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GAO-24-106689 1 (2023-12-12)

handle is hein.gao/gaopso0001 and id is 1 raw text is: Why This Matters Key Takeaways Many pregnant Americans take prenatal supplements to promote parental and fetal health as soon as they know they are pregnant. Spending on prenatal supplements in the U.S. market is projected to be over $189 million by the end of 2023 and is expected to grow.1 The Food and Drug Administration (FDA) regulates dietary supplements-including prenatal supplements-as a special category of food. Therefore, unlike drugs, dietary supplements are subject to a limited pre-market approval process. As a result, FDA may not discover mislabeling and contamination until after the products are on the market. We were asked to assess the accuracy of over-the-counter prenatal supplement labels for amounts of certain nutrients-vitamins and minerals-and determine whether the supplements also contain harmful substances, such as heavy metals. We contracted with an accredited laboratory to conduct testing. This report describes the accuracy of labels for amounts of tested nutrients and possible contaminants in selected best-selling prenatal supplements based on the laboratory testing. It also provides information on FDA's role overseeing prenatal supplements and describes what consumers need to know about prenatal supplements and labels. For all data and results, see GAO-24-107042. . Eleven of the 12 prenatal supplement products we tested contained at least one tested nutrient with an average amount outside acceptable deviations from the label value. One product had an average amount of folic acid that may cause health concerns based on metrics from the Institute of Medicine. None of the prenatal supplement products we tested contained selected heavy metal contaminants at concentrations likely to be a health concern based on metrics used by FDA. Prenatal supplements are not a substitute for a healthy diet but can help meet the nutritional needs of the fetus and pregnant individual. FDA lacks the authority to regulate dietary supplements-including prenatal supplements-with the same rigor as drugs, and oversight primarily occurs once the supplements are already on the market. We recommend that Congress consider measures for allowing FDA sufficient authority to carry out its oversight of dietary supplements. FDA agreed with this matter. Page 1 GAO-24-1 06689 PRENATAL SUPPLEMENT TESTING Page 1 GAO-24-106689 PRENATAL SUPPLEMENT TESTING

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