The Food and Drug Administration (FDA) is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, foods (including animal foods), cosmetics, and electronic products that emit radiation. Unlike drugs which must be proven safe and effective before they can be marketed to consumers, dietary supplements are regulated as foods by the FDA which means they do not require prior approval from them before being offered for sale. However this does not mean that dietary supplements are completely unregulated as higher risk devices such as mechanical heart valves or implantable infusion pumps typically require FDA approval of a pre-marketing application for approval before being marketed. The FDA also performs batch launch tests on many biological products in order to continuously monitor their quality.In addition to this regulatory framework for manufacturing and labeling dietary supplements have different guidelines for testing safety and efficacy than pharmaceutical drugs.
This means that statements about structure or function of dietary supplements must include a disclaimer stating that they have not been evaluated by the FDA.Finally it is important to note that while it is important to consult with a health professional before using any dietary supplement due to potential conflicts with medications or medical conditions it is also important to be aware of inaccurate wording about what a supplement does in order to comply with FDA guidelines on approved claims.Key Takeaways• The FDA regulates dietary supplements as foods rather than drugs. This means they do not require prior approval from them before being offered for sale.• Higher risk devices such as mechanical heart valves or implantable infusion pumps typically require FDA approval. The FDA also performs batch launch tests on many biological products in order to continuously monitor their quality.• Dietary supplements have different guidelines for testing safety and efficacy than pharmaceutical drugs. Statements about structure or function of dietary supplements must include a disclaimer stating that they have not been evaluated by the FDA.
