What Are the Rules on Dietary Supplements? A Comprehensive Guide

Learn about the rules on dietary supplements, including regulations from the Food and Drug Administration (FDA). Find out what companies must do to ensure their products are safe and properly labeled.

What Are the Rules on Dietary Supplements? A Comprehensive Guide

The Food and Drug Administration (FDA) has established regulations for both finished dietary supplements and dietary ingredients. Unlike drugs, dietary supplements do not require FDA approval before they can be sold or marketed. It is the responsibility of supplement companies to guarantee that their products are safe and that the claims on the label are accurate and not deceptive. If a product does not contain a “new dietary ingredient” (one introduced after October 15, 1999), the company does not have to provide safety tests to the FDA before it is marketed.

However, all dietary supplement companies must adhere to the FDA's Good Manufacturing Practices (GMPs). These GMPs require that companies test their products for identity, purity, strength, and composition. Companies must also ensure that their products are free from contamination and that they are properly labeled. The FDA also requires that dietary supplement companies register with them and provide a list of all ingredients in their products. This list must include any potential allergens or other substances that could cause adverse reactions.

Additionally, companies must provide evidence of any health claims they make about their products. It is important to note that dietary supplements are not intended to diagnose, treat, cure, or prevent any disease. Consumers should always consult with their healthcare provider before taking any dietary supplement. They should also be aware of potential side effects and interactions with other medications.