Entries for regulated goods
Some shipments answer to more than one authority. The customs side can be perfectly correct while the agency side is incomplete — and the cargo still sits.
Licensed U.S. customs brokerage. Customs broker of record; movement coordinated through vetted partners.
A regulated-goods entry is a customs entry for merchandise that a partner government agency reviews at the border in addition to CBP. For FDA-regulated products — food, beverages, dietary supplements, cosmetics, medical devices, OTC drugs, pet food and ingredients — the entry carries additional data including product codes, manufacturer and registration details, affirmations of compliance and, for food, Prior Notice.
Key takeaways
- CBP releases the customs entry; the reviewing agency decides admissibility separately.
- An entry can satisfy CBP entirely and still be held by FDA.
- The additional data must be correct at transmission — it is not a formality added afterwards.
- Product codes are specific; a near-enough code is a common cause of holds.
- This is a specialism within customs brokerage, not a separate service.
What the extra data set involves
The FDA product code, which describes the article far more precisely than the tariff code does. Manufacturer and facility details, and whether registration is current. Affirmations of compliance appropriate to the product. Prior Notice for food shipments, filed within the required window. The FSVP importer, where the food safety rules apply. And labelling that supports what has been declared.
Handled in one filing
The failure mode we see most often is an entry transmitted with customs data settled and agency data entered as supplied, unchecked. It clears CBP, then sits. We prepare both sides together and query the gaps before transmission rather than after a hold notice.
How it works
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01
Product assessed
What it actually is, which agency reviews it, and what data that triggers.
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02
Codes and affirmations matched
Product code and affirmations checked against the goods, not against the last shipment.
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03
Registration and party data verified
Manufacturer, importer and, where relevant, FSVP importer confirmed.
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04
Prior Notice confirmed
Who is filing it, and by when — agreed in writing rather than assumed.
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05
Filed together
Customs and agency data transmitted as one prepared entry.
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06
Status monitored on both sides
Because release from one is not release from both.
Common mistakes
- Assuming Prior Notice was filed. When everyone assumes someone else did it, nobody did.
- Reusing a product code across similar products. Similar is not the same, and the code is specific.
- Stale registration data. Registrations lapse, and the entry carries whatever it was given.
- No identified FSVP importer. Where the rule applies, someone must be named.
- Treating labelling as a post-arrival problem. It is reviewed as part of admissibility.
Questions
Does customs release mean my shipment is cleared?
Not where another agency is involved. CBP may release the customs entry while FDA still holds the shipment for review. Cargo moves freely only when every applicable authority allows it.
Which products does FDA review at import?
Food and beverages, dietary supplements, cosmetics, medical devices, OTC drugs, pet food, and many ingredients and raw materials. Whether a specific product is covered depends on what it is and how it is presented.
What is an FDA product code?
A structured code describing the article, its industry, class and process. It is far more specific than the tariff code and is one of the most common sources of holds when chosen carelessly.
Do you handle non-regulated goods too?
Yes — most of what we file is ordinary commercial cargo. Regulated entries are where we go deepest, not where we stop.
Related
Tell us what you're importing.
Commodity, origin, port and arrival date is enough to start.