Food and Drug Administration (FDA) Regulations
- Food and Drug Administration (FDA) Regulations
- Human Food and Cosmetics Manufacturers Ruling
- Import Alerts
Automated Commercial Environment (ACE) Data Elements
Effective June 15, 2016, customs brokers and entry filers in the U.S. are required to submit additional information through ACE when transmitting shipment information for the release of FDA-regulated products. This means that new mandatory data elements are required and some existing conditional data elements are now mandatory.
Depending on the commodity, the following are some data elements that are now mandatory and must be provided by the shipper.
- Affirmation of Compliance (AofC) Code (see section below)
- Product Code (see section below)
- Device Listing Number (LST)
- Intended Use Code
- Brand Name
- Active Ingredient Name
- Manufacturer Registration Number
- 510 (K) number
Important: Ensure that you are registered with the FDA prior to shipping FDA-regulated commodities.
For an FDA high-level tip sheet, click here
Refer to the FDA Supplemental Guide for the mandatory and conditional data elements for different commodity groups.
For assistance with the FDA document requirements, contact the U.S. FedEx Express Regulatory Consulting Group via email at firstname.lastname@example.org or hotline at 1.800.851.3336.
Affirmation of Compliance (AofC) Codes
AofC codes are used by the FDA as an automated screening tool to determine whether FDA-regulated commodities may proceed without examination, or if they require further review. The applicable codes are electronically transmitted by the entry filer (normally the customs broker) through ACE.
The use of AofC codes is now mandatory; shippers must provide the applicable AofC code, for each commodity, on the Commercial Invoice. An automated ‘may proceed’ can only occur if the relevant AofC code is supplied (although use of a code does not automatically guarantee a ‘may proceed’).
For more information and the list of AofC codes, visit the U.S. Food and Drug Administration website.
Prior Notice of Imported Food Final Rule
The U.S. Food and Drug Administration (FDA) implemented its “Prior Notice of Imported Food Final Rule” on May 6, 2009, as announced in a CFSCAN Constituent Update posted on the fda.gov website. The final rule amended the existing Prior Notice Interim Final Rule (PN IFR) contained in CFR Part I, Subpart I, which had been in effect since December 12, 2003 as part of the Bioterrorism Act of 2002. The PN IFR requires registration of food facilities and prior notice of food imported into the U.S. The final rule revises the IFR in only a few key areas; the most significant are as follows:
In contrast to the IFR, the final rule requires the identity of the manufacturer for all entry types, including In-Transit and Transportation and Exportation entries.
The final rule adds a definition for “manufacturer” and provides an alternative for identifying the manufacturer when the registration number is not known. In addition to the name of the manufacturer, the prior notice submitter must submit either: (a) the registration number of the facility associated with the article of food; or (b) the full address of the site-specific facility and reason why no registration number is being provided.
Specifically, the following reason codes listed in the Interim Final Rule (IFR) compliance policy guide (CPG) will not be accepted on or after May 6, 2009:
G Individual Gift – label name address in lieu of registration number
I Samples – Quality Assurance, research or analysis purposes only
J U.S. Manufacturing facility that is not required to register
L Unable to determine identity of the manufacturer - providing identity of manufacturer’s headquarters
M Unable to determine identity of manufacturer or headquarters - providing invoicing firm’s identity
O Gift Pack for non-business purposes – providing single prior notice and identity of packer
To avoid delays and penalties, you must provide a PN web entry summary confirmation or FedEx Express Prior Notice Form when tendering food shipments to FedEx. If you are exporting food articles into the U.S., ensure that you have registered with the FDA as required, and are able to provide the required Prior Notice data for each shipment. Affected food articles arriving in the U.S. without this information are subject to service delays and possible refusal by the FDA.
Definition of Food in the Bioterrorism Act of 2002
- Articles used for food or drink for consumption by humans or animals
- Chewing gum
- Articles used for components of any such article
Affected Food Commodities
- All food as defined by the FDA, "being exported or offered for export into the United States"
- Food stored or distributed in the U.S.
- Gifts to and from a business
- Samples to be used for quality assurance, tradeshows and testing purposes (for human or animal consumption)
- Trans-shipments through 2 U.S. ports to another country
- Food exported into the U.S. for future export
- Food admitted into a U.S. Foreign Trade Zone (FTZ)
Food Commodities Excluded
- Personal use food accompanying a traveller
- Food exported into the U.S. then immediately exported from the U.S., without leaving the port of arrival
- Meat, poultry, and egg products - exclusively regulated by the U.S. Department of Agriculture
- Homemade goods made in a personal residence, sent by an individual as a personal gift, for non-commercial reasons
- Individual to individual for non-commercial/non-business purposes
- Food contact substances (e.g. packaging material, jars, containers & pesticides) which do not qualify under the FDA's definition of "food"
Prior Notice Submission
Click here to file the Prior Notice directly with the FDA using the FDA Prior Notice System Interface (PNSI).
- Prior Notice must be submitted to the FDA prior to the submission timeframes listed below.
- Any individual with knowledge of the required information, including but not limited to brokers, importers, exporters and U.S. agents, may submit Prior Notice.
- If you are exporting food articles into the U.S., ensure that you have registered with the FDA as required, and are able to provide the required Prior Notice data for each shipment. Affected food articles arriving in the U.S. without this information are subject to service delays and possible refusal by the FDA.
- Shippers are encouraged to submit Prior Notice directly to the FDA to minimize delays for all food shipments entering or transiting the U.S. FedEx Express will submit PN on behalf of our customers; however, the shipper must provide all PN data elements as part of the shipment documentation. Food shipments may be delayed while PN is submitted and confirmed.
Required Submission Timeframe
The specific timeframe for Prior Notice submission is determined by mode of transportation:
- 2 hours before arrival by land by road
- 4 hours before arrival by air or by land by rail
- 8 hours before arrival by water
Information Change after Submission
- A new Prior Notice must be submitted if changes are made after Prior Notice confirmation has been received. When changes are submitted, the clock for Prior Notice submission will be reset.
Prior Notice System Interface (PNSI)
- FedEx strongly encourages you to file Prior Notice directly with the FDA to help minimize delays. Prior Notice can be filed directly with the FDA using the Prior Notice System Interface, which is available on the FDA website.
- To accommodate those transmitters shipping via Express courier, where the transmitter does not have access to the required anticipated arrival information and/or planned shipment information, the transmitter should use 'consumption express courier' as the entry type. This entry type is to be used only by shippers sending articles of food to the U.S. via express couriers.
- Include three copies of the PN web entry summary confirmation and Commercial Invoice with your shipment. The PN web entry summary confirmation number, on its own, is not sufficient. In addition, the PN web entry summary confirmation number must be written in the description field on your FedEx International Air Waybill
A handy reference guide is available on the FDA website.
To avoid possible suspension of your registration number, as a foreign food facility, you were required to renew your registration with the FDA prior to December 31, 2014. In addition, as per the 2011 FDA Food Safety Modernization Act (FSMA), you are also required to continue to renew your registration every two years. For further information, please visit the U.S. FDA website.
Foreign Food Facilities
- Foreign food facilities (those outside the U.S.) that manufacture, process, pack or hold food are required to register with the FDA. They must also have a U.S. agent to act as a communications liaison between the FDA and the foreign food facility for both routine and emergency communications.
- If a foreign food facility that manufactures, processes, packs or holds food sends it to another foreign food facility for further manufacturing, processing or packaging before the food is exported to the U.S., only the last foreign facility is required to register, except if the subsequent facility is conducting de minimis activities such as labeling. In such cases, both facilities must register.
The following entities are exempt from the registration requirement:
- Private residences of individuals
- Non-bottled water and drinking water collection & distribution establishments
- Transport vehicles that hold food only in the usual course of their business as carriers
- Retail food establishments
- Non-profit food establishments
- Fishing vessels
- Facilities regulated exclusively by the USDA
- Electronic registration is encouraged and will be available worldwide, 24 hours a day, 7 days a week. To access the FDA's online form click here.
- Paper registration is also accepted if Internet access is not readily available. Please note that it's a much slower process and you need to ensure that the form is complete and legible.
Human Food and Cosmetics Manufacturers Ruling
Effective Jan. 9, 2007, the FDA issued a ruling that will require all manufacturers and processors of human food and cosmetics to establish and maintain records in order to demonstrate whether the human food or cosmetic is manufactured from, processed with, or contains prohibited cattle materials. For more information, please visit the FDA website.
When filing entry with U.S. Customs and Border Protection (CBP), the importer of record must affirm whether the food or cosmetic was manufactured from, processed with, or otherwise contains cattle material. If requested, the importer of record must provide sufficient records, within 5 days, to demonstrate that the food or cosmetic is not manufactured from, processed with, or does not otherwise contain prohibited cattle material.
As part of its continuing effort to protect consumers’ health and safety, the FDA has guidance documents called Import Alerts which identify products that have significant regulatory issues. The issues may relate to a specific commodity, grower, manufacturer, country, etc.
To view the Import Alerts list, please visit the FDA website.