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, as 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 US regarding declared nutrient and non-nutrient 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, and docosahexaenoic acid (DHA), the presence of other non-nutrient components, and the presence of key safety and informational elements as identified in two DHHS Office of Inspector General (OIG)’s 2003 reports were compiled and compared. Results Compared with nonprescription products, prescription products contained significantly fewer vitamins (mean ±SE, 9±0.2 vs 11±0.3, P=<.05) and minerals (4±0.1 vs 8±0.3; P=<.05). Declared amounts of folic acid were higher in prescription products, while 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 RDAs for pregnant and/or lactating women. Product type also affected 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 usage such as dosing information.

Use of Iodine-Containing Dietary Supplements Remains Low among Women of Reproductive Age in the United States: NHANES 2011–2014

“…Our study found that 73.9% of women taking a supplement containing iodine were taking a product with at least 150 µg per serving (data not shown). Saldanha et al found that for dietary supplements that were specifically marketed as prenatal supplements, the mean iodine content of prescription prenatal supplements was 150 ± 4.8 µg and for non-prescription prenatal supplements, it was 164 ± 6.7 ug [ 26 ]. As it is unlikely there has been a dramatic reduction in the amount of iodine included in dietary supplements containing at least some iodine, the lower median may be due to women reporting less frequent use of supplements.…”

Periconceptional folic acid and risk for neural tube defects among higher risk pregnancies

“…In the less than daily and daily categories, the average daily dose was calculated as the sum of daily doses divided by number of days exposed and categorized as <400, 400 to <1,000, or ≥1,000 μg. When product name was unknown, FA dose was assumed to be 1,000 μg for prescription prenatals, 800 μg for nonprescription prenatals, and 400 μg for other nonprescription supplements, including FA‐only supplements (Saldanha et al, ). Mothers who did not report any supplements containing FA during this period were categorized as nonsupplementers (denoted as “None”) and constituted the reference category.…”

Maternal Dietary Factors and the Risk of Autism Spectrum Disorders: A Systematic Review of Existing Evidence

“…Prenatal vitamins typically contain higher amounts of FA, iron, and Vitamins B6 and B12 as compared to standard adult multivitamins, in order to meet the extra nutrient requirements of pregnancy [Schmidt et al, 2011]. However, there is also wide variability across formulations [Saldanha et al, 2017], and certain prenatal vitamins (such as many gummy vitamins) do not contain key nutrients like iron [WIC, 2018]. Studies examining prenatal vitamins in association with ASD have for the most part attributed observed protective associations to FA within the supplements, although the specificity of effects is difficult to determine.…”