Folic Acid and the American Food Supply: A historical account of the FDA's creation of the current folic acid regulations

Abstract

During the 1980s, scientific studies began to uncover a link between the B-vitamin folic acid and a reduction in the prevalence of neural tube defects, including spina bifida and anencephaly. When Congress passed the Nutrition Labeling and Education Act of 1990, it included a command that the FDA consider the link between folic acid and neural tube defects to determine whether the evidence was strong enough to permit food manufacturers of products containing folic acid to make a claim that their products may help prevent neural tube defects. Although the FDA initially rejected the use of such a claim, faced with mounting pressure from the scientific community and other government agencies, it reversed course and allowed manufacturers to make certain health claims regarding folic acid. It also required that certain products be fortified with folic acid, while banning its addition to other products. This paper details this process in an attempt to show its complexity and the very serious issues it presents. Since the process is largely complete, the paper also attempts to evaluate the process, as a whole, to determine what the FDA did well and what, if anything, the FDA should have done differently.