Herbal Dietary supplements
The first section also presents the overall safety assessment framework of these products as New Dietary Ingredients (NDIs) and the current multi-agency cooperative effort for conducting safety evaluation studies on nominated natural products used as food additives. Although comprehensive reviews of particular herbs are not possible in this context (>20,000 herbs and their products are used in the U.S.), potential benefits and risks are examined for some of the most popular herbs used.
Dietary supplements that contain bioactive constituents found in certain herbs and herb extracts continued to be named and selected by the NTP to be studied, including some of the more popular supplements used by consumers in the U.S. Many of the novel botanical ingredients of dietary supplements are presented in a form, amount, or frequency of use different from conventional uses.
Other botanical food additives and dietary supplements are excluded from this requirement as they represent sources for pharmaceutical preparations . In sports, most supplements made of herbs or plants are used for the purposes of increasing muscle mass and fat loss . Herbal supplements are now used by athletes and nonathletes to enhance endurance and strength, however, many of these supplements have not been proven to be safe and effective according to the current FDA standards.
Despite many benefits from dietary supplements, there are concerns about the safety of the large-scale implementation of these products on consumer health, because of the limited controls over their ingredients prior to release into commerce (e.g., heavy metals contents). As a result of a misleading impression that using products from natural sources has less adverse effects than using synthetic drugs, consumers judge risks associated with using dietary supplements to be lower. Self-administration of food supplements without medical advice is prevalent, not only in healthy individuals but also in various groups of patients. Patients may not disclose to health professionals the use of food supplements and herbal medicines, and therefore, the risks for interactions with or substitutes for prescribed medicines or treatments can exist.
In Australia, most dietary supplements are regulated in a complementary medicines category that includes vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods with specific uses and are regulated by food authorities. The use of herbal products is regulated under the Food and Drug Administration (FDA) as a specific category of foods, and classified as dietary supplements according to the 1994 Dietary Supplement Health and Education Act (DSHEA).
Supplement products are placed under the dietary supplement category in the United States, under the purview of the Food and Drug Administration (FDA); in Europe, they are subject to the European Food Safety Agency (EFSA) jurisdiction, where they are classified as food additives; and in Canada, where the Canadian Department of Health is responsible for oversight, where they are classified as natural health products. Throughout the world, supplement products are designated as either food, food, or health supplements, with different national authorities and regulatory regimes in charge of controlling and monitoring them. In the United Arab Emirates, the Health and Safety Directorate in Dubai City puts such products under the Health Supplements (HS) category, and offers the definition that they are products that are intended to complement diets (except for tobacco) and include a single or a combination of food ingredients, such as amino acids, herbs/botanicals, minerals, or vitamins. Although DSHEA requires supplements to not promise specific treatment on their labels, they can make claims about effects.
The DSHEA requires no evidence of effectiveness, no evidence of safety, and sets no standards of quality for products labeled as supplements. When information about the history of use is not sufficient on its own to demonstrate that the food additive or product containing an NDI would be reasonably expected to be safe, then sometimes toxicological studies and clinical data from humans are used to demonstrate safety for products containing an ingredient. The FDA receives about 50 NDI notices per year, and comments on FDAs reply letters raising concerns about the sufficiency of safety information in notices illustrate some of the issues raised by natural products safety when used in dietary supplements. The body of work examining heavy metal measurements in supplements is limited, and studies on hazards associated with the use of herbal substances contaminated with heavy metals are rare.
Analysis of results also suggests that the quantity of heavy metals concentrations in tested food additives can vary depending on where products are manufactured. The presence of at least one of the three analysed heavy metals was found in 79.2% of supplements produced by terrestrial plants (n=19) and 88.2% of supplements produced by microalgae (n=15). The form of supplements (powder, teabag, pill) and type of the major ingredients (terrestrial plants, microalgae) had a minor effect in separating heavy metals in products.
In some 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. In such cases, general-purpose multivitamin/mineral supplements that supply a recommended dietary allowance (RDA) can be used, except when directed by an individual practitioner. In addition to nutritional support, common rationales for using dietary supplements include improving health and wellbeing, and the prevention and control of diseases. Alongside food habits, food supplements (FS) have emerged as one of the possible intervention strategies for age-related and oxidative stress-related pathologies . The use of FS is especially common in older adults. Regardless of marketing of natural supplements aimed at improving health and fitness, one must also consider that certain plants can contain performance-enhancing substances in their constituents, as well as some products made from herbal extracts can be contaminated or adulterated with banned substances in sports.