66 Food & Drug L.J. 265 (2011)
Biopharming, Bananas and Bureaucracy: The Banana Vaccine as a Case Study for Products That Straddle the Definitional Food/Drug Divide; Birdsall, Margaux

handle is hein.journals/foodlj66 and id is 277 raw text is: Biopharming, Bananas and Bureaucracy: The Banana
Vaccine as a Case Study for Products that Straddle the
Definitional Food/Drug Divide
MARGAUX BIRDSALL
I. INTRODUCTION
At first glance, most people can identify a food. It looks edible, smells edible
and fits neatly into the mental perception of a food product. Despite this clear
imagery, a food might not always be a food. In the past decade, bananas, potatoes
and tomatoes have all been genetically modified to produce antigens that vaccinate
the consumer against diseases.
The growth of plants traditionally used for food but genetically altered to pro-
duce drugs is called biopharming.2 The products of this novel industry have started
to come onto the market and soon, many more will be available; from vaccines in
bananas, to plants producing insulin,3 to food crops that produce proteins for use
in other drugs.4
The traditional methods of vaccination against a disease are expensive and com-
plicated. Often, vaccination requires refrigeration of the vaccine, multiple shots and
products that are expensive to produce.5 The refrigeration requirement in particular
imposes great difficulties on distribution and the overall cost.6 Using a food vaccine
solves that problem. The food vaccines do not require refrigeration and in the case
of a banana, would be cheap to grow.' Every new product that brings a potential
benefit to society also brings risks. Despite that reality, new products like a food
vaccine will still come on the market and society must be ready to regulate them.
These products, like all foods and drugs, must be regulated to make sure they
conform to certain safety standards. As the primary agency responsible for the
regulation of food and drugs,8 the Food and Drug Administration (FDA) is the
most likely agency to be responsible for regulating these genetically modified plant
vaccines. How FDA should go about this process however, is unclear. The banana
vaccine, for example, could be treated as a food, since it is an edible banana that
confers nutritive value, or as drug, since it is also a vaccine against hepatitis B. As
yet, there are no regulations for a food that is a drug.
Ms. Birdsall is a 2011 graduate of the Chicago-Kent College of Law.
1 See DANIEL F. KLESSIG, BOYCE THOMPSON INSTITUTE FOR PLANT RESEARCH. EXPLORATIONS: 78TH
ANNUAL REPORT 24 (2001).
2 Kisung Ko & Hilary Koprowski. Plant Biopharming of Monoclonal Antibodies. 11(1) VIRUS
RESEARCH 93, 94 (2005).
Hugh Levinson, Firm in GM Insulin Breakthrough, BBC NEWS, April 4, 2007, http:/news.bbc.
co.uk/2/hi/healthl6518787.stm.
Ko & Koprowski, supra note 2, at 94.
See, e.g National Institute of Standards and Technology, Proper Vaccine Refrigeration Vital to
Putting Disease on Ice, (January 28. 2010), http://wwwsciencedaily.com/releases/2010/01/1001261 75828.
htm. See also, Center for Disease Control and Prevention. Hepatitis B: FA Qs for the Public, http://www.
cdc.govfhepatitis/B/bFAQ.htm#statistics (last visited April 16, 2010).
6 National Institute of Standards and Technology, supra note 5.
See Remigius N. Nwabueze, What Can Genomics and Health Biotechnology Do for Developing
Countries, 15 Ata. L.J. Sa. & TECH. 370, 384 (2004-2005).
SFOOD AND DRUG LAW AND REGULATION 5 (David 0. Adams et al. eds., 2008).

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