(P11-027-23) Nationally Representative Adult Calcium Dietary Supplements (DS): Nutrient Strength, Health Claims and Performance Quality

Objectives: In the US, calcium ± vitamin D DS are commonly used to improve status for under-consumed nutrients of public health concern. Nutrient amounts and their proper release from dosage forms underlie DS efficacy. In 2008, the FDA approved a health claim for calcium intake and osteoporosis risk reduction. By law, manufacturers using this claim must ensure that their dosage forms meet the USP dissolution standards (21 CFR 101.72). The goals of this study were to measure a panel of micronutrients and test dosage form disintegration and dissolution.

Methods: Content measured by expert laboratories in DS with calcium as the primary ingredient at ≥ 80 mg/serving was compared with labels, the Recommended Dietary Allowances (RDA) and Upper Tolerable Intake Levels (UL). To pass in vitro tests from USP monographs, dosage units must disintegrate within 30 min and release at least 75% of labeled calcium amount within 30 or 60 min.

Results: Overall mean ± SD percent differences from labels for calcium, magnesium and vitamin D were 8.05±6.69, 9.25±10.8 and 27.1±26.5, respectively; in 2-3 lots of 102 DS. Higher nutrient strength (daily intakes at or above maximum RDAs) was measured for calcium (mean %RDA ± SD; 111±9.1, n=31), vitamin D (230±154; n=50), magnesium (156±53.5, n=28), zinc (174±42.8; n=16), manganese (152±33.9; n=8) and copper (184±65.6; n=8). Thirty-four (61.8%) of 55 DS as tablets/caplets, 2 (14.3%) of 14 hard-shell capsules, none of 3 chewable tablets, 5 (71.4%) of 7 gummies, 3 (100%) soft chews passed the dissolution test. When the same lots were tested both for disintegration and dissolution, only 23 (67.6%) of 34 tablets/caplets passed both tests, while 9 (90%) of 10 DS failed both tests. Only two (18.2%) of 11 capsules that passed disintegration also passed the dissolution test. Fifteen (65.2%) of the 23 tablets/caplets bearing the calcium health claim and 19(59.4%) of 32 tablets/capsules without the claim passed the dissolution tests.

Conclusions: Although vitamin D and minerals in adult calcium DS may help to close nutrient gaps, a significant number of the DS, including those with the osteoporosis health claim, failed to meet the USP dissolution standards even if they passed disintegration testing. This is a concern for consumers because micronutrients in failed products might not be available for absorption and utilization.

Funding Sources: NIH ODS and the USDA