This statement responds to the Consumer Reports article Prenatal Vitamin Nutrient Levels May Differ From Labeled Amounts, CR's Tests Show.
Prenatal vitamins fill an important gap, helping ensure you’re getting the additional amount of nutrients required for pregnancy, including folic acid, iron, iodine, and other vitamins and minerals shown to be critical for fetal development.
Without supplementation, your blood levels of most vitamins will decrease during pregnancy, and round-the-clock nausea, food aversions, and pregnancy fatigue can make it even harder to meet your increased nutritional needs from food alone.
A prenatal vitamin can help cover your bases, which is why the American College of Obstetricians and Gynecologists recommends them widely before and throughout pregnancy, as does the Academy of Nutrition and Dietetics. ‘The health of our future generation literally depends on this.’
We couldn’t agree more. Consumers—particularly women who are pregnant or planning a pregnancy—should be able to trust that dietary supplements are safe, high-quality and accurately labeled. CRN and its member companies share that commitment. That’s why credible findings suggesting a product may not meet its specifications deserve careful review.
At the same time, Consumer Reports’ findings require important context. Consumer Reports concluded that all 17 prenatal supplements it tested are safe to consume and advised women currently taking a prenatal not to stop. It also found that every product it tested met its highly protective safety limits for arsenic, lead, cadmium and mercury.
The report’s conclusion that many products did not match their labels also warrants closer examination. Consumer Reports selected USP tolerance ranges as its benchmark. Those USP ranges are voluntary for products that do not claim to be USP verified, and falling outside them does not automatically mean a product violates FDA requirements, is unsafe or lacks appropriate quality controls.
Consumer Reports also acknowledges that its testing represents a snapshot based on one to three lots per product. Several manufacturers reported different results from their own or independent laboratory testing. Analytical methodology, nutrient forms, product matrices, and calculation methods can all affect results. Certain nutrient forms and complex product matrices may require fit-for-purpose, scientifically valid analytical methods, and results can differ when a method has not been designed for the specific analyte and matrix being tested. In addition, some amounts above label claim may reflect scientifically justified “overages” used to ensure vitamins maintain labeled potency throughout shelf life.
Dietary supplements are regulated by FDA, and manufacturers must comply with current Good Manufacturing Practices and are responsible for ensuring their products are safe and properly labeled. Many companies invest substantially in robust internal quality systems, supplier qualification programs, and testing protocols to ensure compliance with labeling requirements.
CRN supports rigorous, scientifically sound scrutiny of dietary supplements. But limited testing of 17 products, using in part voluntary benchmarks as the measurement, and sometimes producing results inconsistent with testing results of the manufacturers, should not be used to suggest that prenatal supplements broadly are unsafe or that the industry operates without meaningful oversight.
Prenatal supplements play an important role in helping women meet increased nutritional needs before and during pregnancy, and consumers should continue to follow the guidance of their healthcare providers.