FDAストーリー #019 — フランスの香水メゾンがMoCRAが適用されることを発見 — 米国発売後に

A boutique winery in Mendoza, Argentina, had spent months preparing their first export to the United States. A Malbec and a Torrontés — two wines with strong US market appeal. They hired a designer in Buenos Aires, worked through multiple iterations, and printed 30,000 labels. Total printing cost: $11,000.

Then their US importer reviewed the labels.

問題

Wine, beer, and spirits in the United States are not primarily regulated by the FDA. They fall under the jurisdiction of the Alcohol and Tobacco Tax and Trade Bureau (TTB), a division of the US Department of the Treasury. TTB has its own labeling requirements under 27 CFR Parts 4, 5, and 7 — and those requirements are completely different from FDA food labeling rules. The Argentinian winery had designed their labels based on general FDA food labeling guidance they found online. None of it applied.

TTB requires a Certificate of Label Approval (COLA) before any wine can be sold in the United States. The COLA application requires specific label elements: brand name, class/type designation (e.g., 'Red Wine' or 'Malbec'), appellation of origin, alcohol content, net contents, name and address of the importer, country of origin, sulfite declaration, and a government health warning statement with specific prescribed language. The winery's labels were missing the health warning, had the alcohol content in the wrong format, lacked the importer's name and address, and did not include the sulfite declaration.

コスト

All 30,000 labels were unusable. They could not be modified or stickered over — the health warning and several other mandatory elements had to be integrated into the label design, not added as aftermarket patches. The winery had to redesign the labels from scratch, resubmit to the printer, and wait for a new production run. The reprint cost an additional $11,000. The launch was delayed by seven weeks.

FDABridgeがお手伝いします

FDABridge specializes in FDA-regulated products — food, cosmetics, drugs, and dietary supplements. Wine, beer, and spirits are primarily TTB-regulated, not FDA-regulated. When this winery contacted us, we identified the jurisdictional issue immediately and referred them to a TTB compliance specialist. We do this whenever a client's product falls outside FDA jurisdiction — we tell you honestly and connect you with the right resource.

But here is what this story teaches: before you print a single label, before you spend a dollar on design, know which US agency regulates your product. If it is food, cosmetics, drugs, or supplements — we handle it. fdabridge.com/contact. If it is alcohol or tobacco — you need a TTB specialist, and we will tell you that before you waste your money.