Dietary supplements are regulated by the Food and Drug Administration (FDA) as food, not as drugs. However, many dietary supplements contain ingredients that have strong biological effects that may conflict with a medication you are taking or with a medical condition you may have. Additionally, products that contain hidden drugs are sometimes falsely marketed as dietary supplements, putting consumers at even greater risk. For these reasons, it is important to consult with a health professional before using any dietary supplement. The FDA is a federal agency responsible for regulating products that affect public health, such as food products, medicines, medical devices, cosmetics and even tobacco products.
The FDA plays an important role in ensuring the safety of the products we use every day, but it does not grant prior approval to every industry it oversees. Drugs are used to treat, prevent, mitigate, diagnose or cure diseases. Clinical trials in humans must demonstrate that a drug is safe and effective for its intended use. The drug must then be manufactured under controlled conditions and packaged to meet strict labeling standards before the FDA pre-approves it for consumer use. Unlike drugs, dietary supplements are for nutritional purposes only. Because supplements are not considered medicines, they are not controlled in the same way.
While the FDA has regulations for manufacturing and labeling, dietary supplements have different testing, safety and efficacy guidelines than pharmaceutical drugs. Unlike drugs, supplements do not require prior FDA approval before they are released for sale to the consumer. The Dietary Supplements Health and Education Act of 1994 (DSHEA) defined the role of supplements and described what dietary supplement companies can legally say about their products. The law dictates that, since supplements are not drugs, supplement companies cannot insinuate or claim that their product diagnoses, treats, cures or prevents diseases of any kind. The FDA does not “approve dietary supplements” because it does not approve foods. The FDA only approves pharmaceutical drugs.
The FDA oversees the manufacture and labeling of supplements and regularly inspects companies to ensure that they comply with all regulations. If a supplement company does not comply with FDA regulations, the FDA may prohibit it from selling its product. The FDA is not authorized to review the safety and efficacy of dietary supplements before they are marketed. This attempt to require supplement producers to guarantee the quality and safety of their products was counteracted by one of the most intense lobbying campaigns in history. A guidance document published by the Federal Trade Commission (FTC) in 1998 contains non-binding recommendations and announcements do not require prior approval. The FDA established regulations in 1941 to regulate the labeling of vitamins, establishing a minimum daily requirement for each vitamin, but the agency did not restrict the amount of vitamin allowed in supplements at that time. Health Education and Dietary Supplements Act (26%) Health and supplement lobby groups worked hard to ensure that the FDA could not maintain any control over vitamins through the Nutrition Labeling and Education Act (NLEA) or any other method. These three types of statements are not approved by the FDA and do not require an FDA evaluation before they are used in the labeling of dietary supplements: antioxidant vitamins, germanium, ginseng, shark cartilage, red clover, Venus flycatcher, bee pollen, herbal teas, dandelion, saw palmetto, honeysuckle, aloe vera, pancreatic enzymes and colonic rinses. Dietary supplements not only include vitamins but can include minerals, amino acids, botanicals and substances such as probiotics, enzymes and metabolites.
The supplement manufacturer is required to ensure that vitamins and supplements are safe before entering the market. The products now sold in the rapidly expanding “dietary supplement” industry include not only vitamin and mineral formulas but also those derived from herbs, glands, amino acids and enzymes of all kinds in any combination and quantity sold in tablets, capsules, gel capsules powders or liquids.