Dietary Supplement Facility Registration with FDA: Complete Guide

How FDA Regulates Dietary Supplements

Dietary supplements are regulated as a category of food under the Dietary Supplement Health and Education Act of 1994 (DSHEA), which amended the FD&C Act. While dietary supplements have their own specific rules for labeling, manufacturing, and adverse event reporting, the basic FDA facility registration requirement is the same as for other food categories.

Key regulatory frameworks for dietary supplements include:

• Facility registration: Section 415 of the FD&C Act and 21 CFR Part 1, Subpart H
• cGMP requirements: 21 CFR Part 111 — specific manufacturing, packaging, labeling, and holding requirements for dietary supplements
• Labeling: 21 CFR Parts 101 and 101.36 (Supplement Facts label) plus DSHEA provisions
• New Dietary Ingredient (NDI) notifications:Section 413(a)(2) of the FD&C Act — required for supplements containing ingredients not marketed before October 15, 1994
• Adverse event reporting: The Dietary Supplement and Nonprescription Drug Consumer Protection Act requires reporting of serious adverse events within 15 business days

Facility Registration Process

Dietary supplement manufacturing, packaging, and warehousing facilities register with FDA through the same system used for food facilities:

1. Create an FDA account: Register at access.fda.gov if you don't already have one.
2. Access FFRM: Navigate to the Food Facility Registration Module.
3. Select facility type: Choose "manufacturer/ processor" and select "dietary supplements" as a product category.
4. Designate a U.S. Agent (foreign facilities): Foreign facilities must provide U.S. Agent information. Assurentry provides U.S. Agent services for dietary supplement facilities.
5. Submit registration: Complete and submit. You will receive an FDA registration number (and FEI number for new facilities).
6. Renew biennially: Renew during the October 1– December 31 window of even-numbered years.

cGMP Requirements (21 CFR Part 111)

Dietary supplement manufacturers must comply with Current Good Manufacturing Practice (cGMP) regulations specific to supplements under 21 CFR Part 111. These are more detailed than general food cGMP requirements and include:

• Identity testing: You must verify the identity of each component (ingredient) used in your supplements before use in manufacturing (§111.75)
• Master manufacturing records: Written procedures for each unique product formulation (§111.205)
• Batch production records: Documentation of each production batch, including quantities, equipment used, and in- process testing results (§111.255)
• Quality control: A quality control unit with authority to approve or reject components, packaging, labels, and finished products (§111.103)
• Testing specifications: Established specifications for identity, purity, strength, and composition of finished products (§111.70)

Foreign Manufacturer Requirements

Foreign manufacturers of dietary supplements face additional requirements when exporting to the United States:

• FDA facility registration with U.S. Agent: Required under Section 415. Your U.S. Agent must be based in the United States and available to receive FDA communications.
• FSVP compliance by U.S. importer: The U.S. importer must have a Foreign Supplier Verification Program that covers your facility, per 21 CFR Part 1, Subpart L.
• Prior Notice: All dietary supplement shipments require Prior Notice filing before arrival at U.S. ports.
• Labeling compliance: Labels must meet U.S. requirements, including the Supplement Facts panel (21 CFR §101.36), ingredient lists, and required disclaimers.
• cGMP compliance: Foreign facilities are subject to the same 21 CFR Part 111 requirements and may be inspected by FDA.

Getting Started with Assurentry

Whether you are a domestic supplement manufacturer needing to register for the first time or a foreign facility seeking U.S. market access, Assurentry can help:

• U.S. Agent services for foreign dietary supplement facilities
• FDA food facility registration and biennial renewal management
• Guidance on cGMP compliance, labeling requirements, and NDI notifications