Subscribe for the latest consumer trends, trade news, nutrition science and regulatory updates in the supplement industry!
Join 37,000+ members. Yes, it's completely free.
Study finds mislabeling on prenatal supps, but errs on heavy metal content red flagStudy finds mislabeling on prenatal supps, but errs on heavy metal content red flag
A recent test of prenatal supplements raised an alarm about heavy metal contamination. But both CRN and USP said the standards were misapplied, and no products exceeded acceptable limits.
4 Min Read
At a Glance
- Recent study on prenatal supplements raised heavy metal panic.
- But USP said its standards were misapplied, and no products actually exceeded limits.
- Yet the study's authors also found some of the products tested were understrength on nutrient content.
A recent published analysis of prenatal multivitamins found labeling discrepancies and heavy metal contamination that the authors said put mother and their unborn children at risk. The Council for Responsible Nutrition said the study has a major methodological flaw that was confirmed by USP.
The recent research was published in the American Journal of Clinical Nutrition. It was the work of experts associated with the medical and pharmacy schools at the University of Colorado Anschutz Medical Campus.
The researchers purchased 47 different examples of what they classified as prenatal multivitamin and mineral (PMVM) products. Of these, 15 were prescription products. They then had the products chemically analyzed.
Researchers: Many products found to be understrength
The researchers noted that adequate choline and iodine intakes during pregnancy are critically important for proper development of the fetus, so they paid particular attention to those nutrients in their analysis.
The researchers said they found a pattern of inaccuracy on the product labels. Only 12 of the 47 products listed choline amounts on the labels, and of those, only five met label claim for choline by having an amount within 20% of what was stated on the bottle. Two products had choline overages, while five were more than 20% understrength.
When it came to iodine content, 25 of the 47 products listed the amount on the label. Only four met label claim, while 20 were more than 20% understrength. A lone product was found to have a significant overage.
The researchers also tested the products for arsenic, lead and cadmium levels in excess of what the researchers called “USP purity limits.” They found that seven, two and 13 products, respectively, had excess levels of these contaminants.
The researchers called for greater oversight of these products by FDA.
“Current PMVM labels are misleading with the potential to harm pregnant persons and fetuses through omission or inaccurate content of essential nutrients and inclusion of heavy metals,” they concluded.
CRN and USP both say heavy metals standards were misapplied
Both CRN and USP took issue with the heavy metals finding, saying the researchers seemed to have misunderstood the how those standards work.
“USP has determined that the limits as well as the units were incorrectly applied and that the values presented in the first publication of the study were inaccurate,” said USP in a statement issued after the study was published. The statement said USP was in contact with the authors of the study to get the error corrected.
The CRN statement went into more detail.
“The referenced limits pertain to ingredient testing and are measured in mcg/g, not per daily dose. Correct application of the appropriate USP standards (General Chapter 2232 for dietary supplements) shows that all tested products were well below established safety limits for heavy metals. This is consistent with findings from a separate, recent Government Accountability Office (GAO) report, which confirmed that trace amounts of heavy metals in prenatal supplements are not a health concern based on FDA metrics,” the CRN statement read.
Mister: Damage is done
CRN president and CEO Steve Mister rued the damage that had already been done by the erroneous paper.
“It is particularly unfortunate that it has taken a month since the study was initially released in prepublication form and a press release was issued by the author’s university to get acknowledgement that the inflammatory conclusion was in error. During that time, numerous media have erroneously reported on the study’s conclusions in reliance on misinformation. And countless women have unnecessarily experienced anxiety over the safety of their vitamin regimens during their pregnancies,” he said.
CRN called for a quick retraction of the alarmist press release that accompanied the paper. The press release garnered significant mainstream media attention and generated some alarmist headlines.
Corresponding author Laura Borgelt, PharmD, said she and her coauthors were aware of the issue surrounding the assessment of the heavy metal levels.
"We initially referenced an article that provided information about the United States Pharmacopeia Chapter 2232 standards for individual ingredients, but now recognize that the standards for finished products are more applicable to our study. While we did find measurable amounts of heavy metals in some prenatal vitamins, the levels did not exceed USP standards for finished products," Borgelt said in an email to SupplySide Supplement Journal.
"We're actively working to align our findings with the correct information and look forward to presenting an updated, more accurate version of our peer-reviewed publication," she continued.
As for the issue of some products having been found to be understrength, Mister said testing complex mixtures to tease out the amounts of one or two ingredients is a difficult task. Responsible manufacturers spend time and money developing testing procedures for their own products and when researchers pull products from shelves and use generic testing methods, mistakes can creep in.
About the Author
You May Also Like