Regulating Food Additives

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

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

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

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

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