(P27-034-25) Children’s Calcium ± Vitamin D Dietary Supplements (DS): Nutrient Strength and Compliance with FDA Guidance for Performance Quality and Labeling of Chewable Tablets

Objectives: Calcium and vitamin D under-consumption is a public health concern and achieving adequate magnesium intake remains a challenge in the U.S. Calcium ± vitamin D DS are commonly used by adults as well as children to improve nutritional status. This study assessed micronutrient content, dosage units’ performance in disintegration and dissolution tests, and the presence of label warnings on the necessity of chewing the chewable tablets before swallowing.

Methods: The tested children’s DS (n=21, 2-3 lots, with calcium as the primary ingredient at ≥ 80 mg/serving) included gummies (n=11), chewable tablets (n=8), a wafer and a liquid DS. Minerals and vitamin D were measured by expert laboratories with inductively coupled plasma mass spectrometry and liquid chromatography tandem mass spectrometry, respectively. To pass performance tests from United States Pharmacopeia (USP), dosage units must disintegrate within 30 min and release at least 75% of labeled ingredient amount within 30-60 minutes.

Results: Differences from labels for calcium, phosphorus, magnesium, and vitamin D measured content were largely within the limits set by USP. All DS contained calcium and phosphorus below Recommended Dietary Allowances (RDA): mean ± SD, 35.1±17.2 and 33.5±17 %RDA (measured amount per day/RDA for ages 4 to 8 years) ×100%). Six of 7 DS were below Upper Tolerable Intake Level (UL) for magnesium in supplemental form58.4±12.5 %UL; 1 at 232 %UL. Nutrient strength and its variability for vitamin D was higher than for calcium: 81.5± 113.7%, n=18; three DS were above the RDA (211.5±146.3%). Only 2 of 8 chewable tablets DS passed disintegration tests. Nine of 10 gummy DS and 1 of 8 chewable tablets passed dissolution tests for calcium, and 1 of 6 for magnesium. Only half of the DS labels displayed warnings for choking hazards or instructions to chew chewable tablets before swallowing.

Conclusions: Although the micronutrient content in children’s calcium DS may help to decrease the nutrient gaps, the prevalence of failed disintegration and dissolution test results for chewable tablets raises concerns about micronutrient bioavailability and DS safety. The absence of chewing instructions meant to decrease choking and impaction risks in children on product labels highlights a need for improved adherence to FDA guidance for chewable tablets.

Funding Sources: NIH ODS and the USDA ARS