Dietary supplement standardization

Putzbach, K. et al. Determination of bitter orange alkaloids in dietary supplement standard reference materials by liquid chromatography with ultraviolet absorbance and fluorescence detection. J. Chmmatogr. A. 2007, 1156, 304-311. 

Pure reference standards of B complex vitamins can be obtained from USP. Once a LC-MS method for pantothenic acid analysis from multivitamin dietary supplements is developed, the multi-element multivitamin dietary supplement Standard Reference Material 3280 (SRM 3280) from the National Institute of Standards and Technology (NIST, Gaithersburg, MD, USA) can be used for validation and quality control. 

Sander LC, Sharpless KE, Satterfield MB, Diara T, Phinney KW, Yen JH, Wise SA (2005) Determination of ephedrine alkaloids in dietary supplements standard reference materials. Anal Chem 77 3101-3112. doi 10.1021/ac0484530... 

For any intervention intended to impact favorably upon human health, it is important to evaluate its safety and efficacy in order to demonstrate that it does not cause harm and it does provide the expected benefit. The gold standard method for evaluating any intervention, whether it be a botanical product, dietary supplement, drug, medical device or medical procedure, is the randomized, clinical trial (RCT). A clinical trial is a type of experiment conducted in human subjects where the effects of at least two interventions are compared. Often, the clinical trial takes the form of an active treatment compared to an inactive control or placebo. 

Standardization is the process by which all batches of a dietary supplement produced by a single manufacturer contain the same amount of active ingredient ) [29]. FDA does not require dietary supplements to be standardized. Consumers cannot be certain of the quality of a dietary supplement when purchased. Uncertainties include whether the herb s active ingredients are in the product, whether the ingredients are bioavailable, whether the dose is appropriate, and whether each batch contains the same components in the same quantity. Each dietary supplement may vary depending on the manufacturer, and therefore switching brands of a particular supplement is not advisable. 

Good manufacturing practices (GMPs) ensure that products meet specific quality standards, are not adulterated or misbranded, and contain the correct ingredients and doses stated on the label. GMPs specifically for dietary supplements are being proposed from the FDA. Cases of adulteration have been reported to the FDA, and examples include a plantain product adulterated with digitalis and hibiscus tea adulterated with warfarin [29]. 

ConsumerLab.com is an independent testing company that evaluates whether certain dietary supplements have met their standardization claims. Dietary supplements that have been tested include herbs (ginkgo, saw palmetto, ginseng), vitamins (vitamin C), and others (glucosamine, chondroitin, SAMe). Products that meet the German testing standards are published at the ConsumerLab.com website [33]. 

Unfortunately, many clinical studies evaluating the efficacy of dietary supplements are flawed. Some of the flaws in the studies include non-randomization, being unblinded, lack of standardized products, small sample sizes, short treatment durations, and poorly defined inclusion and exclusion criteria. Many studies do not give detailed information about the dietary supplement used. When an herb is studied, the following information should be described plant species, part(s) used, product form (e.g., powdered crude herb, aqueous extract, ethanol extract, or aqueous alcohol extract) with stated proportions of water to alcohol, specifically extracted fractions, and quantities or concentrations used [48]. 

Recommend products that contain the following on their label scientific name of the botanical, quantity of the herb, name and address of the actual manufacturer, a batch or lot number, date of manufacture, and expiration date. When available, products that are standardized to the active ingredient(s) should be recommended. A common rule of a one-year expiration date on dietary supplements generally applies [5]. 

Products that are standardized to the active ingredient ) should be recommended. Dietary supplements that are known to be harmful should not be recommended or sold. 

Prior RL, Wu X and Schaich K. 2005. Standardized methods for the determination of antioxidant capacity and phenolics in foods and dietary supplements. J Agric Food Chem 53(10) 4290-4302. 

While the dog is a carnivore, it is able to adapt to an omnivorous diet. Requirements for dietary sources of energy, amino acids, glucose precursors, fatty acids, minerals, vitamins, and water have been established based on recommendations by the National Research Council (NRC, 1985). Adult beagles maintained in a laboratory environment function well with one feeding of standard laboratory chow per day. In safety assessment testing, however, some compounds may induce serious dietary deficiencies through induced loss of appetite, malabsorption, or vomiting, and, in these cases, it may be advisable to provide a dietary supplement. 

There are dozens of other examples around the house for which we have similar quality standards in terms of their resistance to flow. Examples include other food products such as honey, pancake syrup, gravy, and ice cream toppings. Hygiene products include shampoo, hand lotion, and liquid soap. We might also cite pharmaceutical formulations, such as cough medicines, milk of magnesia, and liquid dietary supplements, as well as home and car care products such as caulks, glues, and motor oils. 

Since the U.S. Congress passed Dietary Supplement Health and Education Act in October 1994, the landscape of the dietary supplement industry has changed in the United States dramatically. In fact, as early as the late 1980s, the U.S. Pharmacopeia s elected Council of Experts (then known as the USP Committee of Revision) was evoking great interest in the development and establishment of public standards for the multitude of multivitamin and multivitamin-mineral combination products as well other nutritional supplement products marketed in the United States. 

Another difference from drug therapy is that the dosing interval of a nutritional supplement is often not a critical parameter for a positive outcome. This lack of a strong dose-response relationship is an important consideration in setting of standards for dietary supplements and is in stark contrast to the situation for drug products. 

In view of the reported growing importance ascribed to folic acid deficiency in the prevention of various disease conditions, such as neural tube defects, megaloblastic anemia, colon cancer, and colorectal cancer, a dissolution requirement is specified for folic acid when it is present in multivitamin-mineral combination products. Currently, the dissolution standard required in the official articles of dietary supplements (including vitamin-mineral combination products) places folic acid outside the index vitamin hierarchy. Therefore, a mandatory dissolution test for folic acid is required that is independent of and in addition to the mandatory index vitamin test for multivitamin preparations containing folic acid. 

In accordance with the provisions of the Dietary supplement Health and Education Act 1994, in the United States botanical dosage forms can be marketed as dietary supplements provided the label makes no medical claim however, structure-function claim is allowed. In most countries other than the United States, botanical preparations are regulated as drugs thus posing a different set of challenges. This fact must be taken into consideration in standard setting. 

Other dietary supplements and herbal remedies should be held to regulatory standards that are at least as stringent as those for OTC drug products. At the very least, active ingredients should be required to meet standards for purity, content, safety, and some level of effectiveness before they can be marketed. 

Organic farming standards often stipulate the use of alternative products or the avoidance of a specific prohibited material. Some substanees prohibited for organic farming, such as OP-dips, dietary supplements of eopper and zine and avermectins, for example, have an impaet on the environment. 

The kind of natural products listed in the table above, however, are not defined in the United States today as drugs hut as dietary supplements, nutritional supplements, natural foods, or some similar nondrug product. Such products are not subject to the same standards of testing as are synthetic drugs. They are regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994 (Public Law 103-417). According to that law, the makers of natural products used... 

Ca is a comparatively difficult element for the body to absorb and digest. It is essentially only available for consumption associated with various other moieties (e.g., citrate, phosphate, and other anions). Each Ca source has unique physical, structural, and chemical properties such as mass, density, coordination chemistry, and solubility that are largely determined by the anions associated with the Ca +. Aqueous solubility of various Ca salts can vary markedly and comparisons are frequently made under standardized conditions. The water solubility of CCM is moderate when ranked versus other Ca sources frequently used as dietary supplements and food/beverage fortificants. The solubility of CCM (6 2 3 molar ratio) is 1.10-g salt in 100 ml of H2O at 25 °C (Fox et ah, 1993a). Table 6.4 lists the solubility of various Ca sources in water at specific temperatures, and also includes some information on potential sensory characteristics. 

Complementary and alternative medicine CAM. Forms of treatment that are used in addition to (complementary) or instead of (alternative) standard treatments. These practices are not considered standard medical approaches. CAM includes dietary supplements, megadose vitamins, herbal preparations, special teas, massage therapy, magnet therapy, spiritual healing, and meditation. [NIH]... 

Clinicians should be aware that many of their patients may be taking alternative treatments either via self-care or prescribed by CAM practitioners. Inquiring about this should be routine because of potential side effects and drug interactions. A working knowledge of CAM treatments will allow child psychiatrists to give parents and patients advice about safety and effectiveness. Use of St. John s wort in children with unipolar depression may at times be appropriate, particularly in cases where more standard treatments are contraindicated or have failed. However, it should be used cautiously and with an appropriate explanation of its risks and benefits, as a competent clinician would do for any treatment. Use of St. John s wort for other conditions is not currently recommended given the lack of evidence for efficacy. Kava extracts may be used for anxiety, with similar provisos. There are much fewer data about the efficacy and safety of other dietary supplements and their use cannot be supported at this point. 

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