Regulation of essential nutrient additions to animal diets (selenium -- a model case).

Abstract

Responsibility for regulation of essential nutrient additions to animal diets has been assumed by the Food and Drug Administration (FDA) through internal interpretation of the Federal Food, Drug and Cosmetic Act. Thus, these substances are regulated as food additives or through qualification for the generally recognized as safe (GRAS) list. Although essential nutrients, such as selenium, are not optional additives to animal diets that are demonstrably deficient (if animal health and welfare are of concern), supplementation with unapproved nutrients places one in violation of FDA interpretation of law. Selenium was established as a dietary essential in 1957, and practical problems with a deficiency of this nutrient were recognized soon after. Research was begun in 1967 specifically to gain FDA approval for selenium as a dietary supplement. Approval was granted for selenium supplements to swine and certain poultry diets in 1974. At that time, FDA staff members reported that the inability to supplement these diets with selenium had caused annual losses of over $82 million. Annual losses to the beef cattle, dairy cattle and sheep industry were estimated in 1975 at nearly $545 million. In a coordinated effort (initiated in 1975) involving scientists at nine United States universities and the FDA, data were gathered leading to approval in 1979 of selenium supplements for ruminants. The cost of the effort to meet regulatory requirements for selenium has been estimated at more than $1 million. Since this nutrient is not a proprietary product, this effort has been made largely at public expense. The inability to supplement selenium-deficient diets prior to FDA approval has cost hundreds of millions of dollars.