Research Original Research: Brief| Volume 117, ISSUE 9, P1429-1436, September 2017

Is Nutrient Content and Other Label Information for Prescription Prenatal Supplements Different from Nonprescription Products?

      Abstract

      Background

      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.

      Objective

      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.

      Design

      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.

      Results

      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.

      Conclusions

      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.

      Keywords

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      Biography

      L. G. Saldanha is a scientific consultant, Office of Dietary Supplements, National Institutes of Health, Bethesda, MD.

      Biography

      R. B. Costello is a scientific consultant, Office of Dietary Supplements, National Institutes of Health, Bethesda, MD.

      Biography

      J. T. Dwyer is a senior nutrition scientist (contractor), Office of Dietary Supplements, National Institutes of Health, Bethesda, MD.

      Biography

      L. L. Brown is an American Association for the Advancement of Science (AAAS) Science and Technology Policy Fellow, Office of Dietary Supplements, National Institutes of Health, Bethesda, MD.

      Biography

      A. G. Ershow is a senior nutrition scientist, Office of Dietary Supplements, National Institutes of Health, Bethesda, MD.

      Biography

      K. W. Andrews is manager, Dietary Supplement Ingredient Database, Nutrient Data Laboratory, Agricultural Research Service, US Department of Agriculture, Beltsville, MD.

      Biography

      P. A. Gusev is senior research program manager, Dietary Supplement Ingredient Database, Nutrient Data Laboratory, Agricultural Research Service, US Department of Agriculture, Beltsville, MD.

      Biography

      P. R. Pehrrson is research leader, Nutrient Data Laboratory, Agricultural Research Service, US Department of Agriculture, Beltsville, MD.

      Biography

      C. J. Hardy is an interdisciplinary scientist, Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD.

      Linked Article

      • Erratum
        Journal of the Academy of Nutrition and DieteticsVol. 119Issue 5
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          In “Is Nutrient Content and Other Label Information for Prescription Prenatal Supplements Different from Nonprescription Products?” from the September 2017 issue of the Journal (117(9):1429-1436), an error appears in Table 1, which affects the text in the results and conclusions sections on the proportion of products that exceed the UL levels for folate. The Tolerable Upper Intake Levels (ULs) for folate established by the Food and Nutrition Board (FNB) of the National Academies of Sciences, Engineering, and Medicine, applies to the synthetic form of folate obtained from supplements, fortified foods, or a combination of the two, ie, the amounts are in micrograms folic acid and not dietary folate equivalents (DFE).
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