It depends on the category, and on what the facility physically does. For food and dietary supplements, any facility that manufactures, processes, packs, or holds product must register — including a warehouse that only stores it. For cosmetics, drugs, and medical devices, registration attaches to making the product rather than to distributing it, so a private-label distributor that does not manufacture, repack, relabel, or import generally does not register — though it still carries its own labeling and listing obligations.
What does facility registration mean?
It is a notification to FDA that a specific physical facility exists and performs specific regulated activities. It creates a record and an FDA establishment identifier. It is not a review of your product, your formula, or your labeling, and it carries no FDA judgment about quality. Which activities count is set separately for each product category, which is why the same warehouse can be required to register for food and not for cosmetics.
Which facilities have to register, category by category?
Food and dietary supplements have the broadest trigger: under section 415 of the Food, Drug, and Cosmetic Act, a facility that manufactures, processes, packs, or holds food for consumption in the United States registers, with exemptions for farms, retail food establishments, and restaurants. Holding alone is enough, so a pure storage warehouse registers. Cosmetics are narrower — under MoCRA only facilities that manufacture or process cosmetic products register, and facilities that solely label, package, hold, or distribute are excluded, as are retailers and distributors. Drugs are narrower still — under 21 CFR 207.17 only establishments that manufacture, repack, relabel, or salvage register. Devices follow the same shape: a purely domestic distributor that never imports, repackages, relabels, or manufactures does not register, but the first US link in the chain for a foreign-made device registers as an initial importer, and a specification developer registers as well.
Do private-label brand owners need to register?
For cosmetics, drugs, and devices, usually not. Putting your brand on a product someone else manufactures is not itself a registration trigger, and FDA’s drug rules say so directly: private-label distributors that do not manufacture, repack, relabel, or salvage are not required to register. Food and dietary supplements are different — if you own or operate a plant or a warehouse that holds the product, that facility registers regardless of whose name is on the label. And in every category, what you always carry is separate from registration: product listing where it applies, and full responsibility for the label and the claims on it.
What are the renewal deadlines?
They differ by category, and all of them run on a calendar rather than on an event. Drug establishments renew annually, between October 1 and December 31, submitted electronically in SPL format. Food facilities renew every two years, in the same October 1 to December 31 window, in even-numbered years — 2026 is a renewal year. Cosmetic facilities under MoCRA renew every two years, keyed to the initial registration date, while the responsible person updates cosmetic product listings annually.
What happens if a renewal is missed, and why is “FDA registered” a risky thing to advertise?
A missed renewal simply expires the registration. FDA does not send reminders for food facility renewals, and there is no general grace period for the drug window. An expired registration can lead FDA to treat products as misbranded or adulterated, and shipments from an unregistered foreign facility can be detained at the port. Because nothing in daily operations changes, a lapse often surfaces only when a retailer, an importer, or an acquirer checks. The opposite error is advertising the registration itself: it carries no approval, clearance, or endorsement, FDA issues no registration certificates, and it has called on firms to stop producing documents that imply otherwise. Presenting registration as approval can misbrand the product.
Frequently asked questions
We only warehouse and ship. Do we register?
For food or dietary supplements, yes — holding is a trigger. For cosmetics, drugs, or devices, generally no, as long as you are not repacking, relabeling, manufacturing, or importing.
Our contract manufacturer is registered. Does that cover our product?
It covers their facility. It says nothing about your labeling, your claims, your listing status, or your oversight of them.
Is registration the same as product listing?
No. Registration identifies a facility; listing identifies products. Many businesses owe one, some owe both, and the deadlines are different.
Does importing change the answer?
It can. For devices, the first US-based link in the chain for a foreign-made product registers as an initial importer. For food, the foreign facility registers and must name a US agent, while the importer carries its own supplier verification duties.
How do we tell which category we are in?
By what the product is and what claims it makes, not by where it is sold. A product can also fall into more than one category at once, which changes what you owe.
Video Transcript
Do you actually need to register a facility with FDA — or does your manufacturer’s registration already cover you?
It depends on your category and on what the facility physically does. If you make or process the product, you register. If you only distribute it under your own brand, in most categories you do not. Food and dietary supplements are the exception.
For food and supplements, registration is broadest — manufacturing, processing, packing, or simply holding food all trigger it, so even a storage warehouse registers.
Cosmetics, drugs and devices run the other way. Under MoCRA, only facilities that manufacture or process cosmetics register; holding, labeling and distributing are excluded. For drugs, only manufacturers, repackers, relabelers and salvagers register — a private-label distributor does not. A purely domestic device distributor does not either, though importing makes you an initial importer, which does.
Renewals are calendar-driven: drugs every year, October 1 to December 31; food every two years in that window in even-numbered years, and 2026 is one; cosmetics every two years under MoCRA.
Map what each facility in your chain physically does, category by category. Put every renewal on a calendar with one person’s name on it. And remember registration is not approval — FDA issues no certificates, so keep approval-sounding language out of your marketing.
Contact us today.
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- Related video: 3 Registration and Listing Mistakes That Can Freeze Your Product at the Border or on the Shelf
- Related video: Is My Contract Manufacturer Actually Compliant — or Am I on the Hook If They’re Not?
- Service page: FDA Regulatory Counsel
Educational purposes only. This video and page are general information, not legal advice, and do not create an attorney-client relationship. Contact us.