Natural and Dietary Supplements
The regulatory aspects of the food additives industry offer a backdrop to several areas of public health concern, including consumer behaviors regarding usage, safety, and effectiveness, as well as studies that address health effects from regular use of supplements. Dietary supplements and their sometimes questionable claims about health effects are regulated by the FDA in a manner distinct from that of regular foods or medications. The Food and Drug Administration regulates dietary supplements safety, manufacture, and labeling, while our partners at the Federal Trade Commission are responsible for overseeing advertising of these products.
In the U.S., supplement safety is regulated by the U.S. Food and Drug Administration (FDA), but legal limitations have prevented the FDA from effectively regulating supplements (e.g. This has increased risks to public health, and has led to many calls for reform. The Food and Drug Administration regulates the quality, safety, and labeling of supplements, while the Federal Trade Commission oversees advertising and marketing; however, there are significant enforcement challenges, and the best state supervision has yet to be achieved. Quality problems throughout the supply chain are also safety hazards. FDA inspections of dietary supplement production facilities have consistently revealed failures to meet federal standards for quality and accurate labeling. Unlike drugs or devices, the FDA does not regulate the effectiveness of dietary supplements.
Under the Dietary Supplement Health and Education Act (DSHEA)–the 1994 legislation that established the current regulatory framework for dietary supplements–the FDA does not typically perform premarket reviews of dietary supplements, nor are manufacturers required to submit essential information about their products, including names or ingredients, to the agency prior to sale. This leaves the agency without a clear picture of what is on the market at any given moment. Dietary and herbal supplement companies are responsible for evaluating their products for safety and labeling purposes on their own before marketing, in order to make sure that they are compliant with all requirements of the DSHEA. This new law, which amends the federal Food, Drug, and Cosmetic Act, establishes a new regulatory framework for dietary supplement safety and labeling. Under DSHEE, it is a firms responsibility to make sure that dietary supplements that they produce or distribute are safe, and that any statements or claims made about them are supported by sufficient evidence showing they are not false or misleading.
Except for a novel dietary ingredient, in which a premarket review of safety data and other information is required by law, the company does not need to submit to FDA evidence that it relies upon to demonstrate safety or efficacy before or after marketing its products. Additionally, manufacturers must register itself under the Bioterrorism Act with FDA before producing or marketing supplements. Under existing law, the FDA may act only when it finds dietary supplement manufacturers made unlawful claims about their products or broke product labeling rules. Supplements are regulated only lightly; most of the time, the FDA cannot step in to take products off shelves until after receiving reports that a product has hurt consumers.
Compared with most drugs sold in pharmacies, health supplements are lightly regulated by governmental agencies. These products are usually labelled as natural foods, and there are usually health claims made for their benefits. Some supplements may contain ingredients that are not listed on the label, and those ingredients can be unsafe.
People taking medications should use special caution, as some supplements can interfere with their treatments. There are important public health reasons to take certain supplements, including folate and iodine during pregnancy. In certain cases, excess vitamin and mineral intake can be harmful or produce undesirable side effects; thus, maximal levels are needed to assure safe supplementation with foods.
These are applicable only for supplements that contain vitamins and/or minerals in which those products are regulated as foods, and address the supplement ingredients, including 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. Dietary supplements can make generic health claims, nutrient-content claims, or structural-function claims. Some scientific evidence needs to be submitted only for health claims, that is, establishing a direct relationship between the use of supplements and reduced disease risk. In addition, manufacturers are not required to provide evidence to The Food and Drug Administration about product safety prior to marketing of dietary supplements, except when supplements contain a novel dietary ingredient (a dietary ingredient not sold in this country before Oct. 15, 1994) that has not been preserved in the food supply as a food commodity in a form where food has not been chemically altered. For example, the Food and Drug Administrations Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance Guide discusses compliance with the Agencys regulations implementing the Acts labeling provisions; and leveraging resources by continuing to coordinate mutually effective relationships with other Federal and state entities involved in the fight against health fraud. DSHEA effectively gives the Food and Drug Administration more power over supplements, and provides the administration new tools for enforcement–tools that we hope FDA will utilize more frequently and address. DSHEA is important in providing consumers reassurances that the government cannot arbitrarily limit or take away from the market herbal and nutritional products. While it is no guarantee, there are steps consumers can take to increase the likelihood that their supplements do contain what they claim, at the labeled amount, and may actually provide a health benefit.