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.*
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.*
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.