4. Labeling Requirements

General Foods
USA

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

4.1 Mandatory Labeling Parameters

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]

 4.2 Languages

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]. 

4.3 Mandatory Information on Stickers

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

4.4 Product Legal Name

N/A (please refer to Section 4.4 of product-specific guidebooks).

4.5 Product-specific Labeling Statements

N/A (please refer to Section 4.5 of product-specific guidebooks).

4.6 Authority Approval

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

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 [2].

Mandatory information must comply with specific criteria regarding legibility, capitalization of letters, contrasting background, and positioning of the information on the label [3]. Particularly, all capital and lowercase letters in statements of mandatory information must meet the following type size requirements [4]:

• 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’ [5]. The standards for distilled beverages are:

Other requirements are described in the regulation regarding personalized labels [6].

Finally, requirements also exist for cartons, coverings, and cases containing the bottles sale at retail other than shipping containers [7].

4.8 References

1. 21 CFR Part 101 – FOOD LABELING 

https://eur-lex.europa.eu/eli/reg/2011/1169/oj

2. 27 CFR 5.51 Requirement for firmly affixed labels  

https://www.ecfr.gov/current/title-27/section-5.51

3. 27 CFR 5.52 Legibility and other requirements for mandatory information on labels

https://www.ecfr.gov/current/title-27/section-5.52

4. 27 CFR 5.53 Minimum type size of mandatory information