Jan. 12, 2024 – A recent government report reveals that prenatal supplements, commonly used during pregnancy, may not accurately depict the nutrients they contain. According to experts at the Government Accountability Office (GAO), a nonpartisan government agency providing fact-based information to Congress, most over-the-counter supplements tested had at least one nutrient above or below the levels noted on the labels.
With 11 out of 12 supplements found to have varying nutrient levels, one product was even reported to have an average amount of folic acid that “may cause a health concern based on metrics established by the Institute of Medicine [now the National Academy of Medicine].”
Consequently, the GAO recommends that Congress strengthen the FDA’s oversight of dietary supplements, which are currently regulated not as drugs but as foods. Under the Dietary Supplement Health and Education Act of 1994, the FDA lacks the authority to approve dietary supplements before they are sold, despite its ability to restrict or recall products on the market if problems occur.
Although the agency will not publicly release the names of the brands it tested, it has provided the full list of brands and test results to the FDA, ensuring transparency in the process.
The analysis, which evaluated levels of folic acid, iodine, iron, and vitamins A, C, and E, revealed that other than folic acid, the other tested products did not contain average amounts of nutrients likely to be a health concern.
Vitamin E varied the most among the products tested, with a range of 28% to 332% of the amount stated on the label, while vitamin A was found to be outside the acceptable deviations from the label value in nine of the 12 supplements.
The study also tested the supplements for heavy metals such as arsenic, cadmium, lead, and mercury and found trace amounts of lead or cadmium in half of the products, not in amounts likely to be a health concern.
According to Karen L. Howard, PhD, director of science and technology assessment for the GAO, who led the study, makers are free to decide which nutrients to include and what amounts due to the absence of a federal statutory definition for what a prenatal supplement is and what it should contain.
The report recommends that the FDA might consider requiring manufacturers to notify or register with the agency before marketing a product and providing a copy of the label.
The GAO report was conducted at the request of U.S. and further details are available here.