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. The Food and Drug Administration regulates dietary supplements pursuant to the Dietary Supplement Health and Education Act of 1994, but because this obsolete legislation has substantial gaps, the Agency is not effective or efficient at protecting the health of the public. Unfortunately, 1994 legislation known as the Dietary Supplement Health and Education Act [DSHEA] makes it very difficult for FDA to take action and to offer meaningful protections against unsafe products.
Consumer Reports is critical of the Dietary Supplement Health and Education Act, or DSHEA, 1994, which it describes as being friendly to industry, and that it prevented FDA from regulating supplements the way that it regulated prescription drugs. The consumer magazine published a report on Tuesday that highlighted the lack of authority for the Food and Drug Administration to regulate such supplements, and said the agency has seldom used the few powers it does have. In the U.S., supplement safety is regulated by the Food and Drug Administration (FDA), but legal limitations have prevented FDA from effectively regulating supplements (e.g. This has increased risks for public health, leading to many calls for reform. Dietary supplements, which include vitamins, minerals, plant and animal extracts, hormones, and amino acids ingested orally, are used extensively in the US, with four out of five adults reporting having taken one. The dietary supplement market has grown exponentially in the past 25 years–from a $4 billion industry with 4,000 products in 1994 to one of over $40 billion today, with up to 8,00 products2 but consumer safety regulations have failed to keep up.
In the European Union, dietary supplements are regulated as foods, with legislation focused on vitamins and minerals used as ingredients of food 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. The primary European Union legislation is Directive 2002/46/EC, which covers dietary supplements that contain vitamins and minerals. 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 the Food Authority.
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. For supplements that do not contain an emerging dietary ingredient that is, a dietary ingredient not sold to the government prior to Oct. 15, 1994 there is no requirement for manufacturers to provide evidence of a products safety to FDA, before or after marketing. Although the DSHEA does require manufacturers to label their products as supplements and to provide a complete list of ingredients, manufacturers are not required to notify FDA about adverse event reports that they might receive from consumers. 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 give the agency basic information about their products, including names or ingredients, prior to marketing. This leaves the agency without a clear picture of what is on the market at any given time.
Accordingly, the FDA regulates dietary supplement safety mostly through a postmarket assessment, which evaluates whether products are adulterated or misbranded, according to provisions in Food. DSHEA is intended to achieve a proper balance between providing consumers with access to safe dietary supplements they may choose to support and enhance their health, and providing FDA with regulatory power to act against supplements and ingredients in supplements if they are unsafe, prevent safety problems, or make false or misleading claims, or are otherwise promoted or misbranded. As the standards-setting organization committed to public health, the U.S. Pharmacopeia supports manufacturers of dietary supplements in continuing to produce quality products to meet consumers needs. The Food and Drug Administration regulates the quality, safety, and labeling of dietary supplements, while the Federal Trade Commission oversees advertising and marketing; however, there are significant challenges in enforcing regulations, and the best government oversight has yet to be achieved.
Experts from the Institute of Medicine said earlier this year that FDA needs to apply the same rigorous standards for regulating supplements that it uses for drugs, and the Government Accountability Office said that the FDA needs to request from Congress greater authority for supplement regulation. The survey also found about half of adults overestimated FDAs oversight of supplements, incorrectly thinking that the agency reviews or tests those products before they hit the market. When told that is not true, seven-in-ten said that FDA cannot keep consumers safe from unsafe supplements. A separate study published in the Journal of American Internal Medicine found that multiple brands of supplements that contained at least one of four banned stimulants were still in the market for supplements, despite the fact that the FDA had sent warning letters to their manufacturers and issued public notices of these ingredients. To legally be sold in China, each food additive must receive the certificate for health food approval from the C.F.D.A., which indicates Chinas current emphasis is much more on the safety and science-based evidence for the products function. It should be noted that nutritional supplements were exempted from this exemption until 2005, when the state of South Dakota abolished it.