Over the years, FDA has issued a number of Import Alerts across various FDA product categories. No issue and no product is off limits. Import Alerts have targeted firms that have not met dietary supplement GMPs, firms that promote unapproved new drugs in the U.S., firms that distribute devices without FDA clearance or approval, and firms that are not in compliance with requirements of the Foreign Supplier Verification Program (FSVP).
So what is an Import Alert? How does a firm get placed? And more importantly, how does a firm remove themselves from this list?
Import Alerts are an FDA enforcement tool to keep non-compliant, and in some instances dangerous, products from entering the U.S. marketplace. Under an FDA Import Alert, FDA has the authority to detain, without physically examining, products that either have or potentially could violate the Federal Food, Drug & Cosmetic Act due to a history of repeat violations. Import Alerts alert FDA field staff that the Agency has sufficient evidence to automatically refuse admission of future shipments of imported articles based on this presumption of violation. As a result, placement on an Import Alert shifts the burden to an importer to demonstrate product compliance, oftentimes via analytic testing and sampling.
Placement is costly, causes delays, upsets business flow and questions where a Company will source products and/or ingredients. It also harms a Company’s reputation, and disqualifies a Company from being eligible for other trusted trader programs such as FDA’s newer program, the Voluntary Qualified Importer Program (VQIP), applicable to food imports.
To avoid placement on an Import Alert, it’s important to respond to any FDA Notices of Detention, on time and with precision, demonstrating the product’s compliance or how the product will be made compliant. It’s also important to adopt any corrective actions to future shipments so as to avoid repeat violations of the same issue, and to avoid recurrent detentions and refusals. Repeat violations are grounds for the FDA district office to recommend to the Division of Import Operations (DIO) that a firm be recommended. While there’s no magic number for how many violations can trigger FDA scrutiny, if a Company has more than 3 strikes in a narrow timeframe, the Company may experience intensive FDA surveillance followed by Import Alert recommendation. In some instances, even a single shipment refusal can result in placement on an Import Alert.
While Import Alerts are updated daily, and are searchable by industry, country/region, or date published, the below provides a glimpse of the most recent FDA Import Alerts:
The million dollar questions are whether and how a Company can get off an Import Alert.
The short answer is yes, a firm can be removed. The firm must demonstrate that the reasons for placement have been addressed such that the presumption of violative product no longer exists. This is done by understanding the terms of the placement, including the specific products and charges (for example, unapproved color additives), conducting a root cause analysis, and implementing, documenting and verifying corrective actions. In some scenarios, a condition for removal is consecutive non-violative shipments as evidence, or passing an establishment inspection. The end result is that goods can be imported without being subject to automatic detention, allowing goods to clear faster, and providing a business the opportunity to restore trust and good will with the FDA and with its consumers.
Companies seeking to re-establish a clean track record of imports and removal from Import Alert should consult with an expert who has experience with the process and dealing with FDA’s Division of Import Operations.
