Proper application of USP standards confirms safe levels
CRN expresses grave concern regarding the flawed methodology and erroneous conclusions presented in the recently published study, “Content of Selected Nutrients and Potential Contaminants in Prenatal Multivitamins and Minerals: an Observational Study.” The study inaccurately reported that certain prenatal multivitamins contained heavy metals (lead, arsenic, and cadmium) at levels exceeding “USP Purity Limits,” a standard that does not exist for the finished products tested in the study.
Upon review, it was determined that the limits referenced in the study are not applicable to finished products and were erroneously cited. The U.S. Pharmacopeia (USP) has issued a statement that confirms this error. 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 dissemination of this study, accompanied by a press release and subsequent media coverage, has needlessly alarmed pregnant women. Headlines such as “Prenatal vitamins may have dangerous levels of lead and arsenic” in major outlets are based on flawed application of the USP standards and misrepresent the safety of these critical products. Prenatal vitamins play an essential role in supporting maternal and fetal health by meeting vital nutrient needs, as recommended by healthcare professionals and the Dietary Guidelines for Americans.
CRN president & CEO Steve Mister, commented, “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.”
CRN and its members who manufacture and market prenatal vitamins remain committed to the health and safety of consumers and urge for a swift retraction and acknowledgement from the lead authors’ institution (the University of Colorado Anschutz Medical Campus), and the American Journal of Clinical Nutrition, to restore confidence in prenatal multivitamins.
