4. Labeling Requirements

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4. Labeling Requirements

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Whisky
USA

This section provides information on labeling requirements and the label approval process.

4.1 Mandatory Labeling Parameters

General Food

Food and beverage labeling is complex and there are restrictions related to the size of the package and, in some instances such as infant formula, additional requirements. See 21 CFR 101. [1]. Many requirements for General Food do not apply to alcoholic drinks as they later have their own set of labeling requirements.

Category

Alcoholic drinks

Alcoholic beverages have their own set of labeling requirements based on the type of product [2].

In January 2025, TTB proposed to make the following labeling inclusion:

1. All major food allergens used in the production of alcoholic beverages under Notice 238 [16]

Under the proposed regulations, unless an exception applies, labels must declare milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, as well as ingredients that contain protein derived from these foods, if used in the production of the alcohol beverage.

AND

2. Nutritional labeling on all alcoholic beverages which includes distilled beverages mandatory under Notice 237 [17,18].

The alcohol, caloric, and nutrient content would be in the “Alcohol Facts” statement on all alcoholic beverage labels. The petitioners provided the following example [19].

For both proposals, the TTB proposes a compliance date of 5 years from the date that a final rule resulting from this proposal is published in the Federal Register. The comment period was to be closed on 15 April 2025 but has been extended to 15 August 2025 [18].

Product

Whisky

The mandatory label information for distilled spirits is defined in 27 CFR part 5 [2] and 27 CFR part 16 [8] as summarized [3] below (please select any required information to open the TTB page describing the requirement in detail):

Required information on a label – same field of vision*	Required information that may appear on any label
Brand name Class or Type Designation (the kind of distilled spirits based on the standards of identity) Alcohol Content	Age Statement Color Ingredient Disclosures (if applicable) Commodity Statement (if applicable) Health Warning Statement Name and Address Net Contents Country of Origin (imports only)

*This mandatory information must be within the same field of vision (which means a single side of a container (for a cylindrical container, a side is 40 percent of the circumference) where all of the pieces of information can be viewed simultaneously without the need to turn the container).

Additional information regarding the specifics applicable to each component of the label is available via a TTB checklist [4].

There is optional information that can be added to a distilled spirits label:

Most commonly used	Dietary information
Distinctive or Fanciful Name (mandatory for specialty products and optional for other spirits) Alcohol Content (may be expressed in degrees of proof in addition to the required alcohol by volume statement)	Gluten Content Statements Major Food Allergen Labeling Statements Related to Nutrient Content: Serving Facts Alcohol Facts Sugar Content
Production claims	Miscellaneous
Organic Claims	Personalized Labels

4.2 Languages

General Food

All food and beverage products must be labeled in English. If additional languages appear on the label, the information must be identical to that which is in English, 21 CFR 101.15 [1].

Category

Alcoholic drinks

All label information must be in English.

Regulations further specify the following as applicable to alcoholic drinks [5]:

Product

Whisky

All label information must be in English.

4.3 Mandatory Information on Stickers

General Food

It is permitted to use additional stickers on a package to be compliant.[1]

Category

Alcoholic drinks

A foreign manufacturer cannot label a product to comply with their local regulations and then add another label with the information required by US law. The only label allowed on the bottle that is exported to the USA is the one that has a COLA.

Additional stickers are permitted under very specific conditions [6].

5.42 - below applies to USA-based producers or when the Customs & Border Protection Agency requires that a shipment, held at the port, must be relabeled with a new label that has a COLA.

5.43 addresses relabeling by an entity that is not the original bottler.

In 5.44, the ’sticker’ identifies the wholesaler, retailer, or customer.

Product

Whisky

Same as "Category" (alcoholic drinks) above.

4.4 Product Legal Name

Product

Whisky

The legal name for a whisky is dependent upon the recipe used that matches one of the types of distilled spirits noted in Table 1 in Section 3.8 of this guidebook.

4.5 Product-specific Labeling Statements

Product

Whisky

Please refer to Section 4.1 above.

4.6 Authority Approval

General Food

Labels for human food products do not require pre-approval from the FDA.

Category

Alcoholic drinks

TTB must pre-approve the label that will be used on an alcoholic beverage.

There is a web-based process for submitting a label and obtaining a Certificate of Label Approval (COLA). (The manufacturer must register with TTB to use the web-based process.)

Definition of COLA [7]:

There is no cost for label approval. If all the label elements are correctly contained on the proposed product label, approval can be obtained in several weeks. If there is missing or disallowed information, the approval can take several months.

The process to apply for COLA is described in 27 CFR Part 5 Subpart B [8], including specific sections for COLAs for distilled spirits imported in containers.

Furthermore, there is an interactive web-based tool that can help with a distilled product label design. [9]

Product

Whisky

Same as "Category" (alcoholic drinks) above.

4.7 Additional Notes on Labeling

Any label that is not an integral part of the container must be affixed to the container in such a way that it cannot be removed without thorough application of water or other solvents [10].

Mandatory information must comply with specific criteria regarding legibility, capitalization of letters, contrasting background, and positioning of the information on the label [11]. Particularly, all capital and lowercase letters in statements of mandatory information must meet the following type size requirements [12]:

Containers of more than 200 milliliters: all mandatory information must be in script, type, or printing that is at least two millimeters in height.
Containers of 200 milliliters or less: all mandatory information must be in script, type, or printing that is at least one millimeter in height.

There are specific container sizes permitted for distilled spirits, known as ‘standards of fill’ [13]. The standards for distilled beverages are:

Other requirements are described in the regulation regarding personalized labels [14].

Finally, requirements also exist for cartons, coverings, and cases containing the bottles sold at retail other than shipping containers [15].

The standards of fill have been updated for distilled beverages to include the following sizes: 187, 250, 331, 350, 355, 475, 500, 570, 710, and 945 milliliters sizes and 1.5, 2, 3, 3.75 liter sizes[20].