title: Biopharming, bananas and bureaucracy: the banana vaccine as a case study for products that straddle the definitional food/drug divide.
abstract: This paper examines the definition of the terms "food" and "drug" as used in the Food, Drug and Cosmetic Act through the lens of biopharmed products. The paper uses the so-called "banana vaccine" as a case study to highlight the problems that occur when attempting to regulate a product that could be safely used as a food or as a drug. Specifically, the examination of this model illustrates the problems in the current definitional scheme. The paper considers how a product that straddles the definitional line between food and drug could be regulated and proposes a reformation to how the definitions are applied to products to better suit new technology in food and drugs.
authors: Chicago-Kent College of Law, USA.
authors: Margaux
authors: M
authors: Birdsall
mesh_terms: D000383:Agriculture / Q000331:legislation & jurisprudence* / Q000379:methods; D030841:Food, Genetically Modified; D005638:Fruit / Q000276:immunology / Q000378:metabolism; D006801:Humans; D007880:Legislation, Drug; D007881:Legislation, Food; D028521:Musa / Q000235:genetics / Q000378:metabolism; D030821:Plants, Genetically Modified / Q000276:immunology / Q000378:metabolism*; D014481:United States; D014486:United States Food and Drug Administration; D014611:Vaccination / Q000379:methods*; D014612:Vaccines / Q000096:biosynthesis* / Q000235:genetics
chemical_list: D014612:Vaccines