Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) and significantly expanded by FSMA in 2011, requires domestic and foreign food and dietary supplement facilities to register with FDA before operating. Registration is not optional — manufacturing or distributing food or supplements from an unregistered facility is a federal violation.
Who Must Register
Under 21 CFR Part 1 Subpart H, the following facilities must register with FDA:
Domestic food facilities — facilities in the U.S. that manufacture, process, pack, or hold food for human or animal consumption
Foreign food facilities — facilities outside the U.S. that manufacture, process, pack, or hold food that is exported to the U.S.
For dietary supplements, this includes:
Supplement manufacturers (where manufacturing or encapsulation occurs)
Packers (where finished supplements are packaged or labeled)
Holders (warehouses that store finished supplement products)
Who Does Not Need to Register
Certain facilities are exempt from registration:
Farms that grow and harvest fruits, vegetables, and other raw agricultural commodities
Retail food establishments (restaurants, grocery stores) that sell food directly to consumers
Private residences where food is prepared for personal consumption
Fishing vessels that are not used to process fish
Foreign facilities whose food products never enter U.S. commerce
A supplement brand that contracts out all manufacturing, packaging, and warehousing but does not itself operate any facility does not need to register — but each facility it uses must be registered.
How to Register: The FDA Portal
Registration is completed through FDA's Unified Registration and Listing System (FURLS) at www.fda.gov/furls. Registration requires:
Creating an account on the FDA portal
Providing the facility's legal name and address (physical location)
Identifying the facility owner or operator
Specifying the food product categories manufactured at the facility (FDA has a list of product categories)
For foreign facilities: designating a U.S. Agent — a person physically present in the U.S. who can be contacted by FDA on the foreign facility's behalf
Registration is free — FDA does not charge a registration fee. Third-party services that charge for FDA registration are providing document preparation assistance, not a service FDA requires.
Biennial Renewal
Under Section 415(a)(3) of the FD&C Act, facility registrations must be renewed every two years during the October–December renewal window. Renewal periods:
October 1 – December 31 of even-numbered years (2024, 2026, 2028, etc.)
A facility that does not renew its registration during the renewal window has an expired registration. Operating with an expired registration is a violation — and an expired registration is visible in FDA's public facility database, which retailers, distributors, and auditors may check.
Updates and Amendments
Facilities must update their registration within 60 days of any change to:
Facility name or address
Owner or operator information
U.S. Agent (for foreign facilities)
Food product categories manufactured
FDA's Authority to Suspend Registration
One of the most significant FSMA additions to the facility registration framework: FDA may suspend a facility's registration if FDA has a reasonable belief that food from the facility has a reasonable probability of causing serious adverse health consequences or death. A facility with a suspended registration may not introduce food into U.S. commerce — effectively, it is shut down.
Registration suspension is an emergency tool FDA uses in serious situations. It bypasses the typical warning letter → voluntary recall pathway and is used when FDA believes the risk is immediate and the normal process would not adequately protect the public.
Registration Number and FDA Inspections
Once registered, a facility receives a 10-digit registration number (DUNS-based). This number:
Appears on FDA's online facility registry
Is used by FDA to track the facility's inspection history
Is referenced in FDA warning letters and inspection reports
FDA's inspection authority applies to registered facilities — FDA inspectors can request access to registered domestic facilities for routine or cause-based inspections. For foreign facilities, FDA may conduct overseas inspections or rely on third-party audit programs.
Supplement Brands vs. Contract Manufacturers: Who Registers
If a brand does not operate its own facility:
The contract manufacturer registers the manufacturing facility
The contract packer registers the packaging facility
The warehouse/3PL registers if they hold finished products
The brand itself does not register unless it owns or operates a facility. However, the brand should verify that all its contract facilities are properly registered — operating with unregistered contract facilities creates compliance exposure for the brand.
How Truli Helps with Facility Registration Compliance
Registration status verification: Truli verifies that manufacturing, packing, and storage facilities used for a brand's products are registered with FDA and that registrations are current
Renewal deadline tracking: Truli tracks facility registration renewal windows (October–December even-numbered years) and alerts when renewals are approaching
Foreign facility U.S. Agent verification: Truli confirms that foreign contract facilities have valid U.S. Agent designations and current registrations
Related Regulations
21 CFR Part 111 — Supplement cGMP — Manufacturing quality requirements applicable to registered supplement facilities
21 CFR Part 117 — FSMA Preventive Controls — FSMA preventive controls applicable to registered food facilities
FDA FSVP — Foreign Supplier Verification — FSVP requirements for importers that source from foreign registered facilities
Frequently Asked Questions
We're a brand that sells supplements but we don't make them. Do we need to register?
No — if you don't own or operate a food facility (manufacturing, packing, or holding), you don't need to register. However, each facility in your supply chain that manufactures, packs, or warehouses your product must be registered, and you should verify their registration status.
How do I look up whether a facility is registered?
FDA's facility registration database is searchable at FDA's website. You can search by facility name, city, state, or country. The database shows registration status and the most recent registration date.
Our contract manufacturer's registration expired. Are we out of compliance?
Yes — products manufactured at a facility with an expired registration cannot be legally introduced into U.S. commerce. You should immediately contact your contract manufacturer to require them to renew their registration, and assess whether any product manufactured or shipped during the lapse period creates regulatory exposure.
A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
Last updated: April 2026. Reflects FD&C Act Section 415 and 21 CFR Part 1 Subpart H as of April 2026. Book a demo to see how Truli monitors supplement compliance.
