I
assume that what you mean is what is the legal difference
between these products. Obviously, the physical impact
of consumable substance upon a human or animal body
does not depend upon its classification. Vitamin A
doesn’t
affect you any differently whether you consume it from
a cereal, a vitamin pill or as part of a prescription
drug.
The
legal difference between these three categories is dependent
on how they are marketed. The FDA does not pre-review or pre-approve
the marketing of food products. However, foods must be composed
of ingredients that are GRAS (Generally Recognized as Safe)
and any health claims are strictly limited to those permitted
by FDA regulation. On the other hand, drugs (both OTC and prescription)
cannot be marketed without prior FDA approval. In the case of
OTC drugs, the FDA has a series of monographs (essentially standards
of identity) which allow any drugs meeting the standards in
those monographs (e.g. aspirin) to be marketed after receiving
routine FDA approval. Of course, new drug therapies are rigorously
tested for efficacy and safety prior to being approved.
Dietary
supplements fall in a category that is between food and drugs.
At one time the FDA classified what we now call dietary supplements
as food. Because of the limitations placed upon the ingredients
that can be used in food products and the limitations on health
claims that can be made for those products, the Dietary Supplement
Health and Education Act of 1994 created a separate category
for supplements.
Unlike
food, supplements can contain non-GRAS ingredients. Unlike
drugs, supplements do not need prior FDA approval to be marketed
although manufacturers of new supplement products may have
to submit literature to the FDA demonstrating the supplement’s
safety. As is true of any claim on any product, all supplement
health claims have to be factually sustainable
Because
supplements cannot be marketed as either food or drugs, their
advertising is limited to “structure function” claims.
For example, supplements cannot be advertised with descriptive
terms commonly associated with food such as like “delicious,”
“refreshing,” or “great as a salad dressing.”
After all, the stuff is supposed to be medicinal. On the other
hand, supplements cannot be advertised as drugs either. Therefore
words like “cures” or “treats” cannot
be used while terms such as “maintains” can be used.
As our supplement clients know, despite hundreds of pages of
commentary pertaining to the FDA’s supplement regulations,
the demarcation lines between food/supplement marketing and
between supplement/drug marketing can be very unclear.