HealthMap

FDA Regulation of Dietary Supplements

• No Pre-Approval: The FDA does not pre-approve dietary supplement health claims prior to marketing.
• Manufacturer Responsibility: Supplement manufacturers are solely responsible for ensuring that their product claims are truthful and not misleading, and that they are supported by adequate scientific evidence.
• Notification Requirement: While not pre-approved, manufacturers must notify the FDA and submit their supporting evidence for certain health claims at least 30 days before marketing the product.
• Two Main Categories of Claims:
• Authorized Claims: Based on significant scientific agreement and reviewed by the FDA.
• Qualified Health Claims (QHCs): Allowed when the evidence is still emerging, and these must be accompanied by a specific disclaimer reflecting the limited science.
• Post-Market Monitoring: The FDA monitors products after they are on the market and can take action against false, misleading, or illegal claims.