Use
Food is not a drug.
Structure/function versus disease. The carton is evidence. We read it before ACE.
Health Supplements & Wellness
The claim is the hold.
Prior Notice, labeling, and the difference between a food and a drug claim. We flag it from the commercial invoice before the crate is on the floor. A licensed broker still signs the 7501.
Book a consultation Free Entry AuditEWR, JFK, and MIA on one file. DSHEA is not a heading.
A wellness invoice that reads as one SKU is often two facts on a 7501. The article. The claim. Houses that file a single 2106 dump pay for it in FDA holds — not on the subscription calendar.
We flag Prior Notice while the aircraft is still over the water. If the label treats a disease, we pause. We do not file a dietary heading over a drug claim to look fast.
01 · The split
Read the label. Then transmit.
Form
Capsule, powder, liquid.
The heading can follow the form. A “system” with a device in the box is a kit — we split.
Ingredients
Named on the invoice.
Novel ingredients and animal products can pull extra PGA. Unnamed “proprietary blend” is a pause.
Origin
Fill is not the brand.
Where it was manufactured and whose name is on the label can differ. The 7501 has to survive that story.
02 · The gate
FDA Prior Notice sits in the vault.
Dietary supplements arriving as food need Prior Notice before arrival. We will not transmit a 7501 that still owes that confirmation. A subscribe-and-save date is not a filing strategy.
A disease claim is a different file. We pause and ask. We do not guess a heading to keep the truck moving.
03 · The lane
EWR, JFK, and Miami for the wellness air.
European fill books EWR or JFK. Latin-American programs use 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 Dietary supplement versus drug. The label is evidence.
- FDA Prior Notice Confirmation in the vault before arrival.
- Form and ingredients Capsule, powder, liquid. Named ingredients — not only a brand blend.
- Kit contents Device, shaker, or booklet in the carton if they split.
- Country of origin Where it was made — not only where the brand sits.
On the same file
The desk around the wellness line.
Classification
Tariff classification
GRI on intended use and form — not a SKU mapped to last year’s 2106.
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 supplements need FDA Prior Notice?
As food, yes. We flag it from the invoice and block ACE until the confirmation is in the vault.
What if the label claims to treat a disease?
Then it is not a routine dietary entry. We pause. We do not file 2106 over a drug claim to look fast.
What belongs on the commercial invoice?
Product name, form, ingredients, intended use, origin. A landing-page screenshot is not the proof.
Do you clear supplements at EWR?
EWR and JFK take European fill. MIA takes the south. The licensed file is the same desk.
The desk
Bring one messy supplement 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.