Therapeutic Potential of Nutraceuticals and Dietary Supplements law in Virginia

Dietary Supplements

Gulati, O.P., Berry Ottaway, P., Coppens, P. Botanical nutraceuticals, (dietary supplements, enriched foods, and functional foods) in the European Union, focusing especially on regulation of nutrition and health claims. Nutraceuticals and functional foods regulation in the US and globally. Randomized study on Vitamin A supplements on mortality in children with and without HIV infection in Tanzania. Vitamin A supplementation was associated with reduced mortality among patients with Ebola virus disease during a West African outbreak.

High-level dietary vitamin A enhanced T-helper type 2 cytokine production and immunoglobulin A secretory responses in BALB/c mice to influenza A virus infection. Dietary intakes of vitamin C, vitamin E, selenium, and carotenoids. The quantity of a food that is being treated, and its form, must match what is usually expected in diets.

The use of herbal medicinal foods as food supplements in patients receiving usual pharmacologic therapies should be evaluated carefully because of possible drug-food interactions or herb-herb interactions. The potential challenges in the inclusion of these medicinal foods into diets, which provide potential opportunities for future drug development, are also discussed. The preventive benefits of medicinal plants are investigated for potential application as new medical treatments because of their pharmacologically active compounds.

This article reviews the commonly used medicinal foods plants that have appeared in literatures, which have the potential for management of chronic diseases such as diabetes, hyperlipidemia, or cancer, as well as infectious diseases. This paper discussed regulatory changes which may help patients and physicians to make individualized healthcare decisions regarding potential benefits and risks of food supplements as part of their treatments.

It is important that healthcare providers be responsible in reporting to FDA the potential interactions as well as adverse events of patients taking dietary supplements in order to help in monitoring the safety of these products. Dietary supplements should only be used as an adjunct to prescription medications approved by FDA. Patients should be instructed to report to FDA any severe reactions or health-related illnesses that might occur with the use of dietary supplements.

Under existing U.S. Food and Drug Administration (FDA) regulations, manufacturers are not required to provide FDA evidence for a dietary supplements safety and effectiveness in treating any medical condition, as is required of pharmaceutical products. In 1994, the Dietary Supplement Health and Education Act (DSHEA) was passed, giving the U.S. Food and Drug Administration (FDA) authority to limit use of dietary supplements when those products are shown to be unsafe. However, the premarket requirements for dietary supplements remain less strict than for prescription drugs, and the FDA currently does not license or review dietary supplements in the same way that it does for prescription drugs. Current regulations in government to approve and market medications do not include dietary supplements, thus eliminating the financial incentives for manufacturers to carry out large, randomized controlled trials, which are required for drug approval.

A discovery in the dietary supplement industry involves (1) isolation of an active ingredient from an already known food in order to produce a supplement with previously unknown beneficial effects, or (2) the manufacture of a health-promoting supplement using a new combination of active and/or inert ingredients in previously unknown ways.10 The rareness of novel discoveries deters manufacturers from conducting trials, and some studies on ingredients of dietary supplements are restricted to case reports or small clinical trials, usually conducted by independent research groups with limited funds. In the European Union, dietary supplements are regulated as foods, with the legislative emphasis being on vitamins and minerals used as ingredients of dietary supplements. These only apply to supplements containing vitamins and/or minerals in which those products are regulated as foods, and address the ingredients of supplements, including their safety, purity, and bioavailability. In Australia, most food supplements are regulated in a complementary medicines category, including vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods for specific purposes and are regulated by food authorities.

In contrast, nutraceuticals are defined as foods or parts of foods which confer health or health benefits, including disease prevention and treatment . Some botanicals are considered as traditionally herbaceous medicine plants, used in medicinal products and in dietary supplements.

In certain cases, excess vitamin and mineral intake can be detrimental or produce undesirable side effects; thus, maximal levels are needed to assure safe supplementation with foods. The use of multivitamin supplements in older adults nutritional programs is of concern due to their potential use in nutritional programs as an alternative to diets following the U.S. dietary guidelines.

Nearly all patients referred by their health care providers are referred by their physicians. The use of dietary supplements for diabetes requires cautious consideration, as nutritional deficiencies may result in disruptions of carbohydrate metabolism, and supplementation can increase risk for hypoglycemia. Patients should be educated on the potential risks and benefits of the dietary supplements that they are interested in using to manage their diabetes, including determining whether there is evidence supporting a products benefits in diabetes, as well as any statements from the ADA or similar guidelines regarding usage. Nearly all patients who consulted a healthcare provider consulted their physician. Use of dietary supplements in diabetes requires careful consideration because dietary deficiencies can lead to carbohydrate metabolism disturbances, and supplementation may increase risk of hypoglycemia. Patients should be cautioned about the potential risks and benefits of dietary supplements they are interested in using for diabetes management, including determining the existence of any evidence to support the products benefit in diabetes and any ADA statements or similar guidance for use. Unfortunately, the Kaufmann Study also suggests that physicians are not asked as frequently about the use of dietary supplements, even though the studies that have been previously published indicate that a large number of patients are taken, despite the fact that previous published studies indicate many individuals are taking supplements. Given this lack of questioning from physicians, and the absence of questions from physicians is hardly surprising. Given this lack of physician questions, it is also not surprising. Unfortunately, Kaufmann study also suggests that physicians infrequently ask about the use of dietary products, although previously disseminated research suggests that many people take dietary supplements and that potential exists for serious drug-dietary supplement interactions. Given the lack of questioning by clinicians, it is not surprising that patients rarely identified health care providers as their source of information about dietary supplements. The American Diabetes Association has stated that inconclusive data are available about the benefits of dietary chromium in diabetes. Patients need to be evaluated carefully before starting chromium to manage diabetes because of its interaction with different medications. Supplement use is most prevalent in patients who follow a healthful diet model (e.g., eat lots of fatty fish and vegetables). Other patient populations might have used a variety of supplements, with different rates of incidence and levels of seriousness for the possible interactions. This list includes just a fraction of the potentially harmful products sold online and in retail settings to consumers.