Contains Nonbinding Recommendations 
Guidance for Industry 
What You Need to Know About  
Administrative Detention of Foods 
Small Entity Compliance Guide 
Final Guidance 
Additional copies are available from: 
Outreach and Information Center (HFS-009) 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive
 College Park, MD  20740 
(Tel) 888-723-3366 
 http://www.fda.gov/FoodGuidances 
You may submit written comments regarding this guidance at any time.  Submit written 
comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be 
identified with the title of the guidance document.     
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Foods 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine  
Office of Regulatory Affairs  
October 2011; Revised March 2013  Contains Nonbinding Recommendations 
 
 
Table of Contents 
 
 
 
  I.   Introduction   
 
 II.    Background  
 
III.   Questions and Answers   
 
IV.   References  
 
 
 
  2  Contains Nonbinding Recommendations 
Guidance for Industry 
What You Need to Know About 
Administrative Detention of Foods; Small Entity Compliance Guide 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the telephone number listed on the title page of this 
guidance.  
 
 
 
 
I.  Introduction  
 
This guidance document provides updated information pertaining to the Food and Drug 
Administrations (FDA) authority to order the administrative detention of human or animal food 
under section 304(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 
334(h)].  Congress originally established this authority in the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and amended it in 
January 2011 as part of the FDA Food Safety Modernization Act (FSMA). 
 
FDA prepared this guidance to restate the legal requirements in section 304(h) of the FD&C Act. 
Previously, this guidance restated the legal requirements for FDAs administrative detention 
regulation at 21 CFR Part 1, Subpart K, implementing section 304(h) of the FD&C Act.  This 
guidance also served as FDAs Small Entity Compliance Guide (SECG) for 21 CFR Part 1, 
Subpart K in accordance with section 212 of the Small Business Regulatory Enforcement 
Fairness Act (Public Law 104-121).  However, as explained above, section 304(h) was amended 
by FSMA in 2011.  Accordingly, in October 2011, FDA updated this document to provide 
guidance intended to help any entity comply with the requirements of section 304(h) of the 
FD&C Act, including the amendments to section 304(h) of the FD&C Act made by section 207 
of FSMA.  This update clarifies that this document continues to serve as FDAs SECG for 21 
CFR Part 1, Subpart K.  
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
  Contains Nonbinding Recommendations 
II.  Background  
 
The Bioterrorism Act was signed into law on June 12, 2002.  Among other things, the 
Bioterrorism Act amended the FD&C Act by adding subsection (h) to section 304.  This 
provision provided FDA the authority to order the detention of any article of food if, during an 
inspection, examination, or investigation, an FDA officer or qualified employee finds there is 
credible evidence or information indicating that the article of food presents a threat of serious 
adverse health consequences or death to humans or animals.  The Bioterrorism Act also amended 
the FD&C Act by adding subsection (bb) to section 301, making it a prohibited act to move an 
article of food in violation of a detention order or to remove or alter any mark or label required 
by a detention order that identifies an article of food as detained.   
 
In the Federal Register of June 4, 2004 (69 FR 31660), the FDA issued the final regulations 
establishing the procedures for administrative detention, including, among other provisions, the 
criteria for ordering administrative detention.  The administrative detention regulations took 
effect on July 6, 2004, and have been codified at Title 21, Code of Federal Regulations (CFR) 
Part 1, Subpart K (21 CFR Part 1, Subpart K). 
 
Section 207 of FSMA, signed into law on January 4, 2011, amended the criteria for ordering 
administrative detention of human or animal food in section 304(h)(1)(A) of the FD&C Act [21 
U.S.C. 334(h)(1)(A)].  Under the new criteria, FDA can order administrative detention if there is 
reason to believe that an article of food is adulterated or misbranded.  In accordance with section 
207 of FSMA, the FDA issued an interim final rule (IFR) amending the criteria for 
administrative detention in the regulations found in 21 CFR Part 1, Subpart K.  The IFR was 
published in the Federal Register on May 5, 2011 (76 FR 25538), and became effective on July 
3, 2011.  On February 5, 2013, FDA issued a final rule adopting without change the requirements 
in the IFR (76 FR 25538).  
 
 
III.  Questions and Answers 
 
1.  Why is administrative detention needed? 
Administrative detention provides a means through which FDA can hold adulterated or 
misbranded food and prevent it from reaching the marketplace, thus further enhancing FDAs 
ability to ensure the safety of food for U.S. consumers. 
 
2.  What food is subject to administrative detention? 
The term food refers to (1) articles used for food or drink for man or other animals, (2) chewing 
gum, and (3) articles used for components of any such article (section 201(f) of the FD&C Act 
[21 U.S.C.  321(f)]).  The term food also refers to dietary supplements, which are to be treated 
as food under the FD&C Act (section 201(ff) [21 U.S.C.  321(ff)]).  The term dietary 
supplement refers to a product taken by mouth that contains a dietary ingredient intended to 
supplement the diet.  A dietary ingredient in these products may include: vitamins, minerals, 
herbs, or other botanicals, amino acids, and substances such as enzymes, organ tissues, 
glandulars, and metabolites.  Dietary supplements can also be extracts or concentrates and may 
  Contains Nonbinding Recommendations 
come in many forms as long as they are labeled as a dietary supplement and not represented as a 
conventional food or sole item of a meal or diet.  
 
The FDA may order the detention of any article of food that is found during an inspection, 
examination, or investigation under the FD&C Act if the officer or qualified employee has 
reason to believe that the article of food is adulterated or misbranded.  Food that is regulated 
exclusively by the United States Department of Agriculture under the Federal Meat Inspection 
Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act is not subject to 
administrative detention.  All other food is subject to this regulation, whether or not it enters 
interstate commerce.  
 
3.  How long may FDA administratively detain an article of food? 
FDA may detain an article of food for a reasonable period, not to exceed 20 calendar days, after 
the detention order is issued.  However, an article of food may be detained for 10 additional 
calendar days if a greater period of time is required to institute a seizure or injunction action.  
The entire detention period may not exceed 30 calendar days (21 CFR 1.379). 
 
4.  What criteria does FDA use to order an administrative detention? 
An officer or qualified employee of FDA may order the administrative detention of any article of 
food that is found during an inspection, examination, or investigation under the FD&C Act if the 
officer or qualified employee has reason to believe that the article of food is adulterated or 
misbranded (21 CFR 1.378).  When ordering an administrative detention FDA will have factual 
information that a food is adulterated or misbranded.  As expressed in the final rule which 
adopts, without change, the IFR as final, FDA will consider ordering administrative detention on 
a case-by-case basis because these decisions rely on the factual information and circumstances 
specific to each situation.  Further, FDA intends to use this tool in a manner that furthers the 
Agencys public health and prevention-based goals.   
 
5.  Who approves an administrative detention order? 
An administrative detention order is approved by the Director of the FDA District where the 
food to be administratively detained is located, or an official senior to such Director (21 CFR 
1.391).  For more information about FDAs procedures consult the Regulatory Procedures 
Manual (RPM) chapter 4. 
 
6.  What information must FDA include in the administrative detention order? 
The following information is included in the administrative detention order (See 21 CFR 1.393 
for a complete list): 
 
 Detention order number 
 Hour and date of the order 
 Identification of the detained article of food 
 Detention period 
 Statement that the article of food identified in the order is detained for the period shown 
 Brief, general statement of the reasons for the detention 
 Address and location where the article of food is to be detained and the appropriate 
storage and transportation conditions. 
  Contains Nonbinding Recommendations 
 A statement that the article of food is not to be consumed, moved, altered or tampered 
with in any manner during the detention period, unless the detention order is first 
modified under 21 CFR 1.381(c) 
 Name and title of the authorized FDA representative who approved the                  
detention order 
 
 
7.  May an administratively detained article of food be delivered to another entity or 
transferred to another location? 
It is a prohibited act under section 301(bb) of the FD&C Act [21 U.S.C. 331(bb)] to transfer an 
article of food subject to an administrative detention order and/or to alter or remove any mark or 
label that identifies an article of food as administratively detained.  However, there can be 
exceptions which permit the movement of detained articles of food under the supervision and 
control of FDA, as identified in 21 CFR 1.381(c).   
 
 8.  Can an administrative detention order be modified? 
FDA may approve a request for modification of an administrative detention order to allow for 
the destruction of the article of food or movement of the detained article of food to a secure 
facility, to maintain or preserve the integrity or quality of the article of food, or for any other 
purpose that the authorized FDA representative believes is appropriate in the case (21 CFR 
1.381(c)).  Requests for modification of a detention order must be submitted in writing to the 
FDA representative who approved the original detention order and must include the information 
specified in 21 CFR 1.381(d).  
 
 9.  What labeling or marking requirements apply to an administratively detained article of 
food? 
An administrative detention order may require that the detained article of food be labeled or 
marked as detained.  The FDA tag or label (FDA Form 2290) will include among other 
information, a statement that the article of food must not be consumed, moved, altered, or 
tampered with in any manner for the period shown, without the written permission of an 
authorized FDA representative (21 CFR 1.382).  
 
10.  What constitutes perishable food? 
FDA defines perishable food as food that is not heat-treated, not frozen, and not otherwise 
preserved in a manner to prevent the quality of the food from being adversely affected, if held 
longer than seven (7) calendar days under normal shipping and storage conditions (21 CFR 
1.377). 
 
11.  What expedited procedures apply when FDA initiates a seizure action against an 
administratively detained perishable food? 
If FDA initiates a seizure under section 304(a) of the FD&C Act [21 U.S.C. 334(a)] against a 
perishable food that is subject to an administrative detention order, FDA will send the seizure 
recommendation to the Department of Justice within four (4) calendar days after the 
administrative detention order is issued, unless extenuating circumstances exist (21 CFR 1.383). 
 
  Contains Nonbinding Recommendations 
12.  Where and under what conditions must the administratively detained article of food be 
held? 
The administratively detained article of food must be held in the specified location and under the 
conditions specified by FDA in the detention order (21 CFR 1.380).  The administrative 
detention order may require removal of the detained article of food to a secure facility; however, 
movement of the detained food is only permitted after FDA has modified the detention order 
under 21 CFR 1.381(c) (21 CFR 1.380(c)). 
 
13.  Who receives a copy of the administrative detention order? 
FDA will issue the administrative detention order to the owner, operator, or agent in charge of 
the location where the article of food is being detained.  If the owner of the article of food is 
different from the owner, operator, or agent in charge of the place where the article of food is 
detained, then FDA will also provide a copy of the administrative detention order to the owner of 
the article of food, if the owners identity can be determined readily (21 CFR 1.392 (a)). 
 
If FDA issues an administrative detention order for an article of food located within a vehicle or 
other carrier used to transport the food, FDA also must provide a copy of the administrative 
detention order to the shipper of record and the owner and operator of the vehicle or other 
carrier, if their identities can be determined readily (21 CFR 1.392 (b)). 
 
14.  Whats the difference between an import detention and administrative detention? 
FDAs authority to administratively detain food under section 304(h) of the FD&C Act [21 
U.S.C. 334(h)] is separate and distinct from detention that may occur during FDAs import 
admissibility review.  Under section 801(a) of the FD&C Act [21 U.S.C. 334(h)], when food is 
imported or offered for import into the United States, FDA conducts an admissibility review to 
determined whether to admit the product into United States or detain the product.  When it 
appears that an article of food may be subject to refusal of admission, FDA issues a notice 
explaining that it is detaining the product and providing the owner or consignee an opportunity to 
provide testimony (21 CFR 1.94).  Although referred to as detention, generally neither FDA 
nor U.S. Customs and Border Protection (CBP) has physical custody or control of the food; the 
importer generally has actual possession and posts a bond with CBP.  For more information 
about import detention, please refer to the Regulatory Procedures Manual (RPM) chapter 9.  
 
On the other hand for administrative detentions under section 304(h) of the FD&C Act, FDA will 
issue an order to the owner of the suspect food notifying him that FDA is administratively 
detaining the food and that he has an opportunity  to appeal the detention with or without a 
hearing (see 21 CFR Part 1 Subpart K).     
 
 
15.  Who is entitled to appeal a detention order? 
Any person who would be entitled to be a claimant of the administratively detained article of 
food if it were seized under section 304(a) of the FD&C Act [21 U.S.C. 334(a)] may appeal the 
detention order (21 CFR 1.401). 
 
 
 
  Contains Nonbinding Recommendations 
16.  What are the requirements for submitting an appeal? 
For perishable food, an appeal must be filed to the FDA District Director whose district detained 
the article of food within two (2) calendar days of receipt of the administrative detention order.  
For non-perishable food, a notice of intent to file an appeal and to request a hearing must be filed 
within four (4) calendar days of receipt of the administrative detention order.  The actual appeal, 
even if it does not include a request for a hearing, must be filed within ten (10) calendar days of 
the receipt of the administrative detention order (21 CFR 1.402 (a)).  If the owner of the 
administratively detained food decides to appeal the detention order, the owner may also request 
a hearing as part of the appeal by filing a timely notice of intent to request a hearing and then 
noting this request for a hearing as part of the owners appeal.  Pursuant to 21 CFR 16.26, a 
request for a hearing may be denied, in whole or in part, if the Presiding Officer determines that 
no genuine and substantial issue of fact has been raised by the material submitted.  A hearing 
will not be granted on issues of policy or law.  Written notice of a determination of summary 
judgment will be provided, explaining the reasons for denial of the hearing.  If the owner 
requests a hearing as part of the owners appeal, the owner should submit the materials, data, and 
information that the owner believes shows that there is a genuine and substantial issue of fact 
regarding the propriety of the detention and any other information that the person would like the 
Presiding Officer to consider when deciding the appeal and request for hearing.  Likewise, if the 
owner does not request a hearing as part of the owners appeal the owner should still submit 
materials, data, and information that the owner wants the Presiding Officer to consider when 
deciding the appeal.  
 
17.  Will a hearing be held if an appeal is made? 
If the appellant requests a hearing, and FDA grants the request, then for both perishable and non-
perishable foods, the hearing will be held within two (2) calendar days after the date the appeal 
has been filed (21 CFR 1.402 (d)). 
 
18.  When does FDA have to issue a decision on an appeal? 
FDA must confirm, modify or terminate the administrative detention order within five (5) 
calendar days after an appeal is filed and after providing an opportunity for an informal hearing, 
if requested (21 CFR 1.405). 
 
19.  When does an administrative detention order terminate? 
If FDA terminates an administrative detention order or the detention period expires, an 
authorized FDA representative will issue an administrative detention termination notice to any 
person who received the detention order (or that persons representative), releasing the article of 
food, as quickly as possible.  If FDA fails to issue an administrative detention termination notice 
and the detention period expires, the administrative detention is deemed to be terminated (21 
CFR 1.384).  FDA intends to notify the owners of administratively detained goods of the 
termination of administrative detentions, as soon as practicable.  If a detention termination 
cannot be issued on the same day as the decision to terminate the detention because, for instance, 
the parties who would receive the termination notice are unavailable, FDA will issue the 
termination notice, as soon as possible.  
 
If the owner of the administratively detained goods would like to terminate the detention before 
the detention period expires, the owner can request a modification of the detention order as 
  Contains Nonbinding Recommendations 
discussed in number 8 of this document and FDA can modify the order to allow for the voluntary 
destruction of the goods and effectively terminate the detention.  FDA routinely monitors such 
destruction activities.   
 
20.  Who pays the costs associated with the detention order, such as storage, moving, 
disposal or reconditioning? 
 
As stated in the preamble to the 2004 final rule (69 Federal Register 31659 at 31690), the party 
or parties responsible for paying the storage costs of food that FDA orders administratively 
detained is a matter between the private parties involved with the food.  FDA is not liable for 
those costs.  An owner, operator, or agent in charge of the place where the food is located can 
always request modification of a detention order to destroy the food if they do not want to store 
it.   
 
 
IV.  References 
 
We have placed the following references on display in the Division of Dockets Management, 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may 
see them at that location between 9 a.m. and 4 p.m., Monday through Friday.  As of October 19, 
2011, FDA had verified the Web site address for the references it makes available as hyperlinks 
from the Internet copy of this guidance, but FDA is not responsible for any subsequent changes 
to Non-FDA Web site references after October 19, 2011.  FDA has verified that these web 
addresses are still available for the content as of April 29, 2012. 
 
 
1.  For more information on the Food Safety Modernization Act, go to:   
             http://www.fda.gov/Food/FoodSafety/FSMA/ucm247548.htm 
 
2.  The Interim Final Rule to revise 21 CFR 1.378 that published  in the Federal Register on 
May 5, 2011 (76 FR 25538) is located at: 
http://www.fda.gov/Food/FoodSafety/FSMA/ucm257986.htm 
 
3.  The Regulatory Procedures Manual is located at: 
           http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm