Regulatory Procedures Manual

Chapter 9: IMPORT OPERATIONS AND ACTIONS

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This chapter includes the following sections:

Section Topic Page

9-1 IMPORT PROCEDURES ...................................................................................... 6

9-1-1 SCOPE AND PURPOSE ................................................................................ 6

9-1-2 DIVISION OF AUTHORITY ............................................................................ 7

9-1-3 ENTRIES ........................................................................................................ 8

9-1-4 SAMPLING ................................................................................................... 12

9-1-5 PROCEDURES WHEN VIOLATION IS FOUND FOR PRODUCTS THAT

ARE NOT SUBJECT TO ADMINISTRATIVE DESTRUCTION.................................. 15

9-1-6 PAYMENT OF COSTS OF SUPERVISION OF RELABELING AND/OR

OTHER ACTION........................................................................................................ 19

9-1-7 EXPORTATION OF MERCHANDISE REFUSED ADMISSION.................... 20

9-1-8 BOND ACTION............................................................................................. 20

9-2 COVERAGE OF PERSONAL IMPORTATIONS ................................................. 21

9-2-1 PURPOSE .................................................................................................... 21

9-2-2 BACKGROUND ............................................................................................ 21

9-2-3 PERSONAL BAGGAGE ............................................................................... 22

9-2-4 MAIL SHIPMENTS........................................................................................ 22

9-2-5 GENERAL INSTRUCTIONS......................................................................... 23

9-3 “NOTICE OF FDA ACTION – DETAINED” FOR MAIL SHIPMENTS.................. 25

9-3-1 PURPOSE .................................................................................................... 25

9-3-2 BACKGROUND ............................................................................................ 25

9-4 NOTICE OF REFUSAL OF ADMISSION AND ADMINISTRATIVE

DESTRUCTION FOR MAIL SHIPMENTS OF DRUGS................................................. 29

9-4-1 PURPOSE .................................................................................................... 29

9-4-2 BACKGROUND ............................................................................................ 29

9-4-3 ISSUANCE OF NOTICES............................................................................. 29
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9-5 IMPORTATION OF BIOLOGICAL PRODUCTS.................................................. 31

9-6 FDA NATIONAL IMPORT PROCEDURE REGARDING WAREHOUSE ENTRIES

31

9-6-1 PURPOSE .................................................................................................... 31

9-6-2 BACKGROUND ............................................................................................ 31

9-6-3 INSTRUCTIONS........................................................................................... 32

9-7 RELEASE NOTICES........................................................................................... 32

9-7-1 PURPOSE .................................................................................................... 32

9-7-2 BACKGROUND ............................................................................................ 32

9-7-3 GENERAL COMMENTS............................................................................... 32

9-7-4 "STRAIGHT" RELEASE................................................................................ 33

9-7-5 RELEASE WITHOUT EXAMINATION.......................................................... 33

9-7-6 RELEASE WITH COMMENT........................................................................ 33

9-7-7 RELEASE AFTER DETENTION................................................................... 35

9-8 DETENTION WITHOUT PHYSICAL EXAMINATION (DWPE)............................ 35

9-8-1 PURPOSE .................................................................................................... 35

9-8-2 AUTHORITY AND BACKGROUND.............................................................. 35

9-8-3 GENERAL PROCEDURES .......................................................................... 36

9-8-4 RECOMMENDATIONS INVOLVING PESTICIDE RESIDUES..................... 37

9-8-5 DIRECT REFERENCE AUTHORITY RECOMMENDATIONS...................... 37

9-8-6 RECOMMENDATIONS BASED ON EIRs, OTHER GOVERNMENT

AGENCIES, MOUs, ETC. .......................................................................................... 37

9-8-7 DETENTION WITHOUT PHYSICAL EXAMINATION RECOMMENDATIONS .

...................................................................................................................... 38

9-8-8 RECOMMENDATIONS BASED ON ONE VIOLATIVE SAMPLE.................. 38

9-8-9 RECOMMENDATIONS BASED ON INFORMATION AND HISTORICAL

DATA ...................................................................................................................... 39

9-8-10 RECOMMENDATION BASED ON MULTIPLE SAMPLES........................ 40

9-8-11 DETENTION WITHOUT PHYSICAL EXAMINATION OF IMPORTERS

ENTRIES .................................................................................................................. 41

9-8-12 RECOMMENDATIONS BASED ON ESTABLISHMENT INSPECTION .... 42

9-8-13 OTHER SITUATIONS................................................................................ 42
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9-8-14 PARTY NOTIFICATION OF DETENTION WITHOUT PHYSICAL

EXAMINATION DECISION........................................................................................ 42

9-8-15 REMOVAL FROM DETENTION WITHOUT PHYSICAL EXAMINATION.. 43

9-8-16 REMOVAL OF PRODUCTS MANUFACTURERS/COUNTRIES EXCEPT

FRESH PRODUCE.................................................................................................... 45

9-8-17 REMOVAL OF FRESH PRODUCE........................................................... 46

9-8-18 REMOVAL OF IMPORTERS..................................................................... 47

9-8-19 REMOVAL BASED UPON AN ESTABLISHMENT INSPECTION............. 47

9-8-20 NOTIFICATION OF REMOVAL FROM DETENTION WITHOUT PHYSICAL

EXAMINATION .......................................................................................................... 48

9-9 NOTICE OF FDA ACTION - DETAINED FOR NON-MAIL SHIPMENTS ............ 48

9-9-1 PURPOSE .................................................................................................... 48

9-9-2 BACKGROUND ............................................................................................ 48

9-9-3 EVIDENCE, ISSUANCE OF NOTICE, AND PREPARATION OF CHARGES..

...................................................................................................................... 49

9-9-4 CUSTODY OF DETAINED SHIPMENTS ..................................................... 50

9-9-5 DETENTION OF VIOLATIVE PRODUCTS THAT ARE NOT PROPERLY

IDENTIFIED FOR FURTHER PROCESSING AND EXPORTATION UNDER

801(D)(3).................................................................................................................... 50

9-10 RESPONSE (HEARING) TO NOTICE OF FDA ACTION - DETAINED ........... 51

9-10-1 PURPOSE................................................................................................. 51

9-10-2 BACKGROUND......................................................................................... 51

9-10-3 ELIGIBILITY OF RESPONDENTS ............................................................ 52

9-10-4 HEARINGS AND POSTPONEMENTS...................................................... 53

9-10-5 CONDUCT OF HEARING: PERSONAL APPEARANCE OF

RESPONDENT.......................................................................................................... 53

9-10-6 CONDUCT OF HEARING: WRITTEN REPLY (MAIL, FAX, ETC.) FROM

RESPONDENT.......................................................................................................... 54

9-11 NOTICE OF FDA ACTION - REFUSAL OF ADMISSION ................................ 55

9-11-1 PURPOSE................................................................................................. 55

9-11-2 BACKGROUND......................................................................................... 55

9-11-3 INSTRUCTIONS........................................................................................ 55

9-12 RECONDITIONING.......................................................................................... 58
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9-12-1 PURPOSE................................................................................................. 58

9-12-2 BACKGROUND......................................................................................... 58

9-12-3 WHO MAY FILE AN APPLICATION.......................................................... 58

9-12-4 MECHANICS IN PROCESSING APPLICATION ....................................... 58

9-12-5 AMENDED APPLICATIONS...................................................................... 60

9-12-6 REQUESTS FOR ADDITIONAL TIME TO COMPLETE RECONDITIONING

.................................................................................................................. 60

9-12-7 UNSUCCESSFUL RECONDITIONING OF ADULTERATED ARTICLES . 61

9-12-8 DISPOSITION OF LOTS NOT RECONDITIONED TO THE FDA’S

SATISFACTION......................................................................................................... 61

9-12-9 RECONDITIONING OPERATIONS........................................................... 61

9-13 SUPERVISORY CHARGES............................................................................. 63

9-13-1 PURPOSE................................................................................................. 63

9-13-2 BACKGROUND......................................................................................... 63

9-13-3 SUPERVISORY CHARGES...................................................................... 64

9-13-4 PREPARATION AND SUBMISSION OF CHARGE SHEET...................... 66

9-13-5 PAYMENT OF SUPERVISORY CHARGES.............................................. 67

9-14 BOND ACTIONS.............................................................................................. 67

9-14-1 PURPOSE................................................................................................. 67

9-14-2 BACKGROUND......................................................................................... 67

9-14-3 BOND VIOLATION .................................................................................... 68

9-14-4 BOND ACTION PROCEDURES ............................................................... 69

9-14-5 RESPONSIBILITY UNDER THE BOND.................................................... 70

9-14-6 PENALTY RECOMMENDATION .............................................................. 70

9-14-7 MITIGATION INSTRUCTIONS.................................................................. 71

9-14-8 TRACKING OF PENALTY ACTIONS........................................................ 72

9-15 IMPORT INFORMATION DIRECTIVES........................................................... 72

9-15-1 PURPOSE................................................................................................. 72

9-15-2 BACKGROUND......................................................................................... 72

9-15-3 APPROACH .............................................................................................. 73

9-15-4 IMPORT ALERTS...................................................................................... 73
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9-15-5 IMPORT BULLETINS (IB) ......................................................................... 75

9-16 PRIORITY ENFORCEMENT STRATEGY FOR PROBLEM IMPORTERS...... 75

9-16-1 PURPOSE................................................................................................. 75

9-16-2 BACKGROUND......................................................................................... 76

9-16-3 APPROACH .............................................................................................. 77

9-17 IMPORT FOR EXPORT................................................................................... 83

9-17-1 PURPOSE................................................................................................. 83

9-17-2 BACKGROUND......................................................................................... 84

9-17-3 INSTRUCTIONS........................................................................................ 85

9-17-4 TIME FRAME FOR HOLDING IMPORTED PRODUCT ............................ 89

9-17-5 IMPORTED FOR FURTHER PROCESSING ............................................ 89

9-17-6 PRODUCTS SUBJECT TO DETENTION WITHOUT PHYSICAL

EXAMINATION .......................................................................................................... 89

9-17-7 COMPLIANCE WITH RELEVANT EXPORT PROVISIONS...................... 90

9-17-8 IMPORTATION OF FINISHED GOODS FOR STORAGE AND EXPORT

WITHOUT FURTHER PROCESSING AND OTHER ARTICLES NOT INCLUDED

UNDER SECTION 801(d)(3)...................................................................................... 90

9-17-9 IMPORTATION OF VIOLATIVE COMPONENTS FOR FURTHER

PROCESSING INTO OTHER COMPONENTS AND UNFINISHED PRODUCTS..... 90

9-17-10 IMPORT FOR EXPORT PROVISIONS FOR PRODUCTS

MANUFACTURED IN FOREIGN TRADE ZONES..................................................... 91

9-17-11 RECORDS AND INFORMATION TO BE PROVIDED TO FDA UPON

REQUEST.................................................................................................................. 91

9-17-12 AGENCY CONTACTS............................................................................... 91

9-18 IMPORTATIONS FOR TRADE SHOWS/FAIRS, EXHIBITS AND SPECIAL

EVENTS........................................................................................................................ 92

9-18-1 PURPOSE................................................................................................. 92

9-18-2 BACKGROUND......................................................................................... 92

9-18-3 CBP REQUIREMENTS ............................................................................. 93

9-18-4 PROCEDURES FOR TRADE SHOWS, FAIRS, AND EXHIBITIONS ....... 93

9-18-5 SPECIAL EVENTS.................................................................................... 94

9-19 SECURED STORAGE (TEMPORARY REMOVAL DUE TO PENDING

REVISION).................................................................................................................... 94
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9-20 COMMUNICATION CONCERNING ASSESSMENT OF CIVIL MONETARY

PENALTIES BY CBP IN CASES INVOLVING IMPORTED FOOD ............................... 94

9-20-1 PURPOSE................................................................................................. 95

9-20-2 BACKGROUND......................................................................................... 95

9-20-3 INSTRUCTIONS........................................................................................ 95

9-21 NOTICE OF SAMPLING .................................................................................. 96

9-21-1 PURPOSE................................................................................................. 96

9-21-2 BACKGROUND......................................................................................... 96

9-21-3 INSTRUCTIONS........................................................................................ 96

9-22 GRANTING AND DENYING TRANSPORTATION AND EXPORTATION (T&E)

ENTRIES..................................................................................................................... 101

9-22-1 PURPOSE............................................................................................... 101

9-22-2 BACKGROUND....................................................................................... 101

9-22-3 INSTRUCTIONS...................................................................................... 103

9-23 EXHIBITS....................................................................................................... 104

EXHIBIT 9-3 ................................................................................................................ 105

EXHIBIT 9-4 ................................................................................................................ 106

EXHIBIT 9-5 ................................................................................................................ 107

EXHIBIT 9-6 ................................................................................................................ 108

EXHIBIT 9-10 .............................................................................................................. 111

EXHIBIT 9-11 .............................................................................................................. 113

9-1 IMPORT PROCEDURES

Reminder: The statements in this chapter are intended only to provide operating 

procedures for FDA personnel and are not intended to create or confer any rights, 

privileges, or benefits on or for any private person.

9-1-1 SCOPE AND PURPOSE

The procedures outlined in this document cover imported merchandise subject to, but 

not limited to, the following Acts/Regulations:

• Federal Food, Drug, and Cosmetic Act as amended (FFDCA or the Act)
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• Fair Packaging and Labeling Act

• Import Milk Act/Filled Milk Act

• Federal Caustic Poison Act

• Radiation Control for Health and Safety Act

• Public Health Service Act, Part F, Subpart 1, Biological Products

• Federal Cigarette Labeling and Advertising Act

• Comprehensive Smoking Tobacco Health and Education Act of 1986

• Title 21 CFR, especially Part 1, Subpart E - Imports and Exports

• Title 19 CFR Customs Duties, especially Part 141, et. seq. dealing with import

procedures.

The purpose of this chapter is to provide an overview of import procedures for articles

subject to the laws and regulations enforced by the Food and Drug Administration 

(FDA). The chapter also includes an overview of laws and regulations enforced by the 

United States Customs and Border Protection (CBP), as they relate to importation of 

articles regulated by FDA.

The statements in this chapter represent the Agency's current thinking on the 

application of the Import Procedures as identified by current law and regulation. It is 

intended only to provide operating procedures for FDA personnel and does not confer 

any rights on or for any private person and does not operate to bind FDA or the public.

9-1-2 DIVISION OF AUTHORITY

Primary responsibility for administering the nation’s laws relating to import, export and 

the collection of duties is given to CBP, an agency within the Department of Homeland 

Security. FDA, however, is responsible for determining whether or not an article offered 

for importation is in compliance with or in violation of the acts enforced by FDA. This 

includes the responsibility of determining whether or not a violative article may be 

brought into compliance with the appropriate statute and/or regulations, and authorizing 

reconditioning in order to bring the article into compliance.

In order to fulfill their respective responsibilities, CBP and FDA must work in close 

cooperation. For example: the refusal of admission, and subsequent re-exportation, or 

destruction of merchandise found to be in violation of the FFDCA and other Acts 

enforced by FDA is generally carried out under the direction of CBP, except for drugs 

that are subject to administrative destruction, which are destroyed by FDA and not by 

CBP. Additionally, at some ports actual supervision of destruction of violative 

merchandise may be conducted by FDA pursuant to a local FDA/CBP agreement. In 

addition, supervision of reconditioning plans is exercised by either FDA or CBP as 

mutually arranged by FDA personnel. At ports in reasonably close proximity to an FDA 

office, such supervision is ordinarily exercised by FDA. At remote ports, such 

supervision is ordinarily exercised by CBP. 
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9-1-3 ENTRIES

Entry Processing

The responsible FDA office receives notification from CBP of all formal and informal 

entries of articles under FDA jurisdiction at ports of entry located in the office's 

responsibility. Through the use of CBP's Automated Commercial 

Environment/International Trade Data System (ACE/ITDS), currently the sole CBPauthorized Electronic Data Interchange (EDI) system for entries that contain FDAregulated articles and FDA's ACE/Operational and Administrative System for Import 

Support (ACE/OASIS) some electronic entries may be forwarded to off-site offices for 

processing during certain periods of time, e.g., late night coverage of air carrier hubs. 

Automated Broker Interface (ABI) Filers using ACE for cargo release are required to 

provide FDA with information on entries submitted through ACE. The means of 

receiving notification for paper entries can be arranged through local CBP/FDA 

procedures. 

The most satisfactory and efficient means for FDA to receive notification is through 

FDA's electronic entry system, the Operational and Administrative System for Import 

Support (OASIS). Entries processed through this system will be electronically screened 

against criteria developed by FDA.

Electronic entries include all required CBP entry information, including entry number, 

entry date, importer identification, port of entry, vessel/voyage information, filer 

identification, Harmonized Tariff Schedule (HTS) code(s) for product described in 

importing documents (tariff code), information on foreign shipper, country of origin 

quantity, and value. Through the screening process in ACE, CBP determines if the 

article is subject to FDA jurisdiction.

The CBP ACE uses specific codes within ACE to help it identify which articles are 

subject to which agency's jurisdiction. These codes are known as "other government 

agency" (OGA) flags. FDA flags are "FD0", "FD1" and "FD2". FD0 indicates that FDA 

has determined the article, even though subject to FDA's laws and regulations, is 

acceptable for CBP release without further presentation of entry information to FDA. 

• For entries flagged FD1, the article may or may not be subject to FDA regulation.

The filer may, based on information received from the importer regarding the

intended use of the article, specify that the entry is not subject to FDA regulation

and "Disclaim" the entry. Otherwise, information required by FDA laws and

regulations must be submitted. FDA will periodically review "Disclaimed" entries

to confirm the accuracy of the declaration.

• Entries covered by an FD2 flag are considered subject to FDA jurisdiction and

must include information required by FDA laws and regulations.

Note: As of this update additional "other government agency" (OGA) flags have been 

added. If necessary, additional information on OGA flags can be obtained by contacting

OEIO. 
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FDA's electronic screening of the CBP ABI/ACE entry requires the filer to provide the 

following additional information: 

(1) FDA product code (FDA's product code is not the same as the HTS codes used

for CBP screening purposes).

(2) The MID code of the foreign manufacturer (MIDs are used by Customs as the

"Manufacturer's Identification", and it has now been extended to cover all

foreign firms). The MID includes, at a minimum, the two- letter identification of

the foreign country, the name of the foreign firm (which is generally made up of

the first three letters of the first and second names of the firm, where

applicable), up to 4 numbers of the firms address, if present in the address, and

the first three letters of the city where the firm is located. This code is

subsequently transmitted to FDA's screen as the un-coded name of the

identified firm.

(3) The MID information of the foreign shipper, including city and country, which

may or may not be the same as the foreign manufacturer.

(4) The country of origin (which may be different from the country of origin

identified for CBP purposes).

FDA has also established Affirmation of Compliance (A of C) codes which provide FDA 

employees with information concerning the article offered for import (example: medical 

device listing number). Use of the A of C is voluntary, and may or may not provide for a 

more expeditious screening of the entry.

In OASIS, the FDA forms identified as "Notice of Sampling," "Release Notice," "Notice 

of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued 

as specific forms. OASIS will instead generate a "Notice of FDA Action," which will 

provide more specific information on the actions taken broken down by each entry line 

(e.g., "sample collected" or "intended for sampling", "detained", "released", or 

"refused"). As the status changes for a particular line, a new "Notice of FDA Action" will 

be issued to advise the appropriate individuals of the changes. For non-mail shipments, 

which includes parcels not received through the International Mail Facilities via the 

United States Postal Service, the use of the designation "Product Collected by FDA," 

"Detained," "Released," "Refused," or similar language on the "Notice of FDA Action," 

should be considered as satisfying the requirements of the law for "giving notice thereof 

to the owner or consignee." See 21 USC 381(a).

For drugs received through the International Mail Facilities that are subject to 

administrative destruction, the designation “Detained – Subjection to Refusal and 

Administrative Destruction,” and "Refusal of Admission and Administrative Destruction," 

and the resultant issuance of a notice to the owner or consignee may also be used to 

satisfy the requirements of the law for "giving notice thereof to the owner or consignee." 

See 21 USC 381(a).
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For articles received through the International Mail Facilities the use of the designation 

"Product Collected by FDA," "Detained – Subject to Refusal," "Released," "Refusal of 

Admission– Return to Sender," or similar language on the "Notice of FDA Action," and 

the resultant issuance of a notice to the owner or consignee should be considered as 

satisfying the requirements of the law for "giving notice thereof to the owner or 

consignee." See 21 USC 381(a).

An example of a "Notice of FDA Action" showing various decisions for products in an 

entry is attached to this chapter as Exhibit 9-6. 

OASIS notices will usually be mailed to the addressees listed on the Notice. A copy of 

each notice is produced for the filer, importer of record, and consignee designated on 

the entry. (If the same firm fills one or more of those functions, only one copy is 

produced for the firm.) Notices are official documents communicating FDA decisions on 

entries. The distribution of the notices should be made by FDA, not the filer, to ensure 

proper notification to the parties involved (i.e., FAX, express pick-up services, postal 

service, etc.) The key is for FDA to distribute to the responsible firm directly without an 

intermediary.

Formal Entries

All articles offered for import into the U.S. (entries) that have a value greater than $2500 

(or such higher amount as the Secretary of the Treasury may set by regulation) are 

considered by CBP to be formal entries. Entry procedures for formal entries are set 

largely by statute, the most important requirement of which is a bond. Under the terms 

of a formal entry bond, imported articles may be unconditionally released to importers 

pending a determination of the admissibility and amount of duty to be paid on the 

articles. The bond requires importers to redeliver the articles to CBP, upon demand of 

CBP at any time; for example, to allow FDA sampling or for re-exportation following 

refusal of admission. If the importer fails to redeliver the goods, CBP, after consultation 

with FDA, may institute proceeding to collect the liquidated damages provided for in the 

bond. See 19 CFR 113.62 and 21 CFR 1.97.

Generally, importers notify CBP of an entry by the electronic submission of information 

to the CBP ACE/ITDS. The information is forwarded to FDA through ACE. FDA can 

then review the entry on screen to determine if further action is needed, or if additional

paper documentation must be submitted. If FDA requires further documents for review, 

the filer (or importer, where appropriate) will provide FDA with copies of the CBP Entry 

documents (CBP 3461/33461ALT, or other CBP entry forms) and other documents, 

such as a copy of the invoice. If an entry is not filed electronically, the accompanying 

documents will be submitted directly to FDA at the time CBP entry is made in 

accordance with local port operations. Note: As of July 2016, all entries of FDAregulated articles filed electronically are automatically forwarded to FDA through ACE 

Note: the FD 700 set (Importers Entry Notice) and FD 720 set (Land Port Entry Notice) 

are no longer used for FDA notification. In lieu of these forms, CBP entry documents
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(CBP 3461/3461ALT/7501 or alternate), along with appropriate commercial documents 

and/or other required documents, will be submitted to FDA.

CBP forms are available on the CBP site (link).

Informal Entries

Under current CBP procedures, entries with a value of $2500 or less (or such higher 

amount as the Secretary of the Treasury may set by regulation) do not require posting a

redelivery bond. All informal entries of articles under FDA jurisdiction that are entered by 

filers electronically will be forwarded to FDA through the CBP/FDA ACE interface. 

Informal entries not filed electronically will be processed by FDA for admissibility using 

the same criteria as non- electronic formal entries.

When informal entries that include articles under FDA jurisdiction are to be sampled, or 

FDA believes the articles may be in violation of FDA law, FDA may request CBP 

convert the informal entry into a formal entry, which requires the posting of a redelivery

bond. "Section 321 entry" is a term CBP uses for those entries with a value of $800 or 

less. These entries have a fair retail value of $800 or less, as evidenced by the bill of 

lading (or other document filed as the entry). They pass free of duty and tax, and are 

imported by one person on one day. The use of the 321 entry process should not apply 

to multiple shipments covered by a single order or contract, sent separately for the 

express purpose of securing free entry, and avoiding compliance with pertinent laws or 

regulations.

Mail/Personal Baggage

In the case of articles imported by mail or in personal baggage, FDA offices should 

develop procedures with their local CBP International Mail Office or border crossing 

office to cover such products. The procedures should set out such information as who is 

responsible for coverage and when.

CBP is responsible in the first instance for examination of personal baggage. If, in the 

course of their examination of an individual's personal baggage, CBP determines the

individual is entering a product subject to FDA review, the CBP officer will determine if 

the article should be brought to the attention of the local FDA office. Personal 

importations meeting the criteria of entry will be processed in accordance with 

procedures for non-electronic entries. Generally, since most personal importations are 

small in size and value, procedures have been developed for evaluating these 

importations. See RPM subchapter 9-2 "Coverage of Personal Importations."

Voluntary qualified Importer Program

FDA will work with CBP to expedite entry into the United States for Voluntary Qualified 

Importer Program (VQIP) foods. FDA sets screening in its Predictive Risk-based 

Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening tool 
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to recognize shipments of food which are the subject of an approved VQIP application. 

PREDICT is designed to validate the VQIP supply chain information provided at the 

time of entry and recommend the shipment be may proceeded immediately after the 

receipt of entry information, unless examination and/or sampling are necessary for 

public health reasons. A “may proceed” recommendation from PREDICT will typically 

result in the line being may proceeded without going to a FDA reviewer for processing 

(referred to as "a system may proceed").

9-1-4 SAMPLING

Ports Covered by FDA

Most ports of entry into the U.S. are covered by FDA personnel, acting in cooperation 

with CBP. At these ports, where electronic entry submissions are filed, filers receiving a 

message indicating FDA review is required will provide appropriate additional entry 

information to the FDA office in whose territory the port of entry is located. For those 

entries submitted by paper, all appropriate entry documents should be included with the 

package sent to the local FDA office.

After the entry has been evaluated and a decision for additional documentation is made, 

FDA will take appropriate action. If FDA decides to collect a sample, it will provide the 

filer, importer, owner and/or consignee, where appropriate, with a Notice of Sampling 

and advise: 

(1) whether the entry is to be held intact for FDA examination or sampling; or,

(2) specify only those items that need be held.

Generally, when FDA wishes to sample, it will be acting upon its authority in the 

Customs regulations (19 CFR 151.4) to collect its own samples for examination.

Ports not Covered by FDA

There are a number of ports where CBP does not maintain its ACE electronic entry 

process and FDA does not generally cover the port under its normal operating 

schedule. To cover these ports, the responsible FDA office will coordinate coverage 

with the responsible CBP Port manager to ensure FDA notification. If FDA decides to 

examine or sample articles offered for import through such a port, CBP, the importer, 

and broker will be notified.

Generally, for these entries, examination and/or sampling can take place at the point of 

destination. Under certain conditions, however, FDA may ask CBP to collect a sample 

at the point of entry and forward it to the FDA servicing laboratory. Appropriate 

information on the entry, sample requirement, and requirements for holding the entry 

will be provided to the CBP officials and importer by the responsible FDA office. 

Entry Sampling

FDA may request an examination or sample of articles under its jurisdiction. If no 

examination or sample is requested, FDA will notify CBP and the filer, who is 
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responsible for notifying the importer or other designated parties. This is referred to as a 

"May Proceed Notice," and indicates that the shipment may proceed without further 

FDA examination. In the ACE/OASIS process this may occur as a result of the initial 

FDA/OASIS screening prior to the information being forwarded to the office

representative, or after the responsible office performs an "On- Screen-Review" of the 

information provided.

Note: Should the article, at a later time, be found in violation of the law, FDA is not 

prevented from taking legal action (e.g., seizure, injunction) because it allowed 

admission of the article without examination at the time of importation.

If FDA requests an examination or sample, FDA will notify CBP and the broker or filer, 

importer, or other designated parties through the electronic entry system or other form 

of notification (e.g., Notice of FDA Action) of its intent to sample, requesting the relevant 

party to hold the entry. FDA will indicate the specific articles to be sampled.

Notice of Sampling

Whenever FDA intends to sample an article offered for import, it issues a Notice of 

Sampling to the importer of record, consignee, and filer of its intent to sample the article. 

Where an entry is manually processed, a copy of the Notice of Sampling may or may 

not be issued to CBP, depending on local FDA/CBP agreement. Where an entry is 

processed electronically and CBP collects the sample for FDA, the office will input the 

information of the entry/sample into OASIS and provide the Notice of Sampling to the 

importer of record, consignee, and filer specifying which articles were sampled.

For those entries where specific entry lines are not sampled or examined, the Notice of 

FDA Action will be amended to indicate which entry lines are "May Proceeded." See 

RPM subchapter 9-21 "Notice of Sampling" for procedures. 

Payment for Samples

The FDA will pay for all physically sampled articles found to be in compliance with the 

requirements of the Act and applicable regulations (21 CFR 1.91). In addition, FDA will 

pay for samples collected as FDA audits of private laboratory reports of analysis 

submitted to FDA in response to a detention when the article is found to be in 

compliance. FDA does not pay for samples taken in connection with the supervision of a 

reconditioning.

Where an owner or consignee seeks reimbursement it shall bill the FDA office 

responsible for the shipment was offered for import. FDA will not pay for a sample if the

article is initially found to be in violation, even if the article is subsequently released.
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Procedure When no Violation is Found

If the article is found to be in compliance after examination, the importer of record, 

consignee (where applicable), filer, and CBP are notified by a Notice of Release that the 

article may be admitted as far as FDA is concerned. See RPM 9-7 subchapter 9-7 

"Release Notices" for procedures. 

Procedure When Products Cannot Be Sampled or Examined

Under certain circumstances, FDA decides not to sample or examine articles offered for 

import. In these cases, if the entry is made through ACE/OASIS, the shipment should 

be "May Proceeded" through OASIS; if a manual (paper) entry, the shipment should be 

released by issuance of a paper "Notice of Release." The paper "Notice of Release" 

should be annotated to indicate that the article is "May Proceeded" and that FDA has 

made no determination as to the article's compliance with the Food, Drug, and Cosmetic 

Act, or other related acts or regulations.

In the OASIS system, if a notice is issued for the collection or examination of an article 

and the sample is not collected, or where an examination of the sampled article could 

not be accomplished, the filer will be so advised through a revised Notice of FDA Action 

indicating the article is "May Proceeded." The system will print a status of "May 

Proceeded" in the Line Summary and also print a detail section "Lines Which May 

Proceed." If the article FDA chose not to sample was part of a multi-line entry where 

other articles were collected for examination, the Notice of FDA Action automatically 

updates the status of the other articles not released.

In OASIS, the following are definitions used to describe "May Proceed" or "Release" 

actions:

May Proceed: "Product may proceed without FDA examination. FDA has made 

no determination the product complies with all provisions of the Food, Drug, and 

Cosmetic Act or other related acts. This message does not preclude action 

should the article later be found violative." (No compliance decision has been 

made.)

Release: "The product is released after FDA examination. This message does 

not constitute assurance the product complies with all provisions of the Food, 

Drug, and Cosmetic Act or other related acts and does not preclude action 

should the article later be found violative." (A compliance decision has been 

made.)

FDA offices will follow the appropriate instruction under each of the above procedures 

according to their import operations.

Voluntary qualified Importer Program
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FDA will limit examination and/or sampling of VQIP food entries to “for cause” situations 

(i.e., when the food is or may be associated with a risk to the public health), to obtain 

statistically necessary risk-based microbiological samples, and to audit VQIP. In the 

examination and/or sampling circumstances identified, FDA will attempt, to the extent 

possible, to examine an entry and collect samples at the VQIP food destination or other 

location preferred by the VQIP importer. If exportation is warranted, FDA will assist in 

fulfilling an importer’s request to U.S. Customs and Border Protection (CBP) to export 

from the port preferred by the importer. FDA will expedite its laboratory analysis of “for 

cause” or audit samples of VQIP entries, to the extent possible in accordance with 

public health priorities.

Unless directed by assignment or specific sampling instructions from the VQIP Team, 

VQIP sample collection should occur in Domestic/Import (D/I) status. 

9-1-5 PROCEDURES WHEN VIOLATION IS FOUND FOR PRODUCTS THAT ARE

NOT SUBJECT TO ADMINISTRATIVE DESTRUCTION

For the procedures regarding administrative destruction of products determined to be 

drugs valued at $2500 or less see sections 9-3 “Notice of FDA Action – Detained for 

Mail Shipments” and 9-4 “Notice of Refusal of Admission and Administrative Destruction 

for Mail Shipments”. 

"Notice of Detention & Hearing"

Examination or sampling of an article offered for import may indicate that the article 

appears to be in violation of the Act (e.g., section 801(a)), or may be subject to refusal 

of admission under acts and regulations enforced by FDA. If, after examination or 

sampling, detention is the chosen course of action, the filer, owner, and consignee 

where applicable are issued a "Notice of FDA Action - Detained" that shall specify the 

nature of the violation charged. The owner or consignee is entitled to appear before the 

FDA and have the right to introduce testimony in support of admissibility of the article in 

accordance with Section 801(a) of the FFDCA and FDA regulation 21 CFR 1.94. As a 

result, the "Notice of FDA Action - Detained" shall designate a place for the owner or 

consignee (or authorized representative) to provide testimony as to the admissibility of 

the article. Introduction of testimony by the owner or consignee for Agency review and 

consideration can be submitted via multiple forms including a telephone conversation, a 

facsimile, mail, or email, and does not have to be introduced in person. However, an inperson hearing will be scheduled if requested by the owner or consignee. It has 

generally been FDA's procedure to give the owner or consignee 10 working days from 

the date on the notice to provide FDA with testimony or evidence. However, if for some 

compelling reason the responsible FDA office determines that 10 working days is 

insufficient, such as inordinate mail delays due to holiday mailings, this time period may 

be extended. On the OASIS generated "Notice of FDA Action", this date is identified as 

the date to "Respond By". A copy of this Notice is also sent to CBP. See RPM 

subchapter 9-9 "Notice of FDA Action – Detained for Non-Mail Shipment" for 

procedures. 
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Request for Authorization to Relabel or Perform Other Acts

In addition to presenting evidence as to the admissibility of the article, the importer may 

propose a manner in which an article, detained under section 801(a)(3), can be brought 

into compliance with the Act or be removed from coverage under the Act ("rendered 

other than a food, drug, device or cosmetic"). As provided for under 801(b) and 21 CFR 

1.95, FDA may authorize relabeling or other action upon the timely submission of an 

"Application for authorization to relabel or recondition non-compliant articles" Form 

FDA-766" (“Importer’s Certificate”), and the execution of a good and sufficient bond 

("CBP redeliver bond") by the owner or consignee (see 21 USC 381(b)). The redelivery 

bond remains on file with the District Director of CBP for the particular importation. The 

bond applies to any relabeling or other authorized action, and a new bond will not have 

to be filed.

After review of the application to relabel or recondition, FDA will notify the importer of its 

approval or disapproval. If approved (see 21 CFR 1.96 "Granting of authorization to 

relabel and recondition"), the conditions to be fulfilled, and the time limit within which to 

fulfill them will be noted. The original application will be sent to the applicant. Notification 

to other parties will be made where appropriate. A copy will be retained in the files of the 

FDA responsible office. See RPM subchapter 9-10 "Response (Hearing) to Notice of 

FDA Action – Detained for Non-Mail Shipments", and RPM subchapter 9-12 

"Reconditioning" for procedures. 

Inspection After Completion of Authorization to Bring Article into Compliance

After the relabeling or reconditioning operation has been completed, the applicant will 

submit the "Importer's Certificate" (page two of the Form FDA-766). At this point FDA 

may conduct a follow-up inspection and/or sampling to determine compliance with the 

terms of the authorization, or may accept the statement from the importer with no further 

follow-up. The follow-up inspection and/or sampling may be made by an officer of FDA 

or CBP, depending on the location of the reconditioning and agreements between the 

FDA responsible office and the local CBP office. The "Report of 

INVESTIGATOR/INSPECTOR" (page two of the Form FDA-766) shall be completed by 

the inspecting officer and forwarded to the appropriate FDA office.

Procedure When Conditions of Authorization Have Been Fulfilled

If the conditions of the authorization to relabel or recondition have been fulfilled, the 

FDA responsible office will notify the owner or consignee through a Notice of Release 

indicating that the admissible portion of the article is no longer subject to detention or 

refusal of admission. This notice is usually identified as "Originally Detained and Now 

Released." A copy of the Notice is also sent to CBP and the filer. Where there is a nonadmissible portion of the article (rejects), the portion must be destroyed, or re-exported 

under FDA or CBP supervision. A Notice of Refusal of Admission should be issued for 

the rejected portion, with copies distributed to the same parties receiving the Notice of 
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Release. Normally, FDA will include in its approval of the reconditioning a provision for 

any non-admissible portions (rejects) of the reconditioned article be destroyed that 

should not be permitted to be exported.

Procedure When Conditions of Reconditioning Have Not Been Fulfilled. 

If an importer's initial attempt at relabeling or reconditioning is not successful, FDA 

should not consider a request for authorization for a second relabeling or reconditioning 

unless the authorization includes a change or adjustment from the original authorized 

method, and the applicant provides reasonable assurance that the second attempt will 

be successful. If the importer fails to fulfill conditions of an authorization, FDA issues a 

"Notice of Refusal of Admission" to the importer, consignee, where applicable, and the 

filer, with a copy of the Notice to CBP.

Procedure After Hearing - "Notice of Release"

After the hearing on admissibility, the FDA responsible office may determine that the 

article does not appear to be in violation and should be released. In this situation, the 

importer of record and consignee are issued a "Notice of Release" for the detained 

article. The Notice will indicate that the detained article is no longer subject to detention 

or refusal of admission. The Notice will also be identified "Originally Detained and Now 

Released" and, where appropriate, explain the reason for the change of action. A copy 

of the Notice is sent to CBP, and all parties receiving the Notice of Sampling/Notice of 

Detention. See RPM subchapter 9-7 "Release Notice" for procedures. 

Procedure After Hearing - "Refusal of Admission"

If, after consideration of all evidence, the FDA responsible office decides that the 

articles still appear to be in violation, the articles may be refused admission. In this 

situation, FDA notifies the importer, owner, and consignee, where applicable, by issuing 

a "Notice of Refusal of Admission." On this Notice, FDA states the charge(s) exactly as 

shown on the original (or amended) Notice of FDA Action - Detained. A copy of the 

Notice is also sent to CBP. See RPM subchapter 9-11 "Notice of FDA Action - Refusal 

of Admission" for procedures. 

If an article is refused admission, such article must be destroyed or exported under 

CBP's supervision within 90 days of receiving the Notice of Refusal (see 21 USC 381), 

or within such additional time as specified by CBP. The FDA file for the import remains 

open until the FDA responsible office receives notification, usually from CBP, indicating 

that the article was either destroyed or exported. 

Some local FDA and CBP offices have developed combination Notice of Refusal of 

Admission and Notice of Redelivery documents. At this time, use of the combined 

Notice of Refusal of Admission and Notice of Redelivery has not been approved for 

national applications. Until the format of combined notices is authorized, FDA 

responsible offices should continue to follow local procedures as instituted.
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Under the OASIS procedures for issuing the Notice of Refusal of Admission, the notice 

will contain language which includes the reference to the requirement for redelivery. The 

notice will contain all the above required information concerning the product and 

charge(s) and will also include the following statements

"A request has been made to CBP to order redelivery for all the above 

product(s), in accordance with 19 CFR 141.113, which were conditionally 

released to you under terms of the entry bond. Failure to redeliver to CBP 

custody will result in a claim for liquidated damages under the provisions of the 

entry bond."

"These products must be exported or destroyed under CBP supervision within 90 

days from the date of this notice, or within such additional time as the District 

Director of CBP specifies. Failure to do so may result in destruction of the 

products. Distribution of the products may result in their seizure and/or injunction 

or criminal prosecution of persons responsible for their distribution."

Voluntary qualified Importer Program

If exportation is warranted, FDA will assist in fulfilling an importer’s request to U.S. 

Customs and Border Protection (CBP) to export from the port preferred by the VQIP 

importer.

Revocation of VQIP benefits:

• If FDA obtains credible evidence that the VQIP importer participated in smuggling or

other fraudulent activities such as declaring an entry as a VQIP food when it is not,

FDA will immediately revoke participation in VQIP. The Notice of Immediate

Revocation will identify FDA’s reason(s) for revoking participation in VQIP. If the

VQIP importer believes revocation was in error, it may contact FDA upon receipt of

this notice. VQIP participation and, thus, VQIP benefits will immediately cease for all

VQIP foods on the day that FDA sends the Notice of Immediate Revocation. Unless

it is determined based on a review of the evidence submitted by the VQIP importer

that the revocation was enacted in error, FDA will not reinstate participation in VQIP

for the remainder of the VQIP fiscal year. FDA will not approve VQIP applications

for subsequent years, unless the VQIP importer provides sufficient evidence of

affirmative steps to ensure that fraudulent activity does not occur again. Divisions

should refer to section 9-16 Priority Enforcement Strategy for Problem Importers

when dealing with VQIP importers or other individuals who engage in business

practices that appear designed to evade the lawful regulation of imports.

• If FDA finds deviations indicating the participant does not continue to meet one or

more of the eligibility requirements to participate in VQIP, we will send an

electronically generated Notice of Intent to Revoke participation in VQIP. The Notice

of Intent to Revoke will identify FDA’s reason(s) for intending to revoke participation

in VQIP and will indicate that the VQIP importer has 30 days to make and provide

evidence of the corrections to the VQIP team. The VQIP team will be available via
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phone, email, or via the VQIP FURLS Portal. Benefits will continue for those 30 

days unless FDA believes there is a risk to public health, in which case FDA will 

notify the VQIP importer via the Notice of Intent to Revoke.

If all corrections cannot be made within 30 days, the VQIP importer can submit a 

corrective action plan that includes detailed steps and a time line for making 

corrections. FDA will verify the corrective actions by conducting an inspection or by 

reviewing documentation of the corrective actions, whichever is appropriate. If the 

VQIP importer does not respond or does not submit an adequate corrective action 

plan within 30 days, FDA will revoke participation in VQIP. Revocation of benefits 

will be effective on the date on which FDA sends the Notice of Revocation email.

If after revocation, the VQIP importer believes they have made corrections to support 

reinstatement, it may contact FDA. FDA will review the request to determine if corrective 

actions support reinstatement of benefits for the remainder of the VQIP fiscal year.

Note that revocation of VQIP participation does not prevent the Agency from taking 

additional enforcement actions against the indicated firm(s) or product(s), if warranted.

FDA follow up when VQIP importer self-reports a problem:

• The VQIP importer is responsible for promptly reporting all deviations that may

impact their eligibility to participate in VQIP and their plans for correcting the

deviations to FDA. The VQIP QAP should include procedures for taking prompt

corrective actions, for updating procedures as necessary to prevent future

occurrences of the problem, and for notifying FDA. When deviations occur in which a

food(s) may be associated with a risk to public health, FDA may increase “for cause”

or audit samples of VQIP entries. FDA will review the reported information from the

VQIP Importer to determine if there is a risk to public health and/or if a revocation

process needs to be initiated.

9-1-6 PAYMENT OF COSTS OF SUPERVISION OF RELABELING AND/OR

OTHER ACTION

After completion of the authorized relabeling or other action, FDA will submit to CBP 

National Finance Center a detailed statement of expenses incurred by officers or 

employees of the FDA during the supervision of the authorized relabeling or other 

action. See 21 USC 801(c). Expenses include travel, per diem or subsistence, and 

supervisory charges Form FDA-790 Charges for Supervision, Exhibit 9-12 (now IOM

Exhibit 6-3).

The expenses shall be computed based on the following:

• Investigator's time

• Analyst's time

• Per diem allowance

• Travel other than by auto - actual cost of such travel

• Travel by auto (mileage, toll fees, etc.)
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• Administrative support.

Charges for the above will be in accordance with existing regulations. See 21 CFR 1.99 

and RPM subchapter 9-13 "Supervisory Charges" for procedures. CBP, upon receipt of 

the charges for supervision, will send a notice for payment to the identified importer of 

record. The expenses shall include charges of supervision of destruction of the article or 

rejects as provided for by the Tariff Act of 1911, as amended. See 19 U.S.C. 267. The 

owner or consignee shall remit payment to CBP. Payment of supervisory charges 

should not be accepted by FDA representatives. 

9-1-7 EXPORTATION OF MERCHANDISE REFUSED ADMISSION

As provided under Section 801(a), CBP supervises exportation of refused articles in 

accordance with regulations which have been or may be prescribed by the Secretary of 

Treasury. However, if after a reasonable time, FDA has not received notification of 

exportation or destruction of articles refused admission, the FDA responsible office 

should investigate the status of disposition. The investigation should also consider, 

under certain conditions, verifying that the refused articles have been held intact 

pending exportation or destruction. Procedures on refusals to be verified may change 

based on the reason for detention.

9-1-8 BOND ACTION

Under the provisions of section 801(b) of the Act (21 USC 381(b)) and CBP regulations 

(19 CFR 113.62), a bond is required for all conditionally released articles offered for 

importation. This bond provides for relief to the government should the bond holder 

default on the conditions of the agreements identified by the CBP regulation. Default will 

result in the payment of liquidated damages in the amount specified in the bond order.

Bond actions are taken when an entry is distributed after the importer receives 

notification of FDA's intent to examine or sample the article, and the article is distributed 

and cannot be redelivered. Bond actions also are taken when an article has been 

detained and refused, and the article is not destroyed or exported in accordance with 

the requirements of the law.

If FDA has evidence that the entry, or any portion of an entry subject to FDA jurisdiction, 

was disposed of in violation of the terms of the appropriate act or its regulations, or of 

the terms of the bond (see 19 CFR 113.62(e)), it should immediately send such 

evidence to CBP.

If FDA receives evidence that a refused article was not exported or destroyed, it shall 

immediately investigate the matter and send a detailed statement to CBP. The 

statement will show the importer's liability under the redelivery bond or other applicable 

CBP bond. If the facts warrant, when the article was under detention, and the Notice of 

Refusal of Admission has not been issued, FDA should immediately issue a Notice of 

Refusal to the owner or consignee, with a copy to CBP.
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Upon the receipt of a bond holder's application for relief (appeal for Mitigation or 

Cancellation of Assessed Liquidated Damages) as provided under CBP regulations, 

CBP may cancel the liability for liquidated damages incurred under the bond. CBP will 

do so upon the payment of a lesser amount, or upon such other terms and conditions as 

shall be deemed appropriate under the law and in view of the circumstances. However, 

for assessment of liquidated damages involving FDA merchandise, CBP may not act 

unless the FDA office having jurisdiction at the port of entry is in full agreement with the 

action. See 21 CFR 1.97(b) and RPM subchapter 9-14 "Bond Actions" for procedures. 

Exhibit 9-6 of Notice of FDA Action is a model and should not be considered all 

inclusive. The format and language in the actual Notice of FDA Action issued by FDA 

from the OASIS may also appear differently.

9-2 COVERAGE OF PERSONAL IMPORTATIONS

9-2-1 PURPOSE

To provide operating procedures for the coverage of personal-use quantities of FDAregulated imported products in baggage and mail and to gain the greatest degree of 

public protection with allocated resources.

9-2-2 BACKGROUND

Because the amount of merchandise imported into the United States in personal 

shipments is normally small, both in size and value, comprehensive coverage of these 

imports is normally not justified. These procedures clarify how FDA may best protect 

consumers with a reasonable expenditure of resources.

There has always been a market in the United States for some foreign made products 

that are not available domestically. For example, individuals of differing ethnic 

backgrounds sometimes prefer products from their homeland or products labeled in 

their native language to products available in the United States. Other individuals seek 

medical treatments that are not available in this country. Drugs are sometimes mailed to 

this country in response to a prescription-like order to allow continuation of a therapy 

initiated abroad. With increasing international travel and world trade, we can anticipate 

that more people will purchase products abroad that may not be approved, may be 

health frauds or may be otherwise not legal for sale in the United States.

In addition, FDA must be alert to foreign and domestic businesses that promote or ship 

unapproved, fraudulent or otherwise illegal medical treatments into the United States or 

who encourage persons to order these products. Such treatments may be promoted to 

individuals who believe that treatments available abroad will be effective in the 

treatment of serious conditions such as AIDS or cancer. Because some countries do not 

regulate or restrict the exportation of products, people who mail order from these 

businesses may not be afforded the protection of either foreign or U.S. laws. In view of 

the potential scale of such operations, FDA has focused its enforcement resources 

more on products that are shipped commercially, including small shipments solicited by 
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mail-order promotions, and less on those products that are personally carried, shipped 

by a personal non-commercial representative of a consignee, or shipped from foreign 

medical facility where a person has undergone treatment.

9-2-3 PERSONAL BAGGAGE

FDA personnel are not to examine personal baggage. This responsibility rests with the 

CBP. It is expected that a CBP officer will notify their designated FDA representative

when he or she has detected a shipment of an FDA-regulated article intended for 

commercial distribution (see GENERAL INSTRUCTIONS below) an article that FDA has 

specifically requested be detained, or an FDA regulated article that appears to 

represent a health fraud or an unknown risk to health.

When items in personal baggage are brought to FDA's attention, the designated office 

should use its discretion, on a case-by-case basis, in accordance with the instructions 

provided under GENERAL INSTRUCTIONS below, in deciding whether to request a 

sample, detain the article, or take other appropriate action.

9-2-4 MAIL SHIPMENTS

FDA personnel are responsible for monitoring mail importations. Mail importations are

parcels received through the International Mail Facilities, via the United States Postal 

Service. It is expected that a CBP officer from the CBP Mail Division will examine a 

parcel and will set it aside if it appears to contain a drug, biologic, or device, an article 

that FDA has specifically requested be held, or an FDA-regulated article that appears to 

represent a health fraud or unknown risk to health.

FDA should audit those parcels set aside by CBP in accordance with the instructions 

provided under GENERAL INSTRUCTIONS below, using the following procedures:

• Prepare a Collection Report for each parcel sampled.

• Generally, a physical sample is not required on mail importations because a

documentary sample (for example, labeling, labels and inserts) will be

sufficient for most regulatory purposes.

• If a physical sample is needed, collect only the minimum necessary for

analysis by the laboratory.

• The remaining portion should not be removed from the custody of the CBP

Mail Division.

Importations detained in accordance with these procedures should be held by CBP until 

they are either released or refused entry. Attached as help are two specimen letters that 

may be sent with the Notice of FDA Action - Detained when a parcel is detained. See 

Exhibit 9-3 for use in general mail importations and Exhibit 9-4 for use in unapproved 

drug or device mail importations.

On occasion, products detained by FDA will be mixed with non-FDA-regulated products.

When we refuse admission of the FDA-regulated portion, any request for the release of 
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the non-FDA-regulated portion should be referred to the CBP Mail Division with a Notice 

of Refusal of Admission covering the detained article. Final disposition of all 

merchandise, including the destruction of detained merchandise, is the responsibility of 

CBP, except in the case of drugs that are subject to administrative destruction (e.g.,

drugs that are valued at $2500 or less which have been refused admission, or have not 

met the Personal Importation Policy criteria as described in the subsection 9-2-5 

General Instructions section below). In these instances, the drugs will be destroyed by 

FDA. 

9-2-5 GENERAL INSTRUCTIONS

FDA personnel may allow entry of shipments when the quantity and purpose are clearly 

for personal use, and the product does not present an unreasonable risk to the user. 

Even though all products that appear to be in violation of statutes administered by FDA 

are subject to refusal, FDA personnel may examine the background, risk, and purpose 

of the product before making a final decision. Although FDA may use discretion to allow 

admission of certain violative items, this should not be interpreted as a license to 

individuals to bring in such shipments.

Commercial or Promotional Shipments

Commercial and promotional shipments are not subject to these procedures. Whether 

or not a shipment is commercial or promotional may be determined by a number of

factors including, for example, the type of product, accompanying literature, size, value, 

and/or destination of the shipment. FDA personnel may also consider whether an 

importation of drugs or medical devices is a commercial shipment by evaluating whether 

the article appears to have been purchased for personal use or whether the quantity 

suggests commercial distribution (i.e., the supply exceeds what one person might take 

in approximately three months). Commercial shipments generally include shipments 

other than those products that are personally carried, shipped by a personal noncommercial representative of a consignee, or shipped from a foreign medical facility 

where a person has undergone treatment.

Products Other than Drugs, Biologics, and Devices

Many products other than drugs, biologics, and devices that individuals seek to import in 

personal quantities do not pose a significant health risk although they appear to be 

violative and may be the subject of an import alert or detention without physical 

examination based on standards violations, filth, and/or labeling problems. When such 

items are brought to FDA's attention by CBP, it may be appropriate for FDA personnel 

to use their discretion to "Release with Comment" and advise the importer of the 

agency's concerns. FDA personnel should be alert to and should detain those products 

that do pose a significant health risk.
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Drugs, Biologics, and Devices

When personal shipments of drugs, biologics, and devices that appear violative are 

brought to FDA's attention by CBP, FDA personnel will use their discretion to decide on 

a case by case basis whether to detain, refuse, or allow entry of the product. Generally, 

drugs, biologics, and devices subject to Import Alerts are not amenable to these 

procedures. Devices to be used by practitioners for treating patients should not be 

viewed as personal importations subject to this chapter.

Drugs subject to Drug Enforcement Administration (DEA) jurisdiction should be returned 

to CBP for handling.

In allowing personal shipments of drugs or devices, FDA personnel may consider a 

more permissive decision in the following situations:

1. When the intended use is appropriately identified, such use is not for

treatment of a serious condition, and the product is not known to represent

a significant health risk; or

2. When a) the intended use is unapproved and for a serious condition for

which effective treatment may not be available domestically either through

commercial or clinical means; b) there is no known commercialization or

promotion to persons residing in the U.S. by those involved in the

distribution of the product at issue; c) the product is considered not to

represent an unreasonable risk; and d) the individual seeking to import the

product affirms in writing that it is for the patient's own use (generally not

more than 3 month supply) and provides the name and address of the

doctor licensed in the U.S. responsible for his or her treatment with the

product, or provides evidence that the product is for the continuation of a

treatment begun in a foreign country.

If there are any questions about the application of these factors to any product, the 

product should be detained and FDA personnel should consult with the appropriate 

headquarters office.

When evaluating personal importations, FDA personnel may consider issuing a 

"Release with Comment" and, as appropriate, advise the recipient that 

1. The drug (or device) that has been obtained for personal use appears to

be unapproved in the United States;

2. The drug (or device) should be used under medical supervision;

3. FDA may detain future shipments of this product; and

4. The patient's physician should consider for example, enrolling the patient

in an Investigational study or applying for Investigation New Drug (IND),

Compassionate IND, or Treatment IND exemption.
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IMPORT ALERTS

FDA personnel should recommend to OEIO the issuance of an import alert if they 

encounter:

1. Personal importation of products that represent either a direct or indirect

health risk; or

2. The promotion of unapproved foreign products for mail order shipment; or

repeated importation of products that represent fraud*.

*See Compliance Policy Guides Manual (CPG), 120.500, "Health Fraud - Factors in

Considering Regulatory Action."

9-3 “NOTICE OF FDA ACTION – DETAINED” FOR MAIL SHIPMENTS

9-3-1 PURPOSE

To provide operating procedures for FDA personnel for:

1. The evidence to support a detention.

2. Preparation and issuance of the "Notice of FDA Action - Detained."

3. Charges under Section 801 or other Acts enforced by FDA, and, for

administrative destruction, charges under other provisions of the FFDCA.

4. Hearing Process

5. Procedure after hearing

9-3-2 BACKGROUND

In developing FDA's automated import system, OASIS, the specific form "Notice of 

Detention and Hearing" has been replaced by the "Notice of FDA Action" with the 

description of the article sampled and the results of the examination indicating "Detained" 

for the specific article in the entry. For mail shipments, the use of the designation 

"DETAINED– Subject to Refusal", and for mail shipments containing drugs, “DETAINED 

– Subject to Refusal and Administrative Destruction," or similar wording may also be used

to satisfy the requirements of the law for "giving notice thereof to the owner or consignee."

See 21 USC 381(a).

The "Notice of FDA Action" gives notice of the right to a hearing on the detention for 

appearance of a violation, or for drugs subject to administrative destruction, a violation 

(21 CFR 1.94). In addition, the notice identifies charges that an import entry appears to 

violate, or violates the FFDCA, Public Health Service Act (PHS Act) or other acts enforced 

by FDA. Under the FFDCA section 801(a) an article subject to the FFDCA shall be refused 

admission if it appears from the examination or otherwise that 

(1) Such article has been manufactured, processed, or packed under insanitary

conditions or, in the case of a device, the methods used in, or the facilities
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or controls used for, the manufacture, packing, storage, or installation of the 

device do not conform to the requirements of section 520(f), or 

(2) Such article is forbidden or restricted in sale in the country in which it was

produced or from which it was exported, or

(3) Such article is adulterated, misbranded, or in violation of section 505. It also

provides the owner or consignee with an opportunity to introduce testimony

relative to the admissibility of the article.

Also, under the FFDCA section 801(a), as amended, FDA can destroy a drug that has 

been refused admission if the drug is valued at $2500 or less (or such higher amount as 

the Secretary of the Treasury may set) and was not brought into compliance under 

Section 801(b). In addition, FDA intends to exercise its authority to destroy a drug that 

meets the statutory criteria for administrative destruction where the drug has also been 

determined to be adulterated, misbranded, or unapproved in violation of Section 505. 

It should be noted that the Act does not provide specifically for the issuance of a notice 

charging that an entry of imported merchandise appears to be in violation. However, 21 

CFR Section 1.94 provides that if it appears that an imported article may be subject to 

refusal of admission, the responsible FDA office shall give the owner or consignee a 

written notice to that effect.

Evidence Required for Detention

Every detention must be based upon evidence of a violation of the law(s) enforced by 

FDA. This does not mean that comprehensive examinations are required as a condition 

for detention, or that detention cannot be based upon very brief examinations if these are 

sufficient to furnish evidence creating the appearance of a violation, or a violation.

Furthermore, it is not essential that a detention invariably be based upon examination of 

a sample, as Section 801(a) of the FFDCA provides for refusal of admission if "it appears 

from the examination of such samples or otherwise" that the article is violative. However, 

in those cases in which detention is made without examination, there should be 

substantial evidence of a documentary type, (i.e., a violation in a previous shipment of the 

entered product from the same firm-see RPM subchapter 9-8 "Detention without Physical 

Examination" for additional procedures) to warrant a charge of violation.

FDA can destroy drugs refused admission, without the opportunity for export, that are 

valued at $2500 or less and are adulterated, misbranded, or unapproved in violation of 

Section 505 of the FFDCA. The evidence supporting this determination must be collected 

and documented in OASIS by the Investigations Branch for review and evaluation by the 

Compliance Branch. 

Issuance of Notice of FDA Action - Detained

The Notice of FDA Action - Detained provides a list of product being detained, and is 

addressed to the filer, the importer of record who is legally responsible for assuring 
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compliance with all laws and regulations affecting the importation of the merchandise in 

question, and consignee (if different from the importer of record). Copies should also be 

sent to whomever else was sent copies of the "Notice" for the sample collected. See RPM 

subchapter 9-21 "Notice of Sampling" for specific procedures on issuance of this notice.

Preparation of Charges

The statement of charges on the Notice of FDA Action - Detained issued for a detained 

product is the only information the importer has regarding the violation(s) or appearance 

of a violation(s) with which the importation is charged. It should be sufficiently informative 

and complete for the importer to understand clearly the apparent violation(s), or in the 

case of drugs subject to administrative destruction, the violation(s), so that the importer 

can prepare and introduce testimony. 

A separate charge should be made for each apparent violation, or violation in the case of 

drugs subject to administrative destruction. See Exhibit 9-5 to this chapter for charges 

used in OASIS. The charge should cite the section of the FFDC Act violated, quote the 

pertinent portion of that section, and make a brief statement of the specific way in which 

the product appears or has been determined to be in violation. Charges are drafted in 

accordance with Section 801 of the FFDCA, stating “Examination of the following articles 

has been made and these articles are subject to refusal of admission into the United 

States because they do not appear to***” or for articles subject to administrative 

destruction “The article has been determined to be ***” (*** completed as appropriate for 

charge). 

Under the OASIS procedure for issuing the Notice of FDA Action for a detained product, 

the individual responsible for the decision as to the compliance of the article will select 

the appropriate charge from the list of charges available in the OASIS system. The 

selected charge will be incorporated into the Notice of FDA Action, and the annotation 

required to specify the particular concern(s), where applicable, will be incorporated by the 

responsible FDA office. For example, if the article is being detained for the presence of a 

particular pesticide residue, FDA would annotate the charge provided by OASIS (using 

the narrative field) with the name of the specific pesticide residue found or alleged to be 

present.

See Exhibit 9-6 example of the "Notice of FDA Action" issued under the OASIS which 

includes the identification of article(s) for detention.

Hearing Process for Mail Shipments

The owner or consignee is entitled to a hearing before FDA, in order to challenge the 

decision to refuse and/or destroy an article, as required by section 801(a) of the 

FFDCA, or to provide testimony in support of admissibility of the article or to contest the 

administrative destruction of the article, as required by FDA regulation 21 CFR 1.94. It 

has generally been FDA's procedure to give the owner or consignee 10 working days 

following the date of detention shown on the notice (or longer if circumstances require a 
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longer time for response) to provide FDA with testimony or evidence. However, if for 

some compelling reason, the responsible FDA office determines that 10 working days is 

insufficient, such as inordinate mail delays due to holiday mailings, this time period may 

be extended. Introduction of testimony by the owner or consignee for Agency review 

and consideration can be submitted via multiple forms, including a telephone 

conversation, a facsimile, mail, email, or in person. Regardless of the way the testimony 

is introduced, the discussion and findings/outcome of the hearing should be sufficiently 

documented and stored by the Compliance Officer conducting the hearing. For 

example, the Compliance Officer should upload email correspondence or meeting 

minutes following a telephone conversation or in person interview into OASIS to support 

their final decision regarding the article’s disposition. 

For details on the eligibility of respondents see subsection 9-10-3; for hearings and 

postponements see 9-10-14; and for the conduct of a hearing, including personal 

appearance of respondent and written reply (mail, fax, etc.) from respondent, see 

subsections 9-10-5 and 9-10-6. 

Procedure After Hearing for Mail Shipments "Refusal of Admission – Return to 

Sender" or “Refusal of Admission and Administrative Destruction”

If, after consideration of all evidence, the responsible FDA office determines that the 

articles are violative or appear to be violative, the articles may be refused admission. In 

this situation, FDA notifies the importer, owner, and consignee, where applicable, by 

issuing either a "Notice of Refusal of Admission – Return to Sender", or in the case of a 

drug valued at $2500 or less a "Notice of Refusal of Admission and Administrative 

Destruction”. On this Notice, FDA states the charge(s) exactly as shown on the original 

(or amended) Notice of FDA Action - Detained. (See RPM subchapter 9-4 "Notice of 

Refusal of Admission and Administrative Destruction" for procedures.)

After the article is refused admission, FDA has two options depending on the identity 

and value of the article. If the Compliance Officer has determined that the article 1) is a 

drug 2) is valued at $2500 or less and 3) is adulterated, misbranded, or an unapproved 

new drug in violation of section 505 of the FFDCA, the refused product will be destroyed

without providing the owner or consignee with the opportunity to export. 

For all other articles, the refused article(s) are generally returned to sender. The FDA 

file for the import remains open until the article is either destroyed or exported. 

Under the OASIS procedures for issuing the Notice of FDA Action - Refusal of 

Admission and Administrative Destruction, the notice will contain language...

Examination of the following articles has been made and you were given an 

opportunity to respond to a notice that the articles are subject to refusal of 

admission into the United States and subject to administrative destruction. FDA 

has determined that the articles are drugs that are not in compliance with the 

requirements of the law as indicated below. Further, FDA has determined that each 

article is valued at $2500 or less. Because these drugs are not in compliance with 
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the requirements of the law and are valued at $2500 or less, you are hereby 

notified that these articles will be destroyed by FDA in accordance with the FD&CA.

9-4 NOTICE OF REFUSAL OF ADMISSION AND ADMINISTRATIVE

DESTRUCTION FOR MAIL SHIPMENTS OF DRUGS

9-4-1 PURPOSE

To provide operating procedures for issuing the Notice of Refusal of Admission and 

Administrative Destruction when refusing a drug valued at $2500 or less. 

At this time, FDA is using its destruction authority on those refused drugs valued at 

$2,500 or less (or such higher amount as the Secretary of the Treasury may set by 

regulation) that are being imported via international mail. However, any refused drug 

that meets the criteria for administrative destruction may be destroyed regardless of the 

manner in which it is being imported or offered for import into the U.S. FDA 

management for the responsible office should be made aware if administrative 

destruction is appropriate for any such drug that is not being imported via international 

mail.

9-4-2 BACKGROUND

In 2012, Congress amended section 801(a) of the FFDCA (21 U.S.C. 381(a)) to provide 

FDA with 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) after providing 

the drug’s owner or consignee with notice and an opportunity to present testimony to 

the Agency prior to the drug’s destruction. This authority allows FDA to destroy such a 

drug without providing the owner or consignee with the opportunity to export the drug. 

The agency has decided to exercise this authority only after FDA makes a 

determination that a drug that has been refused admission is valued at $2500 or less 

and is adulterated, misbranded, or unapproved in violation of Section 505 of the

FD&CA, and was not brought into compliance as described in Section 801(b). 

9-4-3 ISSUANCE OF NOTICES

Who Should Issue the Notice of Refusal of Admission and Administrative 

Destruction? 

The language of the law places the responsibility for issuing the Notice of Refusal of 

Admission upon the Secretary of the Treasury who in turn has delegated this 

responsibility to the CBP. Traditionally, the Notice of Refusal of Admission is issued by 

the responsible FDA office over the facsimile signature of the Regional or District 

Director of CBP in accordance with local agreement. Each FDA office shall have the 

pertinent facsimile stamp of the signature of the Regional or District Director of CBP 

prepared for this purpose and supplied to the appropriate personnel, or have written 

delegation of authority from the District Director of CBP to issue the Notice of Refusal of 
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Admission under FDA personnel signature. A new stamp should be prepared each time 

there is a change of personnel in the Regional or District Director of CBP position.

When Should the Notice of Refusal of Admission and Administrative Destruction

be Issued?

The Notice of Refusal of Admission and Administrative Destruction should be issued 

after an owner or consignee is given the opportunity to introduce testimony in response 

to a Notice of FDA Action – Detained and, after a hearing relative to the validity of the 

charges for detention, the hearing officer decides that the articles are in violation, or 

when no response to a Notice of FDA Action - Detained is received within the specified 

ten day time frame (excluding Saturdays, Sundays, and holidays) and an extension of 

time for responding has not been granted. Additional time may be noted due to 

circumstances affecting FDA operations.

A Notice of Refusal of Admission and Administrative Destruction should only be issued 

when:

- The product is a drug

- The product is valued at $2,500 or less

- The product is adulterated, misbranded, or an unapproved new drug in violation

of Section 505 of the FFDCA

AND

- A response to a Notice of FDA Action - Detained is not received within the

specified 10 day time frame (excluding Saturdays, Sundays, and holidays) and

an extension of time for responding has not been granted. (Additional time may

be noted due to circumstances affecting FDA operations), or

- After a hearing relative to the validity of the charges for detention, the hearing

officer decides that the articles are in violation.

Distribution of the Notice of Refusal of Admission and Administrative Destruction

The Notice of Refusal of Admission and Administrative Destruction is issued to the 

importer of record (who is the same person or firm who was issued the Notice of 

Sampling). All persons or firms who are sent copies of the Notice of Sampling and 

Notice of FDA Action - Detained must also be sent a copy of the Notice of Refusal of 

Admission and Administrative Destruction.

CBP and USPS will be periodically notified by FDA of all lines of drugs valued at $2500 

or less which are subject to refusal and destruction pursuant to section 801(a) of the 

Act, as amended. For additional procedures see the International Mail Facility (IMF)

SOP, available on the OEIO/DIO Intranet page. 
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Charges on the Notice of Refusal of Admission and Administrative Destruction

The individual violations on a Notice of Refusal of Admission and Administrative 

Destruction should be stated exactly as shown on the Notice of FDA Action - Detained. 

If it becomes necessary to include new or amended charges on a Notice of Refusal of 

Admission and Administrative Destruction, an amended Notice of FDA Action - 

Detained must first be issued providing another ten day period (excluding Saturdays, 

Sundays and holidays or additional time when appropriate) for an opportunity for 

hearing. 

When to close the entry

After issuance of the Notice of Refusal of Admission and Administrative Destruction, the 

entry should be kept in an open status until the final disposition takes place at the IMF 

and the product is placed into a locked drum for destruction. The Drum ID # should be 

entered into OASIS before the entry is closed. 

9-5 IMPORTATION OF BIOLOGICAL PRODUCTS

RPM subchapter 9-3, Importation of Biological Products was removed in January 2008 

per CBER request. For procedures regarding the importation of biological products, 

FDA staff responsible for imports of biological products should contact OEIO or refer to 

Importing CBER-Regulated Products into the United States for links to CBER’s Import 

Compliance Programs (CPGM 7342.007 Imported CBER-Regulated Products; CPGM 

7342.007 Addendum, Imported HCT/Ps).

9-6 FDA NATIONAL IMPORT PROCEDURE REGARDING

WAREHOUSE ENTRIES

9-6-1 PURPOSE

To provide operating procedures regarding submission of entry notification to FDA by

Customs for importers filing warehouse entries.

9-6-2 BACKGROUND

When a product is imported into the United States, the Importer of Record (Importer) 

must file entry paperwork with the U.S. CBP. The importer may choose to file a 

consumption entry, pay any applicable duty, and introduce the product into domestic 

commerce. Alternatively, the importer may file a warehouse entry, store the product in a 

bonded warehouse for up to five years, and pay duty only when the product is 

withdrawn for domestic commerce (withdrawal for consumption). If the importer exports 

the product while it is under bond, no duty is incurred.
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There have been several instances where importers have questioned FDA's authority 

over, or right to see paperwork for, FDA regulated product covered by warehouse 

entries and intended for later export rather than domestic consumption.

Any product brought into the United States from a foreign country is "imported" and, 

therefore, subject to the import provisions set forth in section 801 of the FFDCA. Thus, 

all importers, including those filing warehouse entries, are subject to section 801 

procedures, regardless of whether the intent is to later export the imported products. 

See also Compliance Policy Guide (CPG) Sec. 110.200, "Export of FDA Regulated 

Products From U.S. Foreign Trade Zones."

9-6-3 INSTRUCTIONS

To fulfill its obligation to ensure that regulated products comply with the requirements of 

the FFDCA, FDA should receive notification either electronically or by paper, no later 

than the time the warehouse entry is filed with CBP.

9-7 RELEASE NOTICES

9-7-1 PURPOSE

To provide operational procedures for releasing imported lots for which a Notice of

Sampling has been issued.

9-7-2 BACKGROUND

The FFDCA, and its regulations directs that a notice (Notice of Sampling) shall be given 

to the owner or consignee of imported merchandise sampled or intended to be sampled 

under the authority of the Act. The regulations also require the issuance of a further 

notice to advise the owner or consignee of the result of examination of the sample, for 

which a Notice of Sampling has been issued [21 CFR and 1.90]. The Release Notice 

advises the owner or consignee that the merchandise need not be further held insofar 

as the FDA is concerned.

9-7-3 GENERAL COMMENTS

Release Notice Form, or computer generated notice from OASIS, is issued by FDA 

under the signature of the compliance officer or designated individual authorized by 

OEIO to sign the notice, whenever FDA has no further interest in a lot for which a Notice 

of Sampling (or computer generated notice from OASIS) has been issued.

The Release Notice is routinely issued to the importer of record with a copy to CBP and 

the responsible FDA fiscal office and file. In accordance with local practices, copies may 

also be sent to the customhouse broker and the consignee when either is not named as 

the importer of record. In any case, all persons who are issued a Notice of Sampling 

should also be sent the Release Notice.
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To meet the various circumstances surrounding a release, the following variations of the

Release Notice are currently used:

• "Straight" Release

• Release without Examination

• Release with Comment

• Release after Detention

9-7-4 "STRAIGHT" RELEASE

This release form (or the computer generated notice from OASIS) is issued whenever it 

appears, from sample examination or otherwise, that merchandise, for which a Notice of 

Sampling has been issued, is in compliance with the law.

Examples of OASIS Release Notices will be provided at a later date.

9-7-5 RELEASE WITHOUT EXAMINATION

Whenever a sample cannot be examined, for which a Notice of FDA Action/Sampling 

has been issued; a Notice of FDA Action/Release Notice form as identified in Exhibit 9-6

or the computer generated notice from OASIS is issued amended as follows:

"RELEASED WITHOUT EXAMINATION 

MAY PROCEED WITHOUT FDA EXAMINATION ON THE RESPONSIBILITY 

OF THE IMPORTER"

This statement is typed in caps following the blocked information on the notice. An 

example of the OASIS form will be provided at a later date.

9-7-6 RELEASE WITH COMMENT

Background

It had been the practice when an importation was encountered which did not fully 

comply with the requirements of the Act, but the violation was not of sufficient 

importance to warrant detention of the initial importation, to release the shipment with a 

"Release with Warning" that future similar violative importations might be denied entry. 

Although these "Releases with Warning" did not necessarily mean that the correction 

had to be made before the next importation, that frequently was the intent. The brevity 

of the warning often gave such notices an unintentional air of curtness.

Therefore, the "RELEASE WITH WARNING" and "RELEASE WITHOUT PREJUDICE" 

has been replaced with a "RELEASE WITH COMMENT" as a more flexible means of 

handling minor violations.
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Approach

When an importation is encountered which does not fully comply with the requirements 

of the Acts which we enforce, but the violation(s) is (are) not sufficient to warrant 

detention on a first encountered basis, it may be "Released With Comment." The 

violation(s) must be minor, since a shipment with serious infraction(s) should be 

detained. For example, if an FPLA violation which is not considered subject to NLEA 

concerns is encountered in a product this shipment may be "Released With Comment." 

However, if the importer or country of origin has already received "notice" of our FPLA 

labeling requirements, the shipment may be detained. 

A standard Release Notice is used with a notation "Release With Comment" 

prominently shown immediately following the blocked information on the notice. The 

comments may be placed directly on the Release Notice if sufficient space is available 

or, on an attached letter. If a letter is used, it should be stapled to the Release Notice 

and referred to in the body of the Form, i.e. "Release With Comment, See Attached 

Letter of (date)." An example of a "Release With Comment" is shown as Exhibit 9-6

(examples of OASIS Release With Comment notices will be provided at a later date.)

The violations on which the comments are based should be clearly covered by the Acts 

or regulations which we enforce. The comments should be stated in nonlegal language 

with reference to the specific sections of the Acts or regulations involved.

Generally, the Release With Comment should not be used if the problem is one 

commonly existing in domestic commerce and against which no FDA objection has 

been made. Center non-concurrence of detention recommendations that indicate nonagency support of similar domestic violation and past policy procedures with both 

domestic and imported products will serve as guide.

If the violation is clearly absent from similar domestic products, prompt correction 

should be requested by including the statement "Future shipments may be detained 

unless (nature of violation, i.e. misbranding) is corrected." By omitting this statement, 

the comments would serve as an information guide to provide a better understanding of 

the requirements of the law.

Before issuing a Release With Comment that includes a statement that future 

shipments may be detained we must be in a position to take action. However, other 

shipments that may be enroute at the time the comment issues or within a time frame 

established for correction to be completed may be allowed to proceed if otherwise in 

compliance.

A statement on the Release Notice should be included directing the importer to advise 

the foreign manufacturer/shipper of our comments when applicable. A copy of this letter 

should be requested for the FDA file.
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9-7-7 RELEASE AFTER DETENTION

Release after detention is issued in the following situations:

1. After the issuance of the Notice of FDA Action - Detained (or computer

generated notice from OASIS) the importer of record or other designated

agent may present testimony which shows that the merchandise is in

compliance.

2. In response to the Notice of FDA Action - Detained, the importer of record

reconditions the merchandise to FDA's satisfaction pursuant to the terms

of the Application for Authorization to Relabel or Recondition NonCompliant Articles (Form FDA-766), or else causes it to be brought

outside the jurisdiction of the Act. The latter situation can occur, for

example, when an importer diverts insect-adulterated, food-grade starch

to industrial uses (paper manufacturing, etc.).

Under these situations, a Release Notice is issued with a notation "ORIGINALLY 

DETAINED AND NOW RELEASED" prominently shown following the blocked 

information or as appropriately set from the computer generated notice. If the 

merchandise has been reconditioned, the fact of this reconditioning should also be 

shown on the notice including the loss (if any) during reconditioning, reject material, the 

disposition of reject material, and amount of acceptable material. If supervisory charges 

are also involved, the notice should also bear the statement "Subject to bond liability for 

charges in connection with reconditioning."

9-8 DETENTION WITHOUT PHYSICAL EXAMINATION (DWPE)

9-8-1 PURPOSE

To provide operating procedures regarding:

• Authority

• Criteria for recommending action

• Procedure for recommending action

• Criteria for recommending removal of action

• Procedure for notification of removal

9-8-2 AUTHORITY AND BACKGROUND

Section 801(a) of the FD&C Act states, "If it appears from the examination of such 

samples or otherwise that (1) such article has been manufactured, processed, or 

packed under insanitary conditions . . . or the facilities or controls used for the 

manufacture, packing, storage, or installation of the device do not conform to the 

requirements of Section 520(f), or (2) such article is forbidden or restricted in sale in the 

country in which it was produced or from which it was exported, or (3) such article is 
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adulterated, misbranded, or in violation of Section 505, then such article shall be 

refused admission."

Congress authorized FDA to refuse admission of regulated articles based on 

information, other than the results of examination of samples, that causes an article to 

appear to violate the FD&C Act. 

Information such as an article's violative history, among other things, may cause an 

article to appear adulterated, misbranded, or otherwise in violation of the FD&C Act, as 

described in Section 801(a).

Section 801 of the FD&C Act explicitly authorizes FDA to refuse admission of articles 

that appear to violate the Act.

That section also provides the importer with the right to "introduce testimony bearing on 

the admissibility of the articles." To carry out the provisions of Section 801(a), FDA

detains an article that appears violative and provides notice to the importer of the nature 

of the violation and the right to present testimony regarding the admissibility of the 

article (21 CFR 1.94). Depending on the information submitted by the importer, the 

article may either be admitted or refused entry into the United States. 

Detention without physical examination (DWPE), first used by FDA in 1974, is 

appropriate when there exists a history of the importation of violative products, or 

products that may appear violative, or when other information indicates that future 

entries may appear violative. DWPE has the effect of reminding the importing 

community that FDA is a regulatory agency, not a quality control laboratory. Often, 

importers wait until the Agency has issued a Notice of FDA Action - Detained to 

determine whether the articles they are offering for import comply with the FD&C Act

DWPE properly places the responsibility for ensuring compliance with the law on the 

importer.

9-8-3 GENERAL PROCEDURES

Any FDA unit may recommend detention without physical examination or removal from 

detention without physical examination when it believes that such action is warranted. 

Such recommendations are submitted with supporting data and/or information to the 

OEIO/DIO’s Import Compliance Branch via FDA’s Compliance Management Services 

(CMS) system. 

Supporting information should include an analytical package, inspection report, or other 

supporting evidence, and documentation of center concurrence when no direct 

reference authority exists.

DWPE may also be recommended on the basis of analyses performed by state or local 

agencies where FDA has determined that the sampling and testing conducted by such 

agencies is accurate, acceptable and representative of the product on which the 

recommendation is based.
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For analytical findings for which direct reference authority for addition to DWPE has 

been granted from a center to ORA, FDA import divisions have the discretion to 

consider placing future shipments coming through their ports from a particular packer, 

manufacturer or shipper, under detention where a recommendation for DWPE has been 

submitted for OEIO/DIO concurrence, but has not yet been approved. Shipments of this 

nature do not require additional sampling.

9-8-4 RECOMMENDATIONS INVOLVING PESTICIDE RESIDUES

The Center for Food Safety and Applied Nutrition (CFSAN) will be responsible for 

review and concurrence of DWPE recommendations involving pesticide residues for 

which no tolerance has been established. 

Recommendations for DWPE due to pesticide residues for which there is an established 

tolerance should be submitted directly to OEIO.

9-8-5 DIRECT REFERENCE AUTHORITY RECOMMENDATIONS

Certain recommendations for DWPE are assumed to have appropriate Center 

concurrence. These direct reference authorities are memorialized in Compliance Policy 

Guides (CPG), Compliance Program Guidance Manual chapters, memoranda from the 

Center, or other appropriate documents (e.g. CFSAN delegations, etc.). 

If direct reference authority has been granted for a particular situation, 

recommendations for addition to DWPE will not require Center review or evaluation of 

the analytical worksheets for the violative product.

9-8-6 RECOMMENDATIONS BASED ON EIRs, OTHER GOVERNMENT

AGENCIES, MOUs, ETC.

RECOMMENDING OFFICE RESPONSIBILITIES

When inspections conducted by FDA or by foreign or other government competent

authorities under a Memorandum of Understanding (MOU) or other agreement reveal 

conditions or practices warranting DWPE, the recommending office should submit a

recommendation to OEIO/DIO Import Compliance Branch subjecting product(s) offered 

for import to DWPE. The responsible recommending office should submit the

recommendation to OEIO/DIO Import Compliance Branch within fifteen (15) working 

days of endorsing the report of conditions or practices warranting DWPE. 

When the responsible recommending office is satisfied that the appearance of a 

violation has been overcome, either by re-inspection or submission of appropriate 

documentation, the recommending office will submit a recommendation to OEIO/DIO 

Import Compliance Branch to remove the DWPE action. The responsible 

recommending office should submit a recommendation to OEIO/DIO Import Compliance 
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Branch within fifteen (15) working days of the receipt of evidence to overcome the 

conditions or practices warranting DWPE. 

OEIO RESPONSIBILITIES

OEIO/DIO Import Compliance Branch is responsible for reviewing DWPE

recommendations to ensure that actions are timely and that the Import Alert additions 

and removals are handled appropriately. 

When a recommendation for DWPE is received, OEIO/DIO Import Compliance Branch 

will review the recommendation along with the supporting evidence and then review 

national detention data (if necessary) to determine whether the criteria for DWPE has 

been met. 

Packages, for Import Alert(s) or revised Import Alert(s) consideration/implementation, 

will be coordinated for agency clearance by OEIO/DIO. (See RPM subchapter 9-15, 

"Import Information Directives" for clearance procedures).

FDA’s Compliance Management Services (CMS) system serves as the central 

repository for all DWPE evidence. 

9-8-7 DETENTION WITHOUT PHYSICAL EXAMINATION RECOMMENDATIONS

A recommendation for DWPE consideration should be submitted whenever there is 

information that would cause future shipments of a product(s) offered for entry to appear 

violative within the meaning of Section 801(a) of the Act. The recommendation may be 

based on the violative history of a product, manufacturer, shipper, grower, importer, 

geographic area, or country. The recommendation may also be based on other 

information, such as information that food offered for entry was harvested from polluted 

waters, information that a product was manufactured, processed, packed, or held under 

insanitary conditions or manufactured in a manner that is non-compliant with Good 

Manufacturing Practice (GMPs), pursuant to Section 801(a) of the Act. A product, firm, 

shipper, etc., may also be subjected to DWPE because the product is forbidden or 

restricted for sale in the country in which it was produced or from which it was exported; 

adulterated, misbranded, or in violation of Section 505 (unapproved new drug); or 

appears violative as set forth in Section 536(a). A DWPE may be recommended for an 

article with no prior history of detentions if the recommendation is adequately supported 

by information that indicates that future shipments may be violative.

9-8-8 RECOMMENDATIONS BASED ON ONE VIOLATIVE SAMPLE

Under this circumstance, FDA has evidence that at least one sample has been found 

violative and the violation represents a potentially significant health hazard. The sample 

collection and/or analysis may have been conducted by FDA or another reputable 

Federal, State, or local agency.
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In the following instances, one violative sample, collected while a product is in import or 

domestic status, may support a recommendation for DWPE of products from a specific 

manufacturer, shipper, grower, or from a specific growing area or country (if information 

is sufficient to establish an appearance that the violation extends to that area/country):

1. The product may have adverse health consequences. The appropriate

Center, in most instances, would conclude that the problem would warrant

a Class I or Class II recall.

2. The product (fresh, frozen, or processed) contains actionable levels of a

pesticide residue, aflatoxin, or chemical contaminant.

3. The product is a violative low acid canned food, or acidified food. (i.e.,

failure to have a process on file for a specified product or no registration).

4. The product is violative in a way that is likely to continue due to the

product's ingredients or formulation. For example, products which bear or

contain undeclared significant ingredients (i.e., human allergen),

unapproved colors, or violate their applicable standard of identity, or

products that are unapproved new drugs, or unapproved new animal

drugs, will continue to appear violative until the manufacturer of such

products changes the label or formula for the products or obtains agency

approval necessary for legal marketing.

5. The product is a post amendment device that is not subject to an

approved 510(k) or premarket approval application. A copy of the

recommendation should be sent for concurrence to the Center for Devices

and Radiological Health (CDRH), Office of Compliance.

6. The product's labeling is violative and/or not in accordance with the

Nutritional Labeling and Education Act (NLEA) and such violation is likely

to continue until said labeling is corrected by the manufacturer. (See

CFSAN Compliance Program for specific procedures).

Recommendations for DWPE based on one violative sample should include 

documentation of Center concurrence, if such concurrence is required.

Center concurrence is not necessary when the action is covered by direct reference 

authority, as indicated by, among other things, a CPG. Recommendations should also 

include a copy of the analytical package.

9-8-9 RECOMMENDATIONS BASED ON INFORMATION AND HISTORICAL

DATA

When there is evidence that a product from a specific geographical area or country 

could pose a health hazard, the appropriate Center or ORA office should recommend 

DWPE. In such cases, where there is also information that the product is likely to 

continue to be violative, it may not be necessary to collect and analyze a physical 

sample.
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DWPE may be recommended for products offered for import from a manufacturer, 

shipper, grower, geographical area, or country based on information showing a pattern 

of importation of articles that violate the FD&C Act. The information in the 

recommendation establishing a pattern of continuous violations of the FD&C Act should 

indicate that actions necessary to remove such violations have not been taken. In such 

cases, the procedures outlined immediately below would not necessarily apply. Center 

concurrence is, however, necessary in this situation.

9-8-10 RECOMMENDATION BASED ON MULTIPLE SAMPLES

Recommendations for DWPE based on multiple samples showing violations of the Act 

should include documentation of Center concurrence with the recommended detentions, 

or copies of analytical packages if Center concurrence is not required, i.e., where direct 

reference authority is applicable.

Recommendations for detention without physical examination may be submitted for:

1. Specific product(s) from an individual manufacturer or shipper for

violations that do not pose a significant public health hazard, such as

decomposition, filth, labeling, etc., when:

a. There have been at least three (3) detentions in a recent six-month

period or less; and

b. These detentions represent at least 25% of the total shipments of that

product examined in the applicable time period as known to the

recommending office or unit.

2. Specific product(s) from a country or a specific geographic area when:

a. There are at least twelve (12) detentions in a recent six-month period

or less; and

b. These detentions represent at least 25% of the total shipments of that

product examined in that time period as known to the recommending

office or unit; and

c. These detentions represent a significant number of firms that

manufacture, ship, or grow the product from the geographic area or

country.

3. Multiple products from a manufacturer or shipper when:

a. There are at least six (6) detentions in a recent six-month period or

less; and

b. These detentions represent a variety of products and constitute at

least 25% of the total shipments examined from that firm during the

applicable time period as known to the recommending office or unit.

FDA may consider additional information in conjunction with sample analysis when 

considering whether to recommend products from a manufacturer, shipper, geographic 
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area, or country for DWPE, such as the results of foreign inspections or the other types 

of information discussed in this chapter.

9-8-11 DETENTION WITHOUT PHYSICAL EXAMINATION OF IMPORTERS

ENTRIES

Importers bear the primary responsibility for ensuring that products they import comply 

with all provisions of the FD&C Act. To carry out this responsibility, they may choose to 

inspect the foreign manufacturers or growers of products that they import, to enter into 

agreements with foreign exporters, to make arrangements to have products privately 

examined and analyzed prior to importation, and/or to take other steps to verify proper 

labeling and compliance of products with the FD&C Act before offering them for 

distribution into U.S. commerce.

If the responsible FDA offices have documented an importer's practice of repeatedly 

offering violative articles for importation and attempting to recondition such shipments 

only after FDA detention, or of repeatedly attempting to export shipments or withdraw 

entries after receiving a notice of sampling or other indication of FDA interest (e.g., 

inquiries regarding product location), DWPE should be recommended covering either 

specific commodities or all FDA regulated products offered for entry by that importer, as 

warranted.

DWPE should also be recommended if there is other persuasive evidence that future 

shipments by an importer may be violative. For example:

1. Information received from other government agencies (e.g. U.S. CBP)

concerning violative practices by the importer or the importer's foreign suppliers

that would cause the articles to appear violative under section 801(a) (e.g.,

misdeclaration of products to avoid detention without physical examination);

2. A documented history of attempted importation of violative articles that has

resulted in the issuance of a Warning Letter to the importer with no subsequent

response from such importer or which does not result in the correction of such

practice;

3. Verifiable information in the form of consumer or trade complaints, or otherwise,

that has the effect of causing the articles offered for import to appear adulterated,

misbranded, or otherwise in violation of the FD&C Act as specified in Section

801(a). This information may include repeated requests for notices of refusal or

attempts to cancel or export an entry after receiving a notice of sampling or other

indication of FDA interest.

Based on a review of detention data, the responsible FDA office may recommend that 

an importer be placed on detention without physical examination when the importer 

exhibits a high percentage of violations of a single product, a group of products, or all 

products. All such recommendations, formatted as Import Alerts, should be submitted to 

OEIO for clearance. Each recommendation should include suggested charges; 

however, final charges to be used will be determined by the appropriate Center with 

input from the FDA Office of the Chief Counsel (OCC) as needed.
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9-8-12 RECOMMENDATIONS BASED ON ESTABLISHMENT INSPECTION

Establishment inspections of foreign manufacturers of FDA regulated products that 

reveal significant deviations from GMPs, insanitary conditions, or other practices that 

result in the articles manufactured at such facilities appearing to be misbranded, 

adulterated, or otherwise in violation of the FD&C Act as described in Section 801(a) 

should result in the recommendation of DWPE of the articles offered for import from 

such manufacturer. Foreign manufacturers of FDA regulated products who refuse to 

permit or delay FDA establishment inspection may be subjected to DWPE (see FFDCA 

807(b) (foods); FFDCA 501(j) (drugs, medical devices); and 21 CFR 820.1(d) (medical 

devices)). The recommending office should identify the scope of the recommended 

action based upon review of the establishment inspection report or other evidence.

The instances of DWPE described above may identify one firm, multiple locations of a 

firm, or specific products from one or more firms as appropriate. The criteria for 

determining whether to subject a manufacturer’s or importer’s articles to DWPE may 

differ from Center to Center. The recommending office should consult with the 

appropriate Center or ORA counterpart when making a recommendation for DWPE 

following FDA inspections of foreign manufacturers. 

9-8-13 OTHER SITUATIONS

In cases other than those described above, a recommendation may be made for DWPE

if there is a reason to believe, and evidence to support, that future shipments of a 

product or class of products will appear violative within the scope of Section 801(a).

9-8-14 PARTY NOTIFICATION OF DETENTION WITHOUT PHYSICAL

EXAMINATION DECISION

The FDA will notify different parties regarding the application of DWPE depending on 

the nature and scope of the action. In most instances, a copy of the Import Alert will 

suffice for notification. FDA notification of DWPE actions should be directed to: 

1. National CBP, or other federal agency enforcement branch

2. Local office of CBP (by each appropriate FDA office when necessary)

3. Appropriate foreign embassy or foreign government, (by the Office of

International Programs, OC or the appropriate ORA International liaison)

4. Importer/broker associations, as appropriate (by OEIO/DIO)

5. Specific foreign manufacturers or shippers, as appropriate (by CFSAN -

LACF/AF; CDRH - 510(k), PMA, GMPs; by CDER - pre-approval NDAs, GMPs;

by CVM - pre-approval NADAs, GMPs; by CBER - license revocation)

If notification of the specific foreign manufacturer or shipper is deemed

impractical or impossible due to incomplete information, distance, communication

difficulties, etc., notification should be sent to the importer, requesting transmittal

of the notification to the foreign manufacturer and requesting a response to

include what steps were taken to correct the conditions which brought about the

detention without physical examination.
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6. Industry associations as appropriate (by Centers).

9-8-15 REMOVAL FROM DETENTION WITHOUT PHYSICAL EXAMINATION

FDA decisions to remove a product, manufacturer, packer, shipper, grower, country, or 

importer from DWPE should be based on evidence establishing that the conditions that 

gave rise to the appearance of a violation have been resolved and the agency has 

confidence that future entries will be in compliance with the FD&C Act.

When applicable OEIO/DIO shall consult with the appropriate FDA office regarding a 

proposal to remove a firm or product from DWPE. A recommending office may also 

contact OEIO/DIO directly and recommend a firm and or its product(s) no longer be 

subject to DWPE under a specific Import Alert. An important element of FDA's decision 

to remove a product, manufacturer, packer, shipper, grower, country, or importer is the 

extent to which the evidence shows that future shipments will be in compliance with the 

FD&C Act and implementing regulations. 

Evidence establishing that the conditions that gave rise to the appearance of a violation 

have been overcome may take different forms depending upon the nature of the 

violation and evidence supporting DWPE for the product:

• If a product has been placed on DWPE because it appears violative under

Section 801(a)(1) as the result of adverse findings from an establishment

inspection, FDA may require an establishment inspection which demonstrates

the firm has adequately addressed their violative conditions before removal from

DWPE.

• If a product has been placed on DWPE because it appears violative under

Section 801(a)(2), documentation that a product is no longer forbidden or

restricted for sale from the government of the country in which it was produced or

from which it was exported may be required before removal from DWPE.

FDA may require the manufacturer to submit a description of actions taken to prevent 

the problem from recurring (such as results of a root cause analysis identifying the 

source of the violation and a description of corrective actions implemented) before 

removal from DWPE.

• For those products identified for DWPE because they appear to be violative

under Section 801(a)(3), in addition to the actions taken to prevent the problem

from recurring as described above, a minimum of five (5) consecutive nonviolative commercial shipments may be required to confirm the continued

effectiveness of any corrective actions before the agency can consider that the

appearance of the violation has been overcome, and that it may be appropriate

to remove the DWPE. In some instances, more than 5 consecutive non-violative

shipments maybe needed.
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• Shippers are typically placed on DWPE when the true identity of the

manufacturer of the product that appears violative cannot be determined.

Therefore, if after a six-month period a shipper subject to DWPE has not offered

for entry any shipment that is violative and can provide documentation to FDA

indicating the steps taken to ensure that the shipper does not offer for entry,

articles that do not comply with the FD&C Act, the shipper may be removed from

DWPE. However, if the manufacturer of the violative product is subsequently

identified, removal of such product from DWPE should be based on specific

information that overcomes the appearance of a violation and should be

submitted by the manufacturer, and not by the shipper.

NOTE: FDA may audit these entries to ensure the validity of the analysis.

However, depending on the nature of the apparent violation, a proper registration, 

scheduled process filing, 510(k) substantial equivalence order, Premarket Approval 

Application (PMA), NDA or NADA, re-inspection, or other documentation may be 

necessary before the appearance of a violation is overcome and the DWPE is removed.

If during the review to determine whether the appearance of a violation has been 

removed an apparently violative entry is offered, the review process may be 

discontinued until information is submitted to show that the problem has been corrected.

Under some circumstances, more than the minimum number of in compliance 

consecutive shipments may be necessary to establish that the violative practices or 

conditions have been fully resolved. For example, a shipper, grower, etc., who after 

being removed from DWPE once again begins to ship the same type of violative 

products, may need to present more than five (5) consecutive non-violative shipments 

to remove the appearance of a violation and to be considered for removal from DWPE. 

When there is a continued history of entry of the same non-compliant product(s), 

documentation showing that the cause of the violation has been fully corrected may also 

be necessary.

Splitting shipments into several entries or lines should not be considered as a means to 

increase the number of non- violative shipments. FDA needs to be confident that 

articles offered for importation are in compliance not just on one day, but over the 

course of a reasonable time period. Otherwise, such articles will continue to APPEAR 

violative. If there is reason to conclude that two or more entries (or lines) represent a 

single related shipment or lot, these should be considered to be a single shipment.

Shipments should represent routine commercial entries, and should not be divided or 

staged, such that they are presented essentially to establish a pattern of compliance. 

Shipments that consist of less than 10 to 15 cartons, which do not represent normal 

industry practice (e.g., unless the product is a high value commodity normally shipped in 

smaller quantities such as specialty cheese, etc.), may not be considered in the DWPE

removal process. FDA needs to be certain that adequate product is available for 

representative sampling and private laboratory analysis, as well as for possible audit
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sampling by FDA. (Refer to ORA Laboratory Procedures Manual (LM), Volume III, 

Section 7 for procedures regarding private laboratories). The Office of Regulatory 

Science (ORS) should be contacted regarding the acceptance/non-acceptance of 

laboratory data.

Shipments presented for consideration for removal from DWPE should be in compliance 

with the FD&C Act or other statutes enforced by the Agency. Special situations may 

occur in which data presented may not conclusively demonstrate full compliance of the 

entry with the FD&C Act. In such situations, FDA staff may have additional evidence

which, while allowing the shipment to be removed from DWPE, may still preclude the 

shipment's release.

9-8-16 REMOVAL OF PRODUCTS MANUFACTURERS/COUNTRIES EXCEPT

FRESH PRODUCE

Recommendations for removal from DWPE should be forwarded to OEIO/DIO Import 

Compliance Branch for review when documentation establishes that the appearance of 

a violation has been removed. The recommendation should identify the entry numbers 

that have been analyzed or examined and found to be in compliance. In addition, other 

documentation may be necessary to verify that violative conditions no longer exist, e.g., 

product formulation information, information establishing label revisions, information 

showing a change in the use of food or other chemical additives, etc. The following 

guidelines should also be met:

1. Specific products from an individual manufacturer - the last five shipments have

been documented to be in compliance with the FD&C Act.

2. Specific products from a country or a specific geographic area - the last twelve

(12) shipments have been established to be non-violative. These twelve

shipments should include a representative number of manufacturers/shippers

from the geographic area or country offering the products for entry.

3. Multiple products from a specific manufacturer - the last twelve (12) shipments

have been established to be non-violative. These twelve shipments should

represent the range of products normally entered by the firm or each of the

products covered by the detention without physical examination if only specific

products are listed.

NOTE: For detentions without physical examination based on country or

geographic problems with a product, shippers should not be removed from

detention without physical examination. Shippers should ensure that the

manufacturer of the articles they import is shown on entry documents so that

FDA can determine whether the manufacturer has corrected the Problem(s) with

the Products.
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9-8-17 REMOVAL OF FRESH PRODUCE

Chemical Contamination:

Recommendations to remove fresh produce from detention without physical 

examination for chemical contamination may be made by the responsible FDA office

upon consideration of all relevant information and criteria. OEIO/DIO Import Compliance 

Branch should be notified of all such recommendations.

Pesticides:

Once an illegal pesticide residue has been found, past experience has shown that 

future shipments of the affected food may likely contain the illegal residue(s) throughout 

the growing and shipping season, or longer. FDA, or other interested party, may 

recommend removal of a grower from DWPE when the grower has entered a minimum 

of five (5) consecutive recent shipments without violation and when:

1. The grower demonstrates through adequate documentation that the residue

problem no longer exists;

OR

2. The country/grower/importer demonstrates through adequate documentation

that each lot of produce to be offered for entry originated in fields that were

not treated with the pesticide in question;

OR

3. Information is obtained demonstrating that the produce originated in untreated

fields, including documentation on the types of pesticides used in the

surrounding fields, the dates and method of pesticide application, and the

results of analyses from a representative sampling of the allegedly untreated

field or lot (i.e., along borders and mid section) showing that the product from

the implicated field is in compliance;

OR

4. Information is obtained on the steps that have been instituted to prevent the

occurrence of illegal pesticide residues in future shipments.

Recommendations to remove a product or firm from DWPE may be made at any time if 

supported by information that demonstrates that detention without physical examination 

is no longer warranted.

FDA may end the detention without physical examination after one year of the effective 

date if:

• There is a clearly defined growing season, and

• It is not a recurring problem, and

• There is an adequate program (having government support) set up to monitor

and address the problem, and
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• Evidence has been received which demonstrates that the problem no longer

exists. OEIO will monitor import alerts concerned with the detention without

physical examination of fresh produce to assure that an assessment is made by

the responsible FDA offices and/or headquarters as to whether to remove or

continue the detention without physical examination of a product/grower after its

anniversary date.

9-8-18 REMOVAL OF IMPORTERS

If an importer has been placed on detention without physical examination for the first 

time for a specific product, a recommendation for removal may be appropriate after the 

importer supplies acceptable documentation that the last five (5) shipments of that 

product from a specific manufacturer entered in full compliance with the FD&C Act. 

If the importer has been placed on detention without physical examination for the first 

time for multiple products, a recommendation for removal may be appropriate after that 

importer supplies acceptable documentation that the twelve (12) most recent entries 

were in full compliance. The twelve (12) entries should represent the range of products 

covered by the detention without physical examination and normally entered by the 

importer.

If an importer is on detention without physical examination and it is not the first time, a 

recommendation for removal may be appropriate after that importer supplies acceptable 

documentation that the ten (10) most recent entries were in full compliance, in the case 

of a specific product, or the last twenty-four (24) entries, in the case of multiple 

Products. 

In addition, a request from an importer that he or she be removed from detention 

without physical examination should include in sufficient detail, the steps that he or she 

has taken to prevent the entry of products that appear violative in the future.

9-8-19 REMOVAL BASED UPON AN ESTABLISHMENT INSPECTION

Firms or products placed on DWPE based on a violative establishment inspection, or 

because the products appear to have been manufactured in violation of GMPs, may 

generally be removed from DWPE following a reinspection which in some instances 

may be performed by a reliable entity other than the one that performed the initial 

violative inspection that confirms that corrective actions have been instituted and after 

concurrence by the appropriate Center. In some instances, a firm may present 

information or documentation sufficient to demonstrate that appropriate corrective 

actions are in place to overcome the appearance of a violation and, with the appropriate 

Center concurrence, may be removed from DWPE. 
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9-8-20 NOTIFICATION OF REMOVAL FROM DETENTION WITHOUT PHYSICAL

EXAMINATION

The same FDA units responsible for the initial notification of the imposition of the 

DWPE, per RPM subchapter 9-8, "Party Notification..." should notify the same parties of 

the removal of such detention.

9-9 NOTICE OF FDA ACTION - DETAINED FOR NON-MAIL

SHIPMENTS

9-9-1 PURPOSE

To provide FDA staff with information for:

1. The evidence to support a detention.

2. Preparation and issuance of the "Notice of FDA Action - Detained."

3. Charges under Section 801, or other Acts enforced by FDA.

4. Custody over detained shipments.

5. Detention of illegal products that are not properly identified for further

processing and exportation under 801(d)(3).

9-9-2 BACKGROUND

In developing FDA's automated import system, known as OASIS, the specific form 

"Notice of Detention and Hearing" has been replaced by the "Notice of FDA Action" with 

the description of the article sampled and the results of the examination indicating 

"Detained" for the specific article in the entry. The use of the designation "DETAINED" or 

similar wording should be considered as meeting the requirements of the wording of the 

law and regulation when applied to "giving notice thereof to the owner or consignee."

The "Notice of FDA Action - Detained" gives notice of the right to a hearing on the 

detention for appearance of a violation (21 CFR 1.94). and identifies charges that an 

import entry may violate under the FFDCA, Public Health Service Act (PHS Act) or other 

acts enforced by the FDA. Under the FFDCA section 801(a) an article subject to the 

FFDCA shall be refused admission if it appears to (1) have been manufactured, 

processed, or packed under insanitary conditions or, in the case of a device, the methods 

used in, or the facilities or controls used for, the manufacture, packing, storage, or 

installation of the device do not conform to the requirements of section 520(f), or (2) such 

article is forbidden or restricted in sale in the country in which it was produced or from 

which it was exported, or (3) such article is adulterated or misbranded, or in violation of 

section 505. It also provides the owner or consignee with an opportunity to introduce 

testimony relative to the admissibility of the lot.

It should be noted that the Act does not provide specifically for the issuance of a notice 

charging that an entry of imported merchandise appears to be in violation. However, 21 
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CFR Section 1.94 provides that if it appears that an imported article may be subject to 

refusal of admission, the director of the responsible FDA office shall give the owner or 

consignee a written notice to that effect.

9-9-3 EVIDENCE, ISSUANCE OF NOTICE, AND PREPARATION OF CHARGES

Evidence Required for Detention

Every detention must be based upon evidence of a violation of the law(s) enforced by 

FDA. This does not mean that comprehensive examinations are required as a condition 

for detention or that detention cannot be based upon very brief examinations if these are 

sufficient to furnish evidence creating the appearance of a violation

Furthermore, it is not essential that a detention invariably be based upon examination of 

a sample, as Section 801(a) of the FFDCA provides for refusal of admission if "it appears 

from the examination of such samples or otherwise" that the article is violative. However, 

in those cases in which detention is made without examination, there should be 

substantial evidence of a documentary type, (i.e., a violation in a previous shipment of the 

entered product from the same firm-see RPM subchapter 9-8 "Detention without Physical 

Examination" for additional procedures) to warrant a charge of violation.

Issuance of Notice of FDA Action - Detained

The Notice of FDA Action - Detained which lists articles as being detained is addressed 

to the filer, the importer of record who is legally responsible for assuring compliance with 

all laws and regulations affecting the importation of the merchandise in question, and 

consignee (if different from the importer of record). Copies should also be sent to 

whomever else was sent copies of the "Notice" for the sample collected. See RPM 

subchapter 9-21 "Notice of Sampling" for specific procedures on issuance of this notice.

Preparation of Charges

The statement of charges on the Notice of FDA Action - Detained issued for a detained 

product is the only information the importer has regarding the apparent violation(s) with 

which the importation is charged. It should be sufficiently informative and complete for the 

importer to understand clearly the alleged violation(s) so that the importer can prepare a 

reply for the hearing.

A separate charge should be made for each apparent violation. See Exhibit 9-5 to this 

chapter for charges used in OASIS. The charge should cite the section of the FFDCA

violated, quote the pertinent portion of that section, and make a brief statement of the 

specific way in which the product appears to be in violation. Charges are drafted in 

accordance with Section 801 of the FFDCA, as: "The article is subject to refusal of 

admission pursuant to Section 801(a)(***) in that it appears to ***" (*** completed as 

appropriate for charge). Charges are based on the section of the FFDCA and not the 

regulations unless the FFDCA is not specific enough to identify the exact violation. 
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Under the OASIS procedure for issuing the Notice of FDA Action for a detained product, 

the individual responsible for the decision as to the compliance of the article will select 

the appropriate charge from the list of charges available in the OASIS system. The 

selected charge will be incorporated into the Notice of FDA Action and the annotation 

required to specify the particular concern(s), where applicable, will be incorporated by the 

responsible FDA office. For example, if the article is being detained for the presence of a 

particular pesticide residue, the responsible FDA office would annotate the charge 

provided by OASIS (using the narrative field) with the name of the specific pesticide 

residue found or alleged to be present.

See Exhibit 9-6 example of the "Notice of FDA Action" issued under the OASIS which 

includes the identification of article(s) for detention.

9-9-4 CUSTODY OF DETAINED SHIPMENTS

US CBP regulation and the FFDCA [19 CFR Part 113, 21 U.S.C. 381(b)] provide that a 

bond considered necessary for the protection of the revenue or assurance of compliance 

with any pertinent law, regulation or instruction be posted for merchandise. The bond 

includes a requirement that up to 3 times the value of the entry of merchandise be posted 

to cover cases involving default on the conditions of the bond [19 CFR Part 113.62(m)(1)].

All formal entries of FDA regulated product are considered by CBP to be "Restricted 

Merchandise" and as such are required to have a bond established prior to conditional 

release by CBP. Informal entries, those entries whose value is currently less than $2,500, 

are usually not imported under bond. Informal entries subject to FDA review may be 

requested to have a bond established for them in accordance with CBP regulation. 

Accordingly, physical possession of a shipment need not be retained by CBP pending 

FDA examination when the bond (single entry or term bond) is in place. See 19 CFR 12.3. 

However, if there is reason to believe that the shipment will not be held intact, 

arrangements should be made with CBP officials to maintain physical possession of the 

shipment. [See procedures under RPM subchapter 9-16 "Priority Enforcement Strategy 

for Problem Importers"] 

9-9-5 DETENTION OF VIOLATIVE PRODUCTS THAT ARE NOT PROPERLY

IDENTIFIED FOR FURTHER PROCESSING AND EXPORTATION UNDER 

801(D)(3)

The "FDA Export Reform and Enhancement Act of 1996," referred to as the "Export 

Reform Act," Public Law 104-134 became law on April 26, 1996. Technical amendments 

were enacted on August 6, 1996 (Public Law 104-180). The Export Reform Act contains 

provisions allowing the importation of certain products, including drug and device 

components, food and color additives, and dietary supplements, which would otherwise 

be considered non-compliant with the FFDCA and be subject to refusal of admission, 

when intended for further manufacturing into products to be exported.
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When a product is imported under the provisions of Section 801(d)(3) of the Act, the 

statute requires the importer to submit a statement to the Secretary (FDA) at the time of 

importation that such article is being imported or offered for import with intent to be

incorporated by the initial owner or consignee into a drug, biological product, device, food, 

food additive, color additive, or dietary supplement that will be exported by such owner or 

consignee from the United States in accordance with Section 801(e) or 802 of the Act, or 

Section 351(h) of the Public Health Service Act. Failure to provide this information at the 

time of importation should be viewed by the responsible FDA office as evidence that the 

product does not meet the conditions of Section 801(d)(3). Therefore, if the information 

is not provided at the time of importation, and if the product is otherwise subject to refusal 

of admission pursuant to Section 801(a) of the Act, the responsible FDA office should 

issue a Notice of FDA Action - Detained in accordance with normal procedures. If no 

response is received by the responsible FDA office to the Notice of FDA Action - Detained

that the product meets the requirements for notification of intent for import for export, a

Notice of Refusal should be issued. See RPM subchapter 9-11 "Notice of Refusal of 

Admission, Instructions, "When Should the Notice of Refusal of Admission be Issued?" 

Once issued, cancellation of the Notice of Refusal should only be considered under 

unusual circumstances at the discretion of the responsible FDA office. See RPM 

subchapter 9-11 "Notice of FDA Action - Refusal of Admission", Instructions, "Re-opening

of a Case" and RPM subchapter 9-17 "Import for Export", for additional information and 

procedures for import for export entries.

Relevant Exhibits

Exhibit 9-5 Specimen Charges

Exhibit 9-6 Notice of FDA Action

9-10 RESPONSE (HEARING) TO NOTICE OF FDA ACTION -

DETAINED

9-10-1 PURPOSE

To provide operating procedures for FDA personnel regarding who can respond to a 

Notice of FDA Action - Detained; time frames for responding; and conduct of the hearing.

9-10-2 BACKGROUND

Section 801(a) of the FFDCA provides the owner or consignee of FDA regulated imported 

goods with an opportunity to appear before the Secretary of Health and Human Services 

to introduce testimony relative to the admissibility of their imported shipment.

21 CFR Section 1.94 provides that if it appears that an imported article may be subject to 

refusal of admission, the director of the responsible FDA office shall give the owner or 

consignee a written notice stating the reasons therefore. This regulation further provides 

that this notice shall specify a place and period of time during which the owner or 
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consignee shall have an opportunity to introduce testimony, either orally or in writing, as 

to the admissibility of the shipment.

In developing FDA's automated import system, OASIS, the specific form "Notice of 

Detention and Hearing" has been replaced by the issuance of a "Notice of FDA 

Action," which contains a description of the article(s) and action taken for a specific entry. 

The use of the designation "DETAINED," or other similar wording, under the heading of 

"Current Status," should be considered as meeting the requirements of the wording of the 

law and regulation when applied to "giving notice thereof to the owner or consignee." See 

RPM Exhibit 9-6 for an example of "Notice of FDA Action" for detention.

9-10-3 ELIGIBILITY OF RESPONDENTS

Section 801(a) of the FFDCA and FDA regulation 21 CFR 1.94 provide the owner or 

consignee an opportunity to introduce testimony relevant to the admissibility of the article 

if it appears that an imported lot may be subject to refusal of admission. However, the 

regulations are rather complicated as to the definition of "owner or consignee." 21 CFR 

1.83(a) defines, for the purpose of the regulation, the owner or consignee as the person 

who has the right of a consignee under Sections 483, 484, and 485 of the Tariff Act of 

1930, as amended (19 U.S.C. 1483, 1484, 1485).

For the purposes of the Tariff Act, only the declared consignee as shown on the bill of 

lading may be the importer, unless bill of lading endorsements by this consignee confer 

his rights to other persons. For the purposes of the Tariff Act, the consignee (importer) is 

to be regarded as the owner of the imported goods. If the consignee (importer) is not the 

true owner of the goods, the true owner may file with the District Director of CBP a 

declaration of ownership, which bestows upon the true owner all of the rights of a 

consignee. Thus, we are obligated by statute to recognize as eligible for the presentation 

of testimony, the consignee (importer) or the true owner (if the true owner is not the 

consignee) if there is on file with CBP a declaration of ownership.

In addition to the consignee (importer) and the true owner, we also recognize the eligibility 

of the importer of record to present testimony. (The importer of record is the person or 

firm who guarantees, by bond, proper custody and handling of the imported shipment in 

compliance with the laws governing such shipment. The importer of record may be the 

broker, consignee, true owner, or whoever owns the bond covering the shipment.) In most 

cases, it is the importer of record who responds to the "Notice of FDA Action - Detained."

A designated representative of the consignee (importer), true owner, or importer of record 

may appear in the consignee's (importer's) behalf; however, unless known to be 

authorized representatives, the responsible FDA office should require proper 

documentation designating the individual(s) to be a bonafide representative for the 

purpose of the hearing. Recognition of others may open the way for claims by the 

consignee (importer), true owner, or importer of record that FDA has denied or abridged 

the importer's right to be heard, or for complaints that FDA has permitted unauthorized 

persons to intrude into the case.
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9-10-4 HEARINGS AND POSTPONEMENTS

The "Notice of FDA Action - Detained" provides an opportunity for the introduction of 

testimony or the filing of a statement in writing within ten days (or longer if circumstances 

require a longer time for response) following the date of detention shown on the notice 

(excluding Saturdays, Sundays, and holidays). This is indicated on the Notice by the 

reference to a "Respond By" date. The "introduction of testimony" may take many forms, 

including a telephone conversation, a FAX or mail, and does not have to be introduced in 

person. However, if the consignee (importer), true owner, or importer of record requests 

a hearing as such, it should be scheduled for the earliest possible date.

The response period may be extended at the request of the respondent if it is made within 

the 10-day time-frame shown in the "Notice of FDA Action - Detained," and the requestor 

provides a reasonable basis for extension, and the requested extension is confirmed in 

writing. It is preferable for extension requests to be made in writing, but this is not 

mandatory. Such requests should be answered by the responsible FDA office, in writing. 

If the request is granted, the new time frame should be clearly stated in the response 

letter.

Generally speaking, requests for extension for indefinite or excessively long periods 

should not be granted. This also applies to requests for extensions based upon reasons 

other than to obtain or prepare evidence pertaining to the specific charges of the 

detention. However, extensions should only be granted if some type of resolution is 

actively being pursued.

9-10-5 CONDUCT OF HEARING: PERSONAL APPEARANCE OF RESPONDENT

The import hearing provided by section 801(a) of the Act is a different procedure from a 

hearing pursuant to Section 305 of the Act. Under section 801(a), it is the respondent's 

opportunity to present a defense of the importation and/or to present evidence to show 

how the importation may be made eligible for entry. This type of hearing may vary from a 

series of telephone conversations to a more formal 305 type of meeting. Formal 

memoranda covering import hearings are not required, although a written record should 

be made for the files.

The hearing officer (generally it is the appropriate ORA compliance officer, however, it 

may be any individual designated by the responsible FDA office to conduct such a 

hearing) should avoid any indication of prejudice or pre- judgment until all evidence is 

submitted and should assure that the respondent has been provided ample opportunity 

to present all relevant evidence. If the question arises, the respondent should be made 

aware of their rights of appeal to a higher level of review in the agency, including to the 

specific Center responsible for the detained article, to the Associate Commissioner for 

Regulatory Affairs, to the Commissioner of FDA, to the Secretary of Health and Human 

Services; and to file legal actions with the court.
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The hearing should be confined to relevant matters, and the respondent should be 

required to confine their comments to the submission of relevant evidence and not be 

permitted merely to attempt to question, probe, or pass judgment on FDA's basis for 

detention.

If the facts in the case are such that a decision can be reached regarding the validity of 

the detention charges at the termination of the hearing, the hearing officer should so 

advise the respondent of the decision with confirmation by the issuance of the appropriate 

"Notice," (Refusal, Release, etc.). A copy of the appropriate "Notice" should be sent to 

the importer of record, if this person is not the respondent.

There is no need to dictate a summary of the hearing in the presence of the respondent, 

as is done during a "Section 305 meeting," nor is it necessary to provide the respondent 

with a copy of our memorandum covering the hearing.

Occasionally, a respondent at an import hearing attempts to weigh the relative desirability 

of appealing a refusal of admission against submitting a request for an authorization to 

relabel, recondition, etc. (Form FDA-766), or reopen the basic question of the shipment's 

legality if relabeling or reconditioning is unduly burdensome. The respondent should be 

advised that orderly procedure requires that the respondent first present a view on the 

validity of the FDA charge(s), and then, if the respondent concludes that the charges are 

valid, a request for an authorization to relabel or recondition or refusal can be submitted. 

This should not be taken as preventing a discussion, at the appropriate time, of what is 

needed to bring the article into compliance. Once the hearing has been held and a Form 

FDA-766 has been submitted for an authorization to relabel or recondition, the hearing 

should not be reopened for the purpose of determining whether the article is subject to 

refusal of admission.

On occasion, a respondent will request that a Notice of Refusal of Admission be issued 

immediately so the merchandise can be exported. These requests should also be 

confirmed in writing by the respondent. Requests for issuance of a Notice of Refusal of 

Admission should be acted upon without delay.

9-10-6 CONDUCT OF HEARING: WRITTEN REPLY (MAIL, FAX, ETC.) FROM

RESPONDENT

The response to a Notice of FDA Action - Detained by mail is no different from a hearing 

where a verbal response is provided. The hearing officer must consider the evidence 

developed by FDA and that presented in the written response, and then make a decision 

as to whether or not the importation is violative as charged in the Notice of FDA Action - 

Detained. All such responses should be replied to in writing, e.g., appropriate "Notice" 

with a clear statement of the hearing officer's decision. A copy of this Notice should be 

sent to the importer of record, if the person is not the respondent.

Questions regarding appropriateness of respondent, procedures for conducting the 

hearing, or other concerns not specifically identified in these procedures, should be 

referred to OEIO (301-796-0356). 
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9-11 NOTICE OF FDA ACTION - REFUSAL OF ADMISSION

9-11-1 PURPOSE

To provide operating procedures for FDA personnel for issuing the Notice of Refusal of 

Admission. This section covers all articles excluding drugs valued at $2500 or less. For 

those products see RPM subchapter 9-4 Notice of Refusal of Admission and 

Administrative Destruction for Mail Shipments of Drugs. 

9-11-2 BACKGROUND

Section 801(a) of the FFDCA directs the Secretary of the Treasury to issue a Notice of 

Refusal when it appears from examination of samples, or otherwise, that an imported 

shipment is in violation. This Section also orders the destruction of any such shipment 

refused admission, unless it is exported within 90 days of the date of the notice, or 

within such additional time as may be permitted pursuant to such regulations.

9-11-3 INSTRUCTIONS

Who Should Issue the Notice of FDA Action - Refusal of Admission?

The language of the law places the responsibility for issuing the Notice of FDA Action - 

Refusal of Admission upon the Secretary of the Treasury who in turn has delegated this 

responsibility to the CBP. Traditionally, this notice is issued by the responsible FDA 

office over the facsimile signature of the Regional or District Director of CBP in

accordance with local agreement. Each FDA issuing office shall have a facsimile stamp 

of the signature of the Regional or District Director of CBP prepared for this purpose 

and supplied to the appropriate personnel, or have written delegation of authority from 

the District Director of CBP to issue the Notice of FDA Action - Refusal of Admission 

under FDA personnel signature. A new stamp should be prepared each time there is a 

change of personnel in the Regional or District Director of CBP position.

The name and contact information of the compliance officer or the responsible FDA 

office that issues the Notice of Refusal of Admission is automatically indicated by 

OASIS on the notice. 

When Should the Notice of FDA Action - Refusal of Admission be Issued?

A Notice of FDA Action - Refusal of Admission is issued under the following 

circumstances: 

1. A response to a Notice of FDA Action – Detained is not received within the

specified ten day time frame (excluding Saturdays, Sundays, and

holidays) and an extension of time for responding has not been granted.

(Additional time may be noted due to circumstances affecting FDA

operations).
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2. Efforts to relabel or recondition the detained shipment pursuant to an

approved application (Form FDA-766) have failed.

3. When a detained shipment has been reconditioned pursuant to an

approved application (Form FDA-766), and we have agreed to the

exportation of the reject material, a Notice of FDA Action - Refusal of

Admission is issued covering the rejects.

4. After a hearing relative to the validity of the charges for detention, the

hearing officer rules that the charges are valid and a Form FDA-766 has

not been submitted.

NOTE: If a detention action is being appealed by the importer do not issue the Notice of 

FDA Action - Refusal of Admission until the appeal is decided. The responsible FDA 

office should notify the CBP office of the delay to assure liquidation of the bond does not 

occur. 

Distribution of the Notice of FDA Action - Refusal of Admission

The Notice of Refusal of Admission is always issued to the importer of record (who is 

the same person or firm who was issued the Notice of Sampling). In accordance with 

local practices, copies may also be sent to the customhouse broker and the consignee 

when neither is the importer of record. All persons or firms who are sent copies of the 

Notice of Sampling and Notice of FDA Action - Detained must also be sent a copy of the 

Notice of Refusal of Admission.

Two copies of the Notice must also be sent to CBP.

Charges on the Notice of FDA Action - Refusal of Admission

The Notice of FDA Action – Refusal of Admission should contain only those charges 

that are applicable at the time of refusal. 

If during the detention and hearing period, sufficient testimony is provided to overcome 

one or more of the charges listed, a new Notice of FDA Action – Detained does not 

need to be issued. Charges that have been overcome will instead be omitted from the 

Notice of FDA Action – Refusal of Admission when it is issued. 

If it becomes necessary to add new charges or amend existing charges on the last 

issued Notice of FDA Action - Detained, a new Notice of FDA Action - Detained should 

be issued to reflect all applicable charges (including amendments, additions, or removal 

of charges by FDA). The importer of record should be given a new 10-day detention 

and hearing period (excluding Saturdays, Sundays and holidays or additional time when 

appropriate) to allow for the submission of testimony/evidence or Form FDA-766

Request for Reconditioning for all charges.
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When to Close the Case

After the Issuance of the Notice of Refusal of Admission, the case should be kept in an 

open status until the receipt of the return copy of the Notice of Refusal from CBP 

showing the exportation or destruction of the shipment.

If the return copy is not received from CBP within 100 days, a letter inquiring as to the 

status of the shipment, or other agreed upon procedure established with your local CBP 

port, should be made.

It is important to monitor the final disposition of refused shipments, as FDA has 

encountered the distribution of such merchandise into domestic channels instead of 

exportation or destruction. FDA staff should follow the procedures for follow-up to 

refusals.

Requests for Extension Beyond the Ninety Day Period

If request are received for an extension beyond the 90 day period to export or destroy a 

refused shipment, the requestor should be referred to the appropriate CBP office. Since 

the Notice of Refusal of Admission is the responsibility of CBP, FDA cannot grant such 

extensions.

Reopening of a Case

Unless a Notice of Refusal of Admission was erroneously issued by FDA, consideration 

should not normally be given to requests to void the Notice in order to give the 

requestor an opportunity for a hearing or time to submit an application (Form FDA-766) 

requesting authorization to relabel or recondition. Indiscriminate voiding of this Notice 

tends to indicate to the importer of record that it is not necessary to respond within the 

prescribed period to the Notice of FDA Action - Detained and, also, will generate 

additional paperwork by both FDA and CBP. The latter result is counterproductive to our 

efforts to process all import matters in a timely manner.

If the compliance officer is of the opinion that the voiding of the Notice is advisable, 

concurrence must be obtained from the CBP office responsible for insuring the 

exportation or destruction of the shipment. After the receipt of CBP's concurrence, a 

letter voiding the Notice should be issued to the requestor with copies to CBP and all 

persons and firms receiving a copy of the Notice of FDA Action - Refusal of Admission. 

This letter should provide no more than a ten day period (excluding Saturdays, 

Sundays, and holidays) to afford the opportunity for a hearing or the submission of a 

Form FDA-766. 

Note: Because of the concern for liquidation of the Bond prior to final disposition of a 

detained entry, some FDA offices have instituted procedures to issue the Notice of 

Refusal to CBP before a final decision on reconditioning or appeal have been made. 

FDA offices should follow their local procedures established with their CBP offices when 

such a practice is used.
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9-12 RECONDITIONING

9-12-1 PURPOSE

To establish operating procedures for processing applications (Form FDA-766) 

requesting authorization to bring detained merchandise into compliance.

9-12-2 BACKGROUND

Section 801(b) of the FFDCA provides that an importer of record (also the owner or 

consignee) may submit to the FDA a written application (Form FDA-766) requesting 

authorization to bring into compliance an article adulterated, misbranded, or in violation 

of Section 505 by relabeling or other action, or by rendering it other than a food, drug, 

device, or cosmetic. This Section also provides that the application should be covered 

by a bond for the payment of liquidated damages in the event of default. The approval 

of the application is at FDA's discretion.

9-12-3 WHO MAY FILE AN APPLICATION

Generally speaking, the owner or consignee (provided this firm or individual guarantees 

by a bond, proper custody and handling of the shipment) or their designated agent (i.e. 

customhouse broker, consultant, etc.) is the only one who has the legal right to submit 

an application to recondition or render the detained article not a food, drug, device or 

cosmetic. Under certain circumstances, the importer (broker) or other designated agent 

authorized to act on the matter on behalf of the owner, or manufacturer (if it is a Rad. 

Health item) may also file an application, provided it is covered by a bond in the event of 

default. However, before approving an application submitted by the owner or consignee, 

the importer of record should be contacted to ensure that he has no objection.

Frequently, applications are received from customhouse brokers or ultimate consignees 

who have not posted a bond covering the shipment. Such applications should not be 

considered and should be returned to the applicant with a notation that we can accept 

applications only from the importer of record, owner, or consignee, provided the 

application is covered by a good and sufficient bond, unless appropriate authorization to 

act on behalf of the owner in the matter has been provided to the responsible FDA 

office. 

9-12-4 MECHANICS IN PROCESSING APPLICATION

The Form FDA-766 contains five sections that are described below.

Section 1 - Proposal

The applicant fills out the top portion (page 1) of the form and submits to the responsible 

FDA office which issued the Notice of FDA Action - Detained. A detailed description of 
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the method by which the article(s) will be brought into compliance must be given. For 

example, such proposed methods as "fumigation and cleaning" are not adequate 

without the identity of the fumigant, method and duration of application, detailed 

description of cleaning, etc. In addition, the applicant should indicate the disposition of 

reject material. (Generally, the application should provide for all information identified by 

Regulation 21 CFR Sections 1.95 and 1.96).

Section – FDA Action on Application Section

The "FDA Action on Application" section of the form is used by FDA in either approving 

or disapproving the application. The form should be returned to the applicant with a 

copy to the district file and a copy may be forwarded to CBP for their information. 

If the district questions the adequacy of the proposed method, the matter should be 

referred to the appropriate headquarters center for evaluation and advice.

If past experience has shown that the proposed method will not succeed, the application 

should be disapproved. Applications should be approved only if it appears that the 

relabeling or other action will be successful and result in an acceptable product.

It is suggested that approved applications include the statement "ARTICLES SHOULD 

BE HELD INTACT PENDING THE RECEIPT OF FDA'S RELEASE NOTICE." If it later 

becomes necessary to recommend a bond action to CBP, this statement serves to 

formally advise the applicant of FDA procedures and his or her responsibilities to hold 

the merchandise until a release notice is received from FDA.

If the proposal involves a reconditioning of an adulterated product where the sanitary 

condition of the equipment and facilities is a critical factor, FDA should not approve the 

application until the condition, that FDA be notified within a specified time before the 

start of the reconditioning to enable us to inspect the reconditioning firm, is added by the 

applying party. An example of such a situation would be the reconditioning of insect 

contaminated spices where the cleaning of the product under insanitary conditions 

would adulterate the article under Section 402(a)(4) of the Act.

Applications should not be "approved with the following condition." If there are 

conditions which we feel should be covered in the proposed procedure it should be 

denied and inform the applicant that the FDA will reconsider another application if the 

matter is covered. For example, an application should be denied when the matter of 

rejects has not been resolved. If the applicant fails to propose an acceptable disposition 

of rejects, the application should be denied; inform the applicant of the reason for denial 

on the Form FDA-766 and suggest that a new application which includes disposition of 

rejects will be considered. Only minor points, such as date of completion, etc. should be 

specified under the "approved with the following condition".
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Section 3 - Importer's Certificate 

The "Importer's Certificate" section of the Form FDA-766 is used by the applicant to 

advise the FDA that the relabeling or other action has been completed and that the 

goods are ready for inspection/sample collection. In making this certification, the 

applicant should fill-in the original copy of the application which was returned to him or 

her (as described in RPM subchapter 9-12, Section 2 - FDA Action on Application, 

above) and then submit the application to the FDA.

Section 4 - Report of Investigator/Inspector 

This "Report of Investigator/Inspector" section of the Form FDA-766 is completed by the 

examining FDA or CBP official. This section is later used by the designated division in 

preparing the subsequent Release Notice or Notice of FDA Action - Refusal of 

Admission. 

Section 5 – Data on Reconditioning Articles

The “Data on Reconditioned Articles” section of the Form FDA-766 is completed by the 

examining FDA or CBP official. This section is later used by the designated division 

office in preparing the Form FDA-790 “Charges for Supervision” and quantity 

information on the subsequent Release Notice or Notice of FDA Action – Refusal of 

Admission. 

9-12-5 AMENDED APPLICATIONS

Any changes at any time by the applicant in the reconditioning proposal must be made 

by the filing of an amended application and must be approved by the FDA. Granting of 

verbal requests for changes may result in misunderstandings and may create problems 

if it becomes necessary to initiate bond action against the applicant at a later date.

9-12-6 REQUESTS FOR ADDITIONAL TIME TO COMPLETE RECONDITIONING

At times the applicant cannot complete the reconditioning operation within the specified 

time period. Additional time may be granted by FDA upon a written request from the 

applicant and the showing of reasonable grounds.

Requests for extensions of unduly long periods should not be granted, as the possibility 

of accidental or intentional diversion and additional adulteration of the shipment 

increases with the time factor. Normally, a second request for an extension of time 

should not be granted unless the applicant shows compelling reasons to do so.
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9-12-7 UNSUCCESSFUL RECONDITIONING OF ADULTERATED ARTICLES

At times the applicant is not successful in the reconditioning of an adulterated shipment, 

particularly in cases where the product is contaminated with filth (insects, rodent excreta 

pellets, etc.). Authorization should not be granted for a second attempt at reconditioning 

without the benefit of another application (Form FDA-766).

The applicant may submit a second application if he so desires. However, this 

application should not normally be approved unless it contains meaningful changes in 

the reconditioning operation to insure a reasonable chance at success. A second 

application should not be approved if it merely is a resubmission of the original 

application.

In approving a second application, FDA should include in the "FDA ACTION ON 

APPLICATION" section of the Form FDA-766 "IF THIS ATTEMPT AT 

RECONDITIONING DOES NOT BRING THE ARTICLES INTO COMPLIANCE 

FUTURE APPLICATIONS TO DO SO MAY NOT BE CONSIDERED."

Request for a third attempt at reconditioning generally should not be granted. It is our 

opinion that to allow unlimited attempts at reconditioning only encourage importers to 

import grossly adulterated articles into the U.S.

9-12-8 DISPOSITION OF LOTS NOT RECONDITIONED TO THE FDA’S

SATISFACTION

If the applicant is not able to recondition a shipment to the FDA's satisfaction, a Notice 

of FDA Action - Refusal of Admission should be issued in the usual manner. See RPM 

subchapter 9-11 "Notice of FDA Action - Refusal of Admission." If FDA supervisory 

charges are involved, a Form FDA-790 should be issued. See RPM subchapter 9-13, 

"Supervisory Charges."

9-12-9 RECONDITIONING OPERATIONS

Relabeling of New Drugs

At times an importer of record may desire to bring a drug shipment detained on a new 

drug charge into compliance by revising the labeling to remove claims which placed the 

product into the category of a new drug. Sometimes such a drug appears to be 

composed of harmless ingredients. A typical example is Chinese herbal medications 

labeled for the promotion of blood circulation, sexual rejuvenation, headaches, 

anemophobia, back neuralgia, bone pain, acute or chronic neuralgia and other pain 

caused by rheumatism.

Do not permit the relabeling of a drug detained on a new drug charge as a means to 

bring the item into compliance. To do otherwise is not in the best interest of the 

consuming public. Experience has shown that such drugs may contain undeclared 
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ingredients, such as phenylbutazone and aminopyrine, which present serious hazards 

to the users. Likewise, it should be noted that any drug seized in domestic commerce 

on a new drug charge cannot be relabeled and introduced into commerce, but if 

condemned by the court must be destroyed.

Reconditioning of Green Coffee and Cocoa Beans Due to the Presence of Live 

and/or Dead Insects

This procedure was originally instituted for reconditioning green coffee beans detained 

under Administrative Guideline 7403.01 due to the presence of live and/or dead insect 

infestation (CPG 510.500). The procedure has now been expanded to include cocoa 

beans (CPG 515.750).

In the past when green coffee beans were detained for live and/or dead insect 

infestation, the importer of record submitted an Application for Reconditioning (Form 

FDA-766) indicating fumigation and cleaning prior to delivery to the roasting plant. The 

coffee industry contended that part of the processing of coffee beans at most roasting 

plants includes a cleaning procedure for removal of dead insects and extraneous 

material. The cleaning and rebagging before processing purportedly causes duplication 

of cleaning and results in additional charges for the importer and ultimately for the 

consumer.

To avoid duplication the following alternate reconditioning procedure can be used if the 

importer chooses.

After a detention due to live insect infestation is issued, the importer of record or 

consignee must submit an Application for Reconditioning (Form FDA-766). The form

shall identify the procedure for fumigation (including name and amount of fumigant, time 

of exposure etc.) which is to be used. The application shall also include the name and 

address of the roasting plant where the cleaning phase will be accomplished; the 

identity of the equipment to be used in the cleaning operation; the date and time 

cleaning operations are to begin; and that a signed statement will be submitted to the 

FDA attesting that the reconditioning was properly carried out by the processor when 

the entire reconditioning has been completed. When it is deemed necessary, for 

monitoring purposes, the Form FDA-766 should be approved with the condition that 

rejects (tailings) are to be held for the FDA’s examination and subsequent destruction 

under U.S. CBP or FDA supervision.

As part of the approval of this application (Form FDA-766) the fumigation must be 

accomplished prior to permitting the lot's movement to the roasting plant. ORA, at its 

discretion, may examine the lot to determine the effectiveness of the fumigation. If the 

stated date or time of cleaning has to be changed, the importer should notify the FDA 

office supervising the reconditioning at least 72 hours prior to the time noted in the 

application.

At the time of the initial submission of the Form FDA-766 application under this 

procedure, the file should be checked to determine if there has been a recent inspection 
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of the cleaning facility. If not, the application should be approved with the condition that 

the roasting plant will be inspected to determine if it is acceptable to the FDA prior to the 

movement of the beans to that plant. If the plant is found acceptable, FDA will advise 

the importer that the lot may be sent to the roasting plant. Inspections should be made 

without undue delay to avoid causing importers excessive storage charges.

After the initial inspections FDA may exercise discretion to make follow-up inspections 

to determine if the plants' cleaning operations are being maintained to properly 

recondition detained lots.

All time to conduct inspections to determine if the processors plant and equipment is 

acceptable and those made to check on specific lots after reconditioning shall be 

included in the supervisory charges issued to the importer of record. All movement of 

detained lots shall be under CBP's bond and by acceptable conveyances.

The procedure outlined above, is to be used, with the exception of the fumigation 

procedure, when the detention is for dead insect infestation only. As previously stated 

this procedure is not to be accepted when the detention is for insect damaged and/or 

moldy coffee beans.

Reconditioning of Biologicals

Unlicensed biologicals or biologicals without an effective IND which were refused 

admission are not subject to reconditioning except in the instances where the intended 

use of the product is changed to render the product a non-biological, non-drug product, 

and is so reflected in the associated labeling. Center for Biologics Evaluation and 

Research (CBER) concurrence with any reconditioning application for a biological 

product is required.

9-13 SUPERVISORY CHARGES

9-13-1 PURPOSE

To provide operating procedures for charging expenses in connection with the 

relabeling, or reconditioning of food, drugs, devices, tobacco products, and cosmetics 

being imported or offered for import, pending FDA’s decision as to the admission of the 

product. The procedure includes documenting those expenses with a Form FDA-790 

“Charges for Supervision,” in conjunction with a Form FDA-766 “Application for 

Authorization to Relabel or Recondition Non-Compliant Articles"

9-13-2 BACKGROUND

Section 801(c) of the FFDCA [21 U.S.C. 381(c)] requires the owner or consignee of 

FDA-regulated articles being imported or offered for import to pay for all expenses, 

including travel, per diem or subsistence, and salaries of officers or employees of the 

United States, in connection with the supervision of the relabeling or other action 

(“reconditioning”) authorized by FDA under the provisions of FFDCA section 801(b) to 
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bring the articles into compliance with the Act, or to render the articles other than a food, 

drug, device, or cosmetic. This includes such expenses in connection with the 

supervision of the destruction or export of rejected articles or portions thereof, as may 

be specified in FDA’s relabeling or reconditioning authorization. The amount of such 

expenses is determined by regulation. See 21 CFR 1.99.

In 1985, U.S. CBP financial management consolidated all billing operations for FDA 

supervisory charges at their Accounting Services Division (ASD) in Indianapolis, 

Indiana. Payments of FDA's supervisory charges are deposited into the U.S. Treasury 

Miscellaneous Receipts account.

9-13-3 SUPERVISORY CHARGES

In submitting a Form FDA-766 requesting authorization to relabel or perform other 

action to bring an article into compliance with the Act (see 21 CFR 1.95), the applicant 

agrees to pay for all supervisory costs in accordance with current regulations. 21 CFR 

1.99 describes the supervisory costs that the applicant must pay.

The 21 CFR 1.99 hourly charge rates for the services of FDA supervising officers and 

FDA analysts are based on the federal General Schedule (GS) pay scale. At the 

beginning of each calendar year, ORA HQ sends out an email to the ORA staff to inform 

the field of the current GS pay scale 21 CFR 1.99 hourly charge rates. This email also 

informs the ORA staff of the current mileage reimbursement rates, which are used to 

calculate the charges for the travel expenses of the supervising officer, per 21 CFR 

1.99. References below to “the current rate as given by Regulation (21 CFR 1.99)” and 

“the current mileage rate” should be construed as referring to the current rates as 

specified in the aforementioned annual email. These rates should be reiterated on the

Form FDA-790 in the “charge per unit” column, for the appropriate line item.

21 CFR 1.99 provides that such costs shall include, but not be restricted to, the 

following:

1. Travel expenses of the FDA supervising officer.

• If travel is by government vehicle, charges should be for the mileage costs

plus any toll charges. Mileage costs for government vehicle travel should

be accounted for on the Form FDA-790 under “Automobile Use” and are

calculated by multiplying the current mileage rate by the number of miles

traveled. Toll charges should be accounted for on the Form FDA-790 on

the “Other Transportation Expenses” line.

• If travel is by public transportation, the charge is for the actual cost of such

travel. Public transportation costs should be accounted for on the Form

FDA-790 on the “Other Transportation Expenses” line.

• Supervisory approval should be obtained prior to charging for any

transportation expenses other than those described above but, if

approved, should be accounted for and itemized on the Form FDA-790 on

the “Other Transportation Expenses” line.
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2. Per diem in lieu of subsistence of the FDA supervising officer when away from

his or her home station, as provided by law/current regulations.

3. Services of the FDA supervising officer, calculated at the current rate as given by

Regulation (21 CFR 1.99).

• This rate is designed to account for charges for administrative support of

the supervising officer and for the supervising officer’s travel time to or

from the site of the article, and therefore separate charges should not be

assessed for those items.

4. Services of the FDA laboratory analyst, if applicable, calculated at the current

rate as given by Regulation (21 CFR 1.99).

• This rate is designed to account for administrative support for the

laboratory analyst and for the use of FDA laboratories and equipment, and

therefore separate charges should not be assessed for those items.

The following costs should not be charged for:

1. Time spent reviewing, approving, denying, modifying, and/or processing the

relabeling or reconditioning request and proposal.

2. Services of a compliance officer supporting the supervision (e.g., services

such as determining appropriate courses of action, coordinating logistics of

the supervision, performing the services described in # 1 above, etc.).

3. Services of any FDA Center personnel or personnel at ORA HQ supporting

the supervision. However, charges should include the supervising officer’s or

FDA laboratory analyst’s time spent consulting or otherwise interacting with

FDA Center or ORA HQ personnel regarding the supervision, calculated at

the current supervising officer or analyst rate as given by Regulation (21 CFR

1.99).

If multiple supervising officers or laboratory analysts are necessary, then charges 

should include the services of each of those supervising officers and/or laboratory 

analysts, calculated at the current rate(s) as given by Regulation (21 CFR 1.99).

The minimum total charge for services of each supervising officer and analyst shall not 

be less than the charge for one (1) hour. Time after the first hour shall be computed in 

multiples of one (1) hour, rounding down for fractional parts less than 1/2 hour. For 

example, if a supervising officer provides services of:

• More than 0 minutes, but less than 1 hour and 30 minutes, charge for 1 hour.

• 1 hour and 30 minutes or more, but less than 2 hours and 30 minutes, charge for

2 hours.

• 2 hours and 30 minutes or more, but less than 3 hours and 30 minutes, charge

for 3 hours, etc.
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21 CFR 1.99 states that the cost of supervision includes, but is not limited to, the 

charges described above. Other appropriate miscellaneous expenses not accounted for 

above should be charged for as miscellaneous expenses for the actual cost incurred, 

and should be itemized on the Form FDA-790 on the “miscellaneous expenses” line. 

However, miscellaneous expenses are only warranted under very unusual 

circumstances. Therefore, appropriate supervisory approval should be obtained prior to 

incurring or charging for any miscellaneous expenses.

Incurred supervisory costs should be charged for each relabeling and reconditioning 

attempt, regardless of whether the attempt is successful.

9-13-4 PREPARATION AND SUBMISSION OF CHARGE SHEET

Future enhancements to FDA’s electronic import system (currently OASIS) may result in 

electronic processing of the supervisory charge-sheet (with appropriate identification 

and accounting information) for FDA staff to use when submitting their charges to the 

CBP Revenue Division. Until these electronic system enhancements are operational, 

FDA staff should continue to use Form FDA-790. 

Charges should be assessed on the Form FDA-790 and Form FDA-766 only after 

relabeling or reconditioning of the articles are completed. The forms should be filled out 

and submitted at the same time. The Form FDA-790 “Grand Total” amounts for total 

time and total charge should be equal to the Form FDA-766 “Time and cost of 

supervision” amounts.

In addition to the information identified above for supervisory charges, the Form FDA790 must also include the CBP Entry Number and date of entry, name of the Importer of 

Record, carrier, product description, name of the consignee (if different from the 

importer of record), FDA sample number (if applicable), and appropriate FDA office 

address.

Scan the completed Form FDA-790 and the FDA Notice of Release, FDA Notice of 

Refusal, or FDA Notice of Partial Release for each entry and samples covered by the 

bill, and email a copy of each document to REIMBSVCS@cbp.dhs.gov, addressed to:

U.S. Customs and Border Protection

Revenue Division - Reimbursable Team

6650 Telecom Drive Suite 100

Indianapolis, IN 46278

Contact (also available at the CBP Revenue Division directory (link): 

Sheri Malicoat

Office 317-614-4520 

Maintain the original completed Form FDA-790 and copies of the FDA Notice of 

Release, FDA Notice of Refusal, or FDA Notice of Partial Release in the FDA file. By 

including a copy of the FDA Notice of Release, FDA Notice of Refusal, or FDA Notice of 
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Partial Release with the completed Form FDA-790, there should be no problem 

identifying the exact entry and samples being covered by the bill.

If submission of these documents by email is not possible, mail the original completed 

Form FDA-790 and 1 copy, along with a copy of the FDA Notice of Release, FDA Notice 

of Refusal, or FDA Notice of Partial Release to the above address and contact above.

Maintain copies of the completed Form FDA-790 and the FDA Notice of Release, FDA 

Notice of Refusal, or FDA Notice of Partial Release in the FDA file.

DO NOT send a copy of the completed Form FDA-790 directly to the applicant. It is the 

responsibility of CBP to contact the applicant to obtain payment of the bill. CBP will also 

add on to the bill any expenses incurred by their personnel in connection with an entry.

9-13-5 PAYMENT OF SUPERVISORY CHARGES

CBP will instruct the applicant to send payment to CBP, Revenue Division, not to the 

local FDA office. If the applicant sends payment to FDA, the FDA recipient should return 

the payment to the organization or importer by registered mail with instructions to 

submit the payment to CBP at the above address.

FDA is not routinely notified by CBP when payment is received. If the applicant refuses 

to make payment, CBP will take appropriate action against the importer's bond or place 

a lien against the importer's future importations.

9-14 BOND ACTIONS

9-14-1 PURPOSE

To increase the effectiveness of FDA's import operations by appropriately utilizing the 

CBP bond provisions, in conjunction with FDA's enforcement discretion, in an effort to 

deter the distribution of imported articles prior to FDA release.

9-14-2 BACKGROUND

Sections 801(b) and 536(b) of the FFDCA and 21 CFR 1.97 provide for the delivery to 

the owner or consignee of a lot offered for entry into the United States, pending a 

decision to admit the lot upon the execution of a bond (commonly referred to by FDA as 

a "redelivery bond"). This bond is filed with the CBP and provides for the payment of 

liquidated damages in the event of default. The individual or firm posting the bond is 

referred to as the "Importer of Record."

This bond contains a condition for redelivery of the lot, or any portion thereof, upon 

demand of CBP and also a provision for the performance of conditions as may be 
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legally imposed for the relabeling or other action necessary to bring the article into 

compliance or rendering it other than a food, drug, device, or cosmetic.

FDA personnel have and may utilize enforcement discretion when evaluating cases of 

bond violations and penalty recommendations. While it may be accurate to state that 

FDA "rarely mitigates", it should be pointed out that FDA has, and may wish to exercise, 

enforcement discretion when, in its judgment, appropriate circumstances are present. 

Some examples of appropriate circumstances are stated in Penalty Recommendation.

9-14-3 BOND VIOLATION

Importers are not specifically required by law to hold a shipment in any given location 

once a bond has been filed, pending a decision by FDA whether or not to sample. 

However, in the event FDA decides to collect a sample, CBP can require, under terms 

of the bond, that the importer return the entire shipment or any portion thereof for 

sampling, if the shipment has left the port area. If unable to redeliver upon demand by 

CBP, the importer is subject to assessment of liquidated damages.

In advising importers who inquire about making immediate distribution of any entry, FDA 

personnel should recommend that distribution be withheld pending an Agency decision 

on admissibility. Generally speaking, a bond violation occurs when the importer fails to 

redeliver merchandise, upon CBP demand, that has been distributed for sale before 

sampling and/or release by FDA or before an authorized FDA representative expressed 

that the merchandise may proceed without FDA examination

Following are examples of situations which may, if the merchandise is not redelivered 

on Customs demand, result in bond violations:

1. Distribution of a shipment before FDA has decided whether or not to sample;

2. Distribution of a shipment after FDA has elected to sample but before the

sample(s) can be collected;

3. Distribution of a shipment that appears to be violative, before or after the receipt

of a Notice of FDA Action - Detained;

4. Distribution for sale of a shipment before FDA can inspect and/or sample the

merchandise that was relabeled or reconditioned pursuant to an approved

Application For Authorization To Relabel Or Recondition Non-Compliant Articles

(Form FDA-766);

5. Distribution of a shipment for which a Notice of FDA Action - Refusal of

Admission has issued. As soon as it appears that one of the above situations

may have occurred, FDA personnel should report the situation in writing to the

CBP Port Director, as an investigation may be initiated by CBP to determine

whether a bond violation has occurred. The report to CBP should be strictly

factual, with enough background information for CBP to accurately assess the

case. The report should, at this point, contain no recommendations nor should it

judge the case before the importer of record has had an opportunity to present
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evidence. The FDA should offer CBP full cooperation in conducting any 

investigation that is considered necessary.

If an importer has distributed a shipment before FDA has determined whether to sample 

or after a Notice of Sampling has issued but before the samples are collected, the 

written report should ask CBP to require redelivery for sampling purposes.

If, at the time of the aforementioned report to CBP, the shipment had been sampled and 

a Notice of FDA Action - Detained had already issued on the shipment, a Notice of FDA 

Action - Refusal of Admission should be issued. The Notice of FDA Action - Refusal of 

Admission should be executed in the usual manner.

NOTE: A Notice of FDA Action - Detained and Notice of FDA Action - Refusal of 

Admission are not required in cases where FDA has not sampled the shipment.

Where the articles are distributed prior to FDA sampling, FDA should consider following 

up in domestic channels, for example, by collecting official domestic samples. Where 

samples have been collected by FDA and are shown to be violative, and the goods are 

not redelivered, FDA may consider recommending seizure, or some other action, to 

remove the violative product from distribution channels.

9-14-4 BOND ACTION PROCEDURES

If CBP, after review of FDA's report along with any other information, determines that 

the articles are not entitled to admission, CBP may issue a Notice to the importer of 

record. If redelivery is not made within a specified time (currently 30 days) CBP 

regulations provide for the issuance of another Notice, of penalty or liquidated damages 

incurred and demand for payment. CBP has amended the amount of liquidated 

damages to be assessed to three times the value of the restricted merchandise not 

redelivered (19 CFR 113.6) and increased the amount of the bond required for such 

entries to three times the value of the merchandise. These amounts are subject to 

change. Check CBP regulations for current amounts. The CBP Notice will generally 

request liquidated damages in the amount prescribed by regulation for the undelivered 

merchandise, plus duties. This Notice gives the importer of record an opportunity to 

object to the action if he or she feels there are extenuating circumstances, and to 

explain in a written petition why he or she should not be subject to the stated penalties.

The importer of record generally will submit a petition to CBP to either void the notice of 

penalty and liquidated damages or will offer to pay a lesser amount. If there are 

mitigating circumstances, CBP and FDA may agree to the payment of a lesser amount. 

See 21 CFR 1.97(b).

If the importer of record refuses to pay the amount agreed upon by CBP and FDA, the 

importer has the option of presenting the case to a CBP Court. Generally, if the Court 

rules for the government, the importer must pay the original amount of liquidated 

damages.
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9-14-5 RESPONSIBILITY UNDER THE BOND

When the importer of record is a customhouse broker and not the ultimate consignee, a 

plea is frequently entered for cancellation of liquidated damages on the basis that the 

broker had no part in the distribution of the merchandise. It should be emphasized that 

any importer of record has agreed to the obligations set forth in the bond, most 

importantly, redelivery. If such bond holders were excused from their obligations, the 

bond provisions would be unenforceable, and the distribution of imported goods prior to 

release would be encouraged. It may be pointed out to customhouse brokers that their 

assumption of the responsibility of importer of record was entirely voluntary. By filing the 

entry as importer of record, the customhouse broker assumes all obligations under the 

bond.

9-14-6 PENALTY RECOMMENDATION

In evaluating a bond action case, it should be remembered that the bond penalty is 

intended to make the unauthorized distribution of articles unprofitable. Very often 

penalties are so small that such penalties, in effect, encourage the illegal distribution of 

future imported lots.

In the absence of any aggravating factor, the following mitigating factors may be utilized 

in determining if mitigation is warranted. FDA does have enforcement discretion to 

consider mitigation under other circumstances.

1. The merchandise was exported after detention but prior to the issuance of a

Notice of FDA Action - Refusal of Admission because the importer was not

aware he/she was supposed to wait for the Refusal before exportation. The

importer is able to supply documentation that the specific merchandise

detained was, indeed, exported.

2. A shipment was released by CBP under an Immediate Delivery Entry (I.D.)

and distributed prior to FDA release because it was the initial entry subject to

the FFDCA by the importer who was not aware of FDA requirements.

3. Conditions out-of- control of importer - Examples:

a. An entry is stored in a public storage warehouse pending FDA clearance

but is inadvertently shipped even though the importer has issued

instructions to hold the merchandise until further notice. The importer

must be able to document the issuance of such instructions, which must

be verifiable by FDA.

b. A shipment being held pending FDA clearance is stolen or damaged or

destroyed in an accident. FDA personnel should obtain written

documentation of the theft or accident from the importer before

considering recommending mitigation.
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4. It is the responsible party's first/only failure to redeliver within two (2) years,

and the firm's cooperation with FDA has been positive in providing access to

records, initiating recalls, etc.

5. There exists either a non-violative FDA analysis or "acceptable" private

laboratory analysis for which audit sample is not available. NOTE: repetitive

failure (more than once within two (2) years) to have audit samples available

constitutes an aggravating factor. See aggravating factors below.

6. Importer has an excellent compliance history with FDA.

a. The importer has had only one or two bond offenses since doing

business, constituting a small percentage of the importer's total entries

which FDA has chosen to examine; and

b. The importer has an excellent recorded history of entering product in

compliance with the Act and has fully cooperated with FDA while in

business; and

c. The importer makes a reasonable attempt to retrieve the entry as soon

as it is brought to his/her attention.

The enforcement discretion available to FDA staff may be utilized when determining 

whether or not to mitigate bond penalties based on other factors FDA deems pertinent.

Although often used by importers in the past as "extenuating circumstances," the 

following are not considered examples of true mitigating circumstances:

1. The amount of merchandise missing;

2. The seriousness of the violation

Note: FDA may consider a firm's history of previous bond violations to show that the 

importer (e.g., broker serving as importer of record) was aware of FDA and CBP 

procedures, and that mitigation may not be appropriate.

In addition, there are some aggravating factors which would generally preclude any 

mitigation. These factors follow.

1. Attempt to deliberately evade FDA surveillance.

2. Fraud

3. Un-redelivered product has resulted in injury or poses a risk to the public

health.

9-14-7 MITIGATION INSTRUCTIONS

The "redelivery bond" is a CBP requirement and the mitigation process is a CBP 

procedure. Therefore, FDA will not consider mitigation until a mitigation petition is filed 

with CBP and forwarded to FDA for evaluation.

As with the basic decision to mitigate, FDA does have enforcement discretion, based on 

judgment and evaluation of the facts, to determine the degree of mitigation. The 
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following general procedures should be considered in determining the amount of 

mitigation:

1. In instances involving the documented exportation of the merchandise, first

time importers, and situations out of control of the importer, (see items 1

through 6 in Penalty Recommendation) FDA may, based on an evaluation

of the facts in the petition, agree to mitigate the penalty to a nominal amount

or recommend no penalty.

2. In all other instances, the responsible FDA office should generally consider

mitigating the penalty to the level of the value of the non-redelivered

merchandise. The degree of mitigation can vary depending on the district's

evaluation of the facts in the petition. However, except for those instances

noted in item 1. of this section, mitigation below the value of the nonredelivered merchandise should be considered only in exceptional

circumstances.

If the office has doubts concerning the amount of the penalty recommendation, they 

should submit the case to OEIO for review and advice.

9-14-8 TRACKING OF PENALTY ACTIONS

Until this functionality is available in OASIS, each office shall maintain a log of bond 

violations and assessment of penalties, in the event that it becomes necessary to 

check on the past violations of an importer of record. The specific format for such a log 

is at the office's discretion; however, it should contain at least the following information 

when available: name and address of the importer of record; product involved; value of 

merchandise not recovered; penalty paid; date of action; sample number; reason for 

the detention; and concise reason for the bond action. It is no longer necessary to send 

a list of bond actions to OEIO. 

9-15 IMPORT INFORMATION DIRECTIVES

9-15-1 PURPOSE

To identify and disseminate import information (problems, violative trends, etc.) for 

providing an effective import coverage program.

To formalize the procedures for initiating, preparing, clearing, issuing, revising, and 

canceling import information directives (Import Alerts and Import Bulletins).

9-15-2 BACKGROUND

Prior to 1972, FDA had no formal system to disseminate import problem information, 

although Import Circulars were occasionally issued for that purpose. FDA's coverage of
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imported products was often conducted on a district-by-district basis, resulting in less 

effective consumer protection.

A formal system known as Import Alert Procedures was established in 1972. Import 

Alerts replaced the Import Circulars. Detailed procedures for initiation, preparation, 

clearance, issuance, revision, and cancellation of alerts were added in later RPM 

revisions. 

The FDA Import Alert Retrieval System (FIARS) was made operational in August 1987. 

FIARS is a computerized format for Import Alerts and Bulletins, enabling users to 

search for an alert or bulletin by keyword or full text search. The FIARS program is 

updated by OEIO after new alerts or bulletins are issued by EMS.

9-15-3 APPROACH

Import information directives consist of the following documents issued by OEIO:

• Import Alerts identify problem commodities and/or shippers and/or importers and

provide procedures for import coverage. Import Alerts will identify those products

or shippers that have met the criteria for detention without physical examination.

See RPM subchapter 9-8 for discussion of detention without physical

examination.

• Import Bulletins are generally informational only. While the information may

identify possible problems, bulletins may not provide policy or coverage

procedures, although in some cases sample collections will be advised.

9-15-4 IMPORT ALERTS

Import alerts significantly improve the uniformity of enforcement in import problem 

areas. Import alerts may have a significant impact on national and international 

economic and trade matters.

Initiating an Import Alert

New import alerts may be proposed by ORA units or offices, the centers, or any FDA

unit. Recommendations for import alerts should have the concurrence of the appropriate 

management of the requesting unit.

Submit recommendations for import alerts to OEIO. Include the following information in 

the recommendation memorandum:

• Purpose of the import alert.

• All pertinent background information such as sample results, violation rates or

trends, etc.

• The national significance of the problem (health hazard, etc.).
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• The volume of entries, number of importers, foreign shippers, countries involved,

other product information such as whether it is seasonal in nature, etc.

• An accurate and complete description of the product, including its packaging and

how it is to be stored.

While not required, the submission of a proposed draft of the import alert with the 

recommendation is highly recommended. FIARS guideline document #00-05 provides 

the import alert format.

After review, OEIO will prepare a clearance package containing an import alert draft, the 

Form FDA-2306 (Clearance Record), and any other pertinent information. If the data is 

incomplete or insufficient the initiator of the draft will be advised.

Import Alert Clearance Procedures:

OEIO is responsible for proper clearance and issuance of import alerts. The clearance 

package will be sent to the appropriate center, OEIO, and OCC for clearance; and to 

the Office of Regulatory Science (ORS) and OEIO management as necessary. If 

revision is necessary, the package should be returned to OEIO for correction. Upon 

clearance, OEIO will issue the alert via electronic mail service (EMS), load the alert into 

CMS and provide appropriate screening in the national entry database.

Clearance Timeframes:

Every effort should be made to expedite clearance of import alerts. Each clearance 

point should attempt to review and clear each alert within 2 days. Import alerts involving 

health hazards should be hand- carried to the next clearance point and/or telephone 

clearance should be obtained.

When clearance delays are encountered, clearance units should inform appropriate 

OEIO staff (301-796-0356). Upon approval, OEIO will issue the import alert via 

electronic mail.

Review of Import Alerts

As conditions permit, all import alerts over two years old will be reviewed semi-annually 

by OEIO to determine whether they are current. This review will include an evaluation of 

detention activity for the previous one year period, the health significance of the 

problem, etc. When the evaluation so indicates and the Centers agree the alert will be 

deleted or revised as needed.

Import Alert Filing Procedure

Import Alerts will be numbered within industry code (i.e., import alerts dealing with 

seafood begin with industry code "16"). 
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9-15-5 IMPORT BULLETINS (IB)

OEIO will issue Import Bulletins on an as-needed basis. Bulletins are usually advisory 

only and may not disseminate policy or procedures. They will issue on the responsibility 

of OEIO. They will be numbered chronologically within Industry Code preceded by "B" 

(16-B01, etc.). Import Bulletins are generally valid for 90 days after issuance. Any 

information from ORA and FDA units which falls into this category may be forwarded for 

consideration as an Import Bulletin

OEIO will review Import Bulletins to see if information has developed which indicates 

the need for an alert. If individual offices or units develop such information they should 

notify OEIO. 

9-16 PRIORITY ENFORCEMENT STRATEGY FOR PROBLEM

IMPORTERS

9-16-1 PURPOSE

To provide procedures for dealing with importers or other individuals who engage in 

business practices that appear designed to evade the lawful regulation of imports. The 

procedures outlined in this chapter should not be considered all-inclusive, nor are they 

intended to limit local options. Situations that appear to involve criminal activity (e.g. 

smuggling, falsification of records) should also be referred to the Office of Criminal 

Investigations (OCI) for their information and follow-up, as appropriate.

Priority attention should be given to firms with a history of any of the following actions:

1. Distributing imported articles in domestic commerce following receipt of a Notice

of FDA Action specifying the intention of Sampling, or the Detention or Refusal of

the articles; or prior to receipt of a Notice of FDA Action specifying the articles

are released.

2. Repeatedly importing violative articles.

3. Falsifying documents at time of entry, reconditioning, or re-export, including

misdeclaring articles to avoid detention without physical examination or other

regulatory action.

4. Re-entering previously refused articles into the United States.

5. Failing to recall or redeliver to CBP, at its request, an article for which a Notice of

FDA Action specifying that the article was refused by FDA has been issued.

6. Introducing or delivering for introduction into domestic commerce (after entry)

any article which is adulterated or misbranded, or which is a new drug without an

approved New Drug Application.

7. Committing any prohibited act. See 21 USC 331.
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9-16-2 BACKGROUND

In developing OASIS, the specific forms "May Proceed Notice," "Release Notice," "Notice 

of Sampling," "Notice of FDA Action - Detained," and "Notice of Refusal" have been 

replaced by the issuing of "Notices of FDA Action," which includes a description of the 

specific FDA action (May Proceed, Release, Sampling or Intention of Sampling, Detained, 

or Refusal) identified for the specific line in the entry. The use of the designations "Product 

May Proceed," "Product Released by FDA," "Product Collected by FDA," "Product 

Detained by FDA," or "Product Refused Entry by FDA," or similar wording should be 

considered as meeting the standard, "giving notice thereof to the owner or consignee." 

See 21 USC 381(a); 21 CFR 1.94.

In 1988, the Agency conducted a short-term enforcement operation aimed at determining 

the disposition of food articles refused admission. Thirteen percent of articles refused 

admission for non-labeling violations had been distributed in interstate commerce, rather 

than redelivered for export or destruction.

In 1990, the Agency discovered an importer of ceramic dinnerware circumventing 

detention without physical examination by declaring the entries as statuary, a nonregulated article.

Between 1990 and 1992, New York District, in conjunction with the CBP, investigated and 

documented an importer's history of violative practices regarding the importation of frozen 

seafood products. Practices included repeatedly importing violative articles; falsifying 

documents and manipulating articles to avoid detention without physical examination; 

refusing or not permitting timely inspection of entries; importing previously refused 

articles; and smuggling. As a result of the investigation, in 1992 the firm's president was 

indicted by the U.S. District Court in New Jersey. He was subsequently convicted on 138 

counts for submitting false documents to FDA and for illegally re-importing previously 

rejected salmonella contaminated seafood. On February 5, 1993, all frozen seafood 

products imported by the firm were placed on detention without physical examination.

Between 1992 and 1995, Florida District and OCI, in conjunction with CBP, investigated 

and documented an importer's history of violative practices regarding the importation and 

handling of frozen shrimp. Practices included repeatedly importing violative articles; 

falsifying documents to avoid detention without physical examination; manipulating 

articles in attempts to have packers removed from detention without physical 

examination; and laboratory shopping (sending samples of product that is detained 

without physical examination to different private labs and then submitting to FDA only the 

analysis which shows the product in compliance, even though the other lab found the 

product violative). Further, Florida District identified three shipments of shrimp imported 

by the firm which were seized because of decomposition. Prior to the seizures, the firm 

attempted to sell the decomposed shrimp, which had been rejected by eight consignees 

and the National Marine Fisheries Service. The firm also was discovered washing 

decomposed, imported shrimp with a copper sulfate solution in an attempt to conceal the 

decomposition. On March 10, 1995, all frozen shrimp imported by the firm was placed on 

detention without physical examination. As a further result of the investigation, the firm 
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and its top management were indicted by the U.S. District Court in Florida. The firm's vice 

president was convicted on 12 felony counts, including conspiracy, obstructing justice, 

violating CBP law, and tainting shrimp and selling it with the intent to defraud and mislead.

9-16-3 APPROACH

The following enforcement approaches have general applicability. They should be 

considered when dealing with firms engaged in the types of practices listed in the

"Purpose" section above, when conventional import coverage and enforcement avenues 

appear insufficient to address the problem. The approaches include review and approval 

of reconditioning proposals (FDA-766), the use of Warning Letters (sequential, when 

appropriate), recall, seizure, injunction, or prosecution.

As always, use of enforcement discretion should be considered in determining the 

appropriate regulatory response. When egregious actions are encountered, a sequential 

approach may not be appropriate. Also, situations that appear to involve criminal activity 

(e.g., smuggling, falsification of records) should be referred to OCI for their information 

and follow-up, as appropriate.

WARNING LETTERS

Issuance of Warning Letters to remind firms of their responsibilities to import articles that 

comply with the provisions of the FFDCA and other laws enforced by FDA, and to assure 

that only non-violative articles enter domestic commerce in the United States, is often an 

appropriate first action. Warning Letters may be issued to the importer of record, owner, 

or consignee (if other than the importer of record) with copies to CBP, and may be issued 

for the following reasons:

1. Failure to hold an entry intact pending receipt of a Notice of FDA Action

specifying that the article was Released by FDA. A copy of the Warning Letter

should be attached to the redelivery request sent to CBP when such a request is

made.

2. The first documented attempted entry with misleading information. Misleading

information includes, for example, low-acid canned foods from a non-registered

plant entered under another processor's Food Canning Establishment (FCE)

number; or articles from firms subject to detention without physical examination;

or articles declared as non-regulated articles to avoid detention without physical

examination or other agency action.

3. The first documented instance of submission of a foreign government certification

document or private laboratory analytical report that does not match the entry in

question.

4. An importer's failure to provide FDA with information regarding the availability for

sampling or location of an entry for which a Notice of FDA Action specifying

FDA's intention of sampling has been issued.
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5. To inform an importer that FDA has requested that CBP deny it permission to file

an entry bond, thus restricting its shipments to CBP's custody until admissibility

has been determined.

6. Consistently importing violative articles not already subject to detention without

physical examination. The importer should be notified that this practice may

result in future entries being detained without physical examination.

7. Any other situation which warrants an official notification to the firm and further

opportunity for compliance before other action is taken.

The Warning Letter should state that any distribution of refused articles or articles 

sampled or intended for sampling that were distributed prior to release are in violation of 

the FFDCA or other applicable acts enforced by FDA, and may result in domestic seizure 

or other sanctions, including injunction or prosecution

RECONDITIONING PROPOSALS

The FFDCA provides that when an article is submitted for entry is found to be violative, 

the importer has the option of exporting it, destroying it, rendering it not subject to the 

Act, or requesting authorization from the agency to attempt to bring it into compliance 

with the Act. 

If the importer of record decides to attempt to recondition a detained article, section 

801(b) of the Act (21 USC 381 (a)) provides that the owner or consignee (by practice, 

FDA also accepts applications from an importer of record, with a properly posted bond, 

as the agent of the owner or consignee) may submit to the FDA a written application 

Form FDA-766 requesting authorization to bring into compliance an article that is 

adulterated, misbranded, or in violation of Section 505. See 21 USC 381 (a)(3). The 

owner or consignee may bring the article into compliance by relabeling or other action, 

or by rendering it other than a food, drug, device, or cosmetic. (Refer to RPM 

subchapter 9-12, "Reconditioning.") 

The approval of the reconditioning application is at FDA's discretion. The Agency should 

require appropriate controls and provisions as a part of any application before it 

approves the reconditioning. The application is an agreement between the importer (or 

other appropriate party submitting the application) and the Agency.

If FDA has documented an importer's practice of consistently importing violative articles 

not already subject to detention without physical examination and only attempting to 

recondition the articles after detention, FDA may require, as part of any reconditioning 

application, that the importer agree to destroy any article not brought into compliance 

during reconditioning, in lieu of permitting re-export of the violative article.

The responsible office should consult and obtain the concurrence of both the OEIO and 

the appropriate Center Compliance Office before initiating a decision requiring a specific 

importer to destroy rather than re-export violative articles as part of every reconditioning 

process. 
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The information supplied should include, but not be limited to, the following:

1. Documentation of the firm's pattern of importing violative articles.

2. Documentation of prior warning to the firm of their obligation to import the article

in compliance with the FFDCA or other acts enforced by FDA.

3. Documentation which may establish that the article can be imported in

compliance and thus would not require reconditioning after importation.

REQUESTS FOR VOLUNTARY RECALLS

Although requests for voluntary recalls duplicate a request for redelivery action to some 

degree, they also offer definite advantages. Experience indicates that requesting the 

firm to initiate a voluntary action, such as a recall, may result in a more favorable 

response by the firm than a demand for redelivery. A recall may occur more promptly 

because it can be initiated in a matter of days, while redelivery may not take place for 

90 days or more. This is especially significant in hazard-to-health situations. A recall 

may provide FDA with further knowledge of the status of the violative merchandise 

being returned and usually makes it easier to maintain control of the article. This 

ultimately leads to improved consumer protection.

FDA management should very carefully encourage the firm to consider a voluntary 

recall under the following situations:

1. When a potential health hazard situation exists.

2. When there is evidence of distribution of detained or refused merchandise.

When an importer fails to respond fully or in a timely manner to a Warning Letter, or we 

are notified by CBP that an Importer has not responded to a Notice of FDA Action 

Specifying Refusal of the product, it may be an indication the goods are no longer intact. 

A visit to the importer may be appropriate and, if articles are missing, attempt to 

determine the firm's intentions with respect to corrective action.

When a potential health hazard situation exists and the article has been illegally 

distributed, appropriate press coverage may issue naming firm, product, and country of 

origin. Issuance of all publicity must be in accordance with guidelines.

Import recalls are to be conducted in full accordance with the procedures in this RPM. 

Chapter 7- Recall Procedures. Supervision of the disposition of returned articles may be 

made either by FDA or CBP. If disposition will be by destruction, it is suggested that 

FDA provide the supervision. If the articles are to be exported, CBP or FDA may handle 

the supervision.

SEIZURE

Seizure is another enforcement approach that may be considered to gain control over 

violative imported articles. Seizure is an action against an article. Consequently, it will 

be necessary to show, through laboratory analysis or otherwise, that the article seized is 
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actually violative. An importer's history of illegal actions, while relevant, is not itself 

sufficient to support seizure. Whatever the importer's previous history, it will be 

necessary to show that the article itself is violative. Seizure may be considered for an 

article which:

1. Represents a potential hazard to health and has been or is likely to be distributed

in domestic commerce following receipt of a Notice of FDA Action specifying that

the article is Detained or Refused; or

2. Has been fraudulently identified/represented in documents submitted to the

Agency; or

3. Is identified by the Agency as a previously refused article.

When an imported article is seized, and condemned, it is subject to the provisions of 

section 304(d) (21 USC 334(d)) which may allow for re-exportation of the article, 

provided specified conditions are met. Under 21 USC 334(d), certain condemned 

imported articles may be re- exported under limited circumstances. Re-exportation is 

not available for condemned unapproved new drugs (see 21 USC 355), or foods in 

violation of the emergency permit control provision (see 21 USC 344). Such articles 

must be destroyed.

In order to be able to re-export condemned imported articles, the party seeking reexport must satisfy several threshold conditions:

1. The violation did not occur after the article was imported.

2. The party seeking re-export "had no cause for believing that it was adulterated,

misbranded, or in violation before it was released from CBP custody."

3. The party seeking re-export must "establish that the article was intended for

export at the time the article entered commerce." An example of where it may be

possible to demonstrate that a product was intended for export at the time it

entered commerce would be when products are imported for purpose of

transshipment to a destination outside the U.S.

4. Compliance with 21 USC 381 (e) (1):

a. Intended for export.

b. Accords with the specifications of the foreign purchaser (unless the article

is to be exported to the original foreign supplier, in which case there is no

need to comply with this requirement).

c. May not be in conflict with the laws of the country to which it is intended

for export (unless the article is to be exported to the original foreign

supplier, in which case there is no need to comply with this requirement).

d. Labeled on the outside of the shipping package that it is intended for

export

e. Not sold or offered for sale in domestic commerce
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Therefore, there are circumstances where the seizure of an article may not accomplish 

more than detention and refusal of the article, other than stricter control over the goods 

before re- export and compliance with the applicable requirements of Section 801(e) (21 

USC 381(e).

Consequently, in evaluating whether a seizure is an appropriate course of action, FDA

should consider whether the facts in the case would justify recommending to a court 

that re- export of the article would be an unsatisfactory resolution. Among the points to 

consider are:

1. Does a potential health hazard exist?

2. Does the previous history of the person in possession of the articles indicate that

the person may attempt to re-enter the articles into the United States at a later

date?

3. Did the violation occur after the article was imported?

4. Did the importer have cause to believe that the article was in violation before

entry?

5. Does the article meet the legal specifications of the country to which it would be

exported?

6. Was any portion of the article sold or offered for sale in domestic commerce?

7. Is the article in violation of 21 USC 342(a)(1), (2), or (6), 344, 351(a)(3), 352(j),

355 or 361(a) or (d)?

8. If the article is a drug will it be re-exported to the original foreign supplier?

Under certain circumstances, FDA may recommend seizure of violative articles under

21 USC 334 while the articles are still under import status, rather than allow re-export as 

provided under 21 USC 381(a). Generally, seizure of articles while in import status may 

be appropriate if the articles must be destroyed (pose a serious health hazard or it is 

likely that the articles will be reintroduced into the United States), or the public health 

requires that certain conditions be imposed (e.g., conditions in 21 USC 381(e)(1)).

As with citation, prosecution, and injunction, samples collected for seizure consideration 

should, whenever possible, include a 702(b) portion. See 21 USC 372 (b). Such 

samples should be collected, sealed, analyzed, and otherwise handled in accordance 

with procedures normally applied to domestic samples.

State embargo authority and CBP holds are alternative methods to gain control over 

violative articles. CBP may also release an article at our request so that an immediate 

domestic seizure may be conducted. Moreover, if a violative article represents evidence 

of a crime, it may be seized pursuant to a criminal search and seizure warrant. These 

avenues should also be considered, especially if an importer is likely to attempt to 

quickly re-export the article.
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INJUNCTION

If injunction is the action of choice, the case should be developed in accordance with 

the procedures set forth in RPM Chapter 6 - Judicial Actions, subchapter 6-2, 

"Injunctions." Injunctions may require a pattern of actual violations with some 

recognizable danger of a recurrence. The monitoring of an injunction is resource 

intensive. These facts should be taken into consideration when evaluating this course of 

action. Also consider that an injunction often results in a hearing more quickly than does 

a prosecution, particularly if a Temporary Restraining Order (TRO) is requested. This 

can result in quick corrective action as well as more rapid and efficient redelivery if this 

response is requested in the injunction. Also, the burden of proof is less in civil cases 

than in criminal cases, and injunction does not preclude subsequent prosecution for the 

same violation.

When developing an injunction case against an importer or consignee, there must be a 

well- documented history of an illegal practice.

A TRO requires a heightened showing of harm. See RPM Chapter 6 - Judicial Actions, 

subchapter 6-2, "Injunctions" regarding the prerequisites for a TRO in conjunction with 

an injunction action.

CITATION/PROSECUTION

Citation/prosecution should be used when conventional import enforcement approaches 

are determined to be inadequate to correct violative practices, or the violation is 

sufficiently egregious to warrant punishment.

When citation/prosecution is the action of choice, refer to RPM Chapter 6 - Judicial 

Actions, subchapter 6-5, "Prosecution" for the appropriate procedures.

FDA should consider the potential impact of developing citation/prosecution 

recommendations as the action of choice in the following instances:

1. Where there is repetitive illegal distribution of articles after issuance of a Notice

of FDA Action specifying the intention of Sampling or Detention; or

2. Where the importer submits false or misleading entry documents; or

3. Where the importer submits false or misleading private laboratory analytical

results or false certifications; or

4. Where the importer submits false or misleading export documents; or

5. Where the importer repeatedly brings previously refused articles into the United

States; or

6. Where evidence of other fraud exists.

This list is not all inclusive and there may be other situations where citation/prosecution 

is appropriate.
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Any recommendation for citation, prosecution, or injunction must be supported by fully 

documented instances of attempts to circumvent normal import procedures. For a felony 

prosecution recommendation, there must be a fully documented attempt to do the 

same, with evidence of the intent to defraud or mislead. It is not necessary, in 

developing a citation/prosecution recommendation, to show that each specific entry is 

actually violative. However, physical evidence that documents the violative nature of an 

entry (or of several entries) would be useful to highlight the likely result of the firm's 

pattern of behavior.

It is important to remember that sample collection and analytical procedures in these 

cases, as for seizures and injunctions, should differ from routine import work. OCC has 

consistently advised us that when an import physical sample is collected for use in an 

anticipated legal action, a sealed 702(b) portion should be available (21 USC 372 (b). 

This request is further supported by procedures provided in the RPM. Proper chain of 

custody should also be maintained for these samples. Ordinarily, check analyses should 

be conducted on such samples. In instances where CPGs exist and instructions differ 

for domestic legal actions as opposed to import detention, FDA should follow the 

procedures for domestic legal actions in terms of types of analyses, check analyses, 

etc. 

Importers of articles detained without physical examination should not feel free to 

distribute and sell such articles without risk of criminal penalty. Criminal action may be 

possible against importers violating FDA's detention without physical examination 

actions or who routinely ship articles without a Notice of FDA Action indicating the 

articles are Released. Refusal to allow inspection is a violation of the FFDCA. 

Subsequent entry pursuant to an inspection warrant may yield evidence providing the 

basis for a felony violation for refusal to allow inspection. Distribution of an article prior 

to receipt of a Notice of FDA Action indicating the article May Proceed or is Released 

should be considered refusal to permit inspection, as authorized by section 704 (21 

USC 374).

In addition to charges under the FFDCA and CBP law, Title 19 (note especially, 19 USC 

1592 and 1595a), and/or Title 18 charges may also be considered. These include 18 

USC 1001, false statements; 18 USC 1505, obstruction of justice (when a firm 

knowingly and willingly interferes with an FDA inspection by distributing imported 

articles not released by FDA from import status); 18 USC 542, entry by use of a false 

statement; 18 USC 545, smuggling; and 18 USC 371, conspiracy.

9-17 IMPORT FOR EXPORT

9-17-1 PURPOSE

This subchapter is to provide operating procedures for FDA personnel regarding the 

handling of certain products that are offered for import under section 801 of the FFDCA. 

Those products are those that are offered as “imports for export.” The provision of the 

Act that permits such imports, section 801(d)(3), is referred to as the "import for export" 
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provision. These procedures are intended to provide uniform procedures for handling 

such importations by all FDA offices. This chapter represents the Agency's current 

thinking on the application of the import for export provisions of the Act.

9-17-2 BACKGROUND

The FDA Export Reform and Enhancement Act of 1996 (Export Reform Act), Public Law

104-134) amended section 801(d)(3) and d(4) of the Act to allow the importation of

certain articles that are unapproved or otherwise do not comply with the Act, provided

that those imported articles are further processed or incorporated into products that will

be exported from the United States, by their initial owner or consignee in accordance

with section 801(e) or section 802 of the Act or section 351(h) of the Public Health

Service Act (PHSA). On June 12, 2002, the Public Health Security and Bioterrorism

Preparedness and Response Act of 2002 (Bioterrorism Act), Public Law 107-188, was

signed into law. Section 322 of PL 107- 188 amended section 801(d)(3) of the Act. The

amended provision is effective September 9, 2002.

Under the amended provision of the Act, importers wishing to import certain violative 

articles that are intended for further processing or incorporation into another product 

and subsequent export must provide FDA with certain information at the time of initial 

importation. The articles include drugs (or components), devices (or components or 

accessory of a device or other article of a device requiring further processing, which is 

ready or suitable for use for health-related purposes), food additives, color additives and 

dietary supplements. The information includes a statement that confirms the intent to 

further process such article or incorporate such article into a product to be exported and 

identifies entities in the chain of possession of the imported article. Importers also must 

provide certificates of analysis as necessary to identify the article unless the article is a 

device or an article described in Section 801(d)(4). Section 801(d)(3)(A)(i)(III).

Under section 801(d)(3)(A)(ii), at the time of initial importation and before delivery to the 

importer, initial owner, or consignee, a bond must be executed providing for liquidated 

damages in the event of default, in accordance with CBP requirements.

The initial owner or consignee of the article must maintain records of the use and/or 

destruction of such imports and must submit the records or a report to FDA upon 

request. Section 801(d)(3)(A)(iv) and (v). The initial owner or consignee must destroy 

any article or portion not used in an exported product. Section 801(d)(3)(A)(iii).

The amended section 801(d)(3)(B) provides that FDA may refuse admission of an 

article that could otherwise be imported under section 801(d)(3)(A) if there is credible 

evidence or information indicating that such article is not intended to be further 

processed by the initial owner or consignee or incorporated into a drug, biological 

product, device, food, food additive, or dietary supplement that will be exported in 

accordance with section 801(e) or section 802 of the Act or section 351(h) of the PHSA. 

The "import for export" requirements for blood, blood components, plasma, and source 

leukocytes differ from those for drugs and other biological products. The Act allows for 

the importation of these blood products and components provided they comply with 
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section 351(a) of the PHSA or FDA permits such imports "under appropriate 

circumstances and conditions" as determined by CBER (section 801(d)(4) of the Act). 

Tissue products may be imported only if the importation complies with regulations 

promulgated under section 361 of the PHSA. The Bioterrorism Act did not amend 

section 801(d)(4). However, if CBER approves a particular request for import under 

section 801(d)(4), the import must comply with all applicable requirements of the 

amended section 801(d)(3) of the Act. Section 801(d)(4). The import also must comply 

with all applicable export requirements when the product is exported. Section 

801(d)(3)(A)(i)(I) and (iii). The Bioterrorism Act also amends section 301 of the Act. The 

amended section 301(w) prohibits the making of a knowingly false statement in any 

statement, certificate of analysis, record or report required under section 801(d)(3); the 

failure to submit a certificate of analysis; the failure to submit or maintain records; the

release into interstate commerce of any article or portion imported into the United States 

under section 801(d)(3) or any finished product made from such article or portion, 

except for export in accordance with section 801(e) or section 802 of the Act, or section 

351(h) of the PHSA; and, the failure to export or destroy any articles or portions not 

incorporated into a finished product. Section 801(d)(3) requires that the imported article 

or portions must be further processed or incorporated into a drug, biological product, 

device, food, food additive, color additive or dietary supplement that will be exported.

9-17-3 INSTRUCTIONS

INFORMATION SUBMISSION, ENTRY REVIEW, AND DOMESTIC FOLLOW-UP

When a drug or device component, food additive, color additive, or dietary supplement 

is imported under section 801(d)(3), the importer is required to submit a statement to 

FDA at the time of each importation with the following information:

1. That such article (the components, parts, accessories, or articles) is intended to

be further processed by the initial owner or consignee or incorporated by the

initial owner or consignee into a drug, biological product, device, food, food

additive, color additive, or dietary supplement that will be exported from the

United States by the initial owner or consignee in accordance with section 801(e)

or section 802 of the Act or section 351(h) of the PHSA; and

2. Identification of the manufacturer of such article and each processor, packer,

distributor or other entity that had possession of the article in the chain of

possession from the manufacturer to such importer of the article.

The statement must be accompanied by such certificates of analysis as are necessary 

to identify such article unless the article is a device or is an article described in section

801(d)(4). Section 801(d)(3)(A)(i)(III).

In order for FDA to efficiently process such importations, the statement required to be 

provided to FDA pursuant to section 801(d)(3)(A)(i) must include, pursuant to that 

section, a declaration that the article is intended to be imported for further processing by 

the initial owner or consignee into a drug, biological product, device, food, food additive, 
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color additive, or dietary supplement that will be exported in accordance with section 

801(e) or section 802 of the Act or section 351(h) of the PHSA. The statement should 

include information identifying the article and the initial owner or consignee.

Identification of all entities that had possession of the article in the chain of possession 

should include information sufficient to accurately identify the entity such as the name of 

each entity (including business and trade names), complete physical address, 

transaction dates, and any other information to aid in identification such as telephone 

and fax number, and e-mail address. The statement should include information 

sufficient to identify the chain of possession of the article through each entity, which 

could include information such as product coding, lot, batch, or other identification 

numbers. For medical devices, device history records required of domestic and foreign 

manufacturers, pursuant to 21 CFR

820.184, may provide information to assist in meeting this requirement. For imported 

articles subject to section 801(d)(4), the manufacturer in the chain of possession can be

considered to be the initial collection agency, e.g., a blood collection center for purposes 

of information required under section 801(d)(3).

Certificates of analysis, as are necessary to identify the imported article, must 

accompany the statement filed pursuant to 801(d)(3)(A)(i). Section 801(d)(3)(A)(i)(III). 

The submission of such certificates is not required if the imported article is a device or is 

an article described in 801(d)(4). Certificates of analysis, or equivalent documentation 

should provide the article's formulation, ingredients, components, or assay, as 

appropriate to the type of article.

Certificates of analysis could include documents to assure the identity of the substance 

and its components in the chemical and drug industries. A batch certificate could be a 

certificate of analysis. A document that establishes a drug ingredient is certified to meet 

USP requirements could be a certificate of analysis. Documents that provide sufficient 

information to determine the level, potency, identity, strength, quality and purity of the 

drug component and whether prohibited material has been used in the imported article 

could be considered certificates of analysis.

For other products, documents that convey assurance as to the identity of the article 

and its components or substances could be a certificate of analysis. Sufficient 

information should be provided to determine if prohibited material has been used in the 

imported article. For an article of food additive or color additive, a document indicating 

specification of purity or documents establishing the article is a “certified” color or of 

“food grade” or “Codex Alimentarius” grade food additive could meet the requirement of 

a certificate of analysis.

When the initial owner or consignee of the imported article is not the importer, the 

importer should provide FDA with information identifying the initial owner or consignee 

with the entry. In cases where the importer is not the initial owner or consignee and the 

article is intended for multiple owners or consignees, each of whom will serve as the 
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initial owner or consignee for a portion of the article, the importer should submit a 

separate statement identifying each owner or consignee and indicating the amount of 

the entry each is to receive. Failure to provide this information at the time of importation 

may be viewed by FDA as evidence that the product does not meet the conditions of 

section 801(d)(3).

If the information needed to efficiently process importations and to make a “May 

Proceed” decision is not provided at the time the article is offered for entry, and if the 

product is otherwise subject to refusal of admission pursuant to section 801(a), FDA

may issue a Notice of FDA Action - Detained in accordance with normal procedures. 

See RPM subchapter 9-9 "Notice of FDA Action – Detained for Non-Mail Shipments"). If 

a response to the Notice of FDA Action - Detained is not received by the responsible 

FDA office within the designated time (10 days, excluding Saturday, Sunday, and 

Holiday, or date requested by on the notice, or additional time as deemed necessary by 

the responsible FDA office), a Notice of Refusal should be issued. See RPM subchapter

9-11 "Notice of FDA Action - Refusal of Admission" Instructions, "When Should the

Notice of FDA Action - Refusal of Admission be Issued?". Once issued, cancellation of

the Notice of Refusal should be considered only under unusual circumstances at the

discretion of the FDA. See RPM subchapter 9-11 "Notice of FDA Action - Refusal of

Admission" Instructions, "Reopening of a Case".

If the FDA has evidence or information indicating that the imported article is not 

intended to be further processed by the initial owner or consignee, or incorporated by 

the initial owner or consignee, into a product included in section 801(d)(3) that will be 

exported in accordance with the Act or the PHSA, the responsible FDA office should 

contact OEIO before any action is taken on the entry. In certain circumstances, 

application of section 801(d)(3)(B)’s refusal authority may be appropriate

Submissions of Entries

Entries of articles imported pursuant to section 801(d)(3) that are accomplished by 

electronic submission of information through the CBP ACE/ITDS and FDA’s OASIS will 

necessitate that the filer declare that the imported article is intended for further 

processing or incorporation into a product that will be exported in accordance with 

Section 801(d)(3)(A)(i) of the Act. If the filer is not the "importer, initial owner or 

consignee” responsible for further processing or incorporating the imported article into 

the product to be exported, the filer of the entry should provide the name of such firm or 

individual in the FDA consignee field using the appropriate FDA Field Establishment 

Identifier (FEI) number.

When the article is intended for multiple owners or consignees, a separate FDA line 

should be created for each owner or consignee as provided for in the ACE/ITDS

system. FDA has established an Affirmation of Compliance (A of C), identified by the 

code "IFE" (Import for Export), that will indicate that the entry is being made under the 

import for export provisions of the Act. Use of the "IFE" affirmation triggers prompts for 

the submission of Quantity and Value data. If any of this information is not provided, the 
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notification will be considered incomplete by the system. Such lines with "IFE" (or any 

Affirmation) will display the Affirmation in the Entry Line Summary and line detail screen. 

If electronic submission is made, in most cases it is unlikely that all of the information 

required under section 801(d)(3) will be able to be provided through electronic entry. 

FDA should request and review the supporting paper entry documents for all “IFE” 

entries.

Once the FDA has determined that all of the appropriate information has been 

submitted, either by the on screen review process or by review of the entry documents, 

a "May Proceed" should be issued in accordance with OASIS procedures. The filer may 

be held responsible for the accuracy of the information provided through OASIS for 

such importations and import for export entries will be included in the FDA’s filer 

evaluation conducted by the responsible FDA office.

For manual entry submissions, or when FDA has requested supporting paper entry 

documents for an electronic “IFE” entry, all documentation required by section 801(d)(3) 

should be included in the filer's entry package, including the statement and a certificate 

of analysis as necessary. When the imported article is intended for multiple owners or 

consignees, a separate statement and certificate of analysis as necessary should be 

submitted for each owner or consignee indicating the portion of the entry each is to 

receive. The responsible FDA office should reconcile the quantities provided and any 

product not accounted for should be detained if otherwise subject to refusal of 

admission pursuant to section 801(a) as noted above. If FDA determines that all 

information provided in the manual or electronic submission is appropriate, then offices 

should follow their normal procedures for marking the entry "May Proceed".

Follow-up

The FDA office responsible for the entry review should use normal operating 

procedures to determine whether additional follow-up is necessary for entries made 

under section 801(d)(3). This can consist of additional contact with the importer or the 

initial owner/consignee at the time of entry to obtain records to confirm the intended use 

of the article and the final disposition of the article. The responsible FDA office of the

initial owner or consignee should be provided with a copy of the entry paperwork by the 

FDA office performing the entry review (where the home office is not the importing 

office). Entries processed by OASIS will be available to home offices through a 

Structured Query Language (SQL or Sequel) report.

The imported article will continue to be subject to the Customs Temporary Import Bond 

or other bond instrument as required by CBP, under the new section 801(d)(3)(A)(ii) and 

remains subject to section 801(a). Any follow-up regulatory actions regarding the failure 

of the initial owner or consignee to meet the requirements of section 801(d)(3) should 

be referred to OEIO for handling.

When a domestic inspection is conducted at a manufacturer's facility where the 

imported article is being further processed or incorporated into a product intended for 
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export, the inspection should include appropriate review of the domestic manufacturer's 

compliance with section 801(d)(3). For example, the investigator should request the 

manufacturer's import, export, and/or destruction records during an inspection. The 

records/reports should include documentation indicating that the imported article was 

further processed or incorporated into another product and was exported in accordance 

with section 801(e) or section 802 of the Act, or section 351(h) of the PHSA, or 

destroyed. The records should establish that the entire amount of the product or article 

imported is used or exported or destroyed; that the exported products are labeled in 

conformance with section 801(e)(1) and meet the other requirements of section 

801(e)(1) or section 802 of the Act or section 351(h) of the PHSA, as appropriate. 

Please note, however, that for drug and medical device products, an initial owner or 

consignee may be allowed to retain a sample of the imported article in order to comply 

with GMP regulations concerning sample retention.

9-17-4 TIME FRAME FOR HOLDING IMPORTED PRODUCT

Section 801(d)(3) allows for the importation of otherwise prohibited products and articles 

for manufacturing, further processing or incorporation and export. The amended 

provision does not impose any specific limitations on how long a product can be held in 

the United States before it must be further processed or incorporated into a product and 

exported or destroyed. A time limitation may be imposed, however, by CBP through its 

bond requirements.

9-17-5 IMPORTED FOR FURTHER PROCESSING

The legislative history of the Export Reform Act indicates that section 801(d)(3) was 

intended to allow manufacturing and processing activities not previously permitted 

under the Act, and the legislative history of the Bioterrorism Act does not alter that 

intent. The terms "further processed" and "incorporated" can cover a wide range of 

activities. These can include packaging or labeling of finished products and specialized 

processing (such as sterilization) of a product. FDA recognizes that in some instances, 

it may be advantageous to manufacture a product in a foreign country and then ship it to 

the United States for specialized packaging or labeling. Merely storing an article or 

product in the United States before export is not considered “further processing.”

9-17-6 PRODUCTS SUBJECT TO DETENTION WITHOUT PHYSICAL

EXAMINATION

The import for export provision does not preclude the importation of articles that 

otherwise would be subject to detention without physical examination based on an FDA 

examination of previous shipments or a foreign inspection that documented significant 

GMP violations, or manufactured by a foreign firm that has refused to permit an FDA 

GMP inspection [21 CFR 820.1(d)]. Therefore, if these articles are offered for import in 

compliance with section 801(d)(3) or (4) such articles generally could be allowed unless

other grounds exist for refusal of admission. Further procedures on criteria for accepting 

products for IFE that would otherwise be detained without physical examination 

products may be issued by each Center.
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9-17-7 COMPLIANCE WITH RELEVANT EXPORT PROVISIONS

At the time of importation, FDA ordinarily will not know if the finished product will be 

exported under the provisions of section 801(e)(1) or section 802 of the Act or section 

351(h) of the PHSA. Importers, initial owners, and consignees of articles imported or 

offered for import pursuant to section 801(d)(3) or (4) should determine whether the 

intended finished product meets the requirements of one or more of the export 

provisions (section 801(e)(1) and section 802 of the Act and section 351(h) of the 

PHSA). If they do not meet such requirements, they must destroy any products that may 

not be legally exported under the Act or the PHSA, as applicable. Section 

801(d)(3)(A)(i)(I) and (iii).

9-17-8 IMPORTATION OF FINISHED GOODS FOR STORAGE AND EXPORT

WITHOUT FURTHER PROCESSING AND OTHER ARTICLES NOT 

INCLUDED UNDER SECTION 801(d)(3)

Products and articles imported under section 801(d)(3) must be furthered processed or 

incorporated into a drug, biological product, device, food, food additive, color additive or 

dietary supplement that will be exported from the United States. This provision does not 

allow the import of violative products intended only for storage.

Importers of electronic products subject to performance standards are required by U.S. 

Customs regulation, 19 CFR 12.91, to file the form FDA 2877. Block A.7 on form FDA 

2877 needs to be checked to indicate that the device is for medical device processing 

under import for export.

Since the wording of the amended section 801(d)(3) specifically identifies only food 

additives, color additives, and dietary supplements as the only food articles that can be 

imported for export, FDA should not accept notification of import for export of other 

foods that do not meet the criteria of a food additive, color additive, or dietary 

supplement. Similarly, cosmetics, as defined by section 201(i) of the Act, do not meet 

the criteria for import for export under the provisions of section 801(d)(3) and any offers 

for entry for such importations should be refused admission as appropriate.

The amended section 801(d)(3) also identifies specific products into which articles 

imported pursuant to the section can be incorporated for export. These are drugs, 

biological products, devices, foods, food additives, color additives, and dietary 

supplements. Cosmetics are not listed as a product that falls within this provision. 

Therefore, violative color additives intended for processing into a cosmetic product do 

not fall within the scope of section 801(d)(3), and entries for such importations should 

be refused admission, as appropriate.

9-17-9 IMPORTATION OF VIOLATIVE COMPONENTS FOR FURTHER

PROCESSING INTO OTHER COMPONENTS AND UNFINISHED 

PRODUCTS

Many manufacturers assemble their products in various stages. These manufacturing 

steps may include sending partially completed products to firms in the United States for 
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further manufacturing or processing, but not into a finished product. Neither the 

statutory language of the amended section 801(d)(3) nor the legislative history of the 

Export Reform Act or the Bioterrorism Act require that violative components allowed to 

be imported must be incorporated into “finished products.” Because components, or 

"subassemblies," are the finished product of the U.S. manufacturer (although not 

necessarily a consumer ready product) and would constitute a drug, biological product, 

device, food additive, color additive, or dietary supplement within the Act's meaning, the 

agency has concluded that articles imported for use in the manufacture of such 

products fall within the scope of the import for export provision. Therefore, such 

products are subject to the requirements of section 801(e) or section 802 of the Act or 

section 351(h) of the PHSA.

9-17-10 IMPORT FOR EXPORT PROVISIONS FOR PRODUCTS MANUFACTURED

IN FOREIGN TRADE ZONES

Foreign Trade Zones are federally sanctioned sites that, only for tariff purposes, are 

considered outside of the “Customs territory” of the United States. Nevertheless, 

products stored or manufactured in a Foreign Trade Zone are within the territory of the 

United States for the purposes of the Act and are expected to meet the same 

requirements as other products regulated by FDA. See CPGs 110.600 "FDA Authority 

Over Products of Foreign Origin Located in Foreign Trade Zones, Bonded Warehouses, 

or on Bonded Carriers", and 110.200 "Export of FDA Regulated Products from U.S. 

Foreign Trade Zones"). These include the requirements of section 801(d)(3) and section 

801(d)(4).

9-17-11 RECORDS AND INFORMATION TO BE PROVIDED TO FDA UPON

REQUEST

The new section 801(d)(3)(A)(iv) requires that the initial owner or consignee maintain 

records on the use or destruction of the imported articles or portions and to provide 

records when requested. The initial owner or consignee is also required to submit a 

report to FDA, upon request, that provides an accounting of the export or destruction of 

such imported article or portions and the manner in which such owner or consignee 

complied with the requirements of section 801(d)(3). The records should include the 

statements and any certificates of analysis required to be submitted at the time of import 

as described above. Additional records could include documentation with more specific 

identification of the product such as Customs entry number, date, quantities, 

manufacturing process and controls and intent of the importation (i.e., further 

processing into product intended for exportation). Records on export or other disposition 

need to be retained (section 801(d)(3)(A)(iv)) and should include information such as 

quantity, dates, destination, shipping, means of destruction, and any records required 

under the export record keeping and notification regulation. 21 CFR 1.101.

9-17-12 AGENCY CONTACTS

Questions regarding importation of specific products should be referred to the 

appropriate Center (e.g., biological products, tissues, and procedures for considering 

requests to import violative blood products under section 801(d)(4) should be referred to 
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Center for Biologics Evaluation and Research, Office of Compliance and Biologics 

Quality, Division of Case Management, Biological Drug and Device Compliance Branch; 

unapproved drugs should be referred to the Center for Drug Evaluation and Research, 

Office of Compliance; food additives and color additives should be referred to the 

Center for Food Safety and Applied Nutrition, Office of Compliance, Division of 

Enforcement; medical devices and radiation emitting electronic products or their 

components should be referred to the Center for Devices and Radiological Health, 

Office of Compliance, Division of Analysis and Program Operations; feed additives, 

veterinary medical devices, and unapproved animal drugs should be referred to the 

Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of

Compliance.

Information concerning CBER’s review of import for export requests under section 

801(d)(4) (blood and blood products) is available on FDA’s Import for Export Overview 

page (link). 

Questions regarding the procedures to be followed by FDA or by industry relating to 

interaction with CBP should be addressed to the OEIO at 301-796- 0356.

9-18 IMPORTATIONS FOR TRADE SHOWS/FAIRS, EXHIBITS AND

SPECIAL EVENTS

9-18-1 PURPOSE

To provide operating procedures for FDA personnel regarding articles subject to 

regulation by the FDA which are imported as exhibits for trade shows, fairs, and 

exhibitions and regulated articles which are imported for use by participants in special 

events such as athletic competitions.

9-18-2 BACKGROUND

The responsible offices, as well as the OEIO Import Program, frequently receive 

inquiries regarding the importation of regulated articles to be used as trade show 

exhibits to promote business opportunities in the United States. Also, persons who are 

participating in special events or athletic competitions such as The Olympics, Special 

Olympics or World Cup ski races, may request that foods, devices, or medications be 

brought into the United States for the sole use of the participating athlete or team. 

Although many of the articles have not been approved for use in the United States, and 

under normal circumstances would be detained, the FDA does not normally restrict 

foreign visitors from bringing with them native foods or required medications for their 

own use or consumption while in the United States.

Exhibits are usually imported for a short period and may be exported or destroyed 

following the conclusion of the event. Exportation may be to another trade show in 

another country or back to the country of origin. Products imported for special events 
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and athletic competitions are usually used in the United States and any remaining 

products are exported or destroyed after the event is over.

9-18-3 CBP REQUIREMENTS

United States Customs regulations, 19 CFR Part 147, "Trade Fairs" govern the entry of 

merchandise intended for exhibition or for use in constructing, installing or maintaining

foreign exhibits at trade fairs which have been so designated by the Secretary of 

Commerce. The regulations also contain provisions concerning CBP supervision of the 

merchandise and the disposition of the merchandise after the fair has closed.

A special form, "Entry for Exhibition" is used by CBP for exhibitions under the Trade Fair 

Act of 1959. Articles are entered under bond and may be permitted immediate delivery 

to the location where they are intended to be exhibited, placed in public storage for 

examination and subsequent delivery to the site of the trade fair, or into bonded 

warehouses for delivery at a later date. Articles are segregated from domestic articles 

and from imported articles entered under the provisions of the general Customs laws 

that are released from CBP custody.

Disposition of the articles used in trade fairs takes place under CBP supervision at any 

time within 3 months of the closing date of the fair.

9-18-4 PROCEDURES FOR TRADE SHOWS, FAIRS, AND EXHIBITIONS

A Customs regulation, 19 CFR 147.23 (b), addresses the compliance of articles with the 

FFDCA and states, "The entry of food products shall conform to the requirements of the 

FFDCA and the regulations issued thereunder." Therefore, foods entering for exhibits 

should meet the requirements of the Act in that they are not adulterated or misbranded, 

and they should comply with applicable food standards and labeling regulations. 

Although the Customs regulation addresses food products specifically, OEIO interprets 

this section of the Customs regulation to include all FDA regulated articles. Therefore, 

medical and radiological devices, pharmaceuticals, cosmetics, biological products, 

electronics and tobacco products may not be adulterated or misbranded and should 

comply with FDA regulations applicable to that product line.

In general, articles used as exhibits may be handled in several ways: if all articles 

comply with FDA regulations, the general importing procedures would apply. However, 

for non-complying articles, it may be possible for an importer or importer's agent to 

request release of the entry, through the responsible FDA office, for the sole purpose of 

exhibition at the event and providing for the supervised destruction or re-exportation at 

the conclusion of the event. The request for release is made by the importer of record or 

agent to the responsible FDA office where the event is to be held and the local CBP 

office.

• FDA generally will permit release of articles which may not be in full

compliance with U.S. laws and regulations where a placard is used at the
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point of display, advising that the product may not be in compliance with 

applicable FDA regulations and that FDA should be contacted for further 

information for procedures to bring the products into compliance.

• When large shipments of non-complying articles that are intended for

promotion at a trade function, are encountered by FDA, representative

products of the entry may be released for display purposes upon receipt of a

request from the importer or agent to the responsible FDA office. However,

release of commercial size shipments of non- compliant products destined to

be used for promotion at a trade show will be evaluated by FDA on a case by

case basis.

• An example of a model letter for responding to inquiries regarding importation

for trade shows or exhibitions is attached as Exhibit 9-10.

9-18-5 SPECIAL EVENTS

For special athletic events, any foods, medications or devices which are being brought 

into the U.S. for an individual athlete or team use should be held under the supervision 

of the team physician or trainer.

The amounts of both foods and medications should be commensurate with the duration 

of the stay. An inventory of the food items and medications being entered should 

prevent any undue delays when the team or athletes arrive.

Fans, family members and non-participants are not restricted in bringing in familiar food 

items or medications for personal use. This would also apply to individual athletes or 

participants who may be traveling alone. However, it may be advisable to have a 

prescription or letter from a physician accompany necessary medications. Further 

information regarding articles imported for personal use may be found in the subchapter 

9-2, “Coverage of Personal Importation."

A statement for responding to inquiries regarding importation for special events is 

attached as Exhibit 9-11. 

9-19 SECURED STORAGE (TEMPORARY REMOVAL DUE TO

PENDING REVISION)

Temporary Removal Due to Pending Revision

9-20 COMMUNICATION CONCERNING ASSESSMENT OF CIVIL

MONETARY PENALTIES BY CBP IN CASES INVOLVING IMPORTED

FOOD

Procedures for Industry and FDA Employees
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NOTE: For the purpose of this subchapter, all references to foods include both human 

and animal foods.

9-20-1 PURPOSE

To establish procedures to ensure that FDA is aware of the assessment, by CBP, of 

civil monetary penalties against violators in cases involving unsafe food and that CBP is 

aware of any events for which civil monetary penalties are an appropriate regulatory 

action.

9-20-2 BACKGROUND

CBP has enforcement programs under existing statutory authorities that allow for the 

imposition of civil penalties. Under 19 U.S.C. 1592, CBP may impose a civil penalty 

against any person who by fraud, gross negligence, or negligence, enters, introduces, 

or attempts to enter or introduce, any merchandise into the United States by means of 

any document or electronically transmitted data or information, written or oral statement, 

or act which is material and false or by means of any omission that is material. Civil 

penalties can be assessed in amounts up to the domestic value of merchandise so 

imported. Under 19 U.S.C. 1595a(b), CBP may assess a penalty against any person 

who directs, assists financially or otherwise, or is in any way concerned with introducing, 

or attempting to introduce any article into the United States contrary to law. Penalties 

assessed under 1595a (b) also may be in an amount equal to the domestic value of the 

merchandise. CBP has assessed penalties against importers that substitute, rather than 

export merchandise that FDA has refused

While this procedure is currently in operation at CBP, FDA does not always understand 

the requirements for providing adequate information to CBP for assessment of a civil 

penalty. Conversely, FDA is not always kept aware of CBP’s assessment of civil 

monetary penalties involving importation or exportation of food.

9-20-3 INSTRUCTIONS

FDA should alert the local CBP Port Director when a situation is encountered for which 

assessment of civil monetary penalties may be appropriate under the above authorities. 

FDA should coordinate with their local CBP office to make sure CBP informs the local 

FDA office of the imposition of civil monetary penalties involving the entry or attempt to 

enter any FDA-regulated food product. CBP should, in turn, develop procedures to 

receive recommendations for, and to inform FDA of, the imposition of civil penalties for 

violative importations of food.

FDA should meet with local CBP quarterly to discuss enforcement actions, including 

civil monetary penalties. FDA offices who meet with CBP should provide a quarterly 

report to OEIO identifying jointly conducted enforcement actions and/or assessments of 

civil monetary penalties against importers of FDA-regulated foods.
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9-21 NOTICE OF SAMPLING

9-21-1 PURPOSE

To provide operating procedures for FDA personnel in the use of the "Notice of 

Sampling" or "Notice of FDA Action" for collecting samples of imported articles subject 

to the laws and regulations enforced by the FDA.

9-21-2 BACKGROUND

Sections 536(a) and 801(a) (21 USC 360mm and 381(a)) of the FFDCA direct that 

notice of sampling shall be given to the owner or consignee of articles imported or 

offered for import into the United States. FDA regulation (21 CFR 1.90) defines this 

requirement, stating that such notice is given not only for samples collected but may 

also be issued for samples that "will be" collected ("notice of delivery of, or intention to 

deliver, such sample."). The regulation also requires that the owner or consignee 

receiving the notice "shall hold such article and not distribute it until further notice from 

the office or unit director or the collector of Customs of the results of examination of the 

sample."

In developing OASIS, the specific form "Notice of Sampling" has been replaced by the 

"Notice of FDA Action." The Notice of FDA Action informs the recipient to the sample 

collected or of FDA's intention of sampling for each line in the entry. The use of the 

designation "Product Collected by FDA" or similar language should be considered as

meeting the standard "giving notice thereof to the owner or consignee." See 21 USC 

381(a). 

9-21-3 INSTRUCTIONS

Issuing the Notice of Sampling

Traditionally, the Notice of Sampling was issued by the responsible FDA office over the 

facsimile signature of the Regional or District Director of CBP, in accordance with an 

agreement between FDA and CBP. Under the procedures used in the OASIS system, 

however, the notice is no longer signed over a facsimile signature. At ports remote from 

a FDA office, local CBP officials may be re-delegated this responsibility of collecting, 

sampling and delivering the samples to FDA.

Notices of Sampling issued in OASIS are unsigned. They carry the name, address, 

phone number of the person creating the Status and Notice (often different individuals 

will be responsible for this operation for FDA).

When to Issue the Notice of Sampling

The law, as cited above, specifies that the Notice must be issued each time a sample is 

collected. For the purpose of this procedure, a Notice of Sampling or the Notice of FDA 

Action covering the collection of a sample will issue for each article identified for:

1. Physical collection of article submitted to the laboratory for examination;
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2. Documentary collections, including labels, photographs, radiological health

articles, mail entries, and personal importations.

When collection data is entered into OASIS a new Notice will be generated.

Notice of Sampling Terms Used by OASIS For Notification to Filer, Importer, etc. 

at Entry Level

Under OASIS, when an entry is filed through the CBP/AACE to FDA the following 

electronic messages are sent to CBP and the filer to identify the collection of a sample 

or intent to collect a sample: (wording use to explain the meaning of the OASIS 

message may not be exactly the same as presented here due to up-dates in the OASIS 

system) 

1. FDA REVIEW: All FDA regulated articles in the entry must be held intact and

not distributed, pending receipt of written notice or additional message from

FDA.

2. FDA HOLD: Further FDA action is being taken on one or more lines in the

entry.

3. FDA DO NOT DEVAN: All containers or trailers comprising this entry must

be held unopened pending FDA examination, or receipt of written notice or

additional message from FDA. (importer/consignee and/or filer) Notify FDA

when the containers or trailers will be available. All FDA regulated articles

will be examined or sampled by FDA. Following CBP release, the unopened

containers or trailers may be moved to a location approved by FDA.

4. FDA EXAM/SAMPLE: All FDA regulated articles in the entry must be held

intact and not distributed, pending receipt of written notice or additional

message from FDA. (importer/consignee and/or filer) Notify FDA when the

products will be available. The articles will be examined or sampled by FDA.

Following CBP release, the article may be moved to a location approved by

FDA.

Notice of Sampling Terms Used by OASIS for Notification to Filer, Importer, etc. at

Line Level

Under OASIS the following terms will be used by the FDA at the line level to identify the 

collection of a sample or intent to collect a sample: (wording use to explain the meaning 

of the OASIS message may not be exactly the same as presented here due to up-dates 

in the OASIS system)

1. FDA EXAM: Articles must be held intact and not distributed, pending receipt

of written notice or additional message from FDA. The article will be

examined or sampled by FDA. Following CBP release, the article may be

moved to a location approved by FDA.

2. FDA EXAM/NOTIFY: Articles must be held intact and not distributed,

pending receipt of written notice or additional message from FDA. The article

will be examined or sampled by FDA when available. (importer/consignee
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and/ filer) Notify FDA when the article will be available. Following CBP 

release, the product may be moved to a location approved by FDA.

3. FDA EXAM DO NOT DEVAN: All containers or trailers comprising this entry

must be held unopened pending FDA examination or receipt of written notice

or additional message from FDA. (importer/consignee and/or filer) Notify

FDA when the containers or trailers will be available. All FDA regulated

articles will be examined or sampled by FDA. Following CBP release, the

unopened container or trailers maybe moved to a location approved by FDA.

4. FDA EXAM REDELIVER: Articles must be held intact and redelivered for

FDA examination or sampling. (importer/consignee and/or filer) Contact FDA

for redelivery instructions. A written notice with specific information regarding

this request will be sent to the filer, importer of record, and consignee.

In those situations where the article is identified as subject to detention without physical 

examination, or where the action being recommended is for the detention of the article 

and no additional documentary or physical sample is collected, the notice to the filer to 

HOLD for FDA Review should be considered as satisfying the requirement for giving 

notice to the importer. This will also meet the requirement for the article to be held intact 

until final determination on admission has been made.

Distribution of the Notice of Sampling

For notices issued in OASIS, the firm or person whose name is provided as the Importer 

of Record in the ACE shall be issued the Notice of FDA Action for the collection of the 

sample. Copies of the notice generated by OASIS will also be identified for distribution 

to the filer and consignee, where applicable. Notification to CBP is handled through the 

FDA/ACE interface. No documents are sent to CBP under OASIS for this notification.

For entries submitted as paper entries, the responsible FDA office will enter the data 

from the entry documents into the OASIS system, appropriately identify the responsible 

firm or person shown on the CBP Entry Summary (3461/3461ALT or other appropriate 

entry document) as the importer of record, and provide them with a Notice of Sampling 

produced by OASIS. Additional distribution of notices should be made as identified for 

ACE entries. 

Section 801(b) (21 U.S.C. 381(b)) states in part: "Pending decision as to the admission 

of an article being imported or offered for import, the Secretary of the Treasury may 

authorize delivery of such article to the owner or consignee upon the execution by him 

of a good and sufficient bond providing for the payment of such liquidated damages in 

the event of default as may be required pursuant to regulations of the Secretary of the 

Treasury." The importer of record, who may or may not be the owner or consignee, is 

the person or firm that posts the CBP redelivery bond covering the importation of the 

articles and is legally responsible for assuring compliance with all laws and regulations 

affecting the importation. The importer of record may be a custom house broker, filer, 

bank, or other entity that is not directly involved with the ownership of the entry. The 

bond is subject to forfeiture, and the importer of record is subject to regulatory action for 
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violation of the laws and regulations pertaining to the shipment (19 CFR 113.62(l) 

Consequence of Default).

All persons or firms who are sent a Notice of Sampling or Notice of FDA Action for 

sampling, must also be sent other official documents pertaining to the sample, i.e., 

Notices of FDA Action for Release, Detention and Hearing, and/or Refusal of 

Admission.

Failure To Hold Articles Identified for Examination and/or Sampling

If, after an entry has been filed, electronically or manually, and a Notice of Sampling or 

Notice of FDA Action has been issued for the entry to be held for examination or 

sampling, FDA finds that the entry or a portion thereof was not held, and there was 

disregard of the Notice by the importer, a written request to CBP asking for redelivery of 

the merchandise should be made. If the distributed article is not returned to CBP for 

FDA's examination or sample, a bond action should be sought through OASIS or 

current written procedures. See RPM subchapter 9-1 “Bond Action” for procedures on 

request for redelivery/bond action.

For more information, refer to the "MOU with U.S. Customs Service to Establish a 

Working Relationship for Cooperative Enforcement (225-79- 4003)", 10/01/80 (Old 

designation CPG 7155g.03, new designation Section 2-A General Import Agreements) 

and "MOU with U.S. Customs Service regarding Identifying Roles and Authority 

Concerning Electronic Products (225-74-6004), 10/01/88 (Old designation CPG 

7155g.01).

Multiport Coverage

Many importers maintain distribution points throughout the country and will move 

articles to those locations for immediate distribution upon receipt of their releases from 

CBP and other agencies. As long as the articles are under the importer's full control and 

are not further distributed, or has been delivered to their consignee but are still under 

the full control of the importer, the importer may request the article be examined by the 

FDA office in whose jurisdiction the article is held. This practice should not be 

encouraged, nor should importers consider the allowance of such practice to be a 

license to request all their importations be examined at destination. Allowing movement 

and requesting foreign examination/sample should be at the discretion of FDA, 

depending on the article to be examined or sampled.

Under certain conditions, filers may use various means of filing entries, for example 

multiport entries for clearing cargo. Under these provisions of CBP, the filer may be in 

one port location (port A) but enter the cargo in port B. However, the cargo itself may be

physically located at port C, and the examination will take place at port D. For FDA 

coverage, the examination of the cargo may be dependent on the FDA location where 

the cargo is entered and/or where it is physically located. Coverage of such importations 

should be evaluated on a case by case basis. Ultimately, the FDA office responsible for 

the entry will be that office covering the responsible CBP port for the entry.
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Simultaneous Multiple Entries

The following procedures are being provided to assist FDA in the collection of import 

compliance samples from multiple, simultaneous entries (within a 24 hour period) of the 

same product(s) from the same manufacturer/grower or shipper:

The responsible FDA office will identify each entry individually for coverage. OASIS 

does not include provisions for consolidating multiple entries under one number, since 

all actions are based on individual entry numbers. However, FDA may relate one entry 

to another to show they are making their determination of admission on all associated 

entries from the one entry sampled/examined.

Documentation MUST show a direct relationship between the samples, e.g., date of 

manufacture, production codes, fields of harvest, etc.

This procedure is recommended whenever compliance sample of suspect multiple 

shipments are collected. It may also be used when multiple entries are made to 

accommodate different consignees with the same product, such as canned foods.

Under no circumstances where FDA staff receive paper entries should different 

Importer's Entry Notification for portions of the same entry be accepted or processed. 

Each notification should represent a unique entry. If this situation is encountered, FDA

may wish to reject the notifications and request the broker to consolidate the information 

into one notification. Under the OASIS procedure, where entries are filed through the 

CBP ACE, this procedure may not be applicable.

Also, under the OASIS screening procedures, if FDA notices a trend to separate 

shipments from the same manufacturer, shipper, or grower in order to receive a 

favorable "May Proceed" on as many portions of the same product through the 

screening process, FDA may consider requesting, as appropriate, the particular 

product/manufacturer combinations be screened as "examination" to assure all 

shipments are provided to FDA for review before being may proceeded.

Single Entry of Multiple Commodities

Under the OASIS procedures, when an entry consisting of multiple food items is 

presented, the responsible FDA office must issue a single Notice of FDA Action 

identifying all items in the entry for FDA hold/examination. In the case of paper entries, 

designate the entire entry to be held as "foodstuffs", or use another appropriate term.

There is no prohibition against issuance of one Notice of FDA Action for collection of 

samples for an entire multiple commodity entry. In the OASIS procedures, the Notice 

will indicate the specific lines that are to be covered by FDA. The intent of the Notice is 

to provide the owner/consignee with information as to whether the sample(s) have been 

collected or will be collected. It may not be possible to know in advance of an 

examination what problems or conditions will be encountered before the entry is 

examined. Therefore, Notice of FDA Action identifying all commodities present as 
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"HOLD ALL" pending examination does not conflict with FDA regulation or policy. See 

OASIS notice statements under "B", "When to Issue the Notice of Sampling". 

Because the exact article to be examined/sampled may not be known until after the 

vehicle transporting the goods has been unloaded, one Notice is issued to assure that 

all products are held for examination. FDA has authority to request that the entire entry 

be held pending examination, and whether numerous individual Notices, or one blanket 

Notice is issued, the effect is the same: the entire entry must be held.

When the importer advises FDA of the location and the availability of articles in the 

entry, the FDA personnel will visit the site to perform the examination and/or collection.

At this time, a new Notice of FDA Action for the collection of the specific articles is 

issued. Any article not covered by a specific Notice of FDA Action will be designated as 

"Released" or "May Proceed."

(Note: See exhibit 9-6 for examples of Notices which include identification of products 

sampled by FDA.)

9-22 GRANTING AND DENYING TRANSPORTATION AND

EXPORTATION (T&E) ENTRIES

9-22-1 PURPOSE

To provide uniform procedures regarding circumstances when Transportation and 

Exportation (T&E) entries will be granted or denied.

9-22-2 BACKGROUND

CBP regulation 19 CFR 18.10, "Kinds of Entry", lists the various entries and withdrawals 

that may be made for merchandise transported in bond. One kind of entry is the 

transportation and exportation (T&E) entry. A T&E filed with CBP, allows a party to 

transport merchandise in bond through the U.S. and export the merchandise intact to a 

foreign destination without the payment of duties. See 19 U.S.C. 1553, 19 CFR 18.11, 

and 19 CFR 18.20.

T&E entries may be made for products which are being transported through the U.S. to 

be exported. In addition, articles that have been refused admission may be entered 

under T&E after the importer requests and receives written authorization from the 

proper governmental authority and/or complies with any applicable regulations. When 

FDA receives notice from CBP that articles refused by FDA will move under T&E bond 

to a distant port to be exported under CBP supervision, FDA generally will not object to 

movement of the refused articles. In addition, when FDA receives notice from CBP that 

product regulated by FDA, not offered for import will move under T&E entry to a distant 

port to be exported under CBP supervision, FDA generally will not object to movement. 

In most instances FDA may waive the written authority requirement. There may be 

situations, however, where denial of a request for a T&E entry is appropriate.
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FDA has been aware of possible weaknesses in T&E entry procedures for movement of 

refused merchandise to other ports for exportation. For example, in 1975 an incident 

involving frog legs demonstrated the potential for diversion into domestic commerce 

when refused articles are transported under T&E bond.

The frog legs case (U.S. v. 76,552 pounds of Frog Legs, 423 F. Supp. 329 (S.D. Texas,

1976)) highlighted the risks of T&E movement of refused articles. In that case, 

adulterated frog legs, reportedly being exported to Mexico, were in fact being diverted to 

domestic commerce, thus circumventing FDA authority to prevent violative merchandise 

from reaching the American public.

In response to this and other incidents of diversion, FDA met with CBP to discuss 

concerns regarding movement under a T&E entry of violative merchandise. CBP agreed 

that violative shipments should not be permitted movement under T&E procedures 

where FDA objected. This approach was taken to prevent the granting of T&Es in a 

haphazard manner and to eliminate the opportunity for merchandise to become lost, 

stolen, or diverted.

The availability of T&E entry for "restricted and prohibited merchandise" is described in 

the CBP regulations. Section 18.21(b) of the CBP regulations authorizes CBP to deny 

release of this type of merchandise under a T&E entry unless the agency responsible 

for regulating the article provides written permission. Prohibited articles offered for T&E 

entry without the requisite written authority may be seized pursuant to 19 CFR 18.21(b). 

However, it is the practice of CBP and FDA that where FDA has no objection to in-bond 

movement of violative merchandise through the United States for export to a foreign 

destination, CBP may issue a T&E entry without FDA written permission. When FDA 

objects to such movement, it would so notify CBP in writing.

There may also be circumstances where regulatory action such as seizure is 

appropriate for articles moving under a T&E entry. Often, articles will begin moving 

under T&E entry prior to FDA receiving notice from CBP or the importer. In the case 

where a request for T&E is to transport violative articles which FDA believes may be 

intended for future importations into the U.S., regulatory action against the article, even 

though it may already be moving under T&E entry, may be appropriate. For example, 

because of transportation concerns, violative drugs that represent a health risk may be 

shipped to the U.S. prior to entry into Mexico or other nearby countries. The importer 

may request a T&E entry from CBP. After receiving notice from CBP or the importer that 

the articles are moving under T&E entry, if FDA is aware that the drugs may be sold to 

individuals in the United States, FDA may decide it is appropriate to seize the drugs to 

prevent them from illegally entering domestic commerce.

In one instance, a quantity of unapproved drugs that was being transported from 

Romania through the United States under a T&E entry to Tijuana, Mexico was 

condemned and ordered destroyed by CBP. Section 801(b) of the FFDCA, involving 

conditional release for movement of products under CBP redelivery bond, did not apply 
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because that provision does not apply to merchandise that is not eligible for legal import 

under the FFDCA. CBP ordered destruction because it was the only way to ensure that 

the drugs would not be re- imported into the United States. The claimant had stipulated 

that the drugs were new drugs and that no new drug application had been submitted or 

approved. See U.S. v. 300 oz. Gerovital Lotion, and 25,000 Gerovital Tablets, More or 

Less, 492 F. Supp 114 (C.D. Cal. 1980).

9-22-3 INSTRUCTIONS

If an article has been refused admission under the FFDCA, FDA will consider objecting 

to T&E entry under the following circumstances:

1. The article presents a definite hazard to the health of the consumer (e.g.,

article containing toxins or pathogens)

2. There is evidence that the T&E entry procedure is being abused and

violative merchandise is being diverted into domestic commerce (e.g. the

frog legs case cited previously).

3. The distance that the violative product is to be moved is so great that it

might be lost, stolen or diverted, and/or that the movement would be very

difficult to control and/or monitor.

4. The importing firm has a history of diverting violative merchandise into

domestic commerce. See RPM subchapter 9-16 "Priority Enforcement

Strategy for Problem Importers".

If the merchandise has been entered as a consumption or warehouse entry, the 

following statement should appear on the Notices of Detention and Refusal:

"DO NOT ISSUE T&E - PERMISSION AS REQUIRED PURSUANT TO 19 CFR 

18.21(b) IS NOT GRANTED FOR THE ISSUANCE OF A TRANSPORTATION AND 

EXPORTATION ENTRY"

If the merchandise has been entered as a T&E, and CBP has notified FDA of the entry, 

CBP should be notified in writing that FDA opposes granting of the T&E entry.

NOTE: In developing OASIS the FDA forms for Notice of Sampling, Release, Detention 

and Hearing, Refusal, etc., have been replaced by "Notice of FDA Action," with the 

description of the action identified for the specific article in the entry. 

Until OASIS is modified to issue a T&E statement, FDA staff operating under OASIS 

should annotate their Notice of FDA Action appropriately and forward a copy of the 

Notice to the local CBP office and other notified parties.

Decisions to reconsider T&E movement, or submit regulatory actions, where 

appropriate, are at the discretion of the responsible FDA office. 

Questions regarding use of T&Es should be directed to OEIO, and appropriate Center.
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9-23 EXHIBITS

9-1 Exhibit 9-1 has been deleted. See Exhibit 9-6 instead

9-2 Exhibit 9-2 has been removed as an exhibit. See Form FDA-766 “Application for 

Authorization to Relabel or Recondition Non-Compliant Articles” 

9-3 Model Letter For Use in General Mail Importations

9-4 Model Letter For User in Detentions of Drugs and Devices

9-5 Specimen Charges

9-6 Notice of FDA Action

9-7 19 CFR 12.21-12.23 

19 CFR 21.21-23 has been removed as an exhibit. 19 CFR Part 21 is available 

at http://www.gpo.gov/fdsys/granule/CFR-2011-title19-vol1/CFR-2011-title19-

vol1-part12

9-8 21 CFR 601.33

21 CFR 601.33 has been removed as an exhibit. 21 CFR Part 601 is available 

at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm? 

CFRPart=601

9-9 21 CFR 601.22

21 CFR 601.22 has been removed as an exhibit. 21 CFR Part 601 is available 

at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm? 

CFRPart=601

9-10 Letter Responding to Inquiries Regarding Importation for Trade Shows/Fairs and

Exhibitions

9-11 Statement Responding to Inquiries Regarding Importation for Special Events

9-12 Charges for Supervision Form FDA-790

Exhibit 9-12 has been removed. Form-790 is available in the 2021 IOM Chapter 

6, Exhibit 6-3 Charges for Supervision, form found in the intranet. 
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EXHIBIT 9-3 

MODEL LETTER FOR USE IN GENERAL MAIL IMPORTATIONS 

(LETTERHEAD)

A mail shipment of an article from a foreign country addressed to you is being detained 

at the U.S. Post Office. All products of this kind must meet the requirements of the 

Federal Food, Drug, and Cosmetic Act or other laws enforced by the Food and Drug 

Administration. These laws are designed to protect you from, among other things, 

unsafe or misrepresented foods, drugs, biologics, cosmetics, devices, and other 

articles. The product addressed to you does not appear to comply with the law. Please 

read the enclosed Notice of FDA Action - Detained carefully since it explains why FDA 

believes that the product sent to you is in violation. The Notice does not in any manner 

accuse you of violating any law.

If you have good reason to believe that the product does comply with the law and wish 

to discuss it with us, you may personally come to this office, telephone, or write to us 

within the time limit shown on the Notice.

If you do not wish to claim this shipment, you may disregard the Notice and the 

shipment will be returned to the sender without cost to you. The shipment will be 

returned to the sender automatically if we do not hear from you within the time limit 

shown on the Notice.

Sincerely yours, 

Enclosure:
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EXHIBIT 9-4 

MODEL LETTER FOR USE IN DETENTIONS OF DRUGS AND DEVICES 

(LETTERHEAD)

A mail shipment addressed to you of a drug (device) from a foreign country is being 

detained at the U.S. Post Office. All products of this kind must meet the requirements of 

the Federal Food, Drug and Cosmetic Act which is designed to protect you from 

products that have not been shown to be safe and effective and that are not labeled in a 

truthful, accurate and non- misleading manner.

Please read the enclosed Notice of FDA Action - Detained carefully, since it explains 

why the product addressed to you appears to violate U.S. law. The Notice does not 

accuse you in any manner of violating any law.

If the drug is not approved for distribution in the United States, FDA may consider 

releasing the product to you for your own personal use if you provide a statement 

containing:

• adequate documentation that the product is for your own use and for

treatment of a serious condition; include the name and address of the doctor

licensed to practice in the United States who is responsible for your treatment

with this product; or

• adequate documentation that the product is for the continuation of treatment

of a serious condition begun in a foreign country.

Send your statement to this office and we will promptly review your submission and 

consider release of the product.

If you have good reason to believe that the product does comply with the law and you 

wish to discuss it with us, you may come in person to this office, telephone, or write to 

us within the time limit shown on the Notice.

If you do not wish to claim this shipment, you may disregard the Notice and the 

shipment will be returned to the sender without cost to you. The shipment will be 

returned to the sender automatically if we do not hear from you within the time limit 

shown on the Notice.

Sincerely yours, 

Enclosure:
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EXHIBIT 9-5 

SPECIMEN CHARGES

Suggested wording for charges under the Acts enforced by FDA may be found on 

Import Alerts, and as part of reference tables of the OASIS automated system.

Charge codes will no longer be listed in this exhibit. The current list of Violation Codes 

and the text associated with those codes can be found on FDA’s Internet Site at the 

following link:

www.fda.gov/ForIndustry/ImportProgram/ActionsEnforcement/ucm459490.htm 

www.fda.gov > For Industry > Import Program > Actions & Enforcement > Import 

Refusals > Violation Charge Codes And Charge Statement (PDF - 107KB)
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EXHIBIT 9-6 

NOTICE OF FDA ACTION

The attached exhibit of Notice of FDA Action is a model and should not be considered 

all inclusive. The format and wording in the actual Notice of FDA Action issued by FDA

from the Operational and Administrative System for Import Support (OASIS) may 

appear different.

EXAMPLE

United States Food and Drug Administration

OHAFO Office

Notice of FDA Action

Entry Number: 112-9861457-6 

Notice Number: 2

November 6, 1996

Filer:

FBN Freight Services Attention: George

500 Canal St.

New Orleans LA 70130

• Port of Entry: 2704, Los Angeles,

Carrier: NOL RUBY

Entry Date: November 2, 1996

Arrival Date: November 4, 1996

• Importer of Record: Shipley's Donut Shop Inc., Lafayette, LA

• Consignee:

a: Shipley's Donut Shop Inc., Lafayette, LA

b: Specialty Commodities Inc. Fargo, ND

HOLD DESIGNATED

Documents Required and Notify FDA of Availability

Summary of Current Status of Individual Lines

@ LINE: ACE/FDA Product Description Quantity Current Status *

 a 001/001 PINEAPPLE, DEHYDRATED 500 CT RELEASED 11-6- 96
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@ LINE: ACE/FDA Product Description Quantity Current Status * a 002/001 DEHYDRATED GINGER SLICES 10 KG Collected by 

FDA 11-06-96

@ LINE: ACE/FDA Product Description Quantity Current Status * b 003/001 PAPAYA, DEHYDRATED 10 KG Detained 11-06- 96

* Status change since the previous notice. Read carefully the sections which follow for

important information regarding these lines.

• @ Consignee id

FDA will not request redelivery for examination or sampling, if the products not released 

by FDA are moved, following USCS conditional release to a location within the local 

metropolitan area or to a location approved by the FDA office at the number below.

All products in this entry not listed above may proceed without FDA examination. This 

notice does not constitute assurance the products involved comply with provisions of 

the Food, Drug, and Cosmetic Act or other related acts, and does not preclude action 

should the products later be found violative.

Please provide documentation concerning all products in this entry to the FDA office 

below. Include the USCS document (e.g. CBP-3461 or CBP-7501) and commercial 

invoice for these products, annotated to show the ACE/FDA line numbers sent 

electronically.

Also, advise FDA upon actual availability, and include date, location, and warehouse 

control number, where applicable, for all lines in this entry.

Jennifer A Thomas, Inspector 

U.S. Food & Drug Administration 

(213) 555-1212

2nd and Chestnut Streets

Philadelphia, PA 19106

DETENTION WITHOUT EXAMINATION

The following products are subject to refusal pursuant to the Federal Food Drug and 

Cosmetic Act (FD&CA), Public Health Service Act (PHSA), or other related acts in that 

they appear to be adulterated, misbranded or otherwise in violation as indicated below:

LINE

ACE/FDA Product Description Respond By

003/001 Product: PAPAYA, DEHYDRATED November 26, 1996
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FD&CA Section 402(a)(1), 801(a)(3); ADULTERATION

The article appears to be held in a container containing a poisonous or 

deleterious substance which may render it injurious to health.

FD&CA Section 402(a)(2)(B), 801(a)(3); ADULTERATION

The article appears to be a raw agricultural commodity that bears or contains a 

pesticide chemical which is unsafe within the meaning of Section 408(a). The 

article appears to contain quinalphos.

You have the right to provide oral or written testimony, to the Food & Drug 

Administration, regarding the admissibility of the article(s) or the manner in which the 

article(s) can be brought into compliance. This testimony must be provided to FDA on or 

before the dates shown above

SAMPLES COLLECTED

LINE

ACE/FDA Product Description Est. Cost

001/001 PINEAPPLE, DEHYDRATED $ 15.00

• Sample: 10 KG Collected 1 KG from each of 10 cartons

LINE

ACE/FDA Product Description Est. Cost

002/001 DEHYDRATED GINGER SLICES $ .23

• Sample: 1 KG Collected approximately 4 ounces from one carton. LINES

RELEASED

LINE

ACE/FDA Product Description

001/001 PINEAPPLE, DEHYDRATED

These products are released. This notice does not constitute assurance that the 

product released complies with all provisions of the Food, Drug, and Cosmetic 

Act, or other related Acts, and does not preclude action should the product later 

be found violative

Notice Prepared by: Thomas J DiNunzio (QA5)

U.S. Food & Drug Administration
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EXHIBIT 9-10

LETTER RESPONDING TO INQUIRIES REGARDING IMPORTATION FOR TRADE 

SHOWS/FAIRS AND EXHIBITIONS

(LETTERHEAD)

This is in response to your inquiry regarding importing articles regulated by the Food 

and Drug Administration (FDA) for use as exhibits in trade shows/fairs or other 

exhibitions.

With the exception of most meat and poultry products, all food, drugs, biologics, 

cosmetics, medical devices, electronic products that emit radiation, and tobacco 

products as defined in the Federal Food, Drug, and Cosmetic (FD&C) Act and related 

Acts, are subject to examination by FDA when they are being imported or offered for 

import into the United States.

All imported products are required to meet the same standards as domestic goods. For 

example, imported foods must be pure, wholesome, safe to eat, and produced under 

sanitary conditions; drugs and devices must be safe and effective; cosmetics must be 

safe and made from approved ingredients; radiation-emitting devices must meet 

established standards; and all products must contain informative and truthful labeling in 

English.

GENERAL PROCEDURES

The Federal Food, Drug and Cosmetic Act (the Act), Section 801, directs FDA to refuse 

admission of any article that appears to be in violation of the Act.

To ensure that FDA is notified of all regulated products imported into the United States, 

the importer, or his/her representative, must file an entry notice with U.S. Customs and 

Border Protection and acquire a bond to allow the importer to take delivery of the goods 

prior to FDA's decision on the admission of the goods. FDA is notified by Customs of 

the entry and makes a decision as to the article's admissibility. If FDA does not wish to 

examine the entry, the product is allowed to proceed into the United States. When a 

sample of an article offered for import has been requested by FDA, the owner or 

consignee is required to hold the shipment and not distribute it until further notice is 

received regarding the results of the examination of the sample.

Generally, if FDA samples an entry, an FDA representative will collect the sample from 

the shipment and have it analyzed in FDA's laboratory. If the analysis shows the product 

in compliance, the shipment is released into United States commerce. However, if the 

analysis shows an appearance of a violation, the product is subject to refusal of 

admission. If it appears that the article is violative, FDA issues a Notice of FDA Action - 

Detained to the owner or consignee of the article specifying a place and period of time 

whereby the individual may introduce testimony either verbally or in writing concerning 

the detention to prove that the product complies with the law, or can submit a petition to 
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recondition the product to bring it into compliance. The owner or consignee may submit 

an application to FDA to relabel or perform other actions to bring the article into 

compliance, or render the article other than a food, drug, device, or cosmetic.

If the product cannot be brought into compliance, it is refused and the importer is 

required to either re-export or destroy the article under U.S. Customs or other approved 

supervision. If the refused product is not destroyed or re-exported, CBP issues a notice 

for redelivery to the importer of record. Failure to redeliver the refused product may 

result in CBP assessing liquidated damages equal to the value of the merchandise 

involved in the default or three times the value of the merchandise if the article is 

restricted merchandise or alcoholic beverages. All FDA regulated products are 

considered restricted merchandise by CBP.

ARTICLES FOR TRADE SHOWS/FAIRS AND EXHIBITIONS

When articles are being imported where the intent is to display them at an industry or 

consumer trade show or exhibition and all articles comply with FDA regulations, the 

general importing procedures as stated above should be followed. However, for noncomplying articles, it may be possible for an importer or importer's agent to request 

release of the entry, through the appropriate FDA office, for the sole purpose of exhibit 

at a trade function and providing for the supervised destruction or re-exportation of the 

articles at the conclusion of the function.

FDA generally may permit release of such articles which may not be in full compliance 

with U.S. laws and regulations where a placard is used at the point of display, advising 

that the product may not be in compliance with applicable FDA regulations and that 

FDA should be contacted for further information for procedures to bring the products 

into compliance.

When large shipments of non-complying articles, intended for promotion at a trade 

function, are encountered by FDA, representative products of the entry may be released 

for display purposes upon receipt of a request from the importer to the appropriate FDA 

office. However, it will be necessary for importers of commercial size shipments of noncompliant product, if for promotion at a trade show, to request release of these types of 

products which will be evaluated by FDA on case by case basis.

You should contact the appropriate FDA office where the function is to be held for 

further information or to submit a request for release of products for trade shows, fairs, 

or exhibitions.

CUSTOMS AND BORDER PROTECTION REGULATIONS

Customs regulations, 19 CFR Part 147, "Trade Fairs" address entry of merchandise for 

exhibition and your local Customs office should be contacted regarding these 

requirements.

Sincerely yours,
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EXHIBIT 9-11

STATEMENT RESPONDING TO INQUIRIES REGARDING IMPORTATION FOR 

SPECIAL EVENTS

(The example cited below was for use by the Atlanta Committee for the Olympic Games, 

but a similar statement could be used for any event. A statement of this nature is intended 

to be made available by the committee or sponsor of the event to team officials, 

participants, foreign government representatives, media representatives, and fans.)

STATEMENT FOR THE USE BY

ATLANTA COMMITTEE FOR THE OLYMPIC GAMES

(Sponsor Name) (Name of Event)

In keeping with the spirit of the Olympic games, the Food and Drug Administration 

(FDA) wants you to be comfortable during your stay in the United States, including 

having access to personal and familiar necessities. The FDA does not normally restrict 

foreign visitors from bringing native foods or required medications for their own use or 

consumption while in the United States. However, any medications or pharmaceuticals 

which are being brought for team use should be held under the supervision of the team 

physician or trainer. The amounts of both foods and medications should be 

commensurate with the duration of your stay. Additionally, an inventory of the food 

items and medications being entered should prevent any undue delay in your team's 

arrival.

Fans, family members, and other non-participants are also not restricted in bringing in 

familiar food items. However, it may be advisable to have a prescription or letter from a

physician accompany necessary medications. As mentioned above, the amount of 

foods and medications brought in should be commensurate with the duration of your 

stay in the United States.

If you have any questions concerning your food or medications when you are in the 

United States, please contact the local FDA office