Priority Trade Issue: Import Safety

Import safety is a Priority Trade Issue for CBP. It’s a comprehensive, multi-faceted approach by CBP and its Partner Government Agencies (PGA) to safeguard the U.S. public and the economy from the dangers posed by unsafe imported goods.

Goods sent or received through the international postal network (international mail) are subject to the same rigorous standards and requirements as those imported via other methods.

To determine if merchandise you are purchasing from overseas is subject to import safety regulations, you should assume that most products imported into the United States are subject to some form of U.S. federal regulation, even if they are manufactured elsewhere. The key is to identify which specific U.S. government agency or agencies have jurisdiction over that particular product type.

Here's how you can generally figure this out:

1. Identify the Product Type and Intended Use:
   • What is the item? (e.g., toy, food, cosmetic, electronic device, medical device, car part, chemical).
   • What is its intended use? (e.g., for children, for consumption, for medical purposes, for industrial use).
2. Determine the Relevant U.S. Regulatory Agency: Different U.S. government agencies are responsible for regulating different categories of imported goods. Knowing the product type will help you identify the primary agency.

In most circumstances, it is illegal for individuals to import pharmaceuticals or devices into the United States for personal use if those products have not been approved by the FDA for use and sale in the U.S. The FDA cannot guarantee the safety, quality, or effectiveness of medications manufactured abroad that have not undergone its rigorous testing and approval processes.

Yes, the FDA has Personal Importation enforcement discretion that allows for limited exceptions under specific conditions. This is an enforcement guideline and decisions are made on a case-by-case basis.

For personal shipments of medication to be potentially allowed. Please see FDA’s Personal Importation page as well as the FDA’s Regulatory Procedures Manual (RPM), Chapter 9-2: Coverage of Personal Importations.

FDA requirements regarding importing tobacco products can be found at Importing Tobacco Products | FDA

FDA requirements regarding importing medical device products can be found at Importing Medical Devices | FDA

For biological product import requirements: Importing Biologics and CBER Regulated Products

For importing biological specimens for clinical laboratory or basic scientific research: Importing biological specimens for clinical laboratory or for basic scientific research

Information can be found at Importing FDA Regulated Products | FDA

Prior Notice is required; however, FDA has an enforcement discretion policy for food imported for non-commercial purposes with a non-commercial shipper. Guidance can be found at Prior Notice Policy for Sending Gifts to Your Friends and Family | FDA

Guidance can be found at eFiling – CPSC’s Modern Approach for Filing Certificate Data | CPSC.gov

CPSC does not require the eFiling certificate for noncommercial products sent from one consumer to another consumer in the United States.

CPSC does require the eFiling certificate for commercial products bought online and shipped from the retailer to a consumer in the United States.

Products that are one of a kind and are not intended for retail sale by the sender do not require the eFiling certificate. Further information can be found at eFiling – CPSC’s Modern Approach for Filing Certificate Data | CPSC.gov

NHTSA is responsible for setting and enforcing Federal Motor Vehicle Safety Standards (FMVSS) for a wide range of motor vehicle equipment and parts. Their primary goal is to ensure these items meet U.S. safety standards.

Most importations regulated by NHTSA require the filing of form DOT HS-7. However, other importations require additional forms to be filed, such as a vehicle, which is also subject to EPA requirements. Further information can be found at the following links:

• Importation and Certification FAQs
• Requirements for importing a personal vehicle / vehicle parts

NHTSA regulates various motor vehicle equipment and parts.

When importing regulated motor vehicle equipment, the individual (importer) must file a DOT HS-7 Declaration form with U.S. Customs and Border Protection (CBP) at the time of entry. This form declares the lawful basis for the item's admission into the U.S. Further information can be found at Importation and Certification FAQs | NHTSA

Before importing certain seafood into the U.S., importers must meet several National Oceanic and Atmospheric Administration (NOAA) requirements to ensure the seafood is legal and sustainable. Importers must show the seafood was legally caught, provide import and catch records, and follow rules for certain species like tuna, swordfish, and Patagonian toothfish. Additionally, importers must comply with NOAA’s Regulatory Trade Monitoring Programs. Further information can be found at Seafood Commerce and Trade.

The FWS defines “Fish and Wildlife” in 50 CFR 10.12 as any wild animal, whether alive or dead, including without limitation any wild mammal, bird, reptile, amphibian, fish, mollusk, crustacean, arthropod, coelenterate, or other invertebrate, whether or not bred, hatched, or born in captivity, and including any part, product, egg, or offspring thereof.

This would include items such as art made with wildlife parts, medicinal/ bioscience items derived from wildlife, food products containing wildlife and much more. Items fitting the above definition are subject to U.S. Fish and Wildlife Service Import and Export Requirements.

There are a few notable exceptions to the definition such as captive-bred domesticated animals such as cattle, lab mice, chickens, and others as outlined 50 CFR 14.4 which are exempt from FWS Import/ Export Regulations.

All fish and wildlife being imported into or exported from the U.S. must be declared to the FWS via the Declaration form (3-177). Importers or exporters may complete this form electronically via the edecs website: eDecs. Alternatively, brokers filing formal entries for shipments in ACE may submit a FWS message set with their entry transmission.

Commercial entities are required to obtain a FWS Import/Export (I/E) License in order to ship wildlife for commercial purposes. This license may be obtained online at USFWS eLicense.

For shipments containing live or perishable wildlife, you must notify the Wildlife Inspection Office at the port at least 48 hours before the estimated arrival time of the shipment.

Further information about importing and exporting wildlife can be found on the FWS website's Information for Importers & Exporters page.

Shipments containing wildlife must enter or exit the United States through a Designated FWS wildlife port as outlined in 50 CFR 14.12. If an alternative port is needed, FWS may issue a Designated Port Exception Permit (DPEP) under certain circumstances for scientific research, to minimize deterioration or loss, or alleviate undue economic hardship.

Those wishing to obtain a DPEP can mail an application to a FWS permit office via the form 3-200-2 or can submit an electronic DPEP application through their eDecs filer account at eDecs.

Further information can be found at online on the FWS webpage for Information for Importers & Exporters.

Certain species may have special protection under laws and treaties such as the Endangered Species Act (ESA), Migratory Bird Treaty Act (MBTA), or international treaties including the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). Species covered by these regulations may require special permits for international trade.

Information on permits and the applications for these protected species permits can be found on the FWS ePermits website at: U.S. Fish & Wildlife Service ePermits.

Further information can be found on the FWS Guidance document for CITES Document Requirements

The requirements for importing agricultural products into the United States are regulated by the U.S. Department of Agriculture (USDA). CBP Agriculture Specialists inspect shipments to ensure compliance with USDA requirements and prevent prohibited items from entering the country.

Key requirements include:

• Permits: Many agricultural products require an import permit from USDA.
• Inspection: Products may be subject to inspection at the port of entry.
• Documentation: Proper documentation, such as certificates of origin and phytosanitary certificates, may be required.
• Restrictions: Certain products may be restricted or prohibited based on risk assessments.
• Compliance: Importers must comply with USDA regulations specific to the product type.

Further information can be found at Protecting Agriculture.