Every jar of tomato sauce, every wheel of cheese, every bottle of oil that reaches a US shelf from Italy has already cleared a set of rules that has nothing to do with taste. It's easy to underestimate this step, a small producer or a restaurant owner falls in love with a product on a trip home and assumes the hard part is shipping. It isn't. The hard part is everything that happens before the container leaves the port.
The first rule sits on the Italian side. Any foreign facility that manufactures, processes, packs or holds food for the US market has to register with the FDA and name a US Agent, a person or company based in the United States, reachable during US business hours, who receives FDA communications on the facility's behalf. Registration isn't a one-time formality either. It has to be renewed every two years, and 2026 happens to be a renewal year, with the window running from October 1 through December 31. Miss it, and the facility loses its registered status, which is enough on its own to have a shipment turned away at the border.
Two rules, two different owners
The second rule sits on the US side, and it belongs to whoever is importing the product, not the producer in Italy. That US importer has to run a Foreign Supplier Verification Program, a risk-based process of evaluating the supplier and confirming the food meets US safety standards, and file prior notice before each shipment arrives. These two things are often confused for one another, but they aren't the same obligation and one doesn't substitute for the other. A producer can be perfectly registered in Italy and a shipment can still be held up if the US importer's side of the paperwork isn't in order.
The label is not a translation exercise
Even a fully compliant shipment can stall at the last step: the label. US Nutrition Facts panels follow a different format from the EU nutrition table, the major allergens have to be called out in a specific way, and the ingredient list has to run in descending order by weight, all in English. Producers who simply translate their Italian label word for word usually end up redoing it, which costs more time than getting it right the first time.
None of this is a reason to stay out of the US market. It's simply the checklist that separates a product that reaches American kitchens from one that gets stuck in a warehouse. It's also exactly the kind of groundwork we've already built out on the Flavors side of what we do, working as the US-facing partner for Italian producers so that a genuinely good product doesn't lose months to paperwork it was never designed to navigate alone.
Data referenced from the FDA's food facility registration and Foreign Supplier Verification Program guidance.
A great product doesn't sell itself into a new country. Somebody still has to do the paperwork properly, once, so it never has to be done twice.