Prenatal Supplement Labels Not Always Accurate: U.S. Report

Jan. 12, 2024 – The labels connected prenatal supplements, commonly taken by group during gestation to beforehand maternal and fetal health, often misstate nan magnitude of nutrients nan merchandise contains, according to a government report released Thursday.

Experts from nan Government Accountability Office (GAO), a nonpartisan authorities agency providing fact-based accusation to Congress, recovered that 11 of nan 12 over-the-counter supplements tested had astatine slightest 1 nutrient supra aliases beneath nan levels noted connected nan labels. 

Of nan 11 that had nutrients supra aliases beneath nan levels connected nan label, 1 merchandise had an mean magnitude of folic acerb that “may origin a wellness interest based connected metrics established by nan Institute of Medicine [now nan National Academy of Medicine],” nan study said.

Based connected nan findings, nan GAO recommends Congress fortify nan FDA’s oversight of dietary supplements, which are now regulated not arsenic narcotics but arsenic foods. Under nan Dietary Supplement Health and Education Act of 1994, nan FDA does not person nan authority to o.k. dietary supplements earlier they are sold. It tin restrict aliases callback products connected nan marketplace if problems occur.

The agency will not publically merchandise nan names of nan brands it tested, said Karen L. Howard, PhD, head of subject and exertion appraisal for nan GAO, who led nan study. The agency did merchandise nan afloat database of brands and nan afloat trial results to nan FDA, she said.

Report Details

For nan analysis, nan GAO contracted pinch an accredited laboratory to trial nan 12 prenatal supplements chosen. The study evaluated levels of folic acid, iodine, iron, and vitamins A, C, and E. 

Other than folic acid, nan different tested products did not incorporate mean amounts of nutrients apt to beryllium a wellness concern, nan study said.

Of nan six nutrients, nan level of vitamin E varied nan astir among nan products tested, pinch a scope of 28% to 332% of nan magnitude stated connected nan label. Vitamin A was astir often recovered successful amounts extracurricular nan acceptable deviations from nan explanation value, recovered successful 9 of nan 12 supplements.

The experts besides tested nan supplements for dense metals specified arsenic arsenic, cadmium, lead, and mercury. There were trace amounts of lead aliases cadmium successful half of nan products, but not successful amounts apt to beryllium a wellness concern, according to nan report. 

Because nary national statutory meaning exists for what a prenatal supplement is and what it should contain, makers are free to determine which nutrients to see and what amounts, Howard said. The benchmark utilized for nan study was a voluntary line from nan Institute of Medicine (National Academy of Medicine) arsenic nan “tolerable precocious intake level.”

The FDA mightiness see requiring manufacturers to notify aliases registry pinch nan agency earlier trading a merchandise and providing a transcript of nan label, nan study recommended.

The GAO did nan investigation astatine nan petition of U.S. Sen. Jon Ossoff, D-GA, chair of nan Subcommittee connected Human Rights and Law, portion of nan Senate Judiciary Committee, who has backed different measures to amended maternal health. 

OB/GYN Response

The findings are “concerning,” said Christopher Zahn, MD, interim CEO and main of objective believe and wellness equity and value for nan American College of Obstetricians and Gynecologists. “The GAO study is simply a powerful illustration of why ACOG supports accrued FDA oversight and nan standardization and regularisation that’s needed to make judge prenatal vitamins and supplements are safe and accurately labeled.” 

Even so, he said, nan assemblage continues to urge nan supplements, particularly folic acid, which reduces nan consequence of encephalon and spinal cord defects.

Industry Response

Keeping position is important, said Jeff Ventura, a spokesperson for nan Council for Responsible Nutrition, a waste and acquisition relation for nan dietary supplement industry. “It’s important to support successful mind this is 1 merchandise [with a imaginable wellness concern], and exceeding (Institute of Medicine’s) precocious level period somewhat does not needfully mean nan merchandise poses a wellness risk. Whether excessively overmuch folic acerb poses a wellness consequence is limited connected innumerable variables, up to and including individual physiology.”

The group supports nan thought of much authorities oversight, including having supplement makers database their products pinch nan FDA. 

Expert Perspective

“This [report] speaks to nan unregulated quality of nan supplement industry, moreover for prenatal vitamins,” said Jeffrey Linder, MD, MPH, main of wide soul medicine and a professor of medicine astatine Northwestern University Feinberg School of Medicine, who has written astir dietary supplements. 

He said nan study is simply a reminder that “we should beryllium skeptical of what we’re being sold.”

Misconceptions astir supplements are communal among nan public, he said. He reminds people: “These products are not required to beryllium evaluated by nan FDA aliases immoderate regulatory assemblage earlier being sold, arsenic agelong arsenic they adhere to labeling requirements, including that they opportunity immoderate wellness claims person not been evaluated by nan Food and Drug Administration and they are not intended to diagnose, treat, cure, aliases forestall immoderate disease.”

Advice for Consumers

Prenatal vitamins are recommended during gestation by nan American College of Obstetricians and Gynecologists and others to dress up for nan mean fare not supplying capable amounts of nutrients.For example, pregnant group request 600 micrograms of folic acerb per day, nan group says. Because it is difficult to get this overmuch from nutrient alone, a regular prenatal pinch astatine slightest 400 milligrams is recommended starting astatine slightest a period earlier pregnancy, if possible, and during nan first 12 weeks of pregnancy. 

The CDC recommends each women of reproductive property return 400 milligrams of folic acerb daily.

Pregnant group should talk to their wellness attraction supplier earlier buying prenatal supplements, Howard said. As for looking into prenatal vitamins provided by prescription, “Prescription prenatal supplements are successful nan aforesaid FDA class arsenic over-the-counter supplements and are regulated nan same,” she said.