Sec. 562.750 Labeling of Food Articles Distributed Solely in Puerto Rico (CPG 7120.04)
BACKGROUND:
Regulations promulgated under the Federal Food, Drug, and Cosmetic Act, 21 CFR
*101.15(c)(1)*, provide that:
"All words, statements, and other information required by or under authority of
the act to appear on the label or labeling shall appear thereon in the English language:
Provided, however, that in the case of articles distributed solely in the Commonwealth of
Puerto Rico or in a Territory where the predominant language is one other than English,
the predominant language may be substituted for English."
In Puerto Rico the predominant language has been and still is Spanish. Since l945, when
the Philippines became independent, Puerto Rico has been the only area subject to the act
where Spanish or any other language predominates over English.
Some firms print labels in Spanish, *for use on articles distributed solely* in Puerto
Rico. These labels would be considered violative if used on articles shipped to other
areas.
*To avoid the problems created by labels for which use must be restricted to Puerto
Rico, many firms choose to print their labels or labeling in both English and Spanish. A
question has arisen as to how such labels should be prepared to comply with both the
Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.*
POLICY:
Labels and labeling of articles distributed solely in Puerto Rico may be in Spanish
only. Such labels are considered violative for articles distributed elsewhere in areas
subject to the Federal Food, Drug, and Cosmetic Act.
Labels may bear all information required by or under authority of the Federal Food,
Drug, and Cosmetic Act printed both in English and in Spanish. Such labels may be used on
articles distributed anywhere in the United States.
We prefer that such labels have two principal display panels, one bearing all required
information printed in English, the other all required information in Spanish. Each panel
should comply with the requirements of the Fair Packaging and Labeling Act and
regulations.
However, other ways of presenting the required information are acceptable provided all required information appears with sufficient prominence and conspicuousness in each language, and in accord with applicable provisions of the Fair Packaging and Labeling Act and regulations.
*Material between asterisks is new or revised.*
Issued: 7/08/69
Reissued: 10/1/80
Revised: 2/1/89