On January 12, 2024, a government report revealed that the labels of prenatal dietary supplements, commonly taken by people during pregnancy to promote the health of the mother and fetus, frequently misrepresent the amount of nutrients in the product.
A bipartisan government agency, the Government Accountability Office (GAO), found that 11 out of 12 over-the-counter dietary supplements tested had at least one nutrient that was either over or under the values stated on the label. One product contained an average amount of folic acid that „could be detrimental to health based on the established measurements by the National Academy of Medicine“.
Based on the findings, the GAO recommended that Congress strengthen the FDA’s oversight of dietary supplements, which are now regulated as food rather than drugs. The report details the limitation of the FDA to approve dietary supplements before they are sold, but it can restrict or recall products if issues arise.
Karen L. Howard, PhD, director of Science and Technology Assessment at the GAO, stated that the agency will not publicly disclose the names of the tested brands. The GAO commissioned an accredited laboratory to analyze 12 selected prenatal dietary supplements, evaluating levels of folic acid, iodine, iron, as well as vitamins A, C, and E. Apart from folic acid, the other products did not contain average amounts of nutrients that could be harmful, according to the report.
The agency also tested the supplements for heavy metals, including arsenic, cadmium, lead, and mercury. Half of the products contained traces of lead or cadmium, but the amounts were not harmful, the report noted.
Since there is no federal legal definition of prenatal dietary supplements and their contents, manufacturers are free to decide which nutrients, and in what quantities, to include, said Howard. The FDA could consider requiring manufacturers to notify or register their products with the agency before marketing and provide a copy of the label, the report suggested.
The GAO conducted the investigation at the request of US Senator Jon Ossoff, D-GA, who has advocated for other measures to improve maternal health.
In response to the report, Christopher Zahn, MD, Interim CEO and Chief Medical Officer at the American College of Obstetricians and Gynecologists, labeled the results as „concerning“ and expressed support for increased FDA oversight and standardization to ensure that prenatal vitamins and dietary supplements are safe and accurately labeled.
The Council for Responsible Nutrition, a trade association representing the dietary supplement industry, supports the idea of enhanced government oversight, including the possibility for dietary supplement manufacturers to list their products with the FDA.
Jeffrey Linder, MD, MPH, Chief of General Internal Medicine and Professor of Medicine at the Feinberg School of Medicine of Northwestern University, described the report as revealing the unregulated nature of the dietary supplement industry, even with prenatal vitamins. He emphasized the need for skepticism regarding the products that are being sold.
The public often holds misconceptions about dietary supplements, Linder explained. He reminded people that these products do not need to be evaluated by the FDA or any other regulatory body before being sold, as long as they comply with labeling requirements and include disclaimers about health claims.
The American College of Obstetricians and Gynecologists recommends prenatal vitamins to balance the inadequate nutrient intake of an average diet. Pregnant women need 600 micrograms of folic acid per day and should consult with their doctor before purchasing prenatal dietary supplements. Additionally, the CDC recommends 400 micrograms of folic acid daily for all women of childbearing age.
Howard stated that prescription prenatal dietary supplements are subject to the same FDA regulations as over-the-counter supplements.