U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. For Industry
  3. Import Program – Food and Drug Administration (FDA)
  4. Import Basics
  5. FDA’s Administrative Destruction Authority
  1. Import Basics

FDA’s Administrative Destruction Authority

Administrative destruction applies to imported drugs and devices through the international mail valued at $2,500 or less (or such higher amount as the S

The Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in 2012, gave FDA the authority to destroy, without providing an opportunity for export, any refused drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that have been refused admission into the United States.  On April 4, 2016, the Food and Drug Administration (FDA) implemented its administrative destruction authority under section 708 of FDASIA.

The Safeguarding Therapeutics Act (STA), enacted in January 2021, expanded FDA’s administrative destruction authority by providing FDA with the authority to destroy certain refused devices valued at $2,500 or less without providing the owner or consignee with the opportunity for export. The FDA Final Rule for Administrative Destruction was published in the Federal Register on May 31, 2024 and became effective on July 1, 2024. 

Violative drug and device products potentially subject to the FDA’s administrative destruction authority are offered for import through the international mail.  These mail parcels may include drugs or devices that are adulterated, misbranded, or unapproved, and may also contain counterfeit drugs or devices and tainted drug products that purport to be dietary supplements.  These illicit drugs or devices may pose a serious public health threat to consumers in the United States. 

FDA has created a list of frequently asked questions related to administrative destruction that you may find useful.

Back to top

What products will administrative destruction apply to?

Administrative destruction applies to imported drugs and devices through the international mail valued at $2,500 or less (or such higher amount as the Secretary of the Treasure may set by regulation) which are refused admission into the United States.  

For more information on human drugs, visit Human Drugs

For more information on importing human drugs and importing requirements, visit Importing Human Drugs. 

For more information on devices and importing requirements, visit Importing Medical Devices.  

For information on the SUPPORT Act Provisions Related to Imports, visit Overview of the SUPPORT Act Provisions Related to Imports

Back to top

Will this authority impact the availability of FDA-approved drugs and devices?

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

Back to top

How does the FDA determine if my drug or device product is in violation of the FDA's laws and regulations?

The FDA uses a number of ways to determine if a drug or device violates the law and is subject to refusal and destruction. For example, if a drug or device’s labeling is not in English, this may indicate that the drug or device has not met the regulatory requirements to be legally marketed in the United States. The lack of an English language label may indicate that the drug or device is misbranded.  The FDA's import personnel may also collect surveillance samples of products for testing. For example, if a drug were to test positive for an active pharmaceutical ingredient (API) that should not be in the product, it would be considered adulterated. The FDA can also identify certain products that are suspected of being counterfeit. 

Back to top

How will I be notified if my drug or device product violates the FDA's laws and regulations and is subject to administrative destruction?

If the FDA determines that your drug or device is subject to any of these regulatory requirements and is or appears to be in violation, the FDA will provide you with a Notice of FDA Action (also known as a notice of detention and hearing) explaining: 

(1) the reason(s) why the drug or device is subject to refusal, 

(2) if refused admission, the fact that the product would be subject to destruction, and  

(3) your opportunity to appear and introduce testimony to the agency prior to refusal or destruction. You will be provided an FDA contact name and means of making a response. 

For more information on Detention and Hearing, visit Detention & Hearing | FDA 

Back to top

How should I respond to a Notice of FDA Action?

You may provide testimony to the agency stating why the product should not be refused or destroyed. Testimony is any information you wish to submit to overcome the appearance of the violation, or to otherwise support the release of your product. Testimony should be provided to the contact that is listed on the Notice of FDA Action, usually a compliance officer. Responses, or testimony, to Notices of FDA Actions can vary and include telephone conversations, emails, faxes, hard copy evidence or more formal communications, during which you may introduce testimony for consideration by the agency. The FDA will consider the testimony you present and make a final decision on the admissibility. 

If you contest the destruction of the drug or device by providing testimony at a hearing, FDA will make a determination that the drug or device is in violation of the law before destruction. If you do not request a hearing or provide testimony, the drug or device will be processed for destruction. 

Back to top

What is a hearing?

A hearing is an opportunity to present evidence, or testimony, to overcome the appearance of a violation and to give FDA confidence that the product is compliant. The hearing will vary from a series of email or telephone conversations to a more formal meeting.  The hearing officer is generally the FDA compliance officer listed on the Notice of FDA Action (known as a notice of detention and hearing). 

Back to top

What happens after I respond to the initial Notice of FDA Action?

After your imported drugs or devices have been detained by the FDA at an international mail facility and you have been given the opportunity to respond and present evidence, the FDA will issue another Notice of FDA Action. 

If after reviewing all of the evidence, the FDA determines that your products are in violation of the FDA's laws and regulations, they will be refused admission. The FDA will issue a Notice of FDA Action indicating the products have been refused (known as a notice of refusal). The notice of refusal will indicate to you in writing the reason(s) why your drug or device has been refused and is subject to administrative destruction. The notice of refusal will also indicate whether the drug or device will be destroyed or returned to sender. At this point, no further action will be required on your part. 

If after reviewing all of the evidence, the FDA determines that your product(s) are not in violation of the FDA's laws and regulations, they will be forwarded to you. The FDA will issue a Notice of FDA Action indicating the products have been released. 

Back to top

Will I be charged for storage and destruction costs if my imported drugs or devices are detained and destroyed?

FDASIA section 708 and STA provides that the owner or consignee is responsible for the costs of storage and disposal of the drug or device.  At this time, the FDA generally does not intend to pursue recovery of storage and destruction costs against individual consumers who seek to import a drug or device for their own personal use that is then refused and destroyed.

Back to top

What if the value of the imported drugs or devices refused is greater than $2,500? 

Drugs or devices with a value greater than $2,500 are generally not to be processed through an international mail facility because they are considered by U.S. Customs and Border Protection (CBP) to be formal entries and are subject to different entry procedures, which include payment of a bond.

Back to top

What is Personal Importation?  Can you explain what this means in light of administrative destruction?

The FDA’s mission is to ensure that drugs and devices are safe and effective. In carrying out this responsibility, the FDA works to make drugs and devices accessible, and help doctors and patients use them as effectively as possible.   

Any version of a drug or device that has not been approved by the FDA is considered an “unapproved,” and it is illegal for consumers to import unapproved drugs or devices into the U.S.  Drugs or devices from foreign sources that are not FDA-approved do not have the same assurance of safety, effectiveness, and quality as drugs or devices subject to FDA oversight.  In many cases, drugs have been found to be contaminated, counterfeit, contain varying amounts of active ingredients or none at all, or contain different ingredients altogether. Devices have been found to be counterfeit as well.  

If your product is labeled or used in a manner that meets the definition of a device, it will be regulated as a device per FDA’s laws and regulations. For information on device requirements and what is verified at the time of importation please visit: Importing Medical Devices | FDA. 

However, the FDA does consider an individual’s importation of an unapproved drug or a device for personal use, also known as Personal Importation. A patient interested in importing an unapproved drug or an unapproved device not legally marketed in the U.S. for personal use must satisfy all of the following elements:  

  • The drug or device is for use for a serious condition for which effective treatment is not available in the U.S.; 
  • There is no commercialization or promotion of the drug or device to U.S. residents; 
  • The drug or device is considered not to represent an unreasonable risk; 
  • The individual importing the drug or device verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and 
  • Generally, not more than a three-month supply of the drug or device is imported. 

The FDA’s administrative destruction authority does not change the FDA’s current position with respect to personal importation of drugs or devices. 

To learn more about personal importation, please visit the following pages:  

Back to top

What is an International Mail Facility?

Mail entering the United States from abroad first arrives at a U.S. Postal Service (USPS) sorting facility. The USPS then sends packages to U.S. Customs and Border Protection (CBP) for examination. CBP will refer FDA-regulated products to the FDA for review. 

Additional Information regarding the FDA’s administrative destruction authority can be found at: 

Back to top

Back to Top