USP Dietary Supplements Compendium, 2009-2010 by United States Pharmacopeia. Rockville, MD: U.S. Pharmacopeia. Hardcover; 1811 pages. ISBN 978-1889788791. $425.00.
The United States Pharmacopeia (USP) has produced a dedicated Dietary Supplements Compendium (USP-DS). This hefty, comprehensive first-edition volume includes material taken from the US Pharmacopeia – National Formulary (USP-NF) and the Food Chemicals Codex (FCC), now a publication of the USP, as well as additional material pertinent to dietary supplements. For those persons unfamiliar with the USP, it is a nonprofit organization with a mission to provide standards for medicines and foods, thereby ensuring their quality and safety. This volume, the USP-DS, provides standards monographs for dietary supplements in addition to dietary ingredients and other materials used in the formulation of dietary supplements.
The USP was formed in 1820 by a convention of physicians whose goal was the elimination of regional differences in names and formulations of medicines in the United States. The USP standards were officially recognized by federal law in 1848. Today the USP is combined with the National Formulary (NF). The NF was established by the American Pharmaceutical Association in 1888 to provide standards for “unofficial preparations,” that is, remedies not included in the USP but commonly used by pharmacists. The NF was purchased by the USP in 1975 and its information was incorporated into a single publication along with the USP, forming the USP-NF. The USP purchased the FCC from the Institute of Medicine’s National Academy of Science in 2006. The FCC is a compendium of standards for the purity and identity of food ingredients. The USP-DS incorporates standards from all 3 of these bodies, the USP, NF, and FCC.
Early editions of the USP were concerned with the standardization of botanical drugs, but these were phased out in the 1940s and 50s with the development of single-entity chemical drugs. Following the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) by the US Congress, the USP renewed its role in providing guidance on the quality for therapeutic botanicals, now sold as dietary supplements.
The book begins with a section titled “General Chapters,” which contains selected general chapters from the USP that are considered relevant for the analysis and/or manufacturing of dietary supplements. The chapters include information on apparatus required for tests and assays, as well as procedures for those assays. Tests particularly relevant for botanicals include those for microbial contaminants, heavy metals, residual solvents, ash, foreign matter, fiber, starch, pesticides, and aflatoxins. Also included is a description of the use of authenticated reference materials for botanical identification, using characteristic plant morphology and anatomy. The chapter contains processes for making botanical extracts and tinctures. There is a description of various types of chromatography, including paper, thin-layer (TLC), column, gas, high pressure liquid (HPLC), ion, and size exclusion, as well as interpretation of the chromatograms. Also included is a description of the apparatus and methods to measure disintegration (dissolving to a soft mass) and dissolution (identification of specified active components in solution) of tablets and capsules. There are descriptions of spectrometry: ultra-violet, visible, near-infrared, roman, atomic, florescence, mass spectrometry, and nuclear magnetic resonance. Also defined are quality control operations, record keeping and adverse event reporting. There is small section that includes supplemental information on black cohosh (Actaea racemosa, Ranunculaceae), ginger (Zingiber officinale, Zingiberaceae), and valerian (Valeriana officinalis, Valerianaceae). These 3 example monographs include additional information not included in the general standards monographs; namely pre-harvest conditions and post-harvest handling, references to good agricultural practices; compendia history for the ingredient, sources, cultivation, collection, drying, storage and shipping, as well as chemical constituents. The General Chapters section extends over 400 pages, which may give the reader an idea of the breadth of this information.
The General Chapters section is followed by “Official Monographs.” Included in these monographs are standards for identity, purity, and quality. The official botanical monographs include aloe latex (Aloe spp, Liliaceae), bilberry fruit (Vaccinium myrtillus, Ericaceae), cascara sagrada bark (Frangula purshiana, Rhamnaceae), cat’s claw stem bark (Uncaria tomentosa, Rubiaceae), chamomile flowers (Matricaria recutita, Asteraceae), chaste tree fruit (Vitex agnus-castus, Verbenaceae), red clover flowers (Trifolium pratense, Fabaceae), black cohosh rhizome/root, cranberry fruit (Vaccinium macrocarpon, Ericaceae), echinacea (Echinacea angustifolia root/rhizome,
E. pallida root/rhizome, and E. purpurea aerial parts and root/rhizome, Asteraceae), eleuthero root/rhizome (Eleutherococcus senticosus, Araliaceae), slippery elm inner bark (Ulmus rubra, Ulmaceae), feverfew leaves (Tanacetum parthenium, Asteraceae), garlic bulb (Allium sativum, Alliaceae), ginger rhizome, ginkgo leaf (Ginkgo biloba, Ginkgoaceae), American ginseng root (Panax quinquefolius, Araliaceae), Asian ginseng root (P. ginseng), goldenseal root/rhizome (Hydrastis canadensis, Ranunculaceae), green tea leaf (Camellia sinensis, Theaceae), hawthorn leaf with flower (Crataegus monogyna, Rosaceae), horse chestnut seed (Aesculus hippocastanum, Hippocastanaceae), licorice root (Glycyrrhiza glabra, Fabaceae), tomato fruit (Lycopersicon esculentum, Solanaceae), maritime pine stem bark (Pinus pinaster, Pinaceae), milk thistle seed (Silybum marianum, Asteraceae), stinging nettle root (Urtica dioica, Urticaceae), plantago/psyllium seed, husk (Plantago spp., Plantaginaceae), pygeum bark (Prunus africana, Rosaceae), St. John’s wort flowering tops (Hypericum perforatum, Clusiaceae), saw palmetto fruit (Serenoa repens, Arecaceae), senna leaf, pod (Senna alexandrina, Fabaceae), soy bean isoflavones (Glycine max, Fabaceae), turmeric rhizome (Curcuma longa, Zingiberaceae; with separate monograph for isolated curcuminoids) and valerian root/rhizome. Each botanical may have several separate monographs as there are distinct listings for powdered plant materials, extracts, capsules, tablets and fluid extracts. More botanicals are included in the NF section of the compendium, which follows the Official Monographs section.
There is a large section in the USP-DS that includes information from the FCC, such as monographs for essential oils obtained from botanicals used as food ingredients.
Another section of the reference tome includes safety reviews produced by the USP Dietary Supplements Information Expert Committee. Following a short description of the means taken to evaluate the literature, there are safety profiles of the following: ashwagandha (Withania somnifera, Solanaceae), black cohosh, frankincense (Boswellia sacra, Burseraceae), fenugreek (Trigonella foenum-graecum, Fabaceae), green tea extracts, mangosteen (Garcinia mongostana, Clusiaceae), and noni (Morinda citrifolia, Rubiaceae).
A description of the USP Dietary Ingredients Verification program is included. This is a program that certifies the identity, strength, purity, and quality of manufacturers’ ingredients and finished products and subsequently allows them to use the USP verified mark on their packaging and advertising.
A section titled DS regulatory framework incorporates copies of DSHEA, the US Food and Drug Administration (FDA)’s Good Manufacturing Practices (GMPs) for DS and foods, FDA guidance on dietary supplement labeling, adverse event reporting, Federal Trade Commission (FTC) Act requirements related to dietary supplements and advertising guide and, finally, the California Safe Drinking Water and Toxic Enforcement Act of 1986 (better known as CA Proposition 65).
A table of Dietary Reference Intake levels (DRIs), recommended daily intake levels (RDIs), and tolerable upper intake levels (UL) from worldwide sources for vitamins and minerals is also included.
Guidance documents produced by trade associations—the American Herbal Products Association (AHPA), Natural Products Association, Consumer Health Products Association, and Council of Responsible Nutrition—are included. These are: AHPA’s guidance for manufacturer and sale of bulk botanical extracts, AHPA’s use of marker compounds in manufacturing and labeling botanically-derived dietary supplements, AHPA’s guidance for the retail labeling of dietary supplements containing soft or powdered botanical extracts, AHPA’s standardization of botanical products: white paper, AHPA-American Herbal Pharmacopoeia’s good agricultural and collection practice for herbal raw materials and guidance developed by the joint Standardization Ingredient Information Protocol working group, namely Standardized Information on Dietary Ingredients (SIDI). The inclusion of this information is an acknowledgement by the USP of the expertise contained within these groups and the self-regulatory attempts made by responsible organizations in the dietary supplement industry.
What I enjoyed the most, as a pharmacognosist, was the section titled “Illustrations.” This section includes plates with photos of dried raw botanical materials, chemical structures, and example chromatograms. For example, the section for black cohosh includes a photograph of the dried root and rhizomes along with organoleptic characteristics, a drawing of microscopic features, microscopic photographs of transverse sections of the rhizome, microscopic features of the powdered rhizome, chemical structures of constituent triterpene glycosides, TLC plates, and an HPLC chromatogram.
This book is a beautiful, comprehensive work that brings together in one volume many of the resources needed for the industry. The only complaint I have is that it is a bit cumbersome to use. There is no table of contents in the beginning of the book, which leaves the reader no choice but to use the index to search for items. In addition, information on one topic or one ingredient might be found in several different places in the book. However, all in all, the USP has done a fabulous job creating the Dietary Supplements Compendium. It is timely that the book has been published to coincide with the implication of the dietary supplement GMPs. The USP-DS is highly recommended for all persons involved in the dietary supplements industry and especially for manufacturers.
—Marilyn Barrett, PhD Pharmacognosy Consulting Mill Valley, CA