Use
Cosmetic is not a drug.
Cleansing, beautifying, promoting attractiveness. A disease claim is a different file. We read the label before ACE.
Cosmetics & Skincare
Prior Notice is not optional.
We flag FDA Prior Notice from the invoice description and block transmission until the packet is complete. Claims on the label do not replace the filing. A licensed broker still signs the 7501.
Book a consultation Free Entry AuditJFK, EWR, and MIA on one file. 21 U.S.C. § 381 is a gate, not a footnote.
A kit that reads as one SKU is often several facts on a 7501. Cream. Serum. Device. Packaging. Houses that file a single 3304 dump pay for it in FDA holds — not on the launch calendar.
We flag Prior Notice while the aircraft is still over the water. If the responsible party is missing, we pause. We do not transmit a cosmetic entry that still owes FDA.
01 · The split
Name the use. Then transmit.
Formula
Ingredients on the invoice.
Sunscreen, retinoid, and “treatment” language can pull FDA into a harder posture. We flag it from the description.
Kit
Sets split.
A box with cream and a jade roller is not one heading. We allocate. We do not invent a 3304 suffix to look fast.
Origin
Filler is not the brand.
Where it was filled and whose name is on the carton can differ. The 7501 has to survive that story.
02 · The gate
FDA Prior Notice sits in the vault.
Food, beverage, and most cosmetics that FDA reads as such need Prior Notice before arrival. We will not transmit a 7501 that still owes that number. A launch date is not a filing strategy.
The label claim is evidence. It is not the entry. If the carton says “treats acne,” we pause and ask — we do not guess a heading to keep the truck moving.
03 · The lane
Beauty air is JFK, EWR, and Miami.
European fill often books JFK or EWR. Latin-American and duty-free replenishment uses MIA. The dashboard follows the crate. Status is not a Thursday email.
04 · What we need
Send the invoice. We will say if the file holds.
- Intended use Cosmetic, sunscreen, or something closer to a drug. The label is evidence.
- FDA Prior Notice Confirmation in the vault before arrival. We do not transmit without it.
- Kit contents Each article named. A “set” is not a heading.
- Responsible party US agent / manufacturer facts FDA actually wants.
- Country of origin Where it was filled — not only where the brand sits.
On the same file
The desk around the beauty line.
Classification
Tariff classification
GRI on intended use — not a brand SKU mapped to last year’s 3304.
PGA
Partner government agencies
FDA Prior Notice sits in the vault before transmission.
Entry
3461 / 7501
The entry is built as the invoice is read. A licensed broker still signs.
Questions we actually get
The file before the appointment.
Do all cosmetics need FDA Prior Notice?
Most FDA-regulated cosmetics arriving as food/cosmetic merchandise do. We flag it from the invoice and block ACE until the confirmation is in the vault.
What if the label makes a drug claim?
Then it is not a routine 3304 conversation. We pause. We do not file a cosmetic heading over a treatment claim to look fast.
What belongs on the commercial invoice?
Product name, intended use, kit contents, origin, responsible party. A campaign still is not the proof.
Do you clear beauty at JFK?
JFK and EWR take European fill. MIA takes the south. The licensed file is the same desk.
The desk
Bring one messy beauty invoice.
A consultation returns classification notes, PGA flags, and a flat fee. If the file is not one we can defend, we will say so in the memo.