Welcome to firm that helps with all transactions with the FDA and the TTB to get your product fit for the US market.

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

All the companies involved in the production, bottling, handling or storing the product must have been registered with the FDA and got a registration number. 

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the FDA as the food regulatory agency to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. FDA established regulations requiring that: Food facilities register with FDA, and FDA be given advance notice on shipments of imported food.

The FDA requires food and beverage companies (amongst others), located outside of the United States to designate a U.S. Agent when registering with FDA.  FDA sends communications to that agent for everything concerning the company which often require an immediate response. The Registered Agent is the one who assists with FDA registration and reports, provides guidance with FDA requirements for your industry, assist with FDA detentions, monitor your facility’s FDA compliance, and more. 

The Alcohol and Tobacco Tax and Trade Bureau, statutorily named the Tax and Trade Bureau and frequently shortened to TTB, is a bureau of the United States Department of the Treasury, which regulates and collects taxes on trade and imports of alcohol, tobacco, and firearms within the United States.

The Alcohol and Tobacco Tax and Trade Bureau (TTB) implements and enforces a broad range of statutory and compliance provisions to ensure that alcohol products are created, labeled, and marketed in accordance with Federal laws and regulations. Alcohol producers must apply for a Certification/Exemption of Label/Bottle Approval (COLA) and follow the labeling and advertising regulations under the law.

For the companies outside of the US territories, the “Importer” of the company is the only one authorized by the TTB to submit labels for approval.

In the United States, the key players in the alcoholic beverage industry make up a three-tier system and this three-tier system is the law in most states.  With respect to wine, the top-tier of this system is the winery or manufacturer that is producing the wine. However, the foreign producers must obtain an agent who represents and acts on the winery’s behalf within the United States.  This agent, called an “importer” and is licensed and authorized to bring wine into the United States from the manufacturer’s foreign country in the course of trade.  The “importer” therefore may be considered to stand in place of the winery when referring to the top-tier of the three-tier system.

For certain distilled spirits, beers/malt beverages, and wines, TTB must evaluate the ingredients and production process before the product can be made or imported, and before you can submit your labels to TTB. In some cases, TTB also analyzes a sample of the product in its laboratory while reviewing the formula.

The person who holds the TTB Importer's Basic Permit is the one responsible for complying with formula requirements for imported alcohol beverages and subsequently apply for label approval. However, the importer will need to obtain information from the foreign producer in order to submit the formula.

A serving is the quantity that is normally served in a glass for one person. If you ask at the bar for a double whisky, you are asking for 2 servings of whisky to be served at the same time. In the US a bottle of whisky is normally 750 ml (or a “fifth” of a gallon), which would be 15 servings. Traditionally here, one serving of beer is considered to be 12 ounces.

Is the place where the product is created.

The bottling is the place where the liquid is placed in bottles or other containers and is usually where the product is labelled as well.

Is the company who has control of the product after the bottling and before it is shipped. 

Generally, it is the country of origin. For the wine, the varietal designation is the name of the dominant grape used in the wine. In most cases, the wine may only be designated using a grape varietal if 75% of the wine is derived from that variety of grape. When a varietal designation is used on a label, it must be accompanied by an appellation of origin. 

In the case of wine, the appellation of origin is the place where most of the grapes used in the wine were grown. It can be a viticultural area if at least 75% of the wine is derived from grapes grown in the indicated area. When an appellation of origin is required, it must appear on the same label and in the same view as the varietal designation.

All wine contains some natural sulfites. Sulfites are also commonly added to wine for preservation purposes. If your wine contains 10 or more parts per million of sulfites, your label must include a sulfite declaration. If you do not want to include the declaration of sulfites for wine containing less than 10 parts per million of sulfites, you will need to submit your product to the TTB for a sulfite analysis pre-COLA evaluation.

Class and type designations identify the product in the bottle. Federal regulations describe the ingredients and processes used to produce a product of a given class or type. Class and type must be stated on the brand label. For some distilled spirits, the label must include class and type. For others, such as vodka, the label only needs to state the product type. Please read very carefully all the text below, at the end of it you will indicate the number that corresponds to the product that goes in the bottle. 

While you are required to publish the addresses of the companies involved in producing and handling the product, you are permitted but not required to publish the FDA registration number on the label. If you are not registered with the FDA as of yet, we will still provide you with all the information needed for your graphic artist to create a label that complies with the FCR of the US, beforehand, however your TTB agent may not apply for label approval from the TTB unless you have registered with the FDA.

The bioterrorism law: (See TERM T3) In the event of a problem with the product (by accident or intentional) the US wants to trace the product to determine responsibility. If you make the product and you also bottle and keep it under your control all the time until you deliver it to the shipper, then, you answer the appropriate question and you skip all the questions about the bottling and commercial company. This means you are responsible for the full stages of the making process.

However, if the bottling process is done in a different location, in a different address than the address of the distillery, you must fill up the part concerning the bottling company even if you own both companies.

While you are required to publish the addresses of the companies involved in producing and handling the product, you are permitted but not required to publish the FDA registration number on the label. If you are not registered with the FDA as of yet, we will still provide you with all the information needed for your graphic artist to create a label that complies with the FCR of the US, beforehand, however your TTB agent may not apply for label approval from the TTB unless you have registered with the FDA.

The bioterrorism law: In the event of a problem with the product (by accident or intentional) the US wants to trace the product to determine responsibility. If you make the product and you also bottle and keep it under your control all the time until you deliver it to the shipper, then, you answer the appropriate question and you skip all the questions about the bottling and commercial company. This means you are responsible for the full stages of the making process.

While you are required to publish the addresses of the companies involved in producing and handling the product, you are permitted but not required to publish the FDA registration number on the label. If you are not registered with the FDA as of yet, we will still provide you with all the information needed for your graphic artist to create a label that complies with the FCR of the US, beforehand, however your TTB agent may not apply for label approval from the TTB unless you have registered with the FDA.

The bioterrorism law: In the event of a problem with the product (by accident or intentional) the US wants to trace the product to determine responsibility. If you do not make the product and you do not bottle it, but you have it under your control only for commercial purposes, it would mean that your responsiblity is limited to the time you had the product under your control. 

Only your Importer (with the basic Importer License) may submit the formula and the label for approval. In the event that your product needs the formula approval, Importer would need to give specific information to the TTB as it does not accept generic descriptions for ingredients such as "herbs."  The list of ingredients must, among other things, include all sources of alcohol, herbs added, coloring materials, natural and artificial flavoring materials, natural and artificial sweeteners, etc.

Conclusion:
Here is what you need to get your alcoholic beverage product into the USA.

1-      An Importer. This is not the person or entity that buys your product, this is the person who has a license to deal with the TTB on your behalf.

2-      A label designed according the laws and rules for the US, no other label will be admitted if it does not comply with the Federal Code of Regulations.

3-      Only your licensed and authorized importer can submit the label to the TTB on your behalf.

4-      If your product needs formula approval, only your Importer may submit it to the TTB for approval.

5-      You need to register all the companies who have contact with the product up to the moment of its shipping, with the FDA.

6-      You need a licensed FDA agent, with an FDA registration number to accept to be your registered agent and to register you with the FDA.

7-      You need a list of distributors, your TTB agent will most likely have it, and he/she does have access to it (and there are about 20,000). You can do business with the distributors using the name and licenses number of your Importer (if he or she agrees).

We recommend you do not print labels until you have the TTB approval for the label, and in some cases the formula approved as well.