Shipping FDA-regulated products into the US

If you're importing products into the US that are regulated by the Food and Drug Administration (FDA), there are specific requirements you’ll need to meet depending on the type of product. These include registering facilities, submitting prior notice of shipment, and verifying compliance with FDA safety programs.
This article outlines some of the key requirements for importing human foods, food contact items, animal and veterinary products, and cosmetics.

This content is for informational purposes only and doesn’t constitute legal or professional advice. We recommend consulting a licensed customs or legal expert for your specific situation.

Do I need to follow these requirements for all shipments containing FDA regulated products?

Yes. As of July 9, 2025, all shipments containing FDA-regulated products must go through FDA review when entering the US—regardless of their value or country of origin.

Previously, small or “low-value” (de minimis) shipments could bypass FDA review. These exemptions have now been revoked, meaning every shipment must be submitted to the FDA for review. You can find more details about this regulatory change here.

What products are considered human food by the FDA?

Human foods regulated by the FDA including but not limited to the following and typically fall under HTS Chapters: 7-23, 25:

• Food and beverages for human consumption
• Dietary supplements
• Food and color additives

Please note, this list is non-exhaustive and purely indicative.

How do I ship human foods into the US?

To import these products, you’ll need to:

1. Register your facility with the FDA every two years if it manufactures, processes, packs, receives, or holds food. This applies to most foreign manufacturers and some US importers.
2. Submit Prior Notice of Shipment (PN) to the FDA before the shipment arrives in the US.
3. Ensure compliance with the Food Safety Modernization Act (FSMA), which includes meeting requirements under the Foreign Supplier Verification Program (FSVP).

For more details, visit:

• Importing Human Foods: A summary of FDA import requirements for food intended for human consumption, including registration, prior notice, and compliance with food safety laws.
• Registration of Food Facilities: Explains who must register with the FDA, how to register or renew, and what types of facilities are covered.
• Prior Notice of Imported Foods: Provides guidance on how and when to notify the FDA about food shipments before they enter the US.
• FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals: Outlines the responsibilities of importers to verify their foreign food suppliers meet US food safety standards.
• Importing FDA-Regulated Products: Human Foods YouTube: A video overview of FDA rules for importing human food, including registration and FSVP compliance tips.

What products are considered food-contact items by the FDA?

FDA-regulated food-contact products, including but not limited to the following and typically fall under HTS Chapters 39, 69, 70, 82, 83, and 94:

• Cookware and bakeware
• Drinkware and plates
• Cutlery and utensils
• Food storage containers
• Bottle stoppers and food-serving vessels

These items must meet FDA safety standards to ensure that any materials used do not contaminate food during use.

Please note, this list is non-exhaustive and purely indicative.

How do I ship cookware or food-contact products into the US?

To import these products, you’ll need to:

1. Ensure products are safe for food contact and correctly labeled.
2. Verify that any materials used are generally recognized as safe (GRAS).
3. Submit to the FDA’s Food Contact Substance Notification Program if your materials are not already classified as GRAS.

For more details, visit:

• Packaging & Food Contact Substances: Guidance on FDA requirements for products that touch food, including definitions, GRAS criteria, and notification procedures.

What products are considered cosmetics by the FDA?

Cosmetics regulated by the FDA include products intended to cleanse, beautify, promote attractiveness, and alter appearance, excluding pure soap. Common examples include the following and typically fall under HTS Chapters: 33, 3401 and 9616:

• Skincare
• Makeup
• Fragrances
• Hair care items

Please note, this list is non-exhaustive and purely indicative.

How do I ship cosmetics into the US?

To import cosmetics, you’ll need to:

1. Make sure products are safe for use and correctly labeled.
2. Verify that any color additives are FDA-approved for their intended use.

For more information, visit:

• Importing Cosmetics: Explains FDA requirements for importing cosmetic products, including safety standards, labeling rules, and approved color additives.

What products are considered animal or veterinary products by the FDA?

Animal and veterinary products regulated by the FDA include the following and typically fall under HTS Chapters: 23, 30 and 90:

• Animal food and feed (including pet food)
• Animal drugs
• Medicated feed
• Veterinary devices

These products are regulated to ensure safety for both animals and humans who may come into contact with them.

Please note, this list is non-exhaustive and purely indicative, and some of these product types are not permitted on Faire.

How do I ship animal or veterinary products into the US?

To import these products, you’ll need to:

1. Register your facility with the FDA.
   
   1. Facilities handling animal food must register every two years.
   2. Facilities handling veterinary devices must register annually.
      
2. Submit Prior Notice of Shipment to the FDA before the shipment of animal food or feed arrives in the US.
3. Ensure compliance with the Food Safety Modernization Act (FSMA), including the Foreign Supplier Verification Program (FSVP) requirements for animal food products.

For more details, visit:

• Importing Animal and Veterinary Products: Overview of FDA requirements for importing products like pet food, animal feed, animal drugs, and veterinary devices.
• Registration of Food Facilities: Explains who must register with the FDA, how often registration is required, and how to update or renew your facility registration.
• Prior Notice of Imported Foods: Details when and how to notify the FDA about incoming food shipments before they arrive in the US.
• FSMA Final Rule on FSVP: Explains FSVP requirements for importers to verify that their foreign suppliers meet US safety standards.

What other FDA-regulated products should I discuss with a customs broker?

The FDA regulates a wide range of additional product categories. Importing these may require extra licenses, certifications, or documentation. You should consult a licensed customs broker if you're importing:

• Medical devices or diagnostic equipment
• Human-use drugs or biologics
• Radiation-emitting electronics, ex: x-ray devices, lasers, or some cosmetic tools
• Tobacco products or electronic nicotine delivery systems (ENDS)
• Infant formula or medical foods
• Alcohol-based consumer products, ex: mouthwash or hand sanitizer

These products may also require premarket approval or specialized FDA registration. A customs broker can help ensure you're meeting all import requirements and avoid delays. Please note, this list is non-exhaustive and purely indicative, and several of these product types are not permitted on Faire.

What additional resources are available if I want to learn more?

If you’re looking for more details on importing FDA-regulated products, these resources can help:

• FDA Import Program Overview: A general guide to the FDA’s import process and requirements.
• FDA Import Alerts: Lists of products that may be refused entry into the US due to safety or compliance issues.
• Product Code Builder: A tool to help you identify the correct FDA product code for your shipment.