January 28, 2013
In my opinion… to whom it
may concern:
DIETARY SUPPLEMENTS ARE FOODS.
The law is clear. Dietary Supplements are foods. The
Dietary Supplement Health and Education Act of 1994 (DSHEA) says
§3. Definitions. (a) Definition of
Certain Foods as Dietary Supplements. Section 201 (21 U.S.C. 321) is amended by
adding at the end the following: (ff) The term "dietary supplement" -
(1) means a product ...intended to supplement the diet that bears or contains
one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral;
(C) an herb or other botanical; (D) an amino acid; (E) a dietary substance...
or (F) a concentrate, metabolite, constituent, extract, or combination of
[same].
As food, dietary supplements are manufactured under cGMPs
patterned after food cGMPs and are sold with labeling that provides information
about their nutrient content.
In
its FAQ page about Medical Foods, FDA indicates that Dietary Supplements can
fit in that category and can therefore be offered for the dietary management of
health conditions, such as cognitive decline associated with aging. One health claim approved by FDA reads:
“Consumption of phosphatidylserine may reduce
the risk of cognitive dysfunction in the elderly.”
Under these circumstances, it is my professional opinion,
to a reasonable degree of certainty, upon which you may rely, that individuals
may choose to achieve and maintain a healthy status through the use of food
substances, including dietary supplements. Every person has the fundamental
human right to choose what means that person will use for that purpose.
Respectfully submitted,
Ralph Fucetola JD
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