Personal importation of FDA Regulated Products

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Personal Importation of FDA-Regulated Products

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FDA-Regulated Products in Personal Baggage or Sending by Mail or Courier

If you are entering the United States with FDA-regulated products in personal baggage or sending products by mail or courier from abroad, the FDA has guidance that governs personal importations. Personal importation is a product not for further sale or distribution into U.S. commerce.  These products may be carried in baggage or shipped by courier or international mail.

Personal importation of unapproved drugs

The Personal Importation Policy, also known as the PIP, is guidance that sets forth FDA’s enforcement priorities related to the personal importation of drugs that are not FDA approved and, therefore, are in violation of the Federal Food, Drug, and Cosmetic (FD&C) Act and subject to enforcement action.

FDA recognizes there are circumstances under which a United States citizen may wish to seek treatment with an unapproved drug that is not domestically available, or a foreign citizen traveling to the United States may wish to continue treatment with a foreign drug that is not domestically available.

The PIP was developed to address such circumstances and gives FDA instructions on exercising its enforcement discretion to permit the importation of drugs otherwise considered illegal in the United States.

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What Does FDA Regulate?

In-Depth Coverage: Country of Origin

In determining whether exercise discretion is warranted, FDA considers the following factors:

  • The drug must be unapproved and intended for use in a serious medical condition for which there is no effective treatment domestically available
  • There must be no commercialization or promotion of the drug in the United States
  • The drug cannot represent an unreasonable health risk to the patient
  • The request must be accompanied by an affirmation that the drug is for the patient’s use only and by the name and address of the United States–licensed physician responsible for the patient’s treatment
  • The request is generally for no more than a 3-month supply of the drug

The PIP does not give a license to individuals to import unapproved drugs for personal use into the United States. It does not change the law or create or confer any legally enforceable rights, privileges, or benefits on or for any individual, and it does not bind the FDA or the public.

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In-Depth Coverage: Importing Medical Device 

FDA’s Administrative Authority to Destroy Refused Drugs Coming into the United States through the International Mail. 

The FDA has the authority to destroy a refused drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) without providing the owner or consignee with the opportunity to export the drug.

Most drug products subject to the FDA’s administrative destruction authority come into the United States through international mail.  These mail parcels may include drugs that are adulterated, misbranded, or unapproved, and may also contain counterfeit drugs and tainted drug products that purport to be dietary supplements.  All of these violative drugs can pose a serious public health threat to consumers in the United States.

This authority will not impact the availability of FDA-approved drugs or drug products legally marketed in the United States.

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In-Depth Coverage: Food Import Requirements

Can FDA-regulated food products be imported for personal use?

Yes, you can import food for personal use but prior notice may be required. As stated in 21 CFR 1.277(b), prior notice is not required for:

a. Food for an individual’s personal use (i.e., for consumption by the individual, family, or friends, and not for sale or other distribution) when it is carried by or otherwise accompanies the individual when arriving in the U.S.; and

b. Food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the U.S.

c. Food that is carried by or otherwise accompanies an individual when arriving in the U.S. (e.g., is in his or her carry-on or checked baggage) when the food is for that individual’s personal use (21 CFR 1.277(b)(1)). Personal use means that the food is for consumption by the individual, the individual’s pet(s), or by the individual’s family and friends and is not for sale or other distribution.

FDA considers personal use to include food that is for consumption by the individual’s personally owned pets or other companion animals and that is not for sale or other distribution.

However, prior notice is required for food that is imported or offered for import into the U.S. for use, storage, or distribution in the U.S. Prior notice is not required for food that is carried by or otherwise accompanies an individual entering the U.S. (e.g., is in his or her automobile) when the food is for that individual’s personal use (21 CFR 1.277(b)(1)).

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Example 1

You plan to drive back to the U.S. from Canada with a trunk full of food you purchased there to serve at a family picnic. Is prior notice required?

No. Prior notice is not required for food that is carried by or otherwise accompanies an individual when arriving in the U.S. (e.g., is in his or her automobile) when the food is for that individual’s personal use. Personal use means that the food is for consumption by the individual, individual’s pet(s), or by the individual’s family and friends and is not for sale or

Example 2

You plan to drive back to the U.S. from Mexico with my trunk full of shellfish that you plan to sell at a flea market on the U.S. side of the border. Is prior notice required?

Yes. Prior notice is required for food that is imported or offered for import into the U.S. for use, storage, or distribution in the U.S. Prior notice is not required for food that is carried by or otherwise accompanies an individual entering the U.S. (e.g., is in his or her automobile) when the food is for that individual’s personal use. Here, the shellfish are to be sold and are not for personal use.

In-Depth Coverage: Marketing and Advertising Compliance

Example 3

You plan to drive back to the U.S. from Canada with a trunk full of samples of finished packaged foods for testing. Is prior notice required?

Yes. Prior notice is required for food that is imported or offered for import into the U.S. for use, storage, or distribution in the U.S. Prior notice is not required for food that is carried by or otherwise accompanies an individual entering the U.S. (e.g., is in his or her automobile) when the food is for that individual’s personal use. Here, the samples of finished packaged food are to be used for testing and not for personal use

Example 4

You have ordered food for your personal use that is being shipped to you through international mail. Is prior notice required?

Yes. Prior notice must be provided. The exception for food for “personal use” applies only when the food is carried by or otherwise accompanies an individual when arriving in the U.S. This exception does not apply when the food is shipped to the U.S. Although you or any other person with knowledge of the required information may submit prior notice, it would make sense for the foreign shipper to provide prior notice because the prior notice (PN) Confirmation Number, which indicates that FDA has received and confirmed the prior notice for review, must accompany an article of food that is sent to the U.S. via international mail.

Example 5

You own a dairy farm in the U.S. and plan to go to Canada to buy a tractor trailer load of hay and bring the hay back to feed my cows. Is prior notice required for this hay?

Yes, prior notice is required because the personal use exemption would not apply in this situation. Prior notice is not required for food that is carried by or otherwise accompanies an individual entering when arriving in the U.S. (e.g., is in his or her automobile) when the food is for that individual’s personal use. Personal use means that the food is for consumption by the individual or by the individual’s family and friends and is not for sale or other distribution.

Here, the food is for livestock use – feeding the hay to your dairy cows whose milk is sold to others – rather than for personal use.

For further information please refer to Prior Notice of Imported Food Questions and Answers

When would the FDA refuse a personal importation?

  • Product is on an FDA import alert for previous violations.
  • Shipment appears to be intended for commercial distribution.
  • Product appears to present a serious risk to health.
  • FDA-regulated article that appears to represent a health fraud.
  • Food imported with inadequate prior notice.

For more information regarding the personal importation of FDA-regulated products, please refer to FDA website.

In-Depth Coverage: USDA-Regulated Products

Personal Food Importation Regulated by USDA

Other government agencies, such as the U.S. Department of Agriculture (USDA), have specific requirements for the importation of some types of food.  Federal inspection regulations permit the entry of small amounts of meat, poultry or egg products for personal consumption. The amount of a personal consumption shipment cannot exceed 50 pounds for meat, poultry, or dried egg products and 30 pounds for liquid or frozen egg products. The products must be for personal use only and cannot be sold or distributed in U.S. commerce.

Such products are exempt from the Food Safety and Inspection Service (FSIS) import regulation, but they are subject to the Animal and Plant Health Inspection Service (APHIS) animal health requirements. These requirements change frequently, and travelers should contact APHIS for up-to-date information by visiting the website or calling (301) 851-3300.

All travelers entering the United States are required to declare any products of animal origin (including soup or soup products) they may be carrying. The declaration must cover all items carried in checked baggage, carry-on luggage, or in a vehicle. U.S. Customs and Border Protection (CBP) agriculture specialists at the ports of entry will examine the items and determine if they meet the entry requirements of the United States. Additional information on bringing agricultural products into the United States is available from CBP.

For further information please refer to USDA website related to Importing Goods:

Importing Products: FSIS is responsible for assuring that U.S. imported meat, poultry and processed egg products are safe, wholesome, unadulterated, and properly labeled and packaged.

Permits and Certifications: APHIS issues permits for the import, transit and release of regulated animals, animal products, veterinary biologics, plants, plant products, pests, organisms, soil, and genetically engineered organisms.

Importing FDA-Regulated Products: The Import Process

Design your own logistics

To move your cargo from its current location through customs to its final destination we will partner with you to find the best way for your business.

FDA-Regulated Products and Import Requirements

Guidance on customs & logistics solution for traditional and e-commerce importers and exporters

Ocean Cargo

Importer Security Filing (ISF)

An ISF is required when cargo (ocean only) laden on vessel at a foreign port is destined for shipment into the U.S.  Under ISF rule, some details regarding cargo must be transmitted to the CBP at least 24 hours before goods are loaded onto the vessel.

Freight forwarding

Freight Forwarding

Looking for a freight forwarding partner?  To move your cargo from its current location through customs to its final destination we will partner with you to find the best way for your business. Whatever your transportation, logistics or customs clearance needs, we will do our best to customize a solution for your needs. 

Customs Brokerage & Consulting

Customs Clearance

The goods imported into the U.S. are required to be declared to CBP. Our customs broker will help you stay in compliance with customs laws and regulations and clear your goods quickly and efficiently with our electronic Automated Commercial Environment (ACE) and Automated Broker Interface (ABI) Single Window System

Warehousing & Logistics

Warehousing & Distribution

Our warehouse facility offers great potential for serving as a regional hub with over 145,000 SF storage capacity close to Los Angeles Airport & Los Angeles/Long Beach Sea port. With our extensive experience in freight services, your import/export cargo will be handled quickly and effectively.

Country of Origin

Non-resident Importer Program

If you want to sell your products in U.S. marketplaces, but you are a business owner located outside of the U.S. and do not have an entity or presence in the U.S., you need to be established as a Foreign Importer of Record before your products can be imported into the U.S. We can help you.

Customs Binding Ruling

Taking steps to ensure compliance is very important in order to avoid potential problems during the clearance process. The Customs binding ruling program enables importers to receive a binding ruling from CBP on the treatment of your goods when entering the U.S. 

Section 321 Entry

Section 321 Entry

Section 321 entry allows importing free of duty and tax for shipments imported by one person on one day having a fair retail value in the country of shipment not more than $800. We provide our resident and non-resident clients with dedicated ACE eManifest solutions for Section 321 entry of all modes of transportation. 

E-Commerce

E-Commerce

The Internet has made it easy to find and purchase items from almost anywhere in the world. Our e-commerce experts will help you find the right solution for your international transportation, customs clearance, and delivery to your final destination.  We also provide value-added repackaging, warehousing and distribution services. 

Customs Clearance and Import Requirements