Contains Nonbinding Recommendations 
Prior Notice of Imported Food 
Questions and Answers (Edition 4) 
Guidance for Industry 
Additional copies are available from: 
Office of Policy, Compliance and Enforcement 
Office of Regulatory Affairs 
Food and Drug Administration 
12420 Parklawn Drive 
Rockville, MD 20740 
(Tel) 866-521-2297 
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformati
on/default.htm 
You may submit electronic or written comments regarding this guidance at 
any time. Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Dockets Management Staff (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852. All comments should be identified with the docket number 
FDA-2011-N-0179. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Regulatory Affairs 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
October 2023 
1  Contains Nonbinding Recommendations 
Table of Con  tents 
I. Introduction
II. Prior Notice Questions and Answers
A. Background
1. General
2. Outreach
B. Definitions
1. Food  General
2. Food  Chemicals and Food Additives
3. Food  Live Animals
4. Food  Seeds
5. Food  Placebos
6. Food  Popcorn Used as Packing Material
7. FDA Country of Production
8. International Mail
9. Port of Arrival/Port of Entry
10. United States
C. Scope
1. General
2. Airline Food
3. Charities
4. Express Carriers or Express Consignment Operators
5. Farms
6. Food Not for Consumption in the U.S.
7. Foreign Trade Zones
8. Gifts
9. Household Goods
10. International Mail
11. In-transit Shipments
12. Meat
13. [Reserved]
14. Produce
15. Personal Baggage
16. Personal Shipments
17. Samples
18. U.S. Goods Returned
D. Requirements to Submit Prior Notice of Imported Food
1. Submitter and Transmitter
2. Deadlines for Prior Notice
3. Submitting Prior Notice
2  Contains Nonbinding Recommendations 
4. General Informati on Requirements
5. Registration Num bers
6. Grower Identity
7. Product Identity
8. Ultimate Consignee
9. Refusal Country
10. Changes to Prior Notice Submissions
11. Changes to Shipments
12. FDA PNSI and ABI/ACE/ITDS Features
13. Confirmation
E. Consequences
1. Inadequate Prior Notice
2. Transition Period and Exercise of Enforcement Discretion
III. Electronic Access
IV. Where to Get Additional Information
A. Prior Notice Help Desk
B. Useful Websites
3  Contains Nonbinding Recommendations 
Prior Notice of Imported Food 
Questions and Answers (Edition 4) 
Guidance for Industry1 
This guidance represents the current thinking of the Food and Drug 
Administration (FDA or we) on this topic. It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes and 
regulations. To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
I. Introduction
On November 7, 2008, the Food and Drug Administration (FDA or we) published a 
final rule (Prior Notice rule) in the Federal Register requiring submission to FDA of 
prior notice of food, including food for animals that is imported or offered for import 
into the United States (73 FR 66294). The Prior Notice rule implements section 
801(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)), 
which was added by section 307 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188), 
and requires that FDA receive prior  notice of food imported into the United States.   
On May 5, 2011, FDA published an interim final rule Information Required in  Prior 
Notice of Imported Food (76 FR 25542) based on section 304 of the FDA Food Safety 
Modernization Act (FSMA) (Public Law 111-353), which amended section 801(m) of 
the FD&C Act. The interim final rule amended the Agencys regulations on prior 
notice of imported food. As required by section  304 of FSMA, FDA issued the interim 
final rule to require that a person  submitting prior notice of imported food, including 
food for animals, report the name of any country to which the article has been refused 
entry. Section 304 of FSMA also required the interim final rule be published no later 
than 120 days following the date of enactment of the legislation and that the 
amendment made by section 304 of FSMA take effect 180 days after the date of 
enactment. The effective date of the interim final rule was July 3, 2011. 
On May 30, 2013, FDA published a final rule (78 FR 32359) that adopted, without 
change, the interim final rule. 
1 This guidance has been prepared by the Division of Food Defense Targeting and Office of Policy, 
Compliance and Enforcement, Office of Regulatory Affairs, in cooperation with the Center for Food Safety 
and Applied Nutrition and the Center for Veterinary Medicine of the U.S. Food and Drug Administration. 
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Contains Nonbinding Recommendations 
 
 
 
This is the fourth edition of this document. A draft of this edition was issued on 
September 13, 2022. The first, second, and third editions were issued on December 
16, 2003, May 3, 2004, and June 16, 2016, respectively. Revisions and additions since 
publication of the last draft document are noted by date. This guidance document 
provides a list of questions that frequently have been asked about the  requirements of 
the prior notice rule, and the answers to those questions. It  is being issued to help the 
food industry and others comply with the legal requirements established by the Prior 
Notice rule. 
 
In general, FDAs guidance documents do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys 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 
 
II. Prior Notice Questions and Answers 
A. Background 
 
1.  General 
 
1.1  What is prior notice? 
 
Prior notice is notification to FDA that an article of food, including food for animals, 
is being imported or offered for import into the United States in advance of the arrival 
of the article of food at the U.S. border. 
 
Additional information on the Prior Notice rule may be found in sections 1.276-1.285 
(Subpart I) of Title 21 of the Code of Federal Regulations (CFR), and on FDAs 
website at https://www.fda.gov/food/importing-food-products-united-states/prior-
notice-imported-foods-overview-and-background.  For additional information on the 
U.S. Customs and  Border Protections (CBPs) procedures for prior notice, you may 
want to  consult the CBP website at http://www.cbp.gov. 
 
1.2  Why is prior notice required to be submitted to FDA? 
 
Prior notice is required by section 801(m) of the FD&C Act (21 U.S.C. 381(m)) and its 
implementing regulation in 21 CFR part 1, subpart I. 
 
Section 801(m) of the FD&C Act requires advance notification to FDA prior to the 
arrival of food imported or offered for import into the U.S. 
 
1.3  When did prior notice go into effect? 
 
The prior notice requirements took effect on December 12, 2003, with the publication 
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of the Prior Notice Interim Final Rule (68 FR 58974, October 10, 2003). 
 
1.4  What if I have a question about or need clarification on 21 CFR part 1, 
subpart I? 
 
In addition to this document, you may wish to review the preambles to the 2003 
interim final rule, the 2008 final rule, the 2011 interim final rule, and the 2013 final 
rule, which answer many of the questions that we have received regarding prior notice 
requirements. The rules may be found at   
https://www.fda.gov/food/importing-food-products-united-states/historical-
information-about-prior-notice.   
 
If you have further questions about prior notice, you can submit them to FDA by using 
the form at  http://www.accessdata.fda.gov/scripts/email/cfsan/bioterrorismact/helpf2.c  
fm. 
 
Due to the large number of inquiries received and our limited resources, we issue 
guidance documents periodically to answer those questions that are not directly 
addressed in the Prior Notice rule or its preambles. Please check our website 
periodically to obtain a copy of these guidance documents at   
https://www.fda.gov/food/importing-food-products-united-states/prior-notice-
imported-foods.  
 
2.  Outreach 
 
2.1  How can industry learn how to comply with the Prior Notice rule and 
submit prior notice through the CBP Automated Broker Interface of the 
Automated Commercial Environment/ International Trade Data System 
(ABI/ACE/ITDS) or FDA Prior Notice System Interface (FDA PNSI)? 
 
We have prepared several tools, such as tutorials, instructions, and question-and-
answer documents, to help importers and other affected persons submit prior notice 
either through CBPs ABI/ACE/ITDS or FDA PNSI. These are available on FDAs 
website at   
https://www.fda.gov/food/importing-food-products-united-states/filing-prior-notice-
imported-foods.  
 
2.2  Where can I get more information about FDAs prior notice rule? 
 
Information on the prior notice rule may be found on FDAs website at 
https://www.fda.gov/food/importing-food-products-united-states/prior-notice-
imported-foods. Many of your questions can be answered by reading the Prior Notice 
rule or by reviewing the tutorials, fact sheet, and other materials that are posted on the 
website. If your questions are not answered by information on that website, you can 
send an email by using the form found at  
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http://www.accessdata.fda.gov/scripts/email/cfsan/bioterrorismact/helpf2.cfm. We will 
likely answer the questions in guidance documents rather than through individual 
responses.  Please check our website periodically to obtain a copy of these guidance 
documents at 
https://www.fda.gov/food/importing-food-products-united-states/prior-notice-
imported-foods.   
 
2.3  Where can I get more information about CBPs procedures under the 
Bioterrorism Act and the Prior Notice rule? 
 
For additional information on the CBPs procedures for prior notice, consult the CBP 
website at  http://www.cbp.gov. 
 
B. Definitions 
 
1.  Food  General 
 
1.1  For the purposes of the Prior Notice rule, what is food? 
 
Food is defined in 21 CFR 1.276 by reference to section 201(f) of the FD&C Act, 
which defines food as articles used for food or drink for man or other  animals, 
chewing gum, and articles used for components of any such articles (21 U.S.C. 
321(f)). However, for purposes of prior notice, the definition of food does not include 
food contact substances or pesticides  (21 CFR 1.276(b) (5)(i)). Examples of food 
subject to prior notice include, but are not limited to: fish and seafood, live food 
animals, dairy products, shell eggs, fruits, vegetables, raw agricultural commodities for 
use as food or as components of human and animal food (including pet food), food 
ingredients, food additives, infant formula, beverages (including  alcoholic beverages 
and bottled water), bakery goods, snack foods, candy, canned foods, and dietary 
supplements and dietary ingredients. 
 
1.2  Is a bulk commodity like raw cane sugar food subject to prior notice? 
 
A bulk commodity is subject to prior notice if it is food as defined in 21 CFR 
1.276(b)(5). This includes articles for use as food, including for use  as a component of 
food. Bulk commodities such as raw cane sugar are food for prior notice purposes (21 
CFR 1.276(b)(5)(ii)). For the purpose of prior notice, FDA considers an article as one 
that will be used for food if it is reasonably  likely to be directed to a food use. For 
more discussion on this topic, please see the preamble to the 2008 final rule at 73 FR 
66294 at 66300-01 (November 7, 2008). 
 
 
 
2.  Food  Chemicals and Food Additives 
 
2.1  Are chemicals used to manufacture food additives food for prior notice 
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purposes? 
 
Chemicals that are used for food or are used for components of any such articles are 
food and are subject to FDAs Prior Notice rule. However, if the chemicals are used 
for food contact substances or pesticides or components of food contact substances or 
pesticides, prior notice is not required (see 21 CFR 1.276(b)(5)). For more discussion 
on this topic, please see the preamble to the 2008 final rule at 73 FR 66294 at 66301. 
 
2.2  What are some examples of food contact substances? 
 
Food packaging materials, empty food packages, ceramic dinnerware,  brass drinking 
vessels, and corn husks to be used as tamale wrappers are examples of food contact 
substances. Even though these foods are excluded from prior notice requirements in 
section 801(m) of the FD&C Act, they are still subject to other provisions of the 
FD&C Act, including section 801(a) of the FD&C Act (21 U.S.C. 381(a)), and FDA 
will continue to make admissibility decisions about them. 
 
2.3  Are secondary direct food additives, many of which are processing aids, 
exempt from prior notice as food contact substances? 
 
Some secondary direct food additives meet the definition of food contact substances as 
given in section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)) and, therefore, 
would not be subject to the prior notice requirements (21 CFR 1.276(b)(5)(i)(A)). If a 
secondary direct food  additive is not a food contact substance but is, for example, a 
food processing aid, then it would be subject to prior notice. For more discussion of 
this topic, please see the preamble to the 2008 final rule at 73 FR 66294 at 66301. 
 
3.  Food  Live Animals 
 
3.1  Are live animals food for prior notice purposes? 
 
Live animals are food for purposes of prior notice if the live animal is reasonably 
likely to be directed to a food use (73 FR 66294 at 66306) (see 21 CFR 1.276(b)(5)). 
Note that live food animals are not excluded from prior notice under section 
801(m)(3)(B) of the FD&C Act and 21 CFR 1.277(b)(4) or (5) because live food 
animals do not fall within the exclusive jurisdiction of the U.S. Department of 
Agriculture (USDA) under the Federal Meat Inspection Act or Poultry Products 
Inspection Act. If the live animals are imported for a non-food use (e.g., as a pet, for 
show purposes, racing) and are not reasonably likely to be directed to a food use, then 
prior notice is not required. 
 
Live animals are capable of multiple uses, such as food, pets, research, or letting them 
stay wild. In these situations, the question is whether the animal is reasonably likely to 
be directed to a food use. Cows are almost always directed to a food use eventually, 
even if that is not the immediate use. 
 
Some small animals (e.g., guinea pigs) that are imported end up as food. When this 
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food use is not intended or reasonably likely at the time of import, such as when they 
are imported as pets, then prior notice would not be required. 
 
Horses are sometimes imported for a food use  slaughter and export as food (see 
question C.6.1). However, many are imported for non-food uses, such as shows, 
racing, and pets. When imported for a non-food use, a horse is not subject to prior 
notice requirements, unless it is reasonably likely to be directed to a food use. 
 
3.2  If USDAs Animal and Plant Health Inspection Service (APHIS) inspects 
the live animals when they are imported into the U.S., are the live animals 
food for prior notice purposes? 
 
Yes. Live food animals that are subject to border inspections by APHIS are also 
subject to FDAs prior notice requirements. FDA and APHIS may both have 
jurisdiction over live animals. Note that the requirement for prior notice to FDA for 
live food animals does not alter the role of APHIS in, or any APHIS requirements 
relating to, inspection of live animals imported into the U.S. With respect to food 
jointly regulated by USDA (including APHIS) and FDA, only food under the 
exclusive jurisdiction of USDA at the time of importation is excluded from prior 
notice. See 73 FR 66294 at 66306. 
 
3.3  Are game animals food for which prior notice must be given? 
 
Yes. If the animal is reasonably likely to be directed to a food use, the animal is food 
for which prior notice is required (see 21 CFR 1.276(b)(5)). For example, elk imported 
to stock a ranch where the elk are  hunted and used for food would be food under the 
prior notice definition. By contrast, elk imported for repopulating a national park 
where hunting  the elk is not permitted would not be food for which prior notice is 
required. Note that neither live game animals intended for food nor the food products 
derived from them are excluded from prior notice under section 801(m)(3)(B) of the 
FD&C Act and 21 CFR 1.277(b)(4) or (5); neither the live game animals intended for 
food nor the food products derived from them fall within the exclusive jurisdiction of 
USDA under the Federal Meat Inspection Act or Poultry Products Inspection Act. 
 
4.  Food  Seeds 
 
4.1  Are seeds subject to prior notice requirements? 
 
The answer depends on whether the seeds meet the definition of food. FDA considers 
a seed to be food if it is reasonably likely to be directed to a food use (73 FR 66294 at 
66301).  For example, if the seed is for use in animal food, the seed is food and prior 
notice is required (21 CFR 1.276(b)(5); 21 CFR 1.277(a)). Similarly, if the seed is to 
be used for human food, such as sesame seeds to be used in baking or oilseeds for 
processing into edible oil, then prior notice must be submitted  to FDA before the seed 
is imported or offered for import into the U.S. (21 CFR 1.276(b)(5); 21 CFR 1.277(a)). 
 
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If the seed will be used for the production of edible sprouts, such as alfalfa seeds for 
production of alfalfa sprouts, then you must provide prior notice  to FDA before the 
seeds are imported or offered for import.  By contrast, if the seed is only for cultivation 
(even if it is used to grow a plant that may subsequently be consumed as food), then 
prior notice is not required. 
 
FDA has an enforcement discretion policy regarding seeds for planting.  Under the 
policy, FDA and CBP would typically consider not taking any regulatory action 
regarding seeds that will be used for cultivation. The  policy applies when no more 
than a small portion of that seed is diverted from cultivation to animal food or other 
food use. It does not apply, however, where the seed is used for the production of 
edible sprouts, such as alfalfa seeds for the production of alfalfa sprouts. For further 
discussion, see FDAs Compliance Policy Guide Sec. 110.310 Prior Notice of 
Imported Food Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/cpg-sec-110310-prior-notice-imported-food-under-public-
health-security-and-bioterrorism-preparedness). 
 
5.  Food  Placebos 
 
5.1  Is prior notice required for placebos that are imported for testing 
purposes? 
 
If the product is for pharmaceutical testing purposes, e.g., for use in a  clinical trial 
involving a prescription or non-prescription drug, then prior  notice is not required (see 
question C.1.3). However, if the product is being imported for use in the testing of 
dietary supplements or dietary ingredients, prior notice is required. 
 
6.  Food  Popcorn Used as Packing Material 
 
6.1  Is prior notice required for popcorn that is used as a packing material for 
shipping? 
 
When a substance is capable of having a food use and a non-food use, FDA will 
consider the substance to be food for the purpose of prior notice if it is reasonably 
likely to be directed to a food use (73 FR 66294 at 66301).  Therefore, prior notice is 
required if the popcorn used as a packing material is reasonably likely to be directed to 
a food packing use. 
 
 
 
 
7.  FDA Country of Production 
 
7.1  What is the FDA Country of Production and how does it differ from 
CBPs Country of Origin? 
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FDA Country of Production is defined in 21 CFR 1.276(b)(4). For food that is in its 
natural state (21 CFR 1.276(b)(4)(i)), the FDA Country of Production is generally the 
country where the food was grown or collected, including harvested and readied for 
shipment to the U.S. Articles of food grown, including harvested or collected and 
readied for  shipment, in U.S. territories are considered to be grown in the U.S. (21 
CFR 1.276(b)(4)(i)).  However, for wild fish, including seafood, that is  caught or 
harvested outside U.S. waters by a vessel that is not registered in the U.S., the FDA 
Country of Production is the country in which the vessel is registered (21 CFR 
1.276(b)(4)(i)).  For further discussion on this topic, please see 73 FR 66294 at 66355; 
November 7, 2008. 
 
For food that is no longer in its natural state, the FDA Country of Production is 
generally the country where the food was made or processed. However, if the article is 
made from wild fish aboard a vessel, the FDA Country of Production is the country in 
which the vessel is registered (21 CFR 1.276(b)(4)(i)). If food that is no longer in its 
natural state was made in a U.S. Territory, the FDA Country of Production is the U.S. 
(21 CFR 1.276(b)(4)(ii)). 
 
The FDA Country of Production may be different from the CBP Country of Origin. 
For example, the CBP Country of Origin for beans that are grown and dried in the 
U.S., then rehydrated and canned in the Dominican Republic, would be the U.S. (see 
19 CFR 177.22). The FDA Country of Production under the Prior Notice rule would 
be the Dominican Republic. Therefore, for purposes of  the prior notice provisions of 
the FD&C Act, the article of food is canned beans, not dried beans. From a food 
safety standpoint, FDA is most interested in knowing where the article of food was 
processed and canned. To avoid confusion between FDAs prior notice requirements 
and CBP requirements, the rule uses the term FDA Country of Production instead 
of the term originating country or country from which the article originates. FDA 
Country of Production is already familiar to  customs brokers and self-filers using the 
CBPs ABI/ACE/ITDS interface with FDAs  Operational and Administrative System 
for Import Support (OASIS). For more information see 73 FR 66294 at 66355. 
 
8.  International Mail 
 
8.1  Are express carriers, such as FedEx, considered international mail? 
 
As stated in 21 CFR 1.276(b)(8), the term international mail only covers foreign 
national mail services. Express carriers, such as FedEx,  as well as express 
consignment operators, or other private delivery  services are not considered 
international mail unless such service is  operating under contract as an agent or 
extension of a foreign mail service  (21 CFR 1.276(b)(8)). 
 
9.  Port of Arrival/Port of Entry 
 
9.1  What is the port of arrival and how does it differ from the port of 
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entry? 
 
The port of arrival is the water, air, or land port at which the article of food is imported 
or offered for import into the U.S., i.e., the port where the article of food first arrives in 
the U.S. (21 CFR 1.276(b)(11)). For an article of food arriving by water or air, this is 
the port of unloading. For an article of food arriving by land, this is the port where the 
article of food first crosses the border into the U.S. 
 
According to FDA regulations at 21 CFR 1.276(b)(12), the term port of entry means 
the port of entry as defined in CBP regulation 19 CFR 101.1. The term port of entry 
according to CBP regulations refer[s] to any place designated by Executive Order..., 
by  order of the Secretary of the Treasury, or by Act of Congress, at which a Customs 
officer is authorized to accept entries of merchandise, to collect  duties, and to enforce 
the various provisions of Customs and navigation laws (19 CFR 101.1). 
 
9.2  Can the port of arrival differ from the port of entry (i.e., port where  entry 
is made)? 
 
Yes. The port of arrival is the port where the articles of food first arrive in the U.S. A 
consumption or warehouse entry or foreign trade zone admission documentation may 
be presented to CBP at a different port of entry than the port of arrival. Note that 
timeframes for submission of prior notice are tied to the time of arrival in the port of 
arrival, not arrival in the port of entry. 
 
10.  United States 
 
10.1  Is prior notice required for foods that are imported into Puerto Rico? 
 
Yes, prior notice is required for food that comes from outside the U.S. into the 
Commonwealth of Puerto Rico, but not for food shipped from the Commonwealth of 
Puerto Rico into the 50 states or the District of Columbia. 
 
10.2  Is prior notice required for foods that are imported into the U.S. 
Territories? 
 
No. FDA regulations at 21 CFR 1.276(b)(15) define the U.S. to be the 50 states, the 
District of Columbia, and the Commonwealth of Puerto Rico, but not the U.S. 
Territories. Therefore, prior notice is not required for food shipped into a U.S. 
Territory. However, prior notice is required for food coming from a U.S. Territory 
(e.g., Guam, the U.S. Virgin Islands, and the Northern Mariana Islands) into the 50 
states, the District of Columbia, or the Commonwealth of Puerto Rico. 
 
10.3  Is prior notice required for shipments originating in another country with 
which the United States has a free trade agreement? 
 
Yes. Because the U.S. is defined for purposes of prior notice to be the Customs 
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territory of the U.S. (21 CFR 1.276(b)(15)), food that is imported into the 50 states, 
the District of Columbia, or the Commonwealth of Puerto Rico from a country that is a 
signatory to a free trade agreement with the United States (e.g., United States-Mexico-
Canada Agreement) is subject to prior notice. 
 
C.  Scope 
 
1.  General 
 
1.1  What is the scope of the prior notice rule? What shipments of food 
imported or offered for import into the U.S. require prior notice? 
 
If the article that is shipped to the U.S. is food within the meaning of 21 CFR 
1.276(b)(5), then prior notice generally is required, even if the item is  intended for 
further processing, is not intended for consumption in the U.S., or is not intended for 
commercial distribution. Thus, unless an exemption applies (see 1.2), prior notice is 
required for food for humans and other animals that is imported or offered for import 
into the U.S. for use, storage, or distribution in the U.S., including food for gifts and 
trade and quality assurance/quality control samples, food for transshipment through 
the U.S. to another country, food for future export, and food for use in a U.S. Foreign 
Trade Zone. 
 
1.2  Are there any exemptions from the prior notice requirements? 
 
Yes. As stated in 21 CFR 1.277(b), prior notice is not required for: 
 
a.  Food for an individuals personal use (i.e., for consumption by the individual, 
family, or friends, and not for sale or other distribution)  when it is carried by or 
otherwise accompanies the individual when arriving in the U.S.; 
b.  Food that was made by an individual in his/her personal residence  and sent by that 
individual as a personal gift (i.e., for non-business  reasons) to an individual in the 
U.S.; 
c.  Food that is imported then exported without leaving the port of arrival until export; 
d.  Meat food products, poultry products, and egg products that are subject to the 
exclusive jurisdiction of USDA at the time of importation; and 
e.  Food subject to Article 27(3) of the Vienna Convention on Diplomatic Relations 
(1961) (i.e., shipped as baggage or cargo  constituting the diplomatic bag). 
 
1.3  Are there exemptions from prior notice for any of the following: 
 
a.  Food items of small value or quantity; 
b.  Food samples for research and development or for testing purposes only and 
not for consumption; or 
c.  Food samples for test marketing? 
 
There are no exemptions from prior notice requirements for: 
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a.  Food based on the size or value of the shipment (73 FR 66294 at 66317); 
 
b.  Samples of food, including food for animals, for research  and development (73 FR 
66294 at 66314-15). However, if the samples are items that are in such early stages 
of research and development that they cannot yet be considered food under 21 
CFR 1.276(b)(5), they would not be subject to prior notice requirements. An 
example of such an item is a substance being tested for possible preservative 
qualities before being tested in any food. FDA has an enforcement discretion 
policy regarding food imported or offered for import without prior notice that will 
be used for quality assurance, research, or analysis purposes, or in vivo testing in 
non-food producing laboratory animals. Under the policy, FDA and CBP should 
typically consider not taking any regulatory action when the samples of food are 
imported in quantities consistent with quality assurance, research, or analysis 
purposes, and the entire sample is used up by the analysis/testing or destroyed 
upon completion of the analysis/testing. For further discussion, see FDAs 
Compliance Policy Guide on FDAs website at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/cpg-sec-110310-prior-notice-
imported-food-under-public-health-security-and-bioterrorism-preparedness; or 
c.  Samples of food, including food for animals, for test marketing (73 FR 66294 at 
66314-15). 
 
1.4 [Question added October 2023] Is food imported from a country with which 
FDA has a Systems Recognition Arrangement or equivalence determination 
exempt from prior notice? 
 
No. Systems Recognition is a partnership between the FDA and a foreign regulatory 
counterpart in which the agencies have concluded that they operate comparable 
regulatory programs that yield similar food safety outcomes. The purpose of this 
partnership is for FDA and foreign regulatory counterparts to share information and 
leverage each others regulatory systems and activities to manage the safety of foods 
covered by a Systems Recognition Arrangement (SRA). The existence of an SRA with 
a given country does not exempt imported foods from that country from FDA prior 
notice requirements. 
 
An equivalence determination is the process of determining whether a countrys food 
safety controls achieve at least the same level of public health protection as measures 
required by U.S. law. While a foreign country is not required to develop and 
implement the same exact procedures and food safety controls that FDA requires, the 
country must objectively demonstrate how its food safety controls meet at least the 
same level of public health protection achieved by U.S. measures. Because a final 
equivalence determination is limited to a specific set of food safety controls in a 
foreign country, imported foods must still comply with all applicable U.S. 
requirements not covered by the scope of FDAs equivalence determination. Since 
FDAs prior notice requirements fall outside the scope of an equivalence 
determination, imported foods covered by a final equivalence determination are not 
exempt from FDA prior notice requirements. 
  14   
Contains Nonbinding Recommendations 
 
 
 
2.  Airline Food 
 
2.1  Is aircraft food exempt from prior notice since any excess is incinerated at 
the U.S. airport?  Is in-flight food, imported in bulk and  moved in-bond to 
U.S. caterers, for use on export flights exempt? 
 
If the aircraft food is consumed on the international flight or discarded and  is not 
entered into the U.S. for use, storage, or distribution, it is outside the scope of the 
regulation, and prior notice is not required (21 CFR 1.277(a)). By contrast, prior notice 
is required for in-flight food that is moved to U.S. caterers for use on export flights or 
on domestic flights (21 CFR 1.277). 
 
3.  Charities 
 
3.1  Is there an exemption for food imported for charity? 
 
No. Food intended for charity is not exempt from prior notice. Although 21 CFR 
Subpart H exempts nonprofit food establishments in which food is prepared for, or 
served directly to, the consumer from the requirements  to register their facilities (21 
CFR 1.226(e)), the Prior Notice rule does not exempt food imported for use by those 
nonprofit food establishments. Thus, imported food that is imported for or by a U.S. 
charity is subject to prior notice (21 CFR 1.277). 
 
4.  Express Carriers or Express Consignment Operators 
 
4.1  Is an article of food that is shipped by an express carrier or express 
consignment operators like FedEx exempt from prior notice? 
 
No. Imported food transported into the U.S. via express carriers or express 
consignment operators is not exempt from the requirements of the Prior Notice rule. 
Articles imported via these private delivery services are subject to prior notice, which 
must be submitted within the  timeframe for the applicable mode of transportation (21 
CFR 1.279). See  73 FR 66294 at 66317; November 7, 2008. 
 
5.  Farms 
 
5.1  Is prior notice required for tomatoes from a foreign farm that packs and 
exports tomatoes to the U.S. given that farms typically dont have to 
register? 
 
Yes. The requirement for prior notice is not based on whether registration is required. 
FDA registration requirements apply to facilities that  manufacture/process, pack, or 
hold food for consumption in the U.S. (21 CFR 1.225). The prior notice requirements 
apply to articles of food imported or offered for import into the U.S. Farms, as defined 
in 21 CFR 1.227(b)(3) and that fall within the exemption, are exempt from 
  15   
Contains Nonbinding Recommendations 
 
 
registration. However, the articles of food grown, harvested, or collected on farms are 
not exempt from prior notice requirements. Thus, generally,  the food that a foreign 
farm exports to the U.S. is subject to the prior notice requirements (21 CFR 1.277). 
 
6.  Food Not for Consumption in the U.S. 
 
6.1  If the food will not be consumed in the U.S., is prior notice required? 
 
Yes. Prior notice requirements apply even when the food will not be consumed in the 
U.S. You must submit prior notice for food that is for transshipment, further 
processing and export, or storage and export (see 21 CFR 1.277(a)). In contrast, the 
requirement to register facilities applies  only to food facilities that 
manufacture/process, pack, or hold food for consumption in the U.S. 
 
7.  Foreign Trade Zones 
 
7.1  Will imported food being admitted into a Foreign Trade Zone (FTZ) need 
to have prior notice? 
 
Yes. Imported food for admission into a Foreign Trade Zone is subject to the Prior 
Notice rule per 21 CFR 1.277.  Prior notice is required before arrival in the U.S. and 
is, therefore, required prior to admission into a Foreign Trade Zone. 
 
7.2  If I submit prior notice before a food is admitted into an FTZ, do I need to 
submit prior notice again before a food is withdrawn from the FTZ? 
 
No. Because prior notice must be submitted before arrival and admission into an FTZ, 
prior notice is not required when the food is withdrawn from the FTZ, either as an 
export or for use within the U.S. However, if the food is withdrawn from the FTZ for 
consumption entry into the U.S., FDA must be notified and will make the admissibility 
decision about the  consumption entry at that time. 
 
8.  Gifts 
 
8.1  Does prior notice apply to homemade food sent as gifts from family living 
outside the U.S.? 
 
No. If the food was made by an individual in his/her personal residence and sent by 
that individual as a personal gift (i.e., for non-business reasons) to an individual in the 
U.S., prior notice is not required (21 CFR 1.277(b)(2)). Other food products sent as 
gifts are subject to the prior notice requirement (see 21 CFR 1.277). More information 
pertaining to food products sent as gifts can be found in the FDA Compliance Policy 
Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-
110310-prior-notice-imported-food-under-public-health-security-and-bioterrorism-
  16   
Contains Nonbinding Recommendations 
 
 
preparedness). 
 
8.2  Does prior notice apply to food in its natural state, grown by an 
individual, and sent to an individual in the U.S. as a gift? 
 
No. Homegrown food sent by one individual to another as a gift (i.e., for non-business 
reasons) is not subject to prior notice (21 CFR 1.277(b)(2)).  Other food products sent 
as gifts are subject to the prior notice requirement (see 21 CFR 1.277). More 
information pertaining to food products sent as gifts can be found in the FDA 
Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the 
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-
sec-110310-prior-notice-imported-food-under-public-health-security-and-
bioterrorism-preparedness). 
 
8.3  Is prior notice required if an individual purchases a food product made by 
a third party, and sends it to an individual in the U.S. as a gift? 
 
Yes. Food products, other than those that are made in personal residence and sent as 
personal gifts, are subject to the prior notice requirement (21 CFR 1.277(a)). FDA 
recognizes that, in these circumstances, the sender who purchased the food  as a gift 
may not have the manufacturer registration number. In this situation, the sender can 
provide the name and full address of the manufacturer and the reason the registration 
number is not provided (21 CFR 1.281(a)(6), (b)(5)). 
 
FDA has an enforcement discretion policy that applies to food sent as a gift that is 
purchased at a commercial establishment for non-commercial  purposes (i.e., not for 
sale, resale, barter, or business use) and sent by a  non-commercial shipper (e.g., the 
individual delivers the food to a post  office or common carrier for delivery to an 
individual in the U.S.). Under the policy, FDA and CBP should typically consider not 
taking any regulatory action when an article of food purchased at a commercial 
establishment and shipped by the purchaser is imported or offered for import and there 
is no prior notice. For additional information, see FDAs Compliance Policy Guide 
Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/cpg-sec-110310-prior-notice-imported-
food-under-public-health-security-and-bioterrorism-preparedness). 
 
 
 
 
 
9.  Household Goods 
 
9.1  Are foods included with my household goods subject to prior notice when 
I move to the U.S.? 
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Contains Nonbinding Recommendations 
 
 
 
Yes. FDA regulations at 21 CFR 1.277 do not exclude household goods of individuals 
moving to the U.S. However, FDA has an enforcement discretion policy that applies 
to most household goods. Under the policy, FDA and CBP should typically consider 
not taking any regulatory action when an article of food is imported or offered for 
import for noncommercial purposes with a noncommercial shipper without prior 
notice. We consider food in household goods, including military and civilian transfers, 
to be food imported or offered for import for a noncommercial purpose. For 
additional information, see FDAs Compliance Policy Guide Sec. 110.310 Prior 
Notice of Imported Food Under the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/cpg-sec-110310-prior-notice-imported-
food-under-public-health-security-and-bioterrorism-preparedness). 
 
9.2  Are foods included with my household goods subject to prior notice even if 
the move is covered by the military? 
 
Yes. FDA regulations at 21 CFR 1.277 do not exclude household goods of military 
personnel moving back to the U.S. However, FDA has an enforcement discretion 
policy that applies to most household goods. Under the policy, FDA and CBP should 
typically consider not taking any regulatory action when an article of food is imported 
or offered for import  for noncommercial purposes with a noncommercial shipper 
without prior  notice. We consider food in household goods, including military and 
civilian transfers, to be food imported or offered for import for a noncommercial 
purpose. For additional information, see FDAs Compliance Policy Guide Sec 
110.310 Prior Notice of Imported Food Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-
sec-110310-prior-notice-imported-food-under-public-health-security-and-
bioterrorism-preparedness). 
 
10.  International Mail 
 
10.1  Is food imported into the U.S. by international mail exempt from prior 
notice? 
 
No. Unless an exemption in 21 CFR 1.277(b) applies, food imported via 
international mail is subject to prior notice, which  must be submitted before the food 
is sent to the U.S. (21 CFR 1.279(c)). 
 
 
 
11.  In-Transit Shipments 
 
11.1  Is prior notice required for food transiting the U.S. for exportation to 
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Contains Nonbinding Recommendations 
 
 
another country, e.g., for a Transportation and Exportation (T&E)  entry? 
 
Yes. Prior notice is required for food for transshipment through the U.S. to another 
country and food for future export (21 CFR 1.277(a)). 
 
12.  Meat 
 
12.1  Is prior notice required for meat, poultry, or egg products that are under 
the jurisdiction of USDA? 
 
If, at the time the food is imported or offered for import, the food is subject to the 
exclusive jurisdiction of the USDAs Federal Meat Inspection Act (21 U.S.C. 601 et 
seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products 
Inspection Act (21 U.S.C. 1031 et seq.), the food is not subject to the requirements of 
prior notice (21 CFR 1.277(b)(4)-(b)(6)) (see B.3).   
 
12.2  Is prior notice required for meat intended for food for animals, including 
pet food and treats? 
 
Yes. Meat intended for food for animals, such as meat fed to zoo animals and meat 
products intended to be incorporated into food for animals, is not under the jurisdiction 
of USDA and is subject to the prior notice requirements. These meats include meat 
derived from cattle, swine, goats, sheep, horses, and mules that are destined for food 
for animals. 
 
12.3  Is prior notice required for casings? 
 
According to USDAs Food Safety and Inspection Service (FSIS) Directive 9000.2: 
 
  Products labeled as (species) intestines are derived from the intestinal tract of 
livestock (animals) and are meat byproducts. As meat byproducts, intestines are 
under FSIS jurisdiction. 
  Products labeled as (species) casings are derived from the intestines of livestock 
(animals) and are used as containers to prepare sausage and other meat food 
products. Casings are under the jurisdiction of the FDA. 
 
Therefore, prior notice is required for (species) casings, but not (species) intestines. 
Artificial casings that are not edible, e.g., those made of plastic, do not meet the food 
definition in 21 CFR 1.276(b)(5) and therefore, do not  require prior notice. 
 
 
 
 
13.  [Reserved] 
 
14.  Produce 
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Contains Nonbinding Recommendations 
 
 
 
14.1  Is produce that is inspected by the Animal and Plant Health Inspection 
Services Plant Protection and Quarantine (PPQ) or graded by USDAs 
Agricultural Marketing Service subject to FDAs prior notice 
requirements? 
 
Yes. Such produce is not under the exclusive jurisdiction of the USDA. Only imported 
food that is regulated exclusively by USDA is exempt from  the prior notice 
requirements. 
 
15.  Personal Baggage 
 
15.1  I am bringing food from a foreign country in my luggage and for my 
personal use. Do I need to submit prior notice to FDA? 
 
No. Prior notice is not required for food that is carried by or otherwise accompanies an 
individual when arriving in the U.S. (e.g., is in his or her carry-on or checked baggage) 
when the food is for that individuals personal use (21 CFR 1.277(b)(1)). Personal use 
means that the food is for consumption by the individual, the individuals pet(s), or by 
the individuals family and friends and is not for sale or other distribution.  See 73 FR 
66294 at 66305; November 7, 2008. 
 
15.2  I plan to drive back to the U.S. from Canada with my trunk full of food I 
purchased there to serve at a family picnic. Is prior notice required? 
 
No. Prior notice is not required for food that is carried by or otherwise accompanies an 
individual when arriving in the U.S. (e.g., is in his or her automobile) when the food is 
for that individuals personal use (21 CFR 1.277(b)(1)). Personal use means that the 
food is for consumption by the individual, individuals pet(s), or by the individuals 
family and friends  and is not for sale or other distribution. See 73 FR 66294 at 66305; 
November 7, 2008. 
 
15.3  I plan to drive back to the U.S. from Mexico with my trunk full of shellfish 
that I plan to sell at a flea market on the U.S. side of the border. Is prior 
notice required? 
 
Yes. Prior notice is required for food that is imported or offered for import into the 
U.S. for use, storage, or distribution in the U.S. Prior notice is not required for food 
that is carried by or otherwise accompanies an individual entering the U.S. (e.g., is in 
his or her automobile) when the food is for that individuals personal use (21 CFR 
1.277(b)(1)). Here, the  shellfish are to be sold and are not for personal use. 
 
 
15.4  I plan to drive back to the U.S. from Canada with my trunk full of samples 
of finished packaged foods for testing. Is prior notice required? 
 
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Contains Nonbinding Recommendations 
 
 
Yes. Prior notice is required for food that is imported or offered for import into the 
U.S. for use, storage, or distribution in the U.S. Prior notice is not required for food 
that is carried by or otherwise accompanies an individual entering the U.S. (e.g., is in 
his or her automobile) when the food is for that individuals personal use (21 CFR 
1.277(b)(1)). Here, the  samples of finished packaged food are to be used for testing 
and not for personal use. 
 
FDA has an enforcement discretion policy regarding food imported or offered for 
import without prior notice that will be used for quality assurance, research, or 
analysis purposes, or in vivo testing in non-food producing laboratory animals. 
Under the policy, FDA and CBP should typically consider not taking any regulatory 
action when the samples of food are imported in quantities consistent with quality 
assurance, research, or analysis purposes, and the entire sample is used up by the 
analysis/testing or destroyed upon completion of the analysis/testing. For further 
discussion, see FDAs Compliance Policy Guide Sec. 110.310 Prior Notice of 
Imported Food Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/cpg-sec-110310-prior-notice-imported-food-under-public-health-
security-and-bioterrorism-preparedness). 
 
15.5  While in Canada, I plan to buy animal food for my pets (such as, dog food, 
cat food, parakeet food, hay for my horses). Is prior notice  required? 
 
No. Prior notice is not required for food that is carried by or otherwise accompanies an 
individual entering the U.S. (e.g., food that is in his or her automobile or trailer) when 
the food is for that individuals personal use (21 CFR 1.277(b)(1)). FDA considers 
personal use to include food that is for consumption by the individuals personally 
owned pets or other companion animals and that is not for sale or other distribution 
(73 FR 66294 at 66305; November 7, 2008). 
 
15.6  I own a dairy farm in the U.S. and plan to go to Canada to buy a tractor 
trailer load of hay and bring the hay back to feed my cows. Is prior notice 
required for this hay? 
 
Yes, prior notice is required because the personal use exemption would not apply in 
this situation. Prior notice is not required for food that is carried by or otherwise 
accompanies an individual entering when arriving in the U.S. (e.g., is in his or her 
automobile) when the food is for that individuals personal use (21 CFR 1.277(b)(1)). 
Personal use means that the food is for consumption by the individual, by the 
individuals family, or by their pets and friends and is not for sale or other distribution. 
See 73 FR 66294 at 66305; November 7, 2008.  Here, the food is for livestock use  
feeding the hay to your dairy cows whose milk is sold to others  rather than for 
personal use. 
 
16.  Personal Shipments 
 
  21   
Contains Nonbinding Recommendations 
 
 
16.1  Is prior notice required for food for personal use that I ship to myself while 
overseas and, therefore, does not accompany me when I return to the U.S.? 
 
Yes. Unless an exemption applies, food purchased abroad and sent to the U.S. (i.e., 
does not accompany the individual when arriving in the U.S.) is subject to prior notice 
(21 CFR 1.277). 
 
However, FDA has an enforcement discretion policy that applies to food for non-
commercial purposes with a non-commercial shipper. Under the policy, FDA and CBP 
should typically consider not taking any regulatory action when an article of food 
purchased by a traveler and mailed to the travelers U.S. address by the traveler is 
imported or offered for import without prior notice. For additional information, see 
FDAs Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under 
the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-
110310-prior-notice-imported-food-under-public-health-security-and-bioterrorism-
preparedness). 
 
16.2  I have ordered food for my personal use that is being shipped to me 
through international mail.  Is prior notice required? 
 
Yes. Prior notice must be provided. The exception for food for personal  use applies 
only when the food is carried by or otherwise accompanies an individual when arriving 
in the U.S. (21 CFR 1.277(b)(1)). This exception  does not apply when the food is 
shipped to the U.S. 
 
Although you or any other person with knowledge of the required information may 
submit prior notice (21 CFR 1.278), it would make sense for the foreign shipper to 
provide prior notice because the prior notice (PN) Confirmation Number, which 
indicates that FDA has received and  confirmed the prior notice for review, must 
accompany an article of food that is sent to the U.S. via international mail (21 CFR 
1.279(e)). 
 
16.3  What if my order is shipped by an express carrier or express consignment 
operators like FedEx? 
 
Prior notice is required. Food transported to the U.S. via express carriers or express 
consignment operators is not exempt from the prior notice requirements. Prior notice 
must be submitted within the timeframe for the applicable mode of transportation (21 
CFR 1.279). 
 
 
 
17.  Samples 
 
17.1  Is food that is a trade sample and that I carry with me into the U.S. 
  22   
Contains Nonbinding Recommendations 
 
 
exempt from prior notice? 
 
No. The exclusion for food carried by an individual applies when the food is for the 
individuals personal use and it is carried by or otherwise accompanies the individual 
when arriving in the U.S. (21 CFR 1.277(b)(1)).  Trade samples are imported or 
offered for import for commercial, not personal, use. 
 
17.2  Are samples of food that are intended for analytical testing for 
contaminants exempt from prior notice? 
 
If the samples are in a form that is not an article of food, such as a slurry of lettuce for 
pesticide analysis or a sterile  sample container filled with juice for heavy metal 
analysis, then prior notice would not apply. However, if the samples are articles of 
food, such as a head of lettuce or a can of juice, then prior notice is required. 
 
FDA has an enforcement discretion policy regarding food imported or offered for 
import without prior notice that will be used for quality assurance, research, or 
analysis purposes, or in vivo testing in non-food producing laboratory animals. 
Under the policy, FDA and CBP should typically consider not taking any regulatory 
action when the samples of food are imported in quantities consistent with quality 
assurance, research, or analysis purposes, and the entire sample is used up by the 
analysis/testing or destroyed upon completion of the analysis/testing. For further 
discussion, see FDAs Compliance Policy Guide Sec. 110.310 Prior Notice of 
Imported Food Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/cpg-sec-110310-prior-notice-imported-food-under-public-health-
security-and-bioterrorism-preparedness). 
 
18.  U.S. Goods Returned 
 
18.1  Is prior notice required for a reimported food product that was 
produced in the U.S., shipped to a foreign country, and then shipped back 
to the U.S. without further processing? 
 
Yes. FDA has determined that, for the purposes of section 801(m) of the FD&C Act, 
the phrase imported or offered for import into the U.S. applies to articles of food of 
U.S. origin that are reimported back into the U.S. See 78 FR 66294 at 66319 and 21 
CFR 1.277.  These reimportations are most often referred to as American Goods 
Returned or U.S. Goods Returned. 
 
 
 
 
D.  Requirements to Submit Prior Notice of Imported Food 
 
1.  Submitters and Transmitters 
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Contains Nonbinding Recommendations 
 
 
 
1.1  Who may submit prior notice to FDA? 
 
Any person with knowledge of the required information may submit prior notice for an 
article of food. This person is the submitter. The submitter may also use another 
person to transmit the required information on his or her behalf. The person who 
transmits the information is the transmitter. The submitter and transmitter may be the 
same person (21 CFR 1.278). 
 
1.2  May I submit a prior notice on behalf of another person? 
 
Yes. Note that if you transmit the required information on behalf of a submitter, you 
are the transmitter. 
 
1.3  Is it possible for the submitter to have his/her legal residence in the 
country of origin and for the transmitter to have his/her legal residence in 
the U.S.? 
 
Yes. There are no geographic restrictions on the location of the submitter or the 
transmitter (21 CFR 1.278). 
 
2.  Deadlines for Prior Notice 
 
2.1  When must prior notice be submitted? 
 
Except for food being sent by international mail, prior notice must be submitted and 
the submission must be confirmed by FDA no less than: 
  2 hours before arrival, if the food is arriving by land by road; 
  4 hours before arrival, if the food is arriving by land by rail; 
  4 hours before arrival, if the food is arriving by air; and 8 hours before arrival, if 
the food is arriving by water (21 CFR 1.279(a)). 
 
For a prior notice submitted via CBPs ABI/ACE/ITDS, you may not submit prior 
notice more than 30 calendar days before the anticipated date of arrival (21 CFR 
1.279(b)(1)). For a prior notice submitted via FDA PNSI, you may not submit prior 
notice more than 15  calendar days before the anticipated date of arrival (21 CFR 
1.279(b)(2)). 
 
For an article of food sent by international mail, prior notice must be  submitted and 
confirmed by FDA before the food is sent (21 CFR 1.279(c)). The PN Confirmation 
Number must appear on the Customs Declaration that accompanies the package (21 
CFR 1.279(e)). 
 
If you are carrying an article of food or if it otherwise accompanies you (i.e., the food 
is in your checked baggage or in the trunk of your car), and the food is not for personal 
use, you must submit prior notice according to the timeframe established for the mode 
  24   
Contains Nonbinding Recommendations 
 
 
of transportation you are using. You must receive confirmation from FDA and provide 
a copy of the confirmation, including the PN Confirmation Number, to CBP or FDA 
when arriving in the U.S. (21 CFR 1.279(f)). 
 
2.2  What is the deadline if the food is transported by truck, but the truck 
arrives via ferry due to a water crossing? 
 
In this case, the deadline is 2 hours prior to arrival. 
 
2.3  What is the deadline if the food walks across the border, such as livestock 
that are driven across? 
 
If cattle are driven across the border, then the food is arriving by land via road and the 
deadline is 2 hours prior to arrival (21 CFR 1.279(a)). 
 
3.  Submitting Prior Notice 
 
3.1  How is prior notice submitted to FDA? 
 
You must submit prior notice to FDA electronically either through the U.S. CBPs 
ABI/ACE/ITDS or FDAs PNSI. 
 
  CBPs ABI/ACE/ITDS allows prior notice to be submitted to FDA through the 
existing ABI/ACE/ITDS interface (21 CFR 1.280(a)(1)). 
  FDA PNSI is available through FDAs website at  http://www.access.fda.gov (21 
CFR 1.280(a)(2)). 
 
Both the CBPs ABI/ACE/ITDS and the FDA PNSI are available 24 hours a day, 7 
days a week for information submission. 
 
You must be authorized to use CBPs ABI/ACE/ITDS interface (19 CFR 143.1), but 
anyone can use FDA PNSI. If you are an authorized user of the ABI/ACE/ITDS, you 
can provide prior notice as part of your CBP entry. 
 
3.2  Do I have to submit prior notice information to both FDA and CBP? 
 
[Response updated October 2023] No. Prior notice must be submitted to FDA. If you 
are an authorized user  of CBPs ABI/ACE/ITDS, you may submit prior notice to FDA 
through the ABI/ACE/ITDS interface or through FDA PNSI at www.access.fda.gov.  
If you are not an authorized user of CBPs ABI/ACE/ITDS, you may arrange for the 
prior notice submission by an authorized user or you may submit prior notice through 
FDA PNSI.  
 
3.3  I am an authorized user of CBPs ABI/ACE/ITDS. Can I use FDA PNSI to 
submit prior notice? 
 
  25   
Contains Nonbinding Recommendations 
 
 
Yes. You may submit prior notice through either system. 
 
3.4  I am shipping food by international mail. How do I provide prior notice? 
 
For articles of food imported or offered for import by international mail, prior notice is 
submitted through the FDA PNSI (see 21 CFR 1.280(a)(2)). Alternatively, if you are an 
authorized user of CBPs ABI/ACE/ITDS, you may provide prior notice through the 
ABI/ACE/ITDS interface instead of PNSI. Prior notice must be  submitted and 
confirmed by FDA before the food is sent (21 CFR 1.279). The PN Confirmation 
Number must appear on the Customs Declaration that accompanies the package (21 
CFR 1.279(e)). 
 
3.5  What happens if the CBP or FDA system for submitting prior notice is not 
working? 
 
If CBPs ABI/ACE/ITDS is not available or if your brokers or your self-filing  system 
is not working, you must submit prior notice through FDA PNSI at 
www.access.fda.gov (21 CFR  1.280(b)). 
 
If we determine that the FDA PNSI or the FDA automated import system OASIS is 
not working, a notification will be posted on the FDAs website (http://www.fda.gov). 
FDA will accept prior notice submissions in the format it deems appropriate during the 
system(s) outage (21 CFR  1.280(c)). 
 
3.6  What happens if my computer system is not functioning, or I dont have 
electricity for a period of time? 
 
If your computer is not functioning or there is no electricity to operate your computer, 
but FDA PNSI and CBPs ABI/ACE/ITDS are  functioning, you must make 
arrangements to use a functioning computer  to submit the required prior notice (21 
CFR 1.280(a). 
 
3.7  If I have problems submitting prior notice through FDA PNSI, how can I 
get help? 
 
Tutorials on use of the FDA PNSI are available on FDAs website at 
https://www.fda.gov/food/importing-food-products-united-states/filing-prior-notice-
imported-foods.  If you are already familiar with how to use the FDA PNSI and you 
are having problems with an online submission through the FDA PNSI, you can gain 
assistance through the following means: 
 
  Phone: For FDA PNSI account questions and/or problems: in the U.S., call toll-
free 1-800-216-7331; from elsewhere, call 240-247-8804. 
  Facsimile: You may send a fax to 301-436-2804. 
  Email: Requests for assistance also may be emailed to  furls@fda.gov.  
 
  26   
Contains Nonbinding Recommendations 
 
 
This technical assistance is available on business days from 9:00 a.m. until 6:00 p.m. 
U.S. Eastern Time. For assistance with ABI/ACE/ITDS transmission, contact your 
CBP client representative. 
 
For Prior Notice policy and procedures assistance: in the U.S., call 866-521-2297; 
from elsewhere, call 571-468-1488. 
 
3.8  Can I submit the prior notice through FDA PNSI or through 
ABI/ACE/ITDS in a language other than English? 
 
No. You must submit all prior notice information in the English language, except that 
an individuals name, the name of a company, and the name of a street may be 
submitted in a foreign language. All information, including these items, must be 
submitted using the Latin (Roman) alphabet (21 CFR 1.280(a)). 
 
If you are not comfortable with English, you may choose to use a transmitter to enter 
the information for you. 
 
3.9  Can anyone submit prior notice through CBPs ABI/ACE/ITDS? 
 
No. CBP allows submissions through ABI/ACE/ITDS only by authorized participants 
(19 CFR 143.1). Individuals can contract with a broker to transmit prior notice for 
them. In this case,  the submitter is the person responsible for providing the 
information, but the broker is the transmitter. 
 
Brokers are licensed private individuals or companies that are regulated by  CBP and 
who aid importers and exporters to move merchandise through CBP, including often 
filing entry of the merchandise with CBP. Brokers provide the proper paperwork and 
payments to CBP for clients and charge a fee for this service. Before brokers apply for 
a license, they must pass the Customs broker examination. See  
http://www.cbp.gov/trade/broker/overview. 
 
Filers can submit a written request to CBP port personnel for a filer code, which is 
subsequently assigned by CBP headquarters. See Chapter 9 of the Customs Broker 
Guidance for the Trade Community (pp. 56-59) (publication date: October 2022). 
 
Individuals who choose not to use a broker or who choose not to become recognized 
by CBP as a filer can submit their prior notice through FDA PNSI (21 CFR 1.280). 
 
 
 
 
 
3.10  Do I have to submit prior notice if I do not have to file a consumption 
entry with CBP? 
 
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Contains Nonbinding Recommendations 
 
 
Yes. The requirement to submit prior notice to FDA is different from the requirement 
to file a consumption entry with CBP. Some foods arriving in  the U.S. do not require a 
CBP consumption entry at the time of arrival, such as entries that move under bond 
(in-bonds) from the port of arrival to an inland port and shipments into a Foreign 
Trade Zone. See  http://www.cbp.gov.  However, any article of food imported or 
offered for import into the U.S. requires prior notice, unless the food is specifically 
excluded from the requirement to submit prior notice (21 CFR 1.277). 
 
3.11  Can I submit any CBP entry or admission for food without prior notice? 
 
No, not if the entry or admission contains food subject to the prior notice 
requirements. You cannot submit a CBP import entry or admission if you have not 
submitted prior notice to FDA for an article of food that requires prior notice, because 
the Harmonized Tariff Schedule (HTS) codes have  been flagged to indicate foods that 
require or may require prior notice. 
 
You must submit prior notice either through CBPs ABI/ACE/ITDS (along with the 
CBP entry information) or through FDA PNSI at http://www.access.fda.gov  (21 CFR 
1.280(a)). 
 
When you submit prior notice through the FDA PNSI, you will receive a PN 
Confirmation Number (21 CFR 1.279(d)). If you subsequently submit import entry or 
admission information through the CBP ABI/ACE/ITDS, you must enter the PN 
Confirmation Number for that submission as an Affirmation of Compliance when the 
CBP entry or admission is filed. See 68 FR 58974 at 58999; October 10, 2003.  The 
PN Confirmation Number will allow CBP to confirm that prior notice was submitted 
to FDA. 
 
3.12  I cannot or do not want to use CBPs ABI/ACE/ITDS. What other way can 
I submit prior notice? 
 
If you cannot or do not want to use the CBP ABI/ACE/ITDS system, you must submit 
prior notice through FDA PNSI at http://www.access.fda.gov (21 CFR 1.280(a)).  You 
will receive a confirmation number when you complete the prior notice through the 
FDA PNSI (21 CFR 1.279(d)). The PN Confirmation Number must accompany the 
food when the article arrives in the U.S. (21 CFR 1.279(g)). 
 
3.13  How do I submit prior notice for foods that are covered by Immediate 
Transportation (IT) or Transportation and Exportation (T&E)  entries? 
 
CBP has modified the ABI/ACE/ITDS interface to allow for submission of prior 
notice to FDA for IT and T&E entries. Prior notice for such entries may also be made 
through the FDA PNSI. 
 
3.14  I ship the same food weekly to the U.S. in a truck under bond to St. Louis. 
When and how do I need to file prior notice? Can I file one prior notice to 
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Contains Nonbinding Recommendations 
 
 
cover all of these repetitive shipments? 
 
The time frame for submitting prior notice is based on the mode of transportation and 
the port of arrival, i.e., the port where the food first arrives in the U.S. (Note that this 
port may be different from the port where the entry documentation is presented to 
CBP.)  Prior notice for food arriving by truck (by land by road) must be confirmed by 
FDA for review at least 2 hours before the truck arrives at the port of arrival where it 
is crossing the border into the U.S. (21 CFR 1.279(a)). 
 
If you are entering under bond and want to file your CBP entry in St. Louis, you can 
file your prior notice either through the FDA PNSI or through CBPs ABI/ACE/ITDS 
interface (21 CFR  1.280(a)). If you submit the prior notice through the FDA PNSI, 
you will receive a PN Confirmation Number (21 CFR 1.279(d)). 
 
This PN Confirmation Number must accompany the food when it arrives in the U.S. 
and must be made available to CBP upon arrival (21 CFR 1.279(g)). 
 
You may not file one prior notice to cover all the repetitive shipments. Each article of 
food requires prior notice (21 CFR 1.281). The Prior Notice rule states that, except for 
food imported by international mail, you may not submit prior notice more than 15 
calendar days before the anticipated date of arrival of the food at the anticipated port 
of arrival if submitted by the FDA PNSI system and not more than 30 calendar days 
before the anticipated date of arrival of the food at the anticipated port of arrival if 
submitted by the CBP ABI/ACE/ITDS system (21 CFR 1.279(b)).  Therefore, you 
would need to submit a prior notice for each article of food contained in each of the 
weekly shipments. 
 
3.15  Is there a filing fee for prior notice? 
 
No. FDA does not charge a fee for filing prior notice or for using the FDA PNSI. 
However, if you choose to use a broker to file the prior notice through the CBP 
ABI/ACE/ITDS interface, the broker may charge a fee for providing that service. The 
collection of duty by CBP is not affected by FDAs Prior Notice rule. 
 
4.  General Information Requirements 
 
4.1  What information must be included in the prior notice? 
 
The information required for prior notice varies, based on the type of entry, mode of 
transportation for the entry, and whether the food is in its natural state. You should 
refer to 21 CFR 1.281 for details on the required information. The preamble to the 
2008 final rule includes a chart that summarizes the information requirements (73 FR 
66294 at 66361). 
 
Tutorials on the FDA (PNSI are  available on FDAs website to help guide you through 
the process for providing the required information when you submit prior notice 
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Contains Nonbinding Recommendations 
 
 
through the FDA PNSI. See 
https://www.fda.gov/food/importing-food-products-united-states/filing-prior-notice-
imported-foods.  
 
4.2  What time do I enter for anticipated time of arrival? 
 
For prior notice, anticipated time of arrival relates to the local time of the  anticipated 
port of arrival. See 21 CFR 1.281(a)(11). For vessels, this would be when the vessel is 
expected to dock in the port where it first arrives in the U.S. For planes, this would be 
when the plane is scheduled to land. For land vehicles, such as trucks, buses, and 
trains, this would be when the vehicle is expected to cross at the border. See 73 FR 
66294 at 66356; November 7, 2008. 
 
5.  Registration Numbers 
 
5.1  What food facility registration numbers must I provide as part of my 
prior notice submission? 
 
If the food is no longer in its natural state, you must provide the name of the 
manufacturer, and either the registration number, city, and country of the 
manufacturer, or both the full address of the manufacturer and the reason the 
registration number is not provided (21 CFR 1.281(a)(6), (b)(5)). 
 
6.  Grower Identity 
 
6.1  If a food from a known grower is commingled with food from unknown 
growers, may the submitter still identify only the consolidator instead of 
the grower? 
 
No. Section 801(m)(1) of the FD&C Act requires grower information to be submitted 
if it is known. The submitter may opt to provide the name and address of the firm that 
has consolidated the articles of food from different growers or different growing 
locations only when the submitter  does not know the identity of any of the growers of 
the consolidated food. If the submitter knows the identity of any grower of a food that 
has been consolidated, a separate prior notice must be submitted for each article of 
food represented by a known grower. Therefore, in the situation in question, if the 
submitter knows the identity of a grower and the article of food associated with that 
grower, then one prior notice would be submitted for the article of food associated 
with the known grower, and a second prior  notice would be submitted for the 
remaining product. For the second prior notice, you could opt to identify the 
consolidator (21 U.S.C. 381; 21 CFR 1.281(a)(7), (b)(6)). See also 73 FR 66294 at 
66355; November 7, 2008. 
 
6.2  Does a grower need to be identified if an article of food can no longer be 
associated with a particular grower? May growing location be used 
instead? 
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Contains Nonbinding Recommendations 
 
 
 
If you do not know the identity of the grower associated with an article of food, you 
may opt to identify the consolidator or you may leave the data element empty. Section 
801(m)(1) of the FD&C Act does not allow for growing location to be submitted in 
lieu of known grower information (21 U.S.C. 381(m)(1); 21 CFR 1.281(a)(7), (b)(6)). 
 
7.  Product Identity 
 
7.1  If my shipment consists of just one type of food in the same size container 
but under different brand names, do I have to submit a separate prior 
notice for food labeled with each brand name? 
 
FDA regulations do not require submission of the trade or brand name of the article; 
therefore, the fact that food is labeled under different brand names does not mean that 
each different label is a separate article of food for the purpose of submitting prior 
notice. However, a separate prior notice must be submitted for each article of food that 
has a different  complete FDA product code, different package size, or different 
manufacturer or grower (21 CFR 1.281(a)). See also 73 FR 66294 at 66339 and 
66345; November 7, 2008. 
 
7.2  How many prior notice submissions are required and what is the 
estimated quantity of food shipped in each of the following four scenarios: 
 
I sell fish to grocery stores in the U.S. The grocery stores will order the fish in bulk. 
The fish is packed and shipped to the U.S. in one of the following manners: 
a.  Bulk tote with 1,000 pounds of whole salmon 
b.  25 50-lb cardboard boxes containing 2-3 lb and 3-4 lb whole salmon (not 
individually wrapped); fish normally will be sold individually in a grocery 
market in a display case of ice 
c.  15 50-lb cardboard boxes containing salmon fillets of various weights (not 
individually wrapped) 
d.  Salmon fillets sold on styro-trays in a poly bag of various weights (typically 
2-3 salmon fillets in a package); larger  salmon may be cut and put in styro 
trays as well 
 
a.  You would be required to submit 1 prior notice. The estimated quantity would 
be 1,000 lbs of whole salmon. 
b.  You would be required to submit 1 prior notice. The estimated quantity would 
be 25 boxes of 50 lbs whole salmon. 
c.  You would be required to submit 1 prior notice. The estimated quantity would 
be 15 boxes of 50 lbs salmon fillets. 
d.  If the trays are unlabeled and sold by bulk weight, then 1 prior notice 
submission would be required, and the estimated quantity would be the bulk 
weight of the shipment. If the trays are labeled for retail sale, 1 prior notice 
submission would be required, and the estimated quantity would be the number 
of trays and the average tray weight. 
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Contains Nonbinding Recommendations 
 
 
 
8.  Ultimate Consignee 
 
8.1  What name and address should be submitted as the ultimate consignee? 
 
FDA considers the location where the imported food is to be delivered as the ultimate 
consignee for the purposes of prior notice. 
 
The preamble to the 2008 final rule states that FDA intends to interpret the ultimate 
consignee consistent with CBPs use of that term in regard to the entry of 
merchandise, which is contained in Customs Directive No. 3550079A, June 27, 
2001, paragraph 6.3.  This paragraph states: 
 
The Ultimate Consignee at the time of entry or release is defined as the party in the 
United States, to whom the overseas shipper sold the imported merchandise. If at the 
time of entry or release the imported merchandise has not been sold, then the Ultimate 
Consignee at the time of entry or release is defined as the party in the U.S. to whom 
the overseas shipper consigned the imported merchandise. If the merchandise has not 
been sold or consigned to a United States party at the time of entry or release, then the 
Ultimate Consignee at the time of entry or release is defined as the proprietor of the 
U.S. premises to which the merchandise is to be delivered. 
 
The preamble only quoted the last sentence of paragraph 6.3, which is about the 
circumstances where the goods have not been sold or consigned  to a U.S. party at the 
time of entry or release. Under these circumstances, the ultimate consignee is defined 
as the Ship to / Deliver to address. 
 
The only comment discussed in the preamble to the 2008 final rule that asked about a 
particular factual scenario asked about the aforementioned  scenario. The preamble 
explained that: 
 
In a case where a customer or consignee has not been identified, as described in the 
previous comment, the public storage warehouse where the merchandise will be 
delivered and stored should be identified as the ultimate consignee in the prior notice 
submission (73 FR 66294 at 66357; November 7, 2008). 
 
FDA believes that the facility where the goods are to be delivered should be 
considered the ultimate consignee in all circumstances. Under the Prior Notice rule, 
food that is imported or offered for import without adequate prior notice is subject to 
refusal of admission. If refused, among other things, the food may not be delivered to 
the importer, owner, or ultimate consignee (21 CFR 1.283(a)(2)(ii)). See also 68 FR 
5428 at 5437-38; February 3, 2003.  Having the Ship to / Deliver to address enables 
FDA to prevent delivery to these parties, such as when the food is delivered to a third 
partys storage facility on behalf of, and accessible by, the importer or owner. For 
example, if the food is going to a warehouse for storage on behalf of Owner A, FDA 
needs the name and address of that warehouse to ensure that any food that has been 
  32   
Contains Nonbinding Recommendations 
 
 
refused admission under prior notice is not delivered there. Moreover, having the 
address where the food is actually delivered is important for product tracking, in case 
the food is or is suspected to be contaminated.  See 68 FR 5428 at 5429; February 3, 
2003. Knowing the name and address of the location where the food is to be delivered 
is also consistent with the purpose of prior notice  enabling FDA to target foods that 
may pose a significant risk to public health, based on the information submitted. The 
Agency targets food based on all parties in the supply chain, and there have been 
instances where FDA has had concerns with food based on where it was actually 
delivered. 
 
FDA regulations at 21 CFR 1.281 require the name and full address of the importer, 
owner, and ultimate consignee. If the food is delivered to the owner, then the name 
and full address of the owner is given for the ultimate consignee. The name and full 
address of the owner only needs  to be given once and does not need to be submitted 
separately when the owner is the same as the importer or ultimate consignee (21 CFR 
1.281(a)(13), (c)(13)). If the food is owned by a foreign shipping firm and is being 
delivered to a public storage warehouse in the U.S. pending its sale, FDA considers the 
public storage warehouse to be the ultimate consignee, and its name and address 
should be submitted in the prior notice. See 73 FR 66294 at 66304 and 66357; 
November 7, 2008.  The name and address of the foreign shipping firm should be 
submitted as the  owner, if it is different from the importer. 
 
9.  Refusal Country 
 
9.1  21 CFR 1.281 (a)(18), (b)(12), and (c)(19) requires the name of any country 
that has refused entry of the article of food to be reported through prior 
notice. Specifically, what types of entry refusals should  be reported 
through prior notice? 
 
You should report refusals of entry/admission (also known as refusals) of food, 
including food for animals, based on food safety reasons given by the government of 
the country that refused entry/admission. See 78 FR 32359 at 32360; May 30, 2013. 
 
  Food safety refusals include, but are not limited to, refusals for intentional or 
unintentional contamination, including the presence of  biological, microbiological, 
chemical, or radiological contaminants. 
 
  Refusals for commercial or other non-food safety reasons (e.g.,  product quotas, 
taxes, import permitting, and documentation issues) should not be reported. 
 
  Any country refers to the country or countries, including the U.S.,  where an 
agency or representative of the government of the country has refused the article of 
food. See 78 FR 32359 at 32360; May 30, 2013. 
 
9.2  If an article of food is refused entry/admission upon arrival at a U.S.  port, 
must the refusal be reported in subsequent prior notice(s) if the article is then 
  33   
Contains Nonbinding Recommendations 
 
 
offered for import at another U.S. port? 
 
Yes. If the refusal was for a food safety reason, in a subsequent prior notice the refusal 
must be reported by indicating U.S. as the country of refusal (21 CFR 1.281(c)). See 
78 FR 32359 at 32360; May 30, 2013. 
 
9.3  Does article refer to only the food in the specific shipment, or does it 
also refer to food from the same batch or lot numbers that was shipped to 
other countries? 
 
For the purpose of reporting the information required under 21 CFR 1.281(a)(18), 
(b)(12), and (c)(19), article refers to the specific food item for  which prior notice is 
being submitted in a specific shipment. 
 
Here, the term article does not refer to food from the same batch or lot numbers that 
is not being imported or offered for import into the U.S. and for which prior notice 
will not be submitted at the time of the specific shipment, or food of a similar type that 
was previously refused entry by a country. See 78 FR 32359 at 32360; May 30, 2013. 
 
10.  Changes to Prior Notice Submissions 
 
10.1  Which changes require me to resubmit prior notice and which changes do 
not? 
 
Changes in the estimated quantity, anticipated arrival information, or  planned 
shipment information do not require resubmission of prior notice after FDA has 
confirmed your prior notice submission for review (21 CFR 1.282(a)(1)(i) through 
(iii)). For all other changes (e.g., if the identity of the manufacturer changes), you 
should cancel the prior notice, and you must resubmit prior notice if you still intend to 
import or offer the food for import into the U.S. (21 CFR 1.282). 
 
10.2  Do I have to resubmit prior notice if the anticipated time of arrival 
changes? 
 
No. Prior notice does not need to be resubmitted if the anticipated arrival information 
changes (21 CFR 1.282(a)(1)(ii)). However, although a new prior notice submission is 
not required, FDA staff may need additional time to respond to the changes in arrival 
information. 
 
10.3  What should I do if other information changes after I submit prior notice? 
 
As per FDA regulations, if required information (except estimated quantity, 
anticipated arrival, and planned shipment information or, for international mail, 
anticipated date of mailing) changes after FDA has  confirmed prior notice for review, 
the prior notice must be resubmitted (21 CFR 1.282(a)). 
 
  34   
Contains Nonbinding Recommendations 
 
 
If the prior notice was submitted as part of a multi-line ABI/ACE/ITDS entry, and 
information about one or more of the products changes, you should cancel the prior 
notice via the ABI/ACE/ITDS by requesting that CBP cancel the entry (21 CFR 
1.282(c)). Prior notice for the new product can be submitted as part of a new entry. If 
you submitted the prior notice via the FDA PNSI, you should cancel the prior notice 
via the FDA PNSI (21 CFR 1.282(b)). See also 73 FR 66294 at 66362-66363; 
November 7, 2008. 
 
11.  Changes to Shipments 
 
11.1  May I add another article of food to an existing prior notice after the prior 
notice has been submitted to FDA? 
 
No. Each article of food requires a separate prior notice (see 21 CFR 1.281(a)(5) and 
1.281(b)(4)) and receives a unique confirmation number (21 CFR 1.279(d)). However, 
FDA is allowing prior notices to be grouped in an ABI/ACE/ITDS entry, or in a prior 
notice envelope for the FDA PNSI submissions and In-Bonds submitted  through 
ABI/ACE/ITDS, in order to reduce data entry for transmitters and to simplify CBP 
review at the border.  For submissions through the FDA PNSI, no articles of food can 
be added to a prior notice envelope after FDA has provided the PN Confirmation 
Number(s). For submissions through ABI/ACE/ITDS, no additional lines may be 
added after the entry is accepted by ACE. 
 
11.2  What can I do if I want to add another article of food to a shipment after 
prior notice was submitted to the FDA? 
 
New articles of food cannot be added to an entry, or prior notice envelope, after it has 
been submitted to FDA. See 21 CFR 1.282.  If a new article of food is being added to 
a shipment for which prior notice(s) has already been submitted and confirmed, a 
separate prior notice must be filed for that article under a new entry/envelope. See 21 
CFR 1.281(a) and (b). 
 
The submission time for the new prior notice will be different from that of the rest of 
the shipment, and this may have an effect on the ability of the shipment to enter the 
U.S.  See 21 CFR 1.279.  For example, if you add another food to a truck at 9:00 am, 
that food is not covered by timely prior notice until 11:00 am; the rest of the food on 
that same truck may be covered by prior notices submitted at 8:00 am and deemed 
timely at 10:00 am. It is recommended that the time for arrival be anticipated on the 
last article of food submitted and confirmed by FDA for review. 
 
 
 
 
11.3  What can I do if I want to remove an article of food from the information 
provided for a shipment? 
 
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Contains Nonbinding Recommendations 
 
 
If the prior notice was submitted through the ABI/ACE/ITDS, you should cancel the 
prior notice by requesting that CBP cancel the existing entry (21 CFR 1.282(c)). If you 
submitted the prior notice via FDA PNSI, you should cancel the prior notice via the 
FDA PNSI (21 CFR 1.282(b)). 
 
12.  FDA PNSI and Automated Broker Interface of the Automated 
Commercial Environment (ABI/ACE) Features 
 
12.1  If I need to revise some information on a prior notice, will some of the fields 
be filled in by the computer automatically or will I need to start  from the 
beginning? 
 
The answer depends on how the prior notice submission is being made. If submitting 
through the CBPs ABI/ACE/ITDS, the ability to pre-fill or otherwise support 
submission will depend on the functionality of the software used by the filer. The 
ABI/ACE/ITDS interface is concerned with the validity of the information in the 
submission, not with how it was generated. 
 
If submitting through the FDA PNSI, the answer varies based on the status of the 
submission. The FDA PNSI will allow a transmitter to pre-enter information and save 
the draft until the time of  actual submission. Before the draft is submitted, changes can 
be made easily to the draft because information previously entered has been saved and 
will be pre-filled. 
 
After the prior notice has been submitted to FDA, no changes can be made unless 
requested by FDA to correct an error found during the review  process before a PN 
Confirmation Number issues to the transmitter (21 CFR 1.282). 
 
12.2  My food is being shipped in several different containers. Does FDA PNSI 
accept multiple container  numbers? 
 
Yes. In the FDA PNSI, you may enter one or more container numbers, separated by 
commas, each with a minimum of one character and a maximum of 25 characters that 
are either a letter or a number, up to a total length of no more 1000 characters. 
 
13.  Confirmation 
 
13.1  Will I receive confirmation that FDA has received the prior notice I 
submitted? 
 
Yes. FDA will notify the transmitter that the prior notice has been confirmed for 
review with a reply message that contains a PN Confirmation Number. For prior notice 
submissions through the CBPs ABI/ACE/ITDS, the PN Confirmation Number 
together with the PN received message will be made available to the transmitter 
(broker or  filer) through the ABI/ACE/ITDS. For prior notice submissions through 
FDA PNSI, a PN Confirmation Number will be provided to the transmitter through 
  36   
Contains Nonbinding Recommendations 
 
 
the FDA PNSI as soon as FDA confirms your prior notice for review. 
 
13.2  Is a copy of the prior notice required to accompany the food? 
 
To ensure that entry proceeds as smoothly as possible, the carrier or individual should 
consider having a copy of the reply message that contains a PN Confirmation Number 
in his/her possession upon arrival. 
 
For food carried by or otherwise accompanying an individual that is not for personal 
use, the individual must provide a copy of the PN confirmation number to FDA or 
CBP upon arrival (21 CFR 1.279(f)). 
 
Food covered by prior notice submitted through the FDA PNSI must be accompanied 
by a copy of the PN Confirmation Number (21 CFR 1.279(g)). 
 
For food arriving by international mail, the PN Confirmation Number must appear on 
the Customs Declaration that  accompanies the package (21 CFR 1.279(e)). 
 
13.3  Does receipt of a Prior Notice (PN) Confirmation Number mean that  the 
food will not be examined or sampled? Does meeting all the requirements 
of prior notice mean that the article of food will not be held or examined 
further? 
 
No. Receipt of a PN Confirmation Number is evidence only that a prior notice has 
been received for FDA review. Based on review of the prior notice, FDA may 
determine that an article of food should not be allowed  to proceed into the U.S. 
without further inspection and sampling at the border. The food may be refused under 
the Prior Notice rule and section 801(m) of the FD&C Act and held if the prior notice 
is inaccurate or if it is untimely and FDA has not had sufficient time to receive, 
review, and respond to the prior notice information. 
 
Furthermore, the food must meet the requirements of all other applicable 
U.S. regulations. If FDA decides not to take action on an article of food under 21 CFR 
1.283 or 1.285(a), this decision has no bearing on whether the article of food is 
admissible or will be granted admission under other provisions of the FD&C Act or 
other U.S. laws.  Thus, for imported food or food offered for import, FDA will 
continue its normal investigative and enforcement activities, and the Agency will also 
continue its process for determining whether the food is subject to refusal under 
section 801(a) of the FD&C Act. 
 
 
 
 
13.4  If receipt of the Prior Notice (PN) Confirmation Number does not mean 
the FDA has determined that timely prior notice was submitted or that the 
information submitted is accurate, what is the value of the PN 
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Contains Nonbinding Recommendations 
 
 
Confirmation Number? 
 
The PN Confirmation Number is FDAs notice to you that your prior notice was 
submitted and received for review by FDA. It is the signal to you that the time frame 
for prior notice for the food covered by that prior notice submission has started. In 
addition, the PN Confirmation Number provides a mechanism for prior notice data, 
submitted to FDA, to be matched with an entry submitted to CBP. The timeliness of 
prior notice cannot be assessed until the food actually arrives in the U.S. and, often, 
the accuracy of the prior notice cannot be fully determined until the food is examined 
upon arrival. 
 
13.5  Do I need to submit samples to accompany my prior notice submission or 
to accompany the shipment? 
 
No. There is no need or opportunity to send samples to FDA with the prior notice 
submission (21 CFR 1.280(a)). FDA will use the information provided with the prior 
notice to determine whether to inspect or sample  the article of food when it arrives in 
the U.S. 
 
E.  Consequences 
 
1.  Inadequate Prior Notice 
 
1.1       What does FDA consider to be inadequate prior notice? 
 
Inadequate prior notice is when: 
 
a.  There is no prior notice submitted for an article of food imported or offered for 
import into the U.S.; 
b.  The information submitted in the prior notice is inaccurate; and/or 
c.  The prior notice is not submitted in accordance with the required timeframes. 
 
FDAs enforcement policies on inadequate prior notice are stated in the Compliance 
Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-
110310-prior-notice-imported-food-under-public-health-security-and-bioterrorism-
preparedness). 
 
1.2  What are some examples of inadequate prior notice? 
 
The following examples of inadequate prior notice are for five articles of food (foods 
A, B, C, D, & E) arriving at the border by truck: 
 
a.  Prior notice was submitted for only 4 of the 5 articles of food (foods A, B, C, & 
D). Inadequate prior notice, e.g., no prior notice, was provided for food E. 
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Contains Nonbinding Recommendations 
 
 
b.  Prior notice for food A was submitted and confirmed for FDA review with PN 
Confirmation Number 999. Food B arrives associated with PN Confirmation 
Number 999. Inadequate prior notice, i.e. inaccurate prior notice, was provided for 
food B. 
c.  Prior notice for food A was submitted and confirmed for FDA review at 9:00 am 
on November 2, 2013. Food A arrives at the port of arrival at 9:30 am on 
November 2, 2013, but CBP has not received an examination decision response 
from FDA. Inadequate prior notice, i.e., untimely prior notice, was provided for 
food A. 
d.  The prior notice for food C includes a registration number for the manufacturer, 
but this registration number does not match the actual registration number of the 
manufacturer of the food. Inadequate prior notice, i.e., inaccurate prior notice, was 
provided for food C. 
e.  The same manufacturer is given in the prior notice for foods A-E; however, each 
food was manufactured by a different manufacturer and the registration number 
does not match the actual registration numbers of the manufacturers of foods B-E.  
Inadequate prior notice, i.e.,  inaccurate prior notice, was provided for foods B-E. 
 
FDAs enforcement policies on inadequate prior notice are stated in the Compliance 
Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002  
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-
110310-prior-notice-imported-food-under-public-health-security-and-bioterrorism-
preparedness).   
 
1.3  What happens to food that is imported or offered for import without 
adequate prior notice? 
 
Except for food arriving by international mail or carried by, or food carried by or 
otherwise  accompanying an individual, articles of food arriving with no prior notice, 
inaccurate prior notice, or untimely prior notice may be refused admission under 
section 801(m)(1) of the FD&C Act and, if refused, will be handled in one of the 
following ways (21 CFR 1.283(a)(1)(i)-(iii)): 
 
a.  Immediately exported, with CBP concurrence, from the port of arrival; or 
b.  Held within the port of entry, unless directed by CBP or FDA. 
 
Refused food is considered general order merchandise under section 490(a) of the 
Tariff Act (19 U.S.C. 1490(a)) and may move only under appropriate custodial bond 
unless immediately exported under CBP supervision (21 CFR 1.283(a)(2)). If the 
refused article is  moved, the submitter must notify FDA of the hold location before 
the food is moved there. The refused food may not be delivered to the importer, 
owner, or ultimate consignee (21 CFR 1.283(a)(2)(ii)). 
 
For food that is carried by or accompanies an individual arriving in the 
U.S. and the food is not for personal use, if adequate prior notice is not submitted or if 
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Contains Nonbinding Recommendations 
 
 
the Prior Notice (PN) confirmation number cannot be  provided to FDA or CBP, the 
food is subject to refusal under section 801(m)(1) of the FD&C Act. If before leaving 
the port, the individual does not arrange to have the food held at the port or exported, 
FDA or CBP may destroy the article of food (21 CFR 1.283(b)). 
 
For food arriving by international mail, if prior notice is inadequate or if  the PN 
Confirmation Number is not affixed as required, the article will be held by CBP for 72 
hours for FDA inspection and disposition (21 CFR 1.283(e)). If FDA refuses the 
article of food under 801(m)(1) of the FD&C Act and there is a return address, the 
parcel may be returned to sender marked No Prior Notice - FDA Refused. If there is 
no return address or FDA determines that the article of food in the parcel appears to 
present a hazard, FDA may dispose of or destroy the parcel at its expense. If FDA 
does not respond within 72 hours of the CBP hold, CBP may return the parcel back to 
the sender or, if there is no return address, destroy the parcel, at FDA expense (21 
CFR 1.283(e)). 
 
FDAs enforcement policies on inadequate prior notice are stated in the Compliance 
Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-
110310-prior-notice-imported-food-under-public-health-security-and-bioterrorism-
preparedness).   
 
1.4  Will my food be held if it arrives earlier than the anticipated time of 
arrival I submitted? 
 
If arrival occurs before the anticipated arrival time, the food could be refused and held 
until the prior notice timeframe has elapsed (see 21 CFR 1.279) or until processing is 
complete, whichever comes first. However, if the prior notice has been fully processed 
by FDA, the food will not be refused because the anticipated arrival time has not yet 
come (21 CFR 1.283(a) (1) (iii)). However, if FDA plans to examine the food, it may 
be held to allow time for FDA staff to arrive. 
 
1.5  What does it mean if, after I receive a Prior Notice (PN) Confirmation 
Number, FDA later refuses the same article of food? 
 
The PN Confirmation Number only confirms that the submission is complete and 
facially valid. If FDAs review process determines that the prior notice is inaccurate 
after receipt of the prior notice is confirmed by  issuance of the PN Confirmation 
Number, the article of food is still subject to refusal under 801(m) of the FD&C Act 
and 21 CFR 1.283(a)(1). 
 
 
1.6  Who will be notified if FDA determines that a food will be held or refused 
under 801(l) or 801(m)(1) of the FD&C Act (in accordance with 21 CFR 
1.285 or 1.283) when the food arrives at the border? 
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Contains Nonbinding Recommendations 
 
 
 
[Response Updated October 2023] FDA will communicate its decision to CBP. 
Notification of prior notice refusals and holds will be provided to the relevant party 
who submitted the prior notice (i.e., submitter or transmitter) upon arrival of the article. 
 
1.7   [Question added October 2023] When must I submit a request asking FDA 
to review its decision of a prior notice refusal under 801(m)(1) of the 
FD&C Act or a prior notice hold under section 801(l) of the FD&C Act? 
 
The request must be submitted within 5 calendar days of the refusal or hold. 21 CFR 
1.283(d)(4); 1.285(j)(4). FDA considers the 5-calendar day clock to start at the time 
FDA provides notice of the refusal or hold to the relevant party who submitted the 
prior notice (i.e., submitter or transmitter) upon arrival of the article (see E.1.6). 
Calendar day means every day shown on the calendar (21 CFR 1.276(b)(1)). We 
consider the clock to be 5 calendar days, not 120 hours. Therefore, the time that we 
provide notification of a refusal or hold, or you submit the request for review, does not 
matter so long as it is within the 5-calendar day window. For example, if we provide 
the notice at 10:00 am on January 1, you would submit the request no later than 11:59 
pm on January 6. 
 
2.  Exercise of Enforcement Discretion 
 
2.1  What enforcement policy is described in FDAs Compliance Policy Guide 
Sec. 110.310 Prior Notice of Imported Food Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002? 
 
The Compliance Policy Guide Sec. 110.310 provides guidance to FDA and CBP staff. 
It describes and provides guidance on FDAs  and CBPs strategy for enforcing and 
otherwise achieving compliance with the Prior Notice rule. The guidance does not 
establish legally enforceable responsibilities, nor does it create or confer any rights for 
or on  any person and does not operate to bind FDA, CBP, or the public. 
 
III.  Electronic Access 
 
Persons with access to the Internet may obtain this document Prior Notice Questions 
and Answers at https://www.fda.gov/food/importing-food-products-united-
states/prior-notice-imported-foods. 
 
 
 
 
 
 
IV.  Where to Get Additional Information 
A.  Prior Notice Help Desk 
  41   
Contains Nonbinding Recommendations 
 
 
 
Phone: 
 
  For FDA PNSI account questions and/or problems: in the U.S., call toll-free 1-
800-216-7331; from elsewhere, call 240-247-8804. 
  For assistance using FDA PNSI: in the U.S., call 1-866-521-2297; from elsewhere, 
call 571-468-1488. 
 
Fax:  301-436-2804 
 
E-mail:  furls@fda.gov  
 
B.  Useful Websites and Resources 
 
FDA Home Page  http://www.fda.gov 
FDA Website on the Bioterrorism Act  https://www.fda.gov/food/guidance-regulation-
food-and-dietary-supplements/registration-food-
facilities-and-other-submissions  
FDAs Prior Notice System Interface (PNSI)  http://www.access.fda.gov 
FDAs Prior Notice Compliance Policy  https://www.fda.gov/regulatory-
Guide, Prior Notice of Imported Food Under  information/search-fda-guidance-
the Public Health Security and Bioterrorism  documents/cpg-sec-110310-prior-notice-
Preparedness and Response Act of 2002  imported-food-under-public-health-security-
and-bioterrorism-preparedness  
 
Prior Notice Rule  https://www.fda.gov/food/importing-food-
products-united-states/historical-information-
about-prior-notice  
Website on the Bioterrorism Act, including  https://www.fda.gov/food/importing-food-
Prior Notice  products-united-states/prior-notice-imported-
foods-overview-and-background  
Main Prior Notice Website  https://www.fda.gov/food/importing-food-
products-united-states/prior-notice-imported-
foods  
Form for Submitting Questions on Prior  http://www.accessdata.fda.gov/scripts/email/cfs  
Notice  an/bioterrorismact/helpf2.cfm 
  42   
Contains Nonbinding Recommendations 
 
 
CBP Home Page  http://www.cbp.gov 
CBP Broker Management Handbook  https://instruction2.mtsac.edu/rjagodka/Importi
(publication date: January 2002)  ng_Information/Customs_House_Broker_Hand
book.pdf  
CBP Website on Becoming a Broker  http://www.cbp.gov/trade/broker/overview 
Customs Broker Guidance for the Trade  https://www.fda.gov/regulatory-
Community (publication date: October 2022)  information/search-fda-guidance-
documents/cpg-sec-110310-prior-notice-
imported-food-under-public-health-security-
  
Website that Contains this Guidance  https://www.fda.gov/food/importing-food-
Document  products-united-states/prior-notice-imported-
foods  
 
 
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