I learned a long time ago to keep tabs on FDA import alerts, which names firms that have been deemed by FDA to be violative of import requirements for a whole host of reasons. Once on the list, imports from that firm can be quarantined until the importer addresses the issue(s) raised by FDA.
I watch the import alert lists on behalf of clients who are exploring out of US manufacturing, because if a firm is on this list, any products they ship (including new ones not yet cited) can be quarantined. You would be surprised what claims some contract manufacturing firms will make to get work, knowing full well their shipments will be held at the dock. My job is to sniff those firms out and say to my client “nope, don’t use that group.”
This particular import alert is for products that require a premarket approval (PMA), individual device exemption (IDE) or 510(k) clearance to enter the US, but the products don’t have them. So they sit on the dock until they get them, which could be a very long time, in some cases these products never enter the US.
This most recent import alert cited two products from two different manufacturers that claimed they were general wellness products seeking enforcement discretion (not regulated by the FDA at this time), but per the import alert the FDA inspector felt they were PMA, IDE or 510(k), so they sit on the dock. This has never happened before for a claimed wellness product.
If you are looking at marketing a wellness product, make sure you have proper guidance in determining if your product meets the wellness criteria for enforcement discretion. If not, and you are importing, it may end up on the dock for what may be a very long time.
This signals that the FDA is paying closer attention to wellness products. Even though this is starting with imports, it is inevitable that closer attention will be paid to domestic products as well.
Do not confuse the FDA January 2026 wellness guidance update as a no rules, free for all scenario. Yes, there are broader opportunities for those seeking wellness products under enforcement discretion, but if you don’t meet the rules, you could see FDA enforcement, including but not limited to product quarantine.
This risk is particularly relevant in the age of AI. The effort cost is becoming close to negligible for the FDA or FTC, with a properly constructed AI tool screening autonomously, to pick up on those crossing the line from enforcement discretion into regulated territory. But the cost on the dinged company can be enormous, in some cases terminal to the health of the company.
