Top FDA Shipping Questions (ShipByMail)

International customers often ask how FDA regulations affect shipments forwarded through ShipByMail. This guide explains what the FDA regulates, what items are restricted, and how our service helps ensure accurate customs paperwork and compliance when exporting goods from the USA.

1. What FDA-regulated items can ShipByMail export?

ShipByMail can export many everyday goods, but certain FDA-regulated products—such as food, dietary supplements, cosmetics, and over-the-counter medicines—may have restrictions. Items requiring FDA pre-approval, including prescription drugs and some medical devices, generally cannot be shipped.

2. Why does the FDA restrict some shipments?

The FDA protects consumer health by regulating product safety, labeling, and ingredients. Items flagged as unsafe, mislabeled, or requiring specialized documentation cannot be exported until they meet FDA requirements.

3. What happens if my package contains an FDA-restricted item?

If ShipByMail identifies an FDA-restricted product, customers are notified immediately. You may store the item for free, wait until restrictions are lifted, or request a return label to send it back to the merchant.

4. Does ShipByMail handle FDA paperwork for me?

ShipByMail completes all export customs forms using the item description, value, and invoice you upload in your dashboard. You simply provide accurate details; we prepare the required customs documentation for shipment.

5. Are vitamins and dietary supplements allowed?

Most supplements can be shipped internationally, but regulations vary by destination country. Some supplements containing restricted ingredients may be held for FDA review or blocked from export.

6. Can cosmetics be shipped through ShipByMail?

Yes, most cosmetics can be shipped. However, products containing prohibited ingredients, misbranded labels, or medicated components may face FDA restrictions and delays.

7. Are over-the-counter medicines allowed?

Non-prescription medicines are usually eligible for export, but quantities, packaging, and labeling must meet FDA rules. Prescription medications cannot be shipped under any circumstances.

8. Why do FDA checks cause delays?

FDA holds typically occur when an item appears misclassified, mislabeled, or requires additional documentation. Clearance can take a couple of weeks depending on the item type and workload.

9. How does ShipByMail help avoid FDA delays?

By requiring accurate item descriptions, invoices, and categories before shipment, ShipByMail reduces the risk of customs holds. We submit an FDA Prior Notice, this allows customs to process the parcel and identify the item. Our team also reviews flagged items and notifies customers if further action is needed.

10. Where can I check if a product is FDA-regulated?

Customers can reference the FDA product categories on FDA.gov or contact ShipByMail support for guidance on whether a specific product can be exported.

11. Do FDA restrictions apply even if the item is a gift?

Yes. FDA regulations apply to all exported goods—personal purchases, gifts, and commercial shipments alike. Gift status does not override safety, labeling, or compliance rules.

12. Does ShipByMail charge extra for FDA-flagged shipments?

No. Storage is free while you wait for clearance or decide how to proceed. If the item must be returned, you only pay the return shipping label cost charged by the merchant or carrier.