Jan. 12, 2024 — The labels of prenatal supplements, which are sometimes taken by people while pregnant to advertise maternal and fetal health, often misstate the quantity of nutrients the product accommodates, in accordance with a Government report published on Thursday.
Experts on the Government Accountability Office (GAO), a nonpartisan government agency that gives fact-based information to Congress, found that 11 of the 12 over-the-counter dietary supplements tested contained at the least one nutrient above or below the degrees stated on the labels.
Of the 11 products that had nutrients above or below the degrees stated on the label, one product had a mean amount of folic acid that “may be hazardous to health based on measurements determined by the Institute of Medicine.” [now the National Academy of Medicine]“, says the report.
Based on the findings, GAO recommends that Congress strengthen FDA's oversight of dietary supplements, which are now regulated as foods rather than drugs. Under the Dietary Supplement Health and Education Act of 1994, the FDA does not have the authority to approve dietary supplements before sale. If there are problems, it can restrict or recall products on the market.
The agency will not publicly release the names of the brands it tested, said Karen L. Howard, PhD, director of science and technology assessment at GAO, who led the study. The agency has submitted the full list of brands and complete test results to the FDA, she said.
Report details
For the analysis, GAO commissioned an accredited laboratory to test the 12 selected prenatal nutritional supplements. The analysis assessed the levels of folic acid, iodine, iron and vitamins A, C and E.
Aside from folic acid, the other products tested did not contain average levels of nutrients that could be harmful to health, the report said.
Of the six nutrients, vitamin E content varied the most among the products tested, ranging from 28% to 332% of the amount stated on the label. Vitamin A was most commonly found in amounts outside acceptable label deviations in nine of the 12 dietary supplements.
The experts also tested the dietary supplements for heavy metals such as arsenic, cadmium, lead and mercury. Half of the products contain traces of lead or cadmium, but not in quantities that pose a health risk, the report says.
Because there is no federal legal definition of what a prenatal supplement is and what it should contain, manufacturers are free to decide which nutrients to include and in what amounts, Howard said. The benchmark for the study was a voluntary guideline from the Institute of Medicine (National Academy of Medicine) as a “tolerable upper intake level”.
The FDA may consider requiring manufacturers to notify or register with the agency before marketing a product and supply a duplicate of the label, the report said.
GAO conducted the investigation on behalf of U.S. Senator Jon Ossoff, D-GA, chairman of the Subcommittee on Human Rights and Legal Affairs, a part of the Senate Judiciary Committee, who has supported other measures to enhance maternal health.
Obstetrics/Gynecology response
The results are “concerning,” said Christopher Zahn, MD, interim CEO and chief of clinical practice and health equity and quality on the American College of Obstetricians and Gynecologists. “The GAO report is a powerful example of why ACOG supports increased FDA oversight and the standardization and regulation needed to ensure that prenatal vitamins and dietary supplements are safe and accurately labeled.”
Still, he said, the school continues to recommend supplements, particularly folic acid, which reduces the danger of brain and spinal cord damage.
Industry response
It's vital to maintain track, said Jeff Ventura, spokesman for the Council for Responsible Nutrition, a trade association for the dietary complement industry. “It is important to remember that this is a single product [with a potential health concern], and slightly exceeding the (Institute of Medicine) limit does not necessarily mean that the product poses a health risk. Whether too much folic acid poses a health risk depends on countless variables, including personal physiology.”
The group supports the thought of greater government oversight, including allowing dietary complement manufacturers to list their products with the FDA.
Expert perspective
“The [report] speaks to the unregulated nature of the dietary supplement industry, even for prenatal vitamins,” said Jeffrey Linder, MD, MPH, chief of general internal medicine and professor of medicine at Northwestern University Feinberg School of Medicine, who has written about nutritional supplements.
He said the report was a reminder “that we should be skeptical of what we are being sold.”
Misconceptions about dietary supplements are widespread among the public, he said. He reminds people: “These products are not required to be evaluated by the FDA or any other regulatory agency before sale as long as they comply with labeling requirements, including stating that any health claims have not been evaluated by the Food and Drug Administration.” and they are not intended to diagnose, treat, cure, or prevent any disease.”
Advice for consumers
Prenatal vitamins are recommended during pregnancy American College of Obstetricians and Gynecologists and others to compensate for the average diet that does not provide sufficient nutrients.Pregnant women, for example, need 600 micrograms of folic acid per day, says the company. Since it is difficult to get this much from food alone, a daily prenatal intake of at least 400 milligrams is recommended, starting if possible at least one month before pregnancy and in the first 12 weeks of pregnancy.
The CDC recommends All women of childbearing age take 400 milligrams of folic acid daily.
Pregnant women should speak to their doctor before purchasing prenatal supplements, Howard said. As for the study of prescription prenatal vitamins, “Prescription prenatal supplements fall into the identical FDA category as over-the-counter supplements and are subject to the identical regulations,” she said.