FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
+1 212 444 8202
U.S. FDA Registration
& Labeling Compliance Assistance
Food & Supplements
Navigating FDA registration can be complex. Our specialized team is here to simplify the process for you. Whether you’re looking to bring a new product to the U.S. market, renew your existing registrations, or ensure compliance with evolving FDA standards, we’re here to help.
Why Working with Us?
Our team has deep expertise in understanding your industry’s unique needs and challenges in FDA regulatory compliance. We ensure that your food and supplement products meet all FDA requirements, from registration to labeling. We handle every process step, from document preparation to submission, and follow up with FDA officials when needed.
Food &
Supplements
Navigating FDA registration can be complex. Our specialized team is here to simplify the process for you. Whether you’re looking to bring a new product to the U.S. market, renew your existing registrations, or ensure compliance with evolving FDA standards, we’re here to help.
Why Working with Us?
Our team has deep expertise in understanding your industry’s unique needs and challenges in FDA regulatory compliance. We ensure that your food and supplement products meet all FDA requirements, from registration to labeling. We handle every process step, from document preparation to submission, and follow up with FDA officials when needed.
FDA Food
Facility Registration
The U.S. FDA Bioterrorism Act of 2002 requires all foreign and domestic facilities that manufacture, process, pack, and store food, beverages.
FCE
Registration & SID Filliing
Aside from FDA Food Facility Registration FFR, the US FDA requires most companies to produce shelf-stable food (canned, vacuum packed, etc.).
FDA Food & Supplement Labeling Requirements
The FDA has set clear guidelines for labeling food and dietary supplements to protect public health. Brand owners, manufacturers.
FDA Registration
Certificate & US Agent
Companies registered with the FDA often seek a certificate to use as proof of registration when dealing with trade or industry partners.
FDA Import Alert
& Detention Assistance
FDA Import Alerts protect US consumers from products produced at facilities with a known history of violations. After identifying a violation.
FDA
Export Certificate
The export certificate is an official document issued by the FDA that provides information on a product or facility’s FDA.
FDA Food
Facility Registration
The U.S. FDA Bioterrorism Act of 2002 requires all foreign and domestic facilities that manufacture, process, pack, and store food, beverages.
FCE Registration
& SID Filliing
Aside from FDA Food Facility Registration FFR, the US FDA requires most companies to produce shelf-stable food (canned, vacuum packed, etc.).
FDA Food & Supplement Labeling
Requirements
The FDA has set clear guidelines for labeling food and dietary supplements to protect public health. Brand owners, manufacturers.
FDA Registration
Certificate & US Agent
Companies registered with the FDA often seek a certificate to use as proof of registration when dealing with trade or industry partners.
FDA Import Alert
& Detention Assistance
FDA Import Alerts protect US consumers from products produced at facilities with a known history of violations. After identifying a violation.
FDA
Export Certificate
The export certificate is an official document issued by the FDA that provides information on a product or facility’s FDA.
Frequently Asked Questions (FAQ)
Who must register a food or dietary supplement facility with the FDA?
Any domestic or foreign facility that manufactures, processes, packs, or holds food, beverages, or dietary supplements for U.S. consumption must register with the FDA before commercial distribution.
When are FCE registration and SID filings required for shelf-stable food products?
Commercial processors of low-acid or acidified canned/bottled foods (such as pickles, sauces, or vegetables) must obtain a Food Canning Establishment (FCE) registration and file a Scheduled Process Identification (SID) for each product line before exporting to the U.S.
What is the difference between food labeling and dietary supplement labeling requirements?
Conventional foods require a Nutrition Facts panel, whereas dietary supplements require a Supplement Facts panel. Dietary supplements can also include specific structure/function claims, provided they feature the standard FDA disclaimer
How often must FDA food facility registrations be renewed?
Food facility registrations must be renewed biennially (every two years) between October 1 and December 31 of even-numbered years; sometime the facility registrations verified via third party US agent and FDA certificate annually. Foreign facilities must also designate an active U.S. Agent to complete the renewal process.
What is an FDA Export Certificate, and how do you obtain one?
An FDA Export Certificate (such as a Certificate of Free Sale) is an official document verifying that a product or facility meets U.S. FDA safety standards, allowing U.S. manufacturers to clear foreign customs during export.
What causes a food or dietary supplement shipment to be detained by the FDA at the border?
Shipments can be detained if the FDA suspects a compliance violation—such as an unregistered facility, missing Prior Notice, unauthorized ingredients or color additives, misbranded labeling, or an active Import Alert.
Frequently Asked Questions (FAQ)
Facilities that manufacture, process, pack, or store food for consumption in the U.S. must register with the FDA.
All domestic and foreign food facilities involved in food production or handling for the U.S. market must register.
Registration must be renewed every two years during the FDA’s biennial renewal period.
You must provide facility details, contact information, and a U.S. agent (for foreign facilities).
Food labels must include the product name, net quantity, ingredient list, allergen declaration, nutrition facts, and manufacturer details.