Ensuring adequate intake of vitamins and minerals is an important component of any healthy lifestyle. For most individuals, simply eating a varied diet is enough to meet these nutrient needs. During pregnancy, however, recommended daily intake of folic acid, iron, calcium, and other nutrients increases substantially. As a result, diet alone is frequently not enough to meet these heightened demands. In the 1970s, supplement companies began developing and marketing prenatal vitamins with folic acid to pregnant consumers in a bid to fill these nutrient gaps. By the 1980s, new research on the correlation between folic acid and neural tube defects in developing fetuses drove doctors to prescribe prenatal vitamins to pregnant patients with a new sense of urgency.
Today, prenatal vitamins are considered an essential component of prenatal care by physicians, maternal health organizations, and related entities for their ability to significantly reduce birth defects and developmental delays. Yet despite their purported necessity and serious impact on both maternal and fetal health, prenatal vitamins are not subject to the type of stringent regulation imposed on drugs. Instead, like other dietary supplements, prenatal vitamins are regulated by the FDA as food, enabling manufacturers to avoid many of the intense premarket safety checks that prevent distribution of unsafe drugs and hindering the FDA’s ability to pull substandard products from the shelves. Consequently, many of the most used prenatal vitamins have been found to be contaminated with dangerous heavy metals or to contain wildly inconsistent levels of labeled nutrients, putting both parent and child at risk. To address these issues, this Note argues that prenatal vitamins should be elevated to a separate subcategory within the category of dietary supplements requiring premarket review for safety and providing the FDA stronger postmarket regulatory authority.
* J.D. Candidate, 2025, University of Illinois College of Law; B.S., 2018, University of California, San Diego. Thank you to the staff, editors, and members of the University of Illinois Law Review for their hard work in editing this Note, to Professor Jacob Sherkow for his advice throughout the process, and to my family for their unwavering support. This Note is dedicated to my husband, Harrison, and our beautiful son, Arthur, who came into our lives at the perfect time.
The full text of this Note is available to download as a PDF.