Regulatory report: CBD as a dietary supplement in the US and EU

As CBD grows in popularity, its regulatory status remains poorly defined. In this report CBD-Intel reviews the regulatory framework of dietary supplements and where CBD fits, or would fit, within that framework.

Both the US and the EU have regulatory standards governing the marketing of food supplements. Most of the US Food and Drug Administration (FDA)’s powers appear to be aimed at regulating what can be said about a substance rather than scutinising them before they are marketed. Claims may be either health claims related to a particular condition, or general structure/function claims.

In Europe, regulatory authority is divided between the EU and individual member states. The EU defines CBD as a novel food, requiring express authorisation.

In the US, its approval by the FDA in a pharmaceutical product precludes its use as a food or dietary supplement though that has been subject to court involvement.

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Table of contents

  1. Executive summary
  2. Introduction
  3. United States
  4. Europe
  5. Current status of CBD as a dietary supplement
  6. Case study: melatonin – a comparison of evidence
  7. Conclusion

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