Project Number: 8040-52000-068-39-I
Project Type: Interagency Reimbursable Agreement
Start Date: Oct 1, 2018
End Date: Sep 30, 2021
The Dietary Supplement Ingredient Database (DSID) (http://dsid.usda.nih.gov; (U.S. Department of Agriculture, 2017) in collaboration with the NIH Office of Dietary Supplements currently provides nationally representative supplement composition data for popular categories of dietary supplements (DS), based on chemical analysis. The USDA identifies and purchases DS products for analysis and manages contracted, collaborative and in-house labs for analysis of nutrients and other bioactive ingredients. This project has recently been expanded to include the analysis of the constituents in botanical DS and to evaluate the performance quality of capsule and tablet dosage forms.
Several types of studies are planned, including ongoing and new pilot and national studies. NDL will design and carry out research to analytically determine the ingredient composition of representative dietary supplements, including essential nutrients and bioactive components. NDL will identify samples for analysis and experienced laboratories for sample analysis, and then monitor the quality of the laboratory data. Results will be statistically evaluated and made publicly available through the DSID. On-going and planned DSID Studies: 1) Prescription prenatal MVM pilot study: Scientifically evaluate the relationship between label and analytical values and assess the variability for vitamins and minerals in these prenatal MVM. Three lots of 24 products (representing an estimated 61.2% of the market share) are being tested for their chemical content and evaluated against labeled levels for prioritized vitamins and minerals and docosahexaenoic acid (DHA). Each product is being tested for disintegration and dissolution (and tablets and capsules for hardness) using current USP specifications. 2) Green tea containing dietary supplements (DS) study: As a follow up to the first green tea study, the products in this study have more complex matrices (include other botanicals, vitamins, etc.). Representative and top-selling products are being tested for their content of caffeine and catechins, especially epigallocatechin gallate (EGCG). Samples are also being tested for disintegration testing. 3) Turmeric (and curcumin) containing DS study: Two lots of 40-50 DS are be tested for their levels of curcumin, demethoxycurcumin and bisdemethoxycurcumin and piperine, if claimed. Immediate release forms will also be tested for disintegration. 4) Calcium in DS and non-prescription antacids: In this nationally representative study of approximately 100 DS and non-prescription antacids (a major source of supplemental calcium intake in the U.S.), products will be assessed for their calcium and vitamin D content. Products may also be tested for disintegration and dissolution (and tablets and capsules for hardness) using current USP specifications. 5) Single ingredient vitamin or mineral DS (popular products or those with safety concerns are vitamin D, selenium, chromium, magnesium and manganese) will be analyzed to determine their content and to assess if the overages seen in multivitamin/mineral products are similar to the analytical content of these products. They may also be assessed for their performance with disintegration and dissolution testing. 6) Multiple forms and matrices of ginger dietary supplements, a popular botanical, will be analyzed for their gingerols, gingerdiols, gingerdiones and shogaols content. Analysis will include products with label claims and those without any claim for phytochemical concentration. The patterns seen will be compared to results for the other botanicals studied (green tea and turmeric DS).