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What is a Food?
Introduction to the Food, Drug and Cosmetic Act
Most foods are regulated under the FD&C act
Classification of a product as a food or drug determines how rigorously the product is regulated
Definitions (please note that these have been paraphrased for simplicity):
Food: 1) articles used for food or drink for man or other animals, 2) chewing gum, 3) articles used for components of any
other such articles
Drug: 1) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other
animals; 2)articles (other than food) intended to affect the structure or any function of the body of man or other animals
Device: an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar related
article or component, part or accessory that 1) is used in the diagnosis or treatment of a condition, 2) affects the
structure or function of the body- not primarily via chemical action
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E
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skin moisturizers,
perfumes and lipsticks
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Food Additive: In its broadest sense, a food additive is any substance added to food
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Dietary supplement: A dietary supplement is a product taken by mouth that is intended to supplement the diet and that
contains one or more "dietary ingredients
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Dietary supplements
must be labeled as such and must not be represented for use as a conventional food or as the sole item of a meal or the
diet
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Conventional foods must have a "Nutrition Facts" panel on their labels, but dietary
supplements must have a "Supplement Facts" panel
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Discussion Questions 2
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8
2
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Could bottled water be characterized as a food, a drug, a dietary supplement or all three? How?
Some products can meet the definitions of being a food, drug and a dietary supplement- for example when a product
has two intended uses
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 Because:
o Firstly, in accordance with the definition of a ‘food’ which states that ‘food’ means: 1) articles used for food
or drink for man or other animals, 2) chewing gym, and 3) articles used for components of any such article,
bottled water would be considered a food since it is a drink for man
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Secondly, I would not classify bottled water as a drug, because it is consumed primarily for taste, and nutritive value
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Finally, I would not class bottled water as a form of a dietary supplement because the term “dietary supplement” means
a product that, among other requirements, “is not represented for use as a conventional food or as a sole item of a meal
or the diet
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Additionally,
bottles of bottled water are not labeled as a dietary supplement, and they do not have a ‘supplements facts’ panel on
the container- as dietary supplements must
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2
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Would your answer change if the product were cherry juice concentrate?
I think that cherry juice concentrate, can be classified in all three groups
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o Secondly, cherry juice concentrate has therapeutic claims such as being beneficial to heart health as a
result of containing anthocyanins and therefore could also be considered a drug
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 Additionally, cherry juice concentrate is not typically considered a conventional food
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2
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When would blackboard chalk be a drug?
A drug is firstly defined as an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of
disease in man or other animals- therefore if blackboard chalk was given to a person in an attempt to prevent a disease,
then it could be considered a drug- as long as the chalk was considered safe and was not being consumed primarily for
taste, aroma or nutritive value
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2
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Sky High brand glue is not only efficacious as glue but is widely known to induce a high when sniffed
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Can the glue be regulated by
the FDA?
It is the role of intended use that is in question here
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However, because the glue is firstly named ‘Sky

High’- suggesting its use to induce a ‘high’ is paramount, and secondly because it is being heavily advertised in
magazines read by people into drug culture, this questions the manufactures intent, especially as the glue is known to
induce a ‘high’ if sniffed
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In terms of regulations, it may help, if the glue is tested and the ‘high’ inducing effects of the glue are scientifically
proven, i
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chemical changes/ effects are seen on the brain, or in the body, then the FDA can make a claim that the glue
should be classified as a drug in accordance with the definition of a drug which states that drugs are: articles (other than
food) intended to affect the structure or any function of the body of man or other animals
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e
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2
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Is the definition of ‘food’ good statutory drafting?
In terms of food, good statutory drafting refers to the clarity of a defining a product as a food or not
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Furthermore, in many cases manufacturers can market their products in a certain way to get around their products
being considered a food- for example if a chewing gum manufacturer marketed their product as a laxative gum, it would
be considered a drug and not a food- despite chewing gum clearly being considered a food under normal circumstances
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7
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Coffee is not consumed for its nutritional value
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Whereas, a product is considered a drug if it is intended
for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; or if it is an article
(other than food) that is intended to affect the structure or any function of the body of man or other animals
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In terms of coffee it is the intended
use that would switch it from being a food, to being a drug because it has already been said that coffee is not drunk for
its nutritional value
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2
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If coffee was only promoted as a stimulant, would it still be regulated as a food?
Foods are defined in terms of their functions as foods, rather than in terms of their source, biochemical composition, or
digestibility
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Especially as coffee clearly fits into the category of being a drug- especially if the manufacturers
intend to market it specifically as such- as it can affect the function of the body

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