Dietary Supplements – Label Requirements

12/26/2023   Jane Jackson   Nutra-Files.com

The label of a dietary supplement product must be truthful and contain at least one of three types of claims.

• Health Claim – describe a relationship between a food, food component, or dietary supplement ingredient and reducing the risk of a disease or health-related condition.
• Nutrient Content Claim – describe the relative amount of a nutrient or dietary substance in a product.
• Structure/Function Claim – describing how a product may affect the body. Product labels must include a disclaimer, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Before being allowed to market a drug product, manufacturers must obtain FDA approval by providing evidence a product is both safe and effective. Once marketed, the FDA must prove the product is not safe to remove it from the market.

The FDA requires certain information appear on the dietary supplement label.

General information

• Name of product
• Disclosure the product is a supplement
• Quantity of contents
• Name and place of business of manufacturer, packer, or distributor
• Directions for use

Supplement Facts panel

• Serving size, list of dietary ingredients, amount per serving size (by weight), percent of Daily Value
• If a botanical, include the scientific name of the plant and the name of the plant part used
• If a proprietary blend, include the total weight of the blend and components of the blend in order of predominance by weight

Dietary supplements are not required by federal law to be tested for safety and effectiveness before they are marketed, so the amount of scientific evidence available for various supplement ingredients varies widely. Please read all information provided by the manufacturer including ingredients, dosage recommendations, expected outcomes, possible side effects and emergency action for potential adverse reactions.

Disclaimer

This article should not take the place of medical advice. Please talk with a healthcare professional regarding the use of dietary supplements and what may be best for your overall health.