Resources Biopharming, Bananas and Bureaucracy:...

Biopharming, Bananas and Bureaucracy: The Banana Vaccine as a Case Study for Products that Straddle the Definitional Food/Drug Divide

May 2011

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.


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