Imported Beverage Compliance: What Changes Between Label Approval and First Shipment

Label approval is a milestone for a foreign producer, not the finish line. After it, the product still has to be registered in the states where it will be sold and cleared to enter the country.

Step 1: Federal label approval (COLA)

A Certificate of Label Approval, or COLA, is the label approval issued by the Alcohol and Tobacco Tax and Trade Bureau (TTB). TTB requires a COLA for distilled spirits, for malt beverages, and for wine at 7 percent ABV or more. The importer must hold the COLA at the time of importation.

Some products need one more step first. TTB formula approval applies to certain distilled spirits, malt beverages, and wines, most often when flavoring or coloring is added. It must be in place before a COLA can be issued, so check early whether your product needs it.

Step 2: State registration

Federal approval does not clear a product for every state. Most states also require their own brand or label registration, and each sets its own rules and approval process. The compliance and licensing page answers common questions on timing and on who does what.

Step 3: Confirm who is on the paperwork

Before the first order ships, confirm in writing which party acts as the importer on the entry documents and the label. That party carries legal responsibility from the point of entry, so the producer should know its name and permit before the goods leave the country of origin. The same page covers the difference between an importer and a broker.

Step 4: What happens at import

When the shipment reaches the United States, three things happen that a producer should expect:

• Customs entry. The importer, or a customs broker acting on its behalf, files an entry with U.S. Customs and Border Protection so the goods can be released.
• Federal excise tax and duties. The importer is responsible for these, and Customs and Border Protection collects them at entry. Rates depend on the product category and ABV.
• FDA requirements. The producer’s facility must be registered with the FDA because the Bioterrorism Act of 2002 requires facilities that manufacture, process, pack, or hold food, which includes alcoholic beverages, to register. A foreign facility needs a US agent to register, and the registration must be in place before the first shipment. The importer or its customs broker can file prior notice of each shipment with the FDA before it arrives.

Ask your importer to confirm who files each item and what information it needs from you. Timing for each step varies, so do not plan a launch date around any one of them.

What to plan for

Build your launch calendar around the slowest step you face, which is often state registration, and keep your production dates flexible until the label and state approvals are in hand. For how the tiers fit together after the shipment arrives, read our three-tier system explainer.

To talk through your market entry steps without commitment, contact our team through the RTM Imports contact page.