*Regulations promulgated under the Federal Food, Drug, and Cosmetic Act require that if the label or the labeling of an article subject to the act contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act shall appear on the label or labeling in the foreign language (21 CFR 101.15(c)).
The purpose of this regulation should be considered when deciding whether a representation in a foreign language necessitates the repetition of mandatory statements in that language. Since certain consumers may not understand English, it is the intent of the regulation that they be furnished the mandatory label information in the language they understand.
When the only accepted common or usual name for a food is in a language other than English, use of this common or usual name does not necessitate the repetition of all required information in that language. For example, the U.S. Department of Agriculture has defined certain products with foreign names such as "chili con carne," "tamales," or "chop suey vegetables with meat." FDA, in Sec. 567.100 (CPG 7116.01) recognizes "antipasto" as the common or usual name for an appetizer consisting of mixed vegetables and fish products. Many foreign names such as "brie," "marzipan," "baklava," "petit fours," "croissants," "rigitoni," etc. are also acceptable.*
In deciding whether a representation in a foreign language makes it necessary for information required by or under authority of the act to appear on the label or labeling in that language, we should consider whether the foreign language representation, *such as a prominent repetition in a foreign language of the English name of a food,* is intended to bring the article to the attention of persons who may not understand English. The impact of the entire label and the setting in which statements are presented should be considered in determining this. It is not possible to prepare guidelines detailed enough to cover every possible situation.
*Foreign language representations as in the following examples, standing alone, do not necessarily indicate that an article is intended to attract the attention of persons who may not understand English:
- Use of an accepted name for which there is no English equivalent, such as "antipasto."
- Use of a foreign name included in a standard of identity, such as, "koch kaese," "spaghetti," or "vermicelli."
- Use, in a brand name, motto, or trade-marked design, of one or more foreign words.*
*Material between asterisks is new or revised*
Revised: 2/1/89, 3/95