An Evaluation of Prenatal Prescribed (P) and Non‐Prescribed (N‐P) Supplement Labels

Abstract

In the U.S. a prenatal supplement can be bought off store shelves as dietary supplements (DS), and some are sold behind the counter by prescription. Our objective was to evaluate P and N‐P product labels, and determine if there were differences in nutrient composition and amount for eight nutrients (vitamins A and D, folic acid, iodine, calcium, iron, zinc, and DHA) with data form two publicly‐available databases, Dietary Supplement Label Database (DSLD) and DailyMed. We identified 82 P and 132 N‐P supplements, complete with images of product labels. We used the questions and key label elements identified by the DHHS Office of Inspector General (OIG) in two 2003 reports Dietary Supplement Labels, and An Assessment and Key Elements to evaluate P and N‐P product labels. N‐P contained more vitamins and minerals than P products. The mean number ±SE of vitamins and minerals in the NP were 11±0.2 and 8±0.3 and in P was 9±0.9 and 4±0.1, respectively. Declared label amounts of vitamin A, vitamin D, iodine and calcium were higher in the N‐P products. Folic acid was higher in the P products. The amounts of iron, iodine, and DHA were similar in P and N‐P products. Since P products do not fall under any distinct FDA‐regulated category, there are no specific regulations that govern the labeling of these products. However, the labels did provide a list of ingredients and their amounts consistent with FDA's guiding principle that labels should be truthful and not misleading. 100% of the N‐P but only 43% of the P supplements used the DS labeling format to declare nutrients on the label. The remaining (57%) of P products used an alternative format. 100% of the N‐P labels listed the mandatory DS label information. While labels did provide the required information, such as nutrients, nutrient amounts and dosage, <10% provided the additional information listed in the 2003 OIG key elements for a DS label report. Optional label information would possibly be useful for women taking prenatal supplements, such as recommended daily dose, minimum (and maximum) duration of time for which a supplement should be taken, interactions and contraindications, and possible side effects. Since some supplements contain levels of nutrients that are higher than the recommended levels for pregnant and lactating women, women should be encouraged to discuss their choice and use of an N‐P prenatal supplement with their healthcare provider.Support or Funding InformationOffice of Dietary Supplements, NIH