The Office of Dietary Supplements in concert with the National Library of Medicine recently created the Dietary Supplement Label Database (DSLD) to facilitate the scientific study of dietary supplement labels.1,2 The DSLD allows researchers to extract dietary supplement labels for research purposes. For example, the database may be used to assess label information to ensure that label information is truthful and accurate or to compare and contrast a large number of dietary supplements.
To our knowledge, we report the first analysis of labeled vitamin content for infants and children (<12 months and 12 months to <4 years) through the use of the DSLD. We analyzed whether the content of vitamins as a whole is based on Institute of Medicine (IOM) recommendations.3
The initial data sets were downloaded July 7, 2013, from the DSLD after using the advanced search option to select for 2 intended user groups, younger than 12 months and 12 months to younger than 4 years. Each dietary supplement label was separated by vitamin into separate spreadsheets and analyzed. In the younger than 12 months group, 21 labels were downloaded and analyzed. Three shown to contain a dietary supplement intended for infants younger than 12 months were excluded. In the 12 months to younger than 4 years group, a total of 172 labels were downloaded and analyzed. Data validation including a comparison of DSLD data with scanned labels was subsequently carried out on 10% of vitamin entries in both intended user groups. Vitamin amounts were divided by the IOM3 recommended daily allowance (RDA) or adequate intake (AI) values to reveal a percentage of recommended RDA/AI. The RDA/AI percentages were averaged and standard error of the mean was calculated for each vitamin. Vitamin A concentrations were calculated based on the Office of Dietary Supplements health profession fact sheet4; when the label did not indicate the vitamin A source, preformed units were assumed. The data were then plotted by intended user group (Figure).
Percentage of Institute of Medicine recommended daily allowances or adequate intakes of vitamins in dietary supplements marketed to infants (<1 y) (A) and toddlers (1-3 y of age) (B) plotted as the mean percentage (SEM). Mean values were not included when there were insufficient data from the Dietary Supplement Label Database.
Vitamin D was the only vitamin present in the dietary supplements analyzed to contain at or below the RDA value for both pediatric intended user groups (Figure). The remaining vitamins presented in the IOM list contained values in excess of the RDA/AI values or were not present in enough vitamins (n < 3) to complete an appropriate analysis. Vitamin levels varied from a low of 13% of adequate intake for choline to a high of 936% of adequate intake for biotin (Figure, B).
According to the IOM, infant vitamin supplementation in excess of the RDA/AI for vitamins C, E, K, B6, and B12 as well as thiamin, riboflavin, niacin, folate, pantothenic acid, biotin, choline, and carotenoids is not recommended. Similarly, in the 12 months to younger than 4 years category, vitamin supplementation in excess of RDA/AI is not recommended for vitamins K and B12 as well as thiamin, riboflavin, folate, pantothenic acid, and biotin. The recommendation against excess neonatal and pediatric supplementation is because of a “lack of data of adverse effects in this age group and concern with regard to the lack of ability to handle excess amounts. Source intake should be from food only.”5 None of the tolerable upper intake levels have been defined by the IOM for this reason. However, dietary supplements (Figure) contain significant percentages in excess of the RDA/AI recommendations for vitamin supplementation.
The results of this study question the social responsibility and societal marketing concepts within the dietary supplement industry among those supplements marketed to infants and children younger than 4 years. We contend, based on our analysis, that much of the pediatric vitamin supplementation is not based on IOM recommendations3 and therefore represents wholesale oversupplementation.
Corresponding Author: Michael M. Madden, PhD, LECOM School of Pharmacy, 1858 W Grandview Blvd, Erie, PA 16509 (email@example.com).
Published Online: January 27, 2014. doi:10.1001/jamapediatrics.2013.4187.
Author Contributions: Drs Madden and Cook had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: All authors.
Acquisition of data: All authors.
Analysis and interpretation of data: All authors.
Drafting of the manuscript: All authors.
Critical revision of the manuscript for important intellectual content: All authors.
Administrative, technical, and material support: Madden, DeBias.
Study supervision: Madden.
Conflict of Interest Disclosures: None reported.
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