How 3PLs Can Register for FDA-Approved Warehouse Status

Last updated on June 09, 2025

In this article
7 minutes
Imagine a spotless warehouse stacked with pallets of potato chips or cases of juice. That’s what people imagine when they think of what “food-grade warehousing” often means: strict cleaning protocols, temperature controls, and temperature-controlled environments for sensitive products, plus intensive audits by certifiers to prove it. Quality control, monitoring, and tracking are indeed essential for maintaining standards in these facilities. But here’s the catch: there’s no official “FDA food-grade certificate.” In other words, no inspector from the FDA comes by and stamps a “food-grade” label on your door. Instead, the FDA regulates facilities by simply requiring them to register if they handle food.
Having food-grade certification is a voluntary, industry-driven quality label. FDA Food Facility Registration, however, is a mandatory legal listing for any business that manufactures, processes, packs, or holds food (including dietary supplements and animal feed) for U.S. consumption. To clarify, an FDA-certified warehouse goes through a more rigorous process of demonstrating a higher level of compliance with FDA regulations, which is voluntary. “Registration,” on the other hand, is a basic requirement for all facilities handling food, essentially notifying the agency about their activities.
In short, having SQF or “organic” or even SQF Level 3 qualification is great for customers and safety, and also supports brand reputation and benefits ecommerce businesses, but it doesn’t exempt you from the law. If your 3PL warehouse stores consumer foods, drinks, pet snacks, or supplements, it must be entered in the FDA’s facility registry, regardless of how clean or certified it is. Companies in various industries, such as food, beverage, and supplements, need to comply with these requirements. An FDA spokesperson bluntly reminds us: any facility holding food for U.S. humans or animals must register, unless a specific exemption applies. This is essential for public health and health protection. For example, proper registration allows for the tracking of an E. coli outbreak back through all the facilities where it was held to identify the source.
If your warehouse or fulfillment center stores food, you must register. The supply chain, logistics, and fulfillment services provided by 3PLs are all impacted by these requirements. The FDA’s own FAQ reminds us, under the act (such as the Food Safety Modernization Act) and drug administration oversight, that registration is not optional.
If you’re a manufacturer, you must register. Appropriate storage conditions and maintained standards are required to ensure compliance. If your core business is storage, the products are stored, and inventory management practices must meet regulatory expectations. If you only ship (no storage), you’re probably exempt. However, management systems and control of inventory are still important for compliance.
Different 3PLs have warehouses that offer a range of services and solutions, and choosing the right partner is important for helping you ship FDA-regulated products efficiently.
When Does a 3PL Warehouse Need to Register?
As soon as your warehouse is holding regulated food or feed for sale in the U.S., it falls under the FDA’s food facility rule. That means if your 3PL stores any packaged foods, beverages, snacks, dietary supplements, or animal feeds (even pet chews) destined for U.S. consumers, you must register with the FDA. Dietary supplements count as “foods” under the law, so a vitamin or protein powder you warehouse still triggers FFR. Same if you handle pet treats or livestock feed, animal feeds can be considered food (or drugs), and holding them for distribution requires registration. In practice, virtually all 3PLs storing consumer food or supplement products will need to register. There’s no minimum volume or frequency, even short-term “holding” qualifies. FDA guidance clarifies: “There is no timeframe associated with holding… a facility that holds food… is not exempt.”
Exemptions: The law does carve out a few narrow exceptions, but they usually don’t apply to commercial 3PLs. Common carrier transportation is exempt (trucks, ships, planes) because vehicles are not considered “facilities”. A Post Office or courier sorting center with packages is likewise viewed as transit, not as a holding facility. Retail grocery outlets and restaurants are also exempt (they’re “retail food establishments”), but an independent warehouse that isn’t part of a store chain doesn’t qualify. Importantly, storage of non-food items (like empty bottles, labels, or packaging materials) is exempt too, since the FDA defines “food” as excluding food-contact materials. In short, if your 3PL’s core business is storage of packaged food/beverage/supplement products, you’re in, otherwise, you’re probably out.
- Must register: Facilities manufacturing/processing, packing, or holding food or animal food for U.S. distribution. This includes dietary supplements, snacks, drinks, pet food, feed supplements, etc.
- Does not need to register: Pure carriers/transport trucks (no holding activity); retail stores or restaurants; farms holding their own produce; and facilities storing only packaging or non-food items.
Product Triggers: What Counts as “Food”?
The FDA’s definition of food is very broad, and it explicitly includes dietary supplements and many pet products. In practical terms, any finished food or beverage product triggers registration. That means snacks, cereals, bottled water, sodas, juice, nut butters, supplements, infant formula, spices, etc., all count. A helpful FDA Q&A spells it out: “A dietary supplement and a component of a dietary supplement are ‘foods.’ Accordingly, a facility that … holds a dietary supplement … is required to register as a food facility.” Likewise, pet foods and chews must be registered, they’re considered animal food. By contrast, cosmetics, drugs, medical devices, or chemicals do not fall under the food registration rule (they’re regulated by other FDA centers). So, if your warehouse does mixed storage, only the racks holding food/work trigger FFR.
It’s worth double-checking borderline cases. For example, a facility storing bulk sugar or starch used for food probably needs to register, because those ingredients are food. But if a warehouse only holds bottles, jars, or foam peanuts (food-contact materials), that is not “food,” and you wouldn’t register for those alone. Whenever in doubt, recall this rule of thumb: if it can be eaten (or fed to animals), the warehouse holding it likely needs to register.
How to Register (Step-by-Step)
Registering is straightforward and free. Start by getting an FDA Industry Systems (FIS) account at access (FDA calls this portal “FURLS”). Once logged in, choose the Food Facility Registration Module (FFRM) and hit “Register a Food Facility.” The online system will guide you through sections for facility info, contact data, and product categories. A handy user guide on the FDA’s site walks you through each page.
All domestic and foreign registrants must use the electronic system (paper is only allowed by rare waiver). If you do need a paper backup (e.g., in an emergency or with a waiver), the FDA provides Form FDA 3537. This form is available on the FDA’s website and can be mailed or faxed to the FDA’s registration office. However, 99% of businesses just use the online portal; it’s faster and automatically gives you a confirmation.
Information You Must Provide
The registration form (online or 3537) asks for basic data about your facility and operations. In short, be ready with facility identity and contact info, product categories and activities, and key attestations. Specifically, FDA requires: name, address, phone (and emergency contact phone) of the facility; mailing address (if different); any parent company name; all trade names used at the facility. It also needs the name, address, and phone of the owner/operator/agent in charge, plus their email address (unless FDA granted a waiver).
You must also list which types of foods you handle. FDA provides a menu of “food product categories” (36 choices), just check all that apply (e.g., “beverages,” “bakery goods,” “dairy products,” “supplements,” etc.). For each category, indicate whether you manufacture/process, pack, or hold that product. If you hold multiple categories (snacks, drinks, supplements, etc.), you must list them all.
Importantly, you must also include a Unique Facility Identifier (UFI) that FDA recognizes. Currently, the FDA accepts the D-U-N-S (DUNS) number as the UFI. If you have a DUNS number for your company, include it (if not, getting a DUNS is free via Dun & Bradstreet). Just make sure it’s correct; the FDA will verify that the address matches.
Finally, the form includes a couple of statements and signature fields. You must certify that FDA may inspect the facility per law, and that all provided info is true and accurate. The owner/operator (or an authorized representative) signs off on this. If you file electronically, the system will still record your submission and display your unique registration number (FEI) and PIN on screen. In other words, once you click submit, you instantly get your FDA registration number.
(Foreign facilities note: U.S. law requires a U.S.-based agent as well. Foreign registrants must provide the name, address, phone, and email of their U.S. agent contact.)
No Fees or Fancy Licenses
Here’s a relief for ecommerce brands: The FDA does not charge any fee for food facility registration. Domestic facilities pay nothing. (Foreign facilities must hire a U.S. agent, but that’s an independent business service fee, not an FDA fee.) There’s no formal inspection or license process tied to the registration itself; you don’t need an FDA “permit.” The registration simply identifies you in the FDA’s database.
Minimum qualifications: You don’t need a food degree to register. Any business that legitimately handles food (and isn’t otherwise exempt) can register. The key requirements are simple: have a real physical facility or address, designate who the owner/operator is, and be ready to let FDA inspectors in if there’s a problem (FDA will ask for an inspection assurance on the form). Beyond that, you should follow good hygiene/CGMP practices (FDA’s Title 21 CFR Part 117), but those standards aren’t part of the registration. In short, if your 3PL warehouse fits the description above, you can (and must) register; the process doesn’t require extra credentials beyond normal business paperwork.
Timeline: Registration, Renewal, and Expiration
The registration process itself is quick. In practice, if you have all the information ready, you can complete an online registration in less than 20 minutes. Once submitted, the FDA site immediately assigns you a registration number (FEI) and PIN, which appear on-screen. There’s no waiting for mail or manual review. You can email or print your registration form right away. As soon as you’re done, your facility is officially in the system.
But don’t forget renewals! The FDA requires a biennial renewal cycle. That means every two years, you must update or resubmit your registration. In practice, the FDA opens the renewal window from October 1 through December 31 of every even-numbered year (e.g., 2026, 2028, etc.). During that period, you log back into FIS, review your info, make any changes (new address, products, contacts, etc.), and resubmit. After Dec 31, any facility that hasn’t renewed is considered expired.
So mark your calendar: the next renewal window opens October 1 of the next even year. If you register for the first time in an odd-numbered year (say June 2025), you must renew by Dec 31, 2026, to avoid lapsing. FDA will normally send reminders, but it’s best to track this yourself. (And remember: renewals are free too.) If your business goes out of scope or closes, you should also cancel your registration in FIS to avoid future reminders.
Key Requirements & Timelines: At a Glance
- Who must register: Any facility manufacturing/processing, packing, or holding food or animal feed for U.S. distribution (snacks, beverages, supplements, pet food).
- Who is exempt: Pure carriers (trucks, ships) in transit; retail stores and restaurants; farms holding their own produce; facilities storing only non-food items.
- How to register: Online via FDA’s FIS portal (FURLS Food Facility Registration Module); paper only by FDA waiver.
- Information needed: Facility/contact details; food categories and activities; Unique Facility Identifier; attestations and signature.
- Timeline: Instant registration upon online submission; biennial renewal October 1 – December 31 of even years; expiration if not renewed.
- Fees: There is no FDA fee for domestic registration or renewal. (Foreign firms only pay for their required U.S. agent service.)
- Duration: Each registration lasts until the next biennial renewal period (essentially 2 years). After renewing, you’ll receive a new registration confirmation for the next period.
Staying on top of these rules ensures your 3PL warehouse is legally compliant with the FDA’s food regulations and avoids nasty surprises like cancelled imports or penalties. When in doubt, consult the FDA’s resources (see citations below) or call their FURLS help desk. Safe storing!
Frequently Asked Questions
Do 3PL warehouses need an FDA “food-grade” certificate to store food?
No. There is no official FDA “food-grade” certificate. However, any facility that stores food products must register with the FDA as a food facility. Voluntary certifications (SQF, BRCGS) support trust and safety but do not replace the legal registration requirement.
What products trigger the need for FDA registration?
Any facility storing food, beverages, dietary supplements, or animal feed intended for U.S. consumption must register. This includes snacks, bottled drinks, pet treats, and vitamins. Even temporary “holding” triggers registration.
How does a 3PL warehouse register with the FDA?
Warehouses register through the FDA Industry Systems portal (FURLS) using the Food Facility Registration Module. Registration is free and requires facility details, product handling categories, and a Unique Facility Identifier (e.g., DUNS number).
Are there exemptions to the FDA registration rule?
Yes. Pure carriers in transit, retail stores and restaurants, farms holding their own produce, and facilities storing only packaging materials do not need to register. Most commercial 3PL warehouses handling food must register.
How often must FDA food facility registration be renewed?
Every two years during the October 1 – December 31 window of even-numbered years (2026, 2028, etc.). Registrations expire if not renewed by December 31.
Citations
- Argos Software: 7 Quick Q&As for FDA Food Facility Registration
- FDA: Food Facility Registration User Guide: Registration of Food Facilities, Step-by-Step Instructions
- FDA: Online Registration of Food Facilities
- FDA: Questions & Answers Regarding Food Facility Registration (7th Ed.)
- FDA: Registration of Food Facilities & Other Submissions
- FDA: Reminder: Food Facilities Register/Renew Registration
- Smart Warehousing: Getting Certified as a Food-Grade Warehouse
- Smart Warehousing: The Role of Food-Grade Warehousing in Meeting Regulatory Requirements for Food Storage

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