Prescription Prenatal MVM Pilot Study
A pilot study measuring the ingredient content of representative prescription (Rx) prenatal MVMs is underway. The goal of the study is to evaluate relationships between labeled and analytical levels of vitamins, minerals and docosahexaenoic acid (DHA; C22:6n-3). Quality control (QC) materials were sent with product samples in order to monitor the accuracy and precision of the laboratory data.
Products were identified for purchase by Universal Product Codes (UPC) and the 24 products in the study represent an estimated 61.2% of the US Rx prenatal MVM market. Each product will also be tested using United States Pharmacopeia (USP) methods for disintegration and dissolution, which assess a product’s ability to release its ingredients. Rx prenatal MVMs are not categorized as approved drugs by the FDA, but as dietary supplements (DS) and have the same manufacturing regulations as foods.
DSID Botanical Initiative: Botanical DS studies were initiated in 2014 to answer questions about the constituent content of commonly purchased botanicals. Green tea is a botanical product that is commonly consumed and frequently studied for its health benefits and thus was chosen as the first botanical for the DSID. The results for the first study of green tea DS are reported in DSID-4.
Green tea-2 Pilot Study
A second green tea (GT-2) DS pilot study is now underway. The goal of this study is to measure catechins and caffeine in multi-ingredient DS containing several botanical and non-botanical ingredients. This pilot study includes products that contain label information about the content of GT and products that have GT as a part of a blend and may not contain any numeric information about the amount of GT.
Two lots of 36 multi-ingredient GT DS are being tested for 7 catechins (including (+)-catechin, (-)-epicatechin, (-)-epicatechingallate, (-)-epigallocatechin, (-)-epigallocatechingallate (EGCG), (-)-gallocatechin, (-)-gallocatechingallate) and caffeine. Laboratory results will be compared to label information about amounts of GT added, and to any voluntary information about caffeine or total catechin levels. Quality control (QC) materials were sent with product samples in order to monitor the accuracy and precision of the laboratory data.
Turmeric/Curcumin Pilot Study
The spice turmeric is obtained from the plant rhizomes of the species, Curcuma longa and is native to south Asia. There is some evidence it may possess health benefits due to its antioxidant and anti-inflammatory properties. Beginning in 2018, this DSID study will investigate the phytochemical content of turmeric containing DS in various dosage forms (tablets, powders, liquids, hard- and soft shell capsules). Commercially sold turmeric and curcumin DS (n=30-40 products x 2 lots) will be identified and measured for their curcuminoid content, including curcumin, demethoxycurcumin and bisdemethoxycurcumin. These results will be compared to label information about the content of turmeric and curcuminoids.