Perspectives on the Use of Proprietary Blends in Dietary Supplements.

This paper discusses the rationale for use of proprietary blends on dietary supplement labels, and their implications for researchers and consumers. The Dietary Supplement Health Education Act of 1994 allows the listing of nonnutrient dietary ingredients as proprietary blends on dietary supplement labels for companies to protect their unique formulas. The weight of the blend and names of the ingredients within the blends must be declared, but not the amounts of the individual ingredients within the proprietary blend.

Analytical Challenges and Metrological Approaches to Ensuring Dietary Supplement Quality: International Perspectives.

The increased utilization of metrology resources and expanded application of its' approaches in the development of internationally agreed upon measurements can lay the basis for regulatory harmonization, support reproducible research, and advance scientific understanding, especially of dietary supplements and herbal medicines. Yet, metrology is often underappreciated and underutilized in dealing with the many challenges presented by these chemically complex preparations. This article discusses the utility of applying rigorous analytical techniques and adopting metrological principles more widely in studying dietary supplement products and ingredients, particularly medicinal plants and other botanicals.

Do Multivitamin/Mineral Dietary Supplements for Young Children Fill Critical Nutrient Gaps?

Background: Nearly a third of young US children take multivitamin/mineral (MVM) dietary supplements, yet it is unclear how formulations compare with requirements.

Objective: Describe the number and amounts of micronutrients contained in MVMs for young children and compare suggested amounts on product labels to micronutrient requirements.

Design: Cross-sectional.

Modernization of the National Institutes of Health Dietary Supplement Label Database.

Launched in 2008, NIH's DSLD (https://dsld.nlm.nih.

Perspective: Characterization of Dietary Supplements Containing Calcium and Magnesium and Their Respective Ratio-Is a Rising Ratio a Cause for Concern?

Low magnesium intakes coupled with high calcium intakes and high calcium-to-magnesium (Ca:Mg) intake ratios have been associated with increased risk for multiple chronic conditions such as cardiovascular disease and metabolic syndrome, as well as some cancers (colorectal, prostate, esophageal), and total mortality. A high dietary Ca:Mg ratio (>2.60) may affect body magnesium status while, on the other hand, high intakes of magnesium could adversely impact individuals with an exceedingly low dietary Ca:Mg ratio (<1.

Perspective: Time to Resolve Confusion on Folate Amounts, Units, and Forms in Prenatal Supplements.

Folate-containing prenatal supplements are commonly consumed in the United States, but inconsistencies in units of measure and chemical forms pose challenges for providing authoritative advice on recommended amounts. New regulations require folate to be declared as micrograms of dietary folate equivalents (DFE) on product labels, whereas intake recommendations for reducing the risk of neural tube defects (NTDs) and the Tolerable Upper Intake Level are expressed as micrograms of folic acid. Today, >25% of prenatal supplements contain folate as synthetic salts of L-5-methyltetrahydrofolate (L-5-MTHF), but recommendations do not include this form of the vitamin.

Disintegration and Dissolution Testing of Green Tea Dietary Supplements: Application and Evaluation of United States Pharmacopeial Standards.

Approved performance quality tests are lacking in the United States Pharmacopeia (USP) for dietary supplements (DSs) containing green tea extracts. We evaluated the applicability of USP <2040 > general chapter protocols for disintegration and dissolution testing of botanicals to GT DSs. Of 28 single-ingredient GT DSs tested in 2 to 4 lots, 9 (32.

Characteristics and Challenges of Dietary Supplement Databases Derived from Label Information.

Launched in 2008, the Dietary Supplement Label Database (DSLD) permits the search of any term that appears anywhere on product labels. Since then, the database's search and download features have been periodically improved to enhance use for researchers and consumers. In this review, we describe how to customize searches and identify products and ingredients of interest to users in the DSLD, and provide the limitations of working with information derived from dietary supplement product labels.

Challenges in Developing Analytically Validated Laboratory-Derived Dietary Supplement Databases.

The Dietary Supplement Label Database (DSLD) is sponsored by the Office of Dietary Supplements (ODS) and the National Library of Medicine (NLM). It provides a searchable, free database of the contents of ∼65,000 supplement labels. A companion database of analytically verified product labels [the Dietary Supplement Ingredient Database (DSID)] was created by ODS, NLM, and the USDA.

The Chemical Forms of Iron in Commercial Prenatal Supplements Are Not Always the Same as Those Tested in Clinical Trials.

In the US, 70% of pregnant women use an iron-containing prenatal supplement product; however, only 2.6% of pregnant women have iron-deficiency anemia and 16.3% are iron deficient.

Analytical ingredient content and variability of adult multivitamin/mineral products: national estimates for the Dietary Supplement Ingredient Database.

Background: Multivitamin/mineral products (MVMs) are the dietary supplements most commonly used by US adults. During manufacturing, some ingredients are added in amounts exceeding the label claims to compensate for expected losses during the shelf life. Establishing the health benefits and harms of MVMs requires accurate estimates of nutrient intake from MVMs based on measures of actual rather than labeled ingredient amounts.

Culinary Spice Plants in Dietary Supplement Products and Tested in Clinical Trials.

Dried plant parts used as culinary spices (CSs) in food are permitted as dietary ingredients in dietary supplements (DSs) within certain constraints in the United States. We reviewed the amounts, forms, and nutritional support (structure/function) claims of DSs that contain CS plants listed in the Dietary Supplement Label Database (DSLD) and compared this label information with trial doses and health endpoints for CS plants that were the subject of clinical trials listed in clinicaltrials.gov.

A structured vocabulary for indexing dietary supplements in databases in the United States.

Food composition databases are critical to assess and plan dietary intakes. Dietary supplement databases are also needed because dietary supplements make significant contributions to total nutrient intakes. However, no uniform system exists for classifying dietary supplement products and indexing their ingredients in such databases.

Workshop on DHA as a required nutrient: overview.

Early recognition of the importance of docosahexaenoic acid (DHA) in brain, neural, and visual development, prompted professional bodies to establish dietary recommendations for pregnant women and term and preterm infants. More recent studies show that supplemental DHA can play an important role in reducing the risk for certain age-related diseases. Data from nationwide surveys suggest that the average intake of DHA by US adults is considerably lower than levels suggested by researchers to sustain baseline nutritional status and to achieve the beneficial and protective effects of DHA.

Progress in developing analytical and label-based dietary supplement databases at the NIH Office of Dietary Supplements.

Although an estimated 50% of adults in the United States consume dietary supplements, analytically substantiated data on their bioactive constituents are sparse. Several programs funded by the Office of Dietary Supplements (ODS) at the National Institutes of Health enhance dietary supplement database development and help to better describe the quantitative and qualitative contributions of dietary supplements to total dietary intakes. ODS, in collaboration with the United States Department of Agriculture, is developing a Dietary Supplement Ingredient Database (DSID) verified by chemical analysis.

Dietary supplement ingredient database (DSID): Preliminary USDA studies on the composition of adult multivitamin/mineral supplements.

The Nutrient Data Laboratory of the United States Department of Agriculture (USDA) is collaborating with the Office of Dietary Supplements (ODS), the National Center for Health Statistics (NCHS), and other government agencies to design and populate a dietary supplement ingredient database (DSID). This analytically based, publicly available database will provide reliable estimates of vitamin and mineral content of dietary supplement (DS) products. The DSID will initially be populated with multivitamin/mineral (MVM) products because they are the most commonly consumed supplements.

US Food and Drug Administration regulations governing label claims for food products, including probiotics.

The US Congress has granted the Food and Drug Administration the authority to permit manufacturers to use claims in food labels that fit into the following broad categories: health claims, structure/function claims, nutrient content claims, and dietary guidance messages. This article outlines the scope and evolution of these claims and how they are used in the marketing of probiotics. Probiotics are live microorganisms (in most cases, bacteria) that are similar to beneficial microorganisms found in the human gut.

The caffeine contents of dietary supplements commonly purchased in the US: analysis of 53 products with caffeine-containing ingredients.

As part of a study initiating the development of an analytically validated Dietary Supplement Ingredient Database (DSID) in the United States (US), a selection of dietary supplement products were analyzed for their caffeine content. Products sold as tablets, caplets, or capsules and listing at least one caffeine-containing ingredient (including botanicals such as guarana, yerba mate, kola nut, and green tea extract) on the label were selected for analysis based on market share information. Two or three lots of each product were purchased and analyzed using high-pressure liquid chromatography (HPLC).

Measuring vitamins and minerals in dietary supplements for nutrition studies in the USA.

This article illustrates the importance of having analytical data on the vitamin and mineral contents of dietary supplements in nutrition studies, and describes efforts to develop an analytically validated dietary supplement ingredient database (DSID) by a consortium of federal agencies in the USA. Preliminary studies of multivitamin mineral supplements marketed in the USA that were analyzed as candidates for the DSID are summarized. Challenges are summarized, possible future directions are outlined, and some related programs at the Office of Dietary Supplements, National Institutes of Health are described.