Selected Excerpts from the Prior Notice Interim Final Rule, Guidance Documents, and Fact Sheets
See Final Rule: Information Required in Prior Notice of Imported Food published May 30, 2013 for additional information.
Overview
Home-Made Foods
Gifts of Food
CPG and Enforcement Discretion
Commercial Shipments
Non-Commercial Shipments
Samples
Additional Selected Excerpts
Abbreviated Information on Requirements
Food imported or offered import into the United States for human or animals is subject to prior notice requirements regardless of the mode of transportation. However, the Prior Notice Interim Final Rule treats imported food arriving by international mail somewhat differently than other modes of transportation. The Interim Final Rule defines International mail to mean foreign national mail services. International mail does not include express carriers, express consignment operators, or other private delivery services. See Interim Final Rule §1.276(b)(7).
The timeframe requirements for food arriving by international mail are different, too. If food is arriving by international mail, the prior notice may be submitted more than 5 calendar days before the anticipated date of arrival; however, the prior notice must be submitted before the food is sent to the U.S. In addition, the Prior Notice Confirmation Number must accompany the article of food and must appear on the Customs Declaration that accompanies the package.
When the prior notice submission has been validated, the transmitter will receive a message showing that the prior notice has been received by the Food and Drug Administration (FDA) for review and accepted as facially complete. This message will include a unique Prior Notice Confirmation Number as well as the date and time of the submission and confirmation. The message will confirm that the prior notice is facially complete and has been received by the FDA for review. The Prior Notice Confirmation Number that appears in this message must appear on the Customs Declaration that accompanies the package. The transmitter can print a hard copy of the prior notice submission which also can be used as confirmation for prior notice submission, if necessary. See Interim Final Rule §1.279, and Interim Final Rule 68 FR 58975 Pages 58999-59000.
HOME-MADE FOODS arriving by International Mail
Home-made food is not subject to prior notice requirements if 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 United States; see Interim Final Rule § 1.277.
GIFTS of FOOD no longer in its natural state arriving by International Mail
If the food is sent by an individual as a personal gift (i.e., for non-business reasons) to an individual in the United States, the name and address of the firm that appears on the label under 21 CFR 101.5 may be submitted instead of the name, address, and registration number of the manufacturer. See Interim Final Rule § 1.281.
Compliance Policy Guide and Enforcement Discretion
In the preamble to the interim final rule, FDA stated that it planned to provide guidance to its staff regarding the agency's enforcement policies. Accordingly, a Compliance Policy Guide (CPG) was issued which establishes policies regarding the enforcement of the prior notice requirements, including the requirement to provide a required registration number. This guidance document represents the FDA's and Customs and Border Protection's (CBP) current thinking regarding enforcement of prior notice requirements. It does not create or confer any rights for or on any person and does not operate to bind FDA, CBP, or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
The CPG discusses several situations which impact food shipments arriving by international mail for which we can exercise enforcement discretion:
COMMERCIAL SHIPMENTS arriving by International Mail
Commercial shipments of food arriving in the United States by international mail are subject to prior notice requirements. Since December 2003, the agencies have been exercising enforcement discretion for a period of time before full enforcement. For minor or inadvertent prior notice violations, the action FDA and CBP staff typically should consider taking is education and communication. However, if the violation reflects a history of repeated conduct of a similar nature by a person who had been notified of such violations, then the action FDA and CBP staff typically should consider taking is assessment of CBP Civil Monetary Penalties. See Compliance Policy Guide, Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
NON-COMMERCIAL SHIPMENTS arriving by International Mail
Non-commercial shipments of food arriving in the United States by international mail are generally subject to prior notice requirements. However, since June 2004, the agencies have been exercising enforcement discretion. FDA and CBP should typically consider not taking any regulatory action when an article of food is imported or offered for import for non-commercial purposes with a non-commercial shipper. Generally, a non-commercial purpose is when the food is purchased or otherwise acquired by an individual for non-business purposes and the shipper is an individual (e.g., the individual delivers the food to a post office or common carrier for delivery to self, family member, or friend for non-business purposes, i.e., not for sale, resale, barter, business use, or commercial use.) Examples of foods imported or offered for import that may be covered by this non-commercial category are:
- food in household goods, including military, civilian, governmental agency, and diplomatic transfers;
- food purchased by a traveler and mailed or shipped to the traveler's U.S. address by the traveler;
- gifts purchased at a commercial establishment and shipped by the purchaser, not the commercial establishment.
The shipper and the carrier are different entities, and the carrier is likely to be a commercial entity even when the shipper is an individual. Thus, the food for non-commercial purposes may arrive by international mail or any other mode of transportation, but must be shipped by one individual to another individual (self, family member, or friend) to be considered for non-commercial purposes. For example, when an individual purchases food at Store A and sends that food to an individual by mail, the individual is the shipper and the carrier is the mail service. However, if Store A ships the food, Store A is the shipper. Since Store A is not an individual, this last example is not covered by the criteria because the food was not imported or offered for import with a non-commercial shipper. (While a "person" sometimes can be an individual, partnership, corporation, or association, see 21 U.S.C. 321(e), by "individual" we mean a human being, not a partnership, corporation, or association.) see Compliance Policy Guide, Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
SAMPLES arriving by International Mail
Certain samples of food are generally subject to prior notice requirements.
Food samples not considered articles of food: If the samples are items that are in such early stages of research and development that they cannot yet be considered food for the purposes of prior notice, then they would not be subject to prior notice requirements (Q&A, Section C., Question 1.3). In addition, if the sample is 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 (Q&A, Section C., Question 17.2). See Interim Final Rule 68 FR 58975 Page 58993. See Guidance for Industry, Prior Notice of Imported Food Questions and Answers (Edition 2).
Food samples for quality assurance, research or analysis: If food is imported or offered for import for quality assurance, research or analysis purposes only, not for human or animal consumption and not for resale and if the prior notice submission does not include the registration number assigned to the manufacturing facility that is associated with the article of food, FDA and CBP should typically consider not taking any regulatory action.
Samples of food are considered to be for quality assurance, research or analysis purposes when they are imported in small quantities (i.e., quantities consistent with the quality assurance, research, or analysis purposes) and the entire sample is used up by the analysis or is destroyed after analysis or a reasonable retention period after analysis. The analysis may include sensory analysis or evaluations such as those organoleptic analyses for testing the quality of tea or for testing for histamines. Evidence that an article of food is imported for quality assurance, research, or analysis purposes only might include, among other evidence, that the food and shipment documents are marked accordingly. The enforcement discretion does not apply to samples intended for test marketing, such as tasting at trade shows or product promotional tasting events. See Compliance Policy Guide, Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
Additional Selected Excerpts from the Prior Notice Interim Final Rule, Guidance Documents, and Fact Sheets
Who is authorized to submit prior notice? A prior notice for an article of food may be submitted by any person with knowledge of the required information. This person is the submitter. The submitter also may use another person to transmit the required information on his/her behalf. The person who transmits the information is the transmitter. The submitter and transmitter may be the same person. See Interim Final Rule § 1.278.
What is the definition of "shipper"? The interim final rule defines "shipper" as "the owner or exporter of the article of food who consigns and ships the article from a foreign country or the person who sends an article of food by international mail to the United States." See Interim Final Rule § 1.276(b)(12).
Abbreviated Information on Requirements for Submission of Prior Notice for Foods Arriving by International Mail
Refer to Prior Notice of Imported Foods particularly, Sending Food Gifts Through International Mail and Prior Notice for Food Articles sent by International Mail Step-by-Step Web System Instructions for additional information. For enforcement policies, refer to the Compliance Policy Guide (CPG).
| Article | Prior Notice Required | Generally Enforced |
|---|---|---|
| Home-made foods: Food 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 United States. | No | Not applicable |
| Non-Commercial Shipments: Food imported or offered for import for non-commercial purposes with a non-commercial shipper. A non-commercial purpose is when the food is purchased or otherwise acquired by an individual for non-business purposes and the shipper is an individual (e.g., the individual delivers the food to a post office or common carrier for delivery to self, family member, or friend for non-business purposes, i.e., not for sale, resale, barter, business use, or commercial use.) This includes food purchased by a traveler and mailed or shipped to the traveler's U.S. address by the traveler; gifts purchased at a commercial establishment and shipped by the purchaser, not the commercial establishment. | Yes | No, refer to CPG |
| Gifts of Food that is no longer in its natural state: Generally, the prior notice should include the identity of the manufacturing facility and the registration number of the manufacturing facility (§ 1.281(a)(6)). Here, the manufactured food is sent by an individual as a personal gift (i.e., for non-business reasons) to an individual in the U.S. | Yes | Yes, however, the name and address of the firm listed on the label may be provided in lieu of the registration number (§ 1.281a)(6)) |
| Samples of Food 1: The samples are items that are in such early stages of research and development that they cannot yet be considered food, or the sample is 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. | No | Not applicable |
| Samples of Food 2: Food imported or offered for import for quality assurance, research or analysis purposes only, not for human or animal consumption and not for resale. | Yes | Yes, except for the registration number of the manufacturing facility; refer to CPG |
FAQs
What is a prior notice for imported food shipments? ›
Prior Notice of imported food shipments will give FDA time to: Review and evaluate information before a food product arrives in the U.S. Better deploy resources to conduct inspections. Help intercept contaminated products.
Can you send food through customs? ›Perishable items are illegal to ship to a foreign country. But there are food options and ways of packing food that will allow you to ship them overseas. For instance, items that have a shelf life of at least 6 months can ship if they are in their store-bought, sealed packaging.
How to send food overseas? ›Use a USPS Priority APO/FPO/DPO boxes to ship items overseas. When mailing homemade baked goods, make sure each piece is individually wrapped and then packed into an unbreakable container. Place the gifts in a sturdy box and cushion with packing peanuts or foam. Seal it securely with packing tape.
Can I send packaged food to USA? ›Food that was made by an individual in his/her personal residence or food purchased from a vendor by an individual who sends it as a personal gift (for non-business reasons) to someone in the United States is not subject to Bioterrorism Act requirements.
Do I need FDA prior notice? ›Prior notice is required for human and animal food imported into and transiting through the United States, unless an exemption under the FDA regulation applies.
Does imported food have to be labeled? ›Food offered for import into the United States must comply with the FDA's laws and regulations on food labeling. Food labeling is required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, and drinks.
Can you send food internationally through USPS? ›Perishable items are materials that can deteriorate in the mail, such as live animals, food, and plants. Permissible perishable items are sent at the mailer's own risk. These items must be specially packaged and mailed so that they arrive before they begin to deteriorate.
What happens if you don't declare food at customs? ›Failure to declare food products can result in up to $10,000 in fines and penalties and dismissal from the Global Entry program. Travelers may check the general admissibility of fruits and vegetables by consulting APHIS's FAVIR database at https://epermits.aphis.usda.gov/manual.
Do you have to declare packaged food at customs? ›All travelers entering the United States are REQUIRED to DECLARE meats, fruits, vegetables, plants, seeds, soil, animals, as well as plant and animal products (including soup or soup products) they may be carrying. The declaration must cover all items carried in checked baggage, carry-on luggage, or in a vehicle.
How do you ship perishable food internationally? ›Use an insulated foam container with a minimum of 1-1/2"-thick walls. Line the inside of the container with a watertight plastic liner if your item can melt or thaw. Double-bag perishable products that can melt or thaw and shipments that contain liquid in watertight plastic bags (minimum of 2-mil thickness).
How do you send food through the mail? ›
- Ship in a sturdy box.
- Pack with a cold source, i.e., frozen gel packs or dry ice.
- When using dry ice: ...
- Wrap box in two layers of brown paper.
- Use permanent markers to label outside of the box.
Our full range of services ensures the optimum conditions and proper compliance for perishables such as flowers, fruit, vegetables, cheese, sausages, fresh meat and fish across the supply chain.
What kind of food can you ship internationally? ›- Store-bought food items.
- Vacuum-sealed food.
- Food packed in clean paper boxes, metal food tins, and plastic boxes/bags.
- Dehydrated soups.
- Condiments in unbreakable jars.
- Coffee, tea.
- Dried nuts, fruit, and seeds.
- Specialty foods like tuna, sardines, dips, anchovies.
Open or Close content below Perishable Items
Perishable items are materials that can deteriorate in the mail, such as live animals, food, and plants. Permissible perishable items are sent at the mailer's own risk. These items must be specially packaged and mailed so that they arrive before they begin to deteriorate.
Sending food
If you're shipping food or beverages to the USA as a business, you need to file a Prior Notice of Imported Foods with the US Food and Drug Administration (FDA). This applies to articles shipped for commercial purposes or as gifts.
- Don't advertise misbranded or unapproved drug products. Selling unapproved and/or misbranded drug products is one way to get an FDA Warning Letter. ...
- Don't refuse an inspection. ...
- Keep things clean. ...
- Follow cGMP.
FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and "Notice of Inspection" (FDA Form 482) upon arriving at your plant.
Who files FDA prior notice? ›Information required varies by entry type. Anyone who has knowledge of the required information about an imported shipment may submit Prior Notice through the FDA Prior Notice System Interface.
Which food is exempt from labeling? ›Raw fruits, vegetables, and fish. Foods that contain insignificant amounts of all required nutrients (insignificant means it can be listed as zero after rounding rules - foods that fall under this exemption include tea, coffee, food coloring, etc.).
How do I declare food at US Customs? ›All travelers must complete a CBP Declaration Form 6059B itemizing all purchased merchandise and agricultural products. Here are your options: Complete a paper form that may be obtained at the port of entry or on the flight or cruise. Complete the online form at a Global Entry kiosk.
What foods are exempt from food labels? ›
- Raw fruits.
- Vegetables.
- Fish.
- Dietary Supplements (they are regulated under §101.36)
- Certain egg cartons.
- Infant Formula and foods for children up to 4 yrs of age (modified requirements apply)
CBP- Processing International Mail. Mail entering the United States from abroad first arrives at a United States Postal Service (USPS) Sorting Facility. The Postal Service then sends packages to U.S. Customs and Border Protection (CBP) for examination and to assess duties and taxes, if any is owed.
How do I mail non perishable food? ›Gel packs and dry ice are the best options for keeping your food cool in transit. In general, use dry ice for ice cream and other foods you want to keep frozen, and gel packs to keep food between 32 and 60 degrees F.
How do I send perishable food through USPS? ›...
For surface transportation, each mailpiece must be clearly marked either:
- “Surface Only” or.
- “Surface Mail Only” and “Carbon Dioxide Solid, UN1845” or.
- “Dry Ice, UN1845”
What happens if you bring forbidden items? Travelers who declare agricultural products in their luggage don't face penalties – even if an inspector concludes the items are not eligible to enter the country, the USDA says. In such cases, the food is destroyed.
Why do you have to declare food at customs? ›Travelers entering the United States must declare all agricultural products on their U.S. Customs forms. U.S. agricultural inspectors will examine your items to be sure they meet entry requirements and do not harbor harmful foreign pests or diseases.
Can customs take things out your package? ›No, customs officers will not open up your package or packages without good reason. Every package is put through a scanner machine, or an x-ray machine, to verify that the items you are shipping match your customs forms.
What food has to be declared? ›- cereals containing gluten and their products, namely, wheat, rye, barley, oats and spelt and their hybridised strains.
- fish and fish products.
- crustacea (shellfish, for example prawns) and associated products.
- egg and egg products.
Most countries require travellers to complete a customs declaration form when bringing notified goods (alcoholic drinks, tobacco products, animals, fresh food, plant material, seeds, soils, meats, and animal products) across international borders.
Do customs check all packages? ›When an item is leaving to go overseas, upon arrival at the airport, parcels will go through customs, being scanned and X-rayed. Items that are restricted or banned for export will not be allowed through, so remember to check the list of Prohibited items for international posting before you book your collection.
How long does dry ice last when shipping? ›
Dry ice will last approximately 24 hours when stored in a styrofoam cooler. However, this period only applies to a regular-sized cooler holding up to 2 dry ice blocks. The dry ice will last about 3-4 days in large styrofoam with more dry ice blocks.
How do I ship refrigerated items internationally? ›Opt for the Right Climate-Controlled Packaging
If your items need to be refrigerated, but not frozen, you can ship them with ice packs to keep the temperature below 40 degrees Fahrenheit. However, if you need to keep your items frozen during their journey, you need to swap the ice packs for dry ice.
Perishable foods that are affected by temperature, including refrigerated and frozen foods, should not be shipped internationally. These foods will spoil before they reach their destination.
Can you send food through FedEx? ›At FedEx, we generally recommend that you ship perishables via FedEx Priority Overnight, FedEx First Overnight, FedEx Standard Overnight®, or FedEx 1Day® Freight, and package your products for a transit time of 30 hours.
Will UPS pack and ship frozen food? ›Shipping Frozen Food – UPS
Shipping frozen food is allowed with UPS, but packages must also be packed properly to prevent thawing and leaks. They recommend using a shipping service that has a maximum shipping time of 30 hours, offers shipment tracking, and lets the recipient know when to expect the package.
How much does it cost to ship frozen food? For most industries and products, you can expect to pay between $30 and $150 for shipping frozen food packages. Your final frozen food shipping cost depends on how much you're sending, its destination, package weight, and the shipping service you selected.
Can I ship perishable food via DHL? ›Our full range of services ensures the optimum conditions and proper compliance for perishables such as flowers, fruit, vegetables, cheese, sausages, fresh meat and fish across the supply chain.
What cannot be shipped by DHL? ›- Wastes, living botanicals, livestock, animals, perishables.
- Money, precious metal, jewelry, gemstones, works of art, antiques, checks, ready-to-use credit cards, coins, fiscal stamps, valid telephone cards.
There are some obvious things that you cannot send with DHL (such as animals, illegal substances, guns and explosives for instance). But there are also less obvious items that DHL can't transport, including aerosols, perfumes, aftershaves, eau de toilettes and cash.
Can you send cookies in the mail international? ›Yes, cookies can be sent via mail. USPS, UPS, and FedEx can also ship cookies domestically and internationally.
How do you keep cookies fresh when shipping overseas? ›
Line the bottom of a tin, box or plastic container with a layer of crumpled wax paper or bubble wrap. Stack the wrapped cookies in the container, placing wax paper or bubble wrap between each cookie layer and filling any air space.
Can you take food through international customs? ›You can take everything in your checked baggage: from liquid to solid food. However, you are not allowed to carry liquid or gel-like food products in your carry-on baggage.
What food should I send by mail? ›- Chocolates. For the chocolate obsessed friend, nothing will delight them more than a delivery of their favorite sweet treats. ...
- Cookie dough. ...
- Cake bites. ...
- Dried fruit. ...
- Fruit arrangement. ...
- Savory.
- Cheese collection. ...
- Hot sauce subscription.
We're here to make shipping frozen items easier - from healthcare essentials to frozen foods. We know that frozen products require strict temperature control to remain viable, and each of our solutions provide the reliable shipping you need.
Can I send cookies through USPS? ›Yes, you can mail cookies! You can mail them via USPS, Fedex and UPS and, depending on how fast you want them to arrive, you can choose expedited shipping. You want your cookies to arrive fresh so I recommend using, at a maximum, three to four-day shipping depending on the kind of cookie you're sending.
How can I send someone food internationally? ›Use a USPS Priority APO/FPO/DPO boxes to ship items overseas. When mailing homemade baked goods, make sure each piece is individually wrapped and then packed into an unbreakable container. Place the gifts in a sturdy box and cushion with packing peanuts or foam. Seal it securely with packing tape.
Can you send food in the mail to USA? ›Food can only be shipped to the U.S. if it is being sent from one individual (not a company), to another individual. Customs forms must clearly be marked “gift” and state that the food is for personal consumption. You will also require a full list of the ingredients to be included for Customs.
How do I send food to someone in another country? ›Tap Food or Mart. Tap the country and city you want to deliver to. Enter and confirm the Deliver to address in the GrabFood/GrabMart home screen. Browse for food or mart merchants and add the items to your basket as per usual steps.
What is an import notification? ›Import alerts inform the FDA's field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA's laws and regulations.
What is a prior notice? ›Prior Notice. Notification to the US Food and Drug Administration (FDA) of imported shipments of articles of food prior to their arrival in the United States. Includes information about the product, quantity, and packaging, and related facilities, such as the manufacturer, shipper, owner, and ultimate consignee.
What are the three 3 main documents required for import customs clearance? ›
- Import Declaration.
- Bill of Lading (B/L) or Air Waybill.
- Invoice.
- Packing List.
- Import License (if applicable)
- Certificates of Origin (if applicable)
- Other relevant documents such as catalogue, product ingredients, etc.
A confirmation of Prior Notice declaration must accompany any shipment of food or beverages to the USA*. The Prior Notice declaration must be made: Before the goods enter the USA (even for small quantities or samples). No more than 5 days in advance and no less than 4 hours before the arrival of the shipment.
What are notified goods in customs? ›(d) "notified goods" means goods specified in the notification issued under section 11B. Section 11B. Power of Central Government to notify goods.-
Why would a package go through customs? ›Customs checks all inbound international packages and mail. During this process, a customs officer in the country you're shipping to will review the package to make sure it meets the country's laws, regulations and policies. They will also determine what duties and taxes might be due.
What system is used to send import pre notifications? ›From 1 January 2022, you must pre-notify your consignment via IPAFFS or PEACH. From 1 January 2022, all POAO and ABP consignments must be pre-notified on IPAFFS, and all plants and plant products categorised as 'regulated and notifiable' will need to be pre-notified on either IPAFFS or the PEACH system.
How do you use prior notice in a sentence? ›I had not had prior notice of the complaint that he made about the lack of documents. It will obviously be necessary to give them prior notice and warning. I am told that inspectors carry out regular inspections, usually without prior notice, of all registered premises.
What does PN mean in customs? ›What is Prior Notice (PN)? U.S. Customs and Border Protection. An official website of the United States government.
What does 30 days prior written notice mean? ›Commerce shall give Executive not less than thirty (30) days prior written notice of its intention to terminate his employment, specifying in detail the reason(s) for such termination and the date of termination; and. Sample 1See All (7)
What documents are required to clear customs? ›- 1.1 Import declaration form. ...
- 1.2 Certificate of Conformity (if applicable) ...
- 1.3 Master Bill of Lading. ...
- 1.4 Packing List. ...
- 1.5 Commercial Invoice. ...
- 1.6 Exemption letter (if applicable) ...
- 1.7 Dispatch of documents in time.
- Step 1: Document inspection. This is the point where all the documents listed above come into relevance. ...
- Step 2: Tax and duty calculation. ...
- Step 3: Incoterm choice and payment of taxes and duties. ...
- Step 4: Release of shipment.
What happens if you ignore an FDA warning letter? ›
Failing to comply with FDA warning letters may lead to severe repercus- sions such as product seizures, withholding of regulatory approvals/clearances and even civil penalties. Warning let- ters may also be admitted as evidence in a product liability case.
How serious is an FDA warning letter? ›A Warning Letter is informal and advisory. It communicates the agency's position on a matter, but it does not commit FDA to taking enforcement action. For these reasons, FDA does not consider Warning Letters to be final agency action on which it can be sued.
How do you avoid the FDA Warning letter? ›- Don't advertise misbranded or unapproved drug products. Selling unapproved and/or misbranded drug products is one way to get an FDA Warning Letter. ...
- Don't refuse an inspection. ...
- Keep things clean. ...
- Follow cGMP.