Many types of imported goods are regulated by the Food and Drug Administration (FDA), as well as by US Customs. These include:
most types of foods and beverages, intended for human or animal consumption
medical supplies, including drugs and medical devices
many commercial and household electric or electronic devices
To carry out its regulatory responsibilities, FDA requires a large amount of additional data, beyond the data elements that US Customs generally requires for its own use in managing import operations and cargo clearance. For most import shipments regulated by FDA, this additional data is sent to FDA as part of the regular customs clearance process. The importer’s customs broker keys in the additional FDA required data elements, into FDA-specific additional screens in the customs software the broker uses to prepare the customs entry. The FDA data is then transmitted to US Customs as part of the complete customs entry electronic data package.
When Customs receives that entry data, Customs electronically forwards to FDA the data elements that FDA needs. From this point, Customs and FDA review and cargo release proceed along parallel but separate lines. Each agency issues its own, separate release authorizations or other actions.
When FDA receives their data elements for a specific customs entry, that data is automatically sorted and reviewed by FDA’s automated systems, using pre-programmed “selectivity” criteria. Many goods that are considered “low-risk” for their combination of product, manufacturer, supplier, and importer are immediately FDA released at this time.
Shipments that are not released under the automated “selectivity” criteria generally then go to “on-screen review” by FDA staff. In this process, an FDA officer reviews the data elements submitted for a particular shipment, as well as any “import alerts” or other internal FDA guidelines on file for that particular product, manufacturer, supplier, or importer. The reviewing FDA officer may take one (or more) of several actions, including:
release the shipment
place the shipment on “FDA hold”
require the entry filer to submit a copy of the commercial documents (invoice, packing list, etc.) for the shipment, for more detailed FDA review
designate the shipment for FDA examination and/or sampling
detain the shipment
The results of either automated “selectivity” processing, or “on-screen review”, are electronically transmitted by FDA to US Customs. Customs then electronically forwards the result to the entry filer, through the same electronic interface as the customs and entry data were originally filed.
FDA designates some import shipments for exam and/or sampling by FDA officers. When a shipment is designated for FDA exam, the importer (or customs broker as the importer’s agent) is responsible for:
notifying the appropriate FDA office of the shipment’s availability and location, including identifying shipment information such as warehouse lot numbers
authorizing the warehouse to release the shipment to FDA for exam / sampling
making the contents of the shipment fully available for FDA exam
keeping the rest of the shipment intact, until otherwise authorized by FDA
Depending on the type of product being examined, and the reason(s) that the shipment was selected for exam, FDA may look at any of a very wide range of things, including:
package labeling, including product ingredients and nutrition labels
physical condition of product and packaging
whether any food or beverage product is filthy, decomposed, contaminated with dangerous types of bacteria, or otherwise unfit for human consumption
whether drugs or medical items are properly approved for use in the U.S.
After an FDA officer has examined / sampled a shipment, any necessary testing of the samples taken is done in one of the FDA laboratories. After the internal FDA test report is prepared, that report normally goes to an FDA compliance officer for review. If the test results are favorable, the FDA compliance officer will normally release the shipment. If the results are favorable for only specific items in a shipment, FDA will generally release the specific items that passed the testing, and detain the items that failed the testing. FDA normally notifies the importer and the importer’s customs broker of FDA actions and decisions by:
· electronic messages to Customs, which Customs then forwards to the customs broker
· paper notifications mailed to the importer and to the customs broker
· entry-specific data posted on the FDA’s Import Trade Auxiliary Communications System
To reduce the risk of your FDA regulated products being delayed or refused, Transmark Customs Brokers recommends that importers consult your import specialists before the products are shipped, to identify and minimize possible issues. Contact us today for more information.