The U.S. Food and Drug Administration (FDA) requires most U.S. importers of food and beverages to develop and implement Foreign Supplier Verification Programs (FSVPs). Covered importers must document their foreign suppliers’ FDA compliance, including whether or not each supplier is subject to a FDA Import Alert.
Under FSVP, importers must only import from suppliers whom they have evaluated and approved. FDA requires verification activities outlined in a FSVP to be decided by the level of supplier risk determined from this evaluation. An Import Alert increases the probability that the importer must conduct more comprehensive verification activities to ensure the safety of a supplier’s products, such as onsite audits or sampling. In some cases, the importer may be unable to approve a supplier because they are under Import Alert. For these reasons, suppliers not on alert receive a competitive advantage in the market.
The next FSVP deadline is March 19, 2018, which applies to U.S. importers whose suppliers have fewer than 500 full-time equivalent employees. Before the deadline, food facilities outside of the United States should ensure that they are not subject to an Import Alert that may cause their U.S. Importers to not approve them.
What is an Import Alert?
Products on Import Alert face detention without physical examination (DWPE) at the port of entry. FDA issues Import Alerts when patterns of non-compliance from a specific business or country give the Agency reasonable belief that future shipments may violate regulations.
For example, FDA sampled 16 shipments of dried peppers from ten different shippers in Mexico in 1988. FDA found excessive mold in 14 of those samples. This led to the publication of Import Alert #24-11, which subjects all shipments of dried peppers from Mexico to DWPE unless the shipper’s product is exempt. This is just one instance of over 240 active FDA Import Alerts.
How do I know if my products are on Import Alert?
FDA does not directly notify a facility that it is under Import Alert. Instead, the Agency maintains a public database of Import Alerts with records of which products from which facilities are subject to DWPE. However, determining if products are on Import Alert may require time-consuming searches through numerous alerts for any facilities a given business might have a stake in. Registrar Corp’s FDA Compliance Monitor is a simple alternative that allows businesses to track all of their facilities at once and receive a detailed report of any alerts their products may be under.
My Products are on Import Alert. How do I get them removed?
A business may petition FDA for exclusion from an Import Alert by demonstrating evidence of compliance that overcomes the apparent violation detailed in the Alert. A common misconception is that a facility is excluded from Import Alert after five consecutive non-violative shipments are released by FDA. This is only a small component of a larger process involving other, potentially extensive requirements.
The specific requirements for a petition vary, and are outlined in the guidance issued with an individual Import Alert. These may include documentation of revised food safety plans, revised labeling or formulations, changes implemented in the manufacturing process, or documentation of compliance with a government agency regulating food in the facility’s home country.
Many businesses can be intimidated by the extensive requirements of an Import Alert petition. These businesses may remain under Import Alert, facing DWPE and difficulties satisfying the requirements of an importer’s FSVP, even if they are not in violation of the specified regulations at the time. Despite a solution to the problem, some businesses might have no idea how to begin a petition.
Registrar Corp’s Regulatory Specialists are experienced in developing Import Alert petitions and can help you draft and compile the necessary documentation for Import Alert exclusion. Additionally, importers and suppliers can try Registrar Corp’s FDA Compliance Monitor free for 60 days to see which of their facilities may be on alert. For assistance, call us at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.