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ARS Home » Northeast Area » Beltsville, Maryland (BHNRC) » Beltsville Human Nutrition Research Center » Nutrient Data Laboratory » Research » Publications at this Location » Publication #331376
Title: Is nutrient content and other label information for prescription prenatal supplements different from nonprescription products?

Author
item SALDANHA, LEILA - National Institutes Of Health (NIH)
item DWYER, JOHANNA - National Institutes Of Health (NIH)
item ANDREWS, KAREN - University Of Maryland
item BROWN, LAVERNE - National Institutes Of Health (NIH)
item COSTELLO, REBECCA - National Institutes Of Health (NIH)
item ERSHOW, ABBY - National Institutes Of Health (NIH)
item GUSEV, PAVEL - University Of Maryland
item HARDY, CONSTANCE - Food And Drug Administration(FDA)
item Pehrsson, Pamela

Submitted to: Journal of the Academy of Nutrition and Dietetics
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 4/3/2017
Publication Date: 5/29/2017
Citation: Saldanha, L.G., Dwyer, J.T., Andrews, K.W., Brown, L.L., Costello, R.B., Ershow, A.G., Gusev, P.A., Hardy, C.J., Pehrsson, P.R. 2017. Is nutrient content and other label information for prescription prenatal supplements different from nonprescription products? Journal of the Academy of Nutrition and Dietetics. http://dx.doi.org/10.1016/j.jand.2017.04.002.
DOI: https://doi.org/10.1016/j.jand.2017.04.002

Interpretive Summary: Prenatal supplements are often recommended to pregnant women to help meet their nutrient needs. Many products are available, making it difficult to choose a suitable supplement because little is known about their labeling and contents to evaluate their appropriateness. To determine differences between prescription and nonprescription prenatal supplements available in the United States regarding declared nutrient and nonnutrient ingredients and the presence of dosing and safety-related information. 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 (9±0.2 vs 11±0.3; P=0.05) and minerals (4±0.1 vs 8±0.3; P=0.05). 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 for pregnant and/or lactating women. Product type also influenced ingredients added. Fewer prescription products contained botanical ingredients (6% prescription vs 33% nonprescription) and probiotics (2% prescription vs 8% nonprescription). Only prescription products contained the stool softener docusate sodium. Our analysis of prenatal supplements indicates that prescription and nonprescription supplements differ in terms of declared composition and nutrient strength, but have labels that are similarly sparse regarding aspects of use such as dosing information.

Technical Abstract: Prenatal supplements are often recommended to pregnant women to help meet their nutrient needs. Many products are available, making it difficult to choose a suitable supplement because little is known about their labeling and contents to evaluate their appropriateness. To determine differences between prescription and nonprescription prenatal supplements available in the United States regarding declared nutrient and nonnutrient ingredients and the presence of dosing and safety-related information. 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 (9±0.2 vs 11±0.3; P=0.05) and minerals (4±0.1 vs 8±0.3; P=0.05). 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 for pregnant and/or lactating women. Product type also influenced ingredients added. Fewer prescription products contained botanical ingredients (6% prescription vs 33% nonprescription) and probiotics (2% prescription vs 8% nonprescription). Only prescription products contained the stool softener docusate sodium. Our analysis of prenatal supplements indicates that prescription and nonprescription supplements differ in terms of declared composition and nutrient strength, but have labels that are similarly sparse regarding aspects of use such as dosing information.