Prenatal supplements study suggests industry should review formulations

31 Aug 2017 --- Prescription and nonprescription prenatal supplements significantly differ in terms of declared composition and nutrient strength, but they have labels that are similarly unclear in the information given about aspects of use such as dosing, according to a study in the September 2017 issue of the Journal of the Academy of Nutrition and Dietetics.

“The industry should review their product formulations, especially the amounts of nutrients provided, in light of changes to Daily Values (DVs) in the new food and dietary supplement labeling regulations that were published last year,” Scientific Consultant Leila G Saldanha, Ph.D., tells NutritionInsight, suggesting possible industry action based on the study’s findings.

The results of the study come at a time when prenatal supplements are often recommended to pregnant women to help them meet their nutrient needs. Many products are available, which means it is difficult to choose a suitable supplement because little is known about their labeling and contents to evaluate their appropriateness, according to the study.

The study, therefore, aimed to determine differences between prescription and nonprescription prenatal supplements available in the US regarding declared nutrient and non-nutrient ingredients and the presence of dosing and safety-related information.

Significant differences
Using two publicly available databases with information about prenatal supplement products, information from prescription and nonprescription product labels were extracted and evaluated. For the 82 prescription and 132 nonprescription products, declared label amounts of seven vitamins and minerals, docosahexaenoic acid (DHA), the presence of other nonnutrient components, and the presence of key safety and informational elements as identified in two Department of Health and Human Services Office of Inspector General (OIG)’s 2003 reports were compiled and compared.

Compared with nonprescription products, prescription products contained significantly fewer vitamins and minerals. Declared amounts of folic acid were higher in prescription products, whereas vitamin A, vitamin D, iodine and calcium were higher in the nonprescription products. Amounts of iron, zinc and DHA were similar.

Virtually all products contained levels of one or more nutrients that exceeded the Recommended Dietary Allowances (RDA) for pregnant and lactating women. Product type also influenced ingredients added. Fewer prescription products contained botanical ingredients (6 percent prescription versus 33 percent nonprescription) and probiotics (2 percent prescription versus 8 percent nonprescription). Only prescription products contained the stool softener docusate sodium.

More discussion and research needed
The conclusion section of the paper recommends that pregnant women discuss their choice of prenatal product with their health care provider. “Given the wide variety of types and amounts of nutrients in prescription and nonprescription prenatal products marketed in the United States, including a statement to that effect on the label, would help ensure that the product selected is appropriate to meeting a woman’s nutrient needs,” adds Saldanha.

Further research could also be done into the excessive amounts of some nutrients that some supplements seem to contain.

“Some prenatal supplements provide more than the recommended amounts of one or more nutrients,” offers Saldanha. “With the possible exception of iron and folic acid, we do not know the potential effects of high intakes of these nutrients on the health of the mother and fetus in the short and long term.”

Prenatal health has been in the news recently with the news that researchers have uncovered why prenatal alcohol exposure increases the likelihood of addiction. Recently, DuPont and Happy Family have also partnered on a prenatal probiotic.