems Cancer caused under condition not related to food use Detectable levels Was parts per thousand, now parts per billion FDA – “all foods could be found to contain at least 1 carcinogen” Impossible to be carcinogen free “safe” if cancer risk is 1/1,000,000 or less