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FDA Registration Process for Dietary Supplements

Navigate the FDA registration requirements for dietary supplements with confidence

FDAComplianceRegulations

Selling dietary supplements in the United States requires compliance with FDA regulations. Understanding the registration process, facility requirements, and labeling rules is essential for legal market entry.

Important: This guide provides general information. Consult with a regulatory expert for specific compliance advice.

FDA Facility Registration

All facilities that manufacture, pack, or hold dietary supplements for sale in the US must register with the FDA.

Key Requirements:

  • Register facilities with the FDA using Form 2657
  • Renew registration every two years
  • Include all trade names used by the facility
  • Report significant changes within 30 days

cGMP Compliance

Current Good Manufacturing Practice (cGMP) regulations are required for dietary supplement manufacturers.

Identity

Verify identity of dietary ingredients through at least one appropriate test.

Purity

Test for contaminants including heavy metals, pesticides, and microbes.

Strength

Verify that products meet their labeled specifications.

Composition

Ensure product composition matches batch records and specifications.

Labeling Requirements

Dietary supplement labels must include specific information:

  • Statement of Identity: The term "dietary supplement"
  • Net Quantity: Amount of product in the container
  • Supplement Facts Panel: List of ingredients and amounts
  • Manufacturer Information: Name and address of manufacturer
  • Ingredients List: All ingredients in descending order

Note: New dietary ingredients (NDI) not marketed in the US before October 15, 1994 require premarket notification to the FDA with evidence of reasonable expectation of safety.

DSHEA Compliance

The Dietary Supplement Health and Education Act (DSHEA) of 1994 established the regulatory framework for dietary supplements. Key points include:

  • Supplements are regulated more like foods than drugs
  • Manufacturers are responsible for ensuring product safety
  • Claims must not be misleading
  • Structure/function claims require substantiation
  • FDA must prove a product is unsafe before restricting sale

FDA Inspections

FDA conducts inspections of dietary supplement facilities to ensure compliance with cGMP regulations. Inspections may be:

  • Routine: Scheduled periodic inspections
  • For-Cause: Triggered by complaints or adverse events
  • Follow-up: To verify corrective actions

Non-compliance can result in warning letters, product recalls, import alerts, and in severe cases, criminal prosecution.

FDA-Registered Manufacturing Partner

Kerrypros is an FDA-registered facility with full cGMP compliance. Let us help you navigate the regulatory requirements for your supplement products.