A new federal government report has found quality problems with prenatal supplements. Some of the tested products had too little of the active nutrients, while others bordered on having too much. 

The new U.S. Government Accountability Office (GAO) report was released late last week with the title, Prenatal Supplements: Amounts of Some Key Nutrients Differed from Product Labels. 

GAO experts tested twelve different prenatal vitamin products, including five gummy products, four soft gels and three tablet products. 

The GAO team bought 12 of the best-selling prenatal vitamin products. Five of those were gummies, four were capsules and three were tablets. None of the brands were identified. 

The products were tested for the content of six ingredients: Folic acid, iodine, iron, and vitamins A, C and E. 

Variances in nutrient levels documented 

The products were tested to see whether the levels of these nutrients fell within the Food and Drug Administration’s “acceptable range,” meaning at least 100% of the quantity stated on the label was actually in the product. Similarly, the GAO team also looked to determine whether any of the nutrients exceeded maximum recommended thresholds set by USP (United States Pharmacopeia). 

The researchers found that while most of the products had at least the stated amount of tested nutrients, the content was nonetheless variable. For folic acid, the products ranged from 50% of label claim to almost 250%.  

The ranges for the letter vitamins were even greater, with vitamin A ranging from none to more than 250%, vitamin C varying from 50% up to almost 350%, and vitamin E ranging from 25% up to more than 300%. 

The ranges for the final two ingredients — iodine and iron — were less broad. Iodine content ranged from 50% up to more than 125% of label claim, while iron amounts ranged from slightly more than 100% to about 125%.  

None of the gummy products were formulated with iron. All the other ingredients were at least claimed on the labels except for one soft gel formula that omitted iodine. 

No standard set for prenatal formulas 

The report noted there is no standard for what a prenatal vitamin product should contain.  

“Because there is no federal definition or regulation specific to prenatal supplements, manufacturers have no requirements for the types and amounts of nutrients that should be in a prenatal supplement. As a result, prenatal supplements vary in which vitamins and minerals are included,” GAO noted. 

Formulators are apparently relying on various recommendations from health authorities. Folic acid and iodine are the most important nutrients in these products, as they are directly tied to reducing the prevalence of birth defects. 

As for the letter vitamins, the report raised a concern about the high amount of vitamin C and E in some of the products. According to the World Health Organization, when pregnant women receive high levels of both vitamin C and vitamin E, it can raise the risk of a complication called prelabour rupture of membranes (PROM), in which the amniotic sac ruptures and the risk of infection rises if labor is not induced promptly. 

To increase the standardization of prenatal products, the NIH (National Institutes of Health) Office of Dietary Supplements will hold a workshop in June 2024, the report noted.  

But even if a standard is established, there is still the issue of enforcing compliance. This is complicated, the GAO report said, due to FDA’s ignorance of what supplements are on the market at any one time.  

The GAO authors strongly recommended FDA be given the authority to require premarket registration for dietary supplement products. The organization began advocating for this authority as far back as 2009. 

CRN: Report went too far 

While the Council for Responsible Nutrition agrees with the GAO’s advocacy for a premarket registration requirement, it feels the report went too far in its criticism. 

“This report strikes an unnecessarily alarmist note when the vast majority of these supplements are not only safe, but vital to the health of mothers and their unborn babies,” said CRN’s Andrea Wong, senior vice president of scientific and regulatory affairs. “The worst possible outcome would be for women to read this report and decide not to take prenatal supplements, when research shows the critical benefits these nutrients provide in the form of supplementation.”