Product level · Food, drugs, supplements, household hazardous
A CPR is required for each individual product you sell or distribute. Products with different variants, flavours, dosage forms or packaging sizes must each be registered separately with their own FDA registration number. An active LTO is a non-negotiable prerequisite.
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Overview
A Certificate of Product Registration is the FDA agreeing that one specific product is safe and sound enough to be sold here. It is that product's authority to exist commercially: until the certificate is issued, the product cannot be manufactured, imported or sold.
It hangs off your License to Operate, which is why the LTO always comes first. And it describes the product exactly as registered — one certificate per product, per variant, per dosage, per flavour, per pack size. A range is a stack of certificates, not a single one.
What it is for
What sits underneath everything else you file.
Every product you sell or distribute carries its own CPR and its own FDA registration number. There is no blanket registration for a range.
Different variants, flavours, dosage forms and packaging sizes are each registered on their own. Ten flavours means ten CPRs — worth knowing before you budget.
An active License to Operate is a non-negotiable prerequisite. A CPR cannot be filed against an establishment that is not yet licensed.
Scope
Five categories are registered this way. Find yours to see what the certificate will cover.
Processed food, beverages, bottled water, canned goods and infant formula.
Vitamins, minerals, energy products and other dietary supplements.
Over-the-counter medicines and other pharmaceutical products.
Cleaning products, disinfectants and pesticides.
Veterinary medicines, medicated feeds and antimicrobials for animals.
Cosmetics are notified rather than registered — that is the Cosmetic Product Notification. Medical devices run through a device notification or registration, the CMDN or CMDR. Everything else the FDA regulates comes back to the CPR.
Requirements
A first application asks for the full dossier. A renewal asks for far less, provided nothing about the product has changed.
The full dossier
Four documents, if nothing changed
Send us the product and what you do with it, and we will name the exact documents before you chase a single one — ask us first.
The process
Four stages, beginning with the licence the rest of it stands on.
Every CPR sits on a live License to Operate, so that comes first. Manufacturers, importers, distributors and exporters of regulated products all need one.
We assemble the dossier for each product, variant and pack size and file it through the FDA's online system, which runs a completeness check before anything substantive begins.
The relevant FDA centre works through the dossier, the labels and any samples against the safety, quality and labelling rules for your product type.
On approval the FDA issues the certificate covering the product and its registered variants, and you can manufacture, import and sell.
Validity
It depends on what you registered. Our working figures are two years for supplements and five for food. More broadly, an initial certificate commonly runs two years with renewals extending to five, and pharmaceutical registrations can reach six. Because the certificate describes the product as registered, changing the formulation or the label means an amendment or a fresh application.
File the renewal before the certificate lapses. Products that have not changed can often be set for automatic renewal, while a certificate left to expire risks being treated as a brand new application. Processed food now runs through the FDA's eServices System, which took over from the older ePortal in early 2026, so filings there follow the newer procedure.
Working turnarounds, not best cases. Each line is a filing we handle end to end.
| Filing | Code | Turnaround |
|---|---|---|
| FDA Certificate of Product Registration (CPR)Start here | CM-FDA-005 | 20–30 working days |
Yes. The LTO licenses the establishment, not the product, and it has to be in place before any Certificate of Product Registration or Cosmetic Product Notification can be filed. It is the first step for anyone bringing food, drug, cosmetic or medical device products to market.
A Certificate of Product Registration covers food, drugs, supplements and household hazardous products. A Cosmetic Product Notification covers cosmetics — skincare, haircare, makeup and personal care. The CPN is notification-based rather than a full registration, but it still requires a valid cosmetic-establishment LTO.
Yes. Products with different variants, flavours, dosage forms or packaging sizes are each registered separately and each receive their own FDA registration number. Ten flavours means ten CPRs.
A new LTO application runs 30 to 40 working days. A Certificate of Product Registration takes 20 to 30 working days, and a Cosmetic Product Notification 15 to 20 working days. LTO renewals and variations take 2 to 3 months because they include a facility inspection.
CPR validity is 2 years for supplements and 5 years for food products. A CPN is valid for 1 year and renews annually. LTO renewal has to be filed before the existing licence expires.
We prepare and file on your behalf, track the application through the FDA, and come back to you when something is needed rather than leaving you to chase it. Tell us the product and where you are in the process, and we will confirm exactly which filings apply and in what order.
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