The FDA regulates food additives pursuant to the Dietary Supplement Health and Education Act of 1994, but because this obsolete legislation has major gaps, the agency is not effective or efficient at protecting the health of the public. Supplement safety is a critical concern for individuals of all ages, with varying levels of health and physical fitness. The FDA recommends that supplements be disapproved for safe and effective use. In the U.S., the FDA oversees the safety of supplements, but legal limitations have prevented FDA from effectively regulating supplements (e.g. This has increased risks to public health, which has led to many calls for reform. The most closely watched regulatory challenge regarding the regulation of supplements is the fact that, unlike food additives, drugs, biological products, and medical devices, supplements do not need premarket approval by FDA.
Under the Dietary Supplement Health and Education Act (DSHEA) the 1994 act that established the current regulatory framework for dietary supplements the FDA does not typically perform a premarket review of dietary supplements, nor is it required for manufacturers to submit essential information about their products, including names or ingredients, to the agency prior to marketing. This leaves the agency without any clear picture of what is available in the marketplace at any given moment. Quality issues within the supply chain also present a risk for safety. FDA inspections of dietary supplement manufacturing facilities have consistently revealed violations of federal standards for quality and accurate labeling. Unlike drugs or devices, the FDA does not regulate dietary supplements for effectiveness.
These limitations raise significant questions about whether FDA can effectively act when problems with supplements occur, especially when a company refuses to recall its products voluntarily. Under existing law, the FDA may act only when it finds that supplement manufacturers made unlawful claims about their products or broke product labeling rules. The FDA does not require submissions for GRAS notices; however, if FDA finds a food product poses a human health hazard, product manufacturers are required to issue recalls.
Taken together, listing products and providing a clear mandate for recalls would significantly enhance FDA surveillance of supplements, providing the agency with key information about products in the supplements market and ensuring it can take swift action if it learns that a product poses a risk to public health. For example, FDAs Statement of Administration Policy for Nutritional and Dietary Supplement Product Identity, Nutritional Marking, and Labeling Ingredients discusses implementing provisions in the agencys regulations to address labeling; and resource utilization through continued coordination with other federal and state entities involved in the fight against health fraud. CFSAN has also issued consumer alerts regarding unsafe products, such as an alert that Food and Drug Administration issued regarding dietary supplements that contained Kava, a botanical ingredient; continued communication with the dietary supplement industry regarding practices allowed under DSHA.
The underlying framework of DSHEA allows for all products that were sold as dietary supplements at the time of enactment of the act to remain on the market, except where the FDA can demonstrate a safety issue with the specific product or product line – this is known as the grandfathering provision; manufacturers are required to inform the FDA before marketing of any new ingredients. FDA developed regulations under laws established under the federal Food, Drug, and Cosmetic Act, or other laws under which FDA operates. Premarket approval, however, has given the FDA and U.S. Drug Enforcement Agency authority to take action after the identification or perception of a potential threat to public health of a drug. Safety Monitoring The main mechanism to monitor supplement safety is the voluntary reporting system established by FDAs Center for Food Safety and Applied Nutrition called the Center for AEs Food Safety and Applied Nutrition Reporting System (CAERS).
Dietary supplements may include health claims in general, nutrient-content claims, or structural-function claims. Some scientific evidence is required to be submitted to the FDA for health claims alone, establishing a direct relationship between use of the supplement and reduced risk of disease. Manufacturers are responsible for making sure that these products are safe before selling them, and supplements cannot include any warnings about possible adverse effects. According to the National Institutes of Health (NIH), dietary supplements, including vitamins and minerals, may be toxic if consumed for a long time, in large enough amounts, or in combination with some other chemical substances. Adverse reactions can occur with dietary supplements. Studies have shown that some supplements may worsen dehydration and cause a serious health consequence, such as renal failure. In addition, concerns about safety have been raised regarding the use of regular, high-dose supplements.
The survey also found that roughly half of adults overestimate the FDAs oversight of supplements, incorrectly thinking the agency reviews or tests such products before they hit the market. Now, this is complicated further by the fact that the FDA has a lot of current bureaucrats that detest dietary supplements and would like to see dietary supplements approved ahead of time, thereby driving down the costs of vitamins, minerals, even herbal products. It should be noted that nutritional supplements were exempt before the repeal of exemptions in South Dakota in 2005. It is my view that nutritional supplements are inadequately regulated in the U.S.; however, such products should remain regulated as a subcategory of traditional foods, with the goal of maintaining compliance with the scores of other influential food laws and regulations specific to particular products and/or ingredients (e.g., regulations on fish and domestic fish products should remain relevant for fish oil supplements).
An updated statute should end the practice of labeling proprietary mixes, and mandate listing actual amounts of all the ingredients of the supplement in aFact Panel. Adherence to the recommended consumption of foods when using supplements. Avoid these supplements if you are taking blood-thinning medications. For more information about supplement safety, see your health care provider.