What Prior Notice is, and who it applies to
Prior Notice is advance notification to FDA of an incoming food shipment, required under 21 CFR Part 1, Subpart I. Because dietary supplements are food under the FD&C Act, they're subject to this requirement the same as any other imported food. A product FDA has classified as an unapproved new drug — because of disease claims or rasa shastra-tradition metal ingredients — is not food, and Prior Notice simply doesn't apply to it; it's screened under an entirely different framework at entry.
Timing requirements
| Mode of arrival | Minimum notice before arrival |
|---|---|
| By water | 8 hours |
| By air or rail | 4 hours |
| By road | 2 hours |
The clock starts when FDA confirms your submission for review — not when you hit submit. Build in buffer time, especially near holidays or high-volume shipping windows.
What has to match — and what gets extra scrutiny
- Facility registration number — must match the manufacturing or packing facility's active registration
- FDA product code — must correctly identify the supplement category
- Firm name against import alert listings — a shipping firm listed on an active drug import alert (such as 66-41 or 99-42, covering Ayurvedic products with documented heavy metal findings) faces automatic detention regardless of what's filed on the Prior Notice
- Ingredient declaration against NDI notification — inconsistencies here can trigger a closer look, separate from any food-safety screening
Filing Prior Notice doesn't rescue a misclassified product
An accurate, timely Prior Notice filing addresses the food-import side of compliance. It does nothing for a product FDA would classify as an unapproved drug based on its claims or ingredients — that product needs to clear drug import screening, and a food Prior Notice filing is the wrong tool entirely. Get the classification question settled before Prior Notice mechanics become the priority — see our compliance path overview for that distinction.
Frequently asked
Does Prior Notice apply to dietary supplements?
Yes — as food under the FD&C Act, dietary supplements follow the same Prior Notice requirement and timing as any other imported food.
Does Prior Notice apply to Ayurvedic products classified as unapproved drugs?
No — those products aren't food, so they're screened under drug import procedures instead, which can include automatic detention under an active import alert.