The Food and Drug Administration (FDA) is responsible for overseeing both finished dietary supplements and dietary ingredients. These products are regulated as foods, not as drugs, and the FDA has implemented regulations on the production, labeling, and advertising of dietary supplements. The Dietary Supplement Health and Education Act of 1994 (DSHEA) provides a regulatory framework to ensure the safety of dietary supplements. The FDA initially established regulations in 1941 to regulate the labeling of vitamins, setting a minimum daily requirement for each vitamin.
However, the agency did not limit the amount of vitamin allowed in supplements at that time. This changed in 1973 when the FDA attempted to revise the 1941 regulations to adopt the Recommended Daily Allowance (RDA) and restrict the amount of each vitamin in any product to 150% of the United States FDA regulation (1941-197).Unfortunately, these regulations seemed doomed to fail from the start and were never enforced. Senator William Proxmire (Democrat from Wisconsin) became the champion of the supplement industry and Congress threatened the FDA with legislation that would further restrict its role in regulating vitamins if they proceeded to use the over-the-counter product review process. In response, Congress passed DSHEA in 1994 which required the FDA to regulate dietary supplements as foods, not as drugs. This act also provided authority to establish regulations on the manufacture of dietary supplements, regulate health claims and labeling. Products that contain hidden drugs are sometimes falsely marketed as dietary supplements, putting consumers at even greater risk.
For this reason, it is essential to consult with a healthcare professional before using any dietary supplement. Read these consumer updates for more information. At present, dietary supplement manufacturers must adhere to Good Manufacturing Practices (GMPs) which are designed to ensure that products are safe and accurately labeled. The FDA also has authority to take action against companies that make false or misleading claims about their products. In addition, consumers should be aware that dietary supplements are not intended to diagnose, treat, cure or prevent any disease. It is important to read labels carefully and consult with a healthcare professional before taking any dietary supplement.
