English is not Enough: The Language of Food and Drug Labels

Abstract

Food and drug labels must respond to the needs of the increasing linguistic minority population in the United States. Currently, the FDA only requires that food and drug labels be in English. Due to the growing segment of the population that cannot understand English, the FDA is not able to satisfy its goals of communicating valuable information to consumers through food and drug labels. The majority of the non-English speaking population speaks Spanish, suggesting that the FDA must target this specific linguistic minority with any policy response. The paper poses the question of whether the FDA should require food and drug labels in another language in addition to English. The paper is divided into five chapters. The first chapter covers the history of the FDA's approach to food and drug labels. The California Supreme Court's decision in Ramirez v. Plough is analyzed in the second chapter. The third chapter examines the Canadian model of bilingual French/English food and drug labels. Six possible policy options are covered in chapter four. Chapter five, the policy recommendation, concludes that the FDA should ask for comment on a proposal for bilingual English/Spanish warnings and directions on over-the-counter drugs combined with a foreign language patient package insert program for prescription drugs. The paper concludes that a mandate of bilingual over-the-counter drug labels combined with a foreign language patient package insert program is an appropriate and proportionate FDA response to the increasing needs of linguistic minorities.