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FDA Regulation of Nutritional Supplements
Manufacturers of nutritional supplements do
not need to provide information to the Food and
Drug Administration Board, before they can get
a product out on the market. They also do not
need the board's review and approval of the supplement's
ingredients before selling these products.
FDA regulation of nutritional supplements is
different from those covering "conventional"
foods and drug products; it takes on a post-marketing
responsibility by way of monitoring safety and
product information.
1. Monitoring safety
FDA regulation of nutritional supplements involves
monitoring the safety of a supplement product
that is out on the market. Before the FDA can
take action to restrict the use of a nutritional
supplement, it has to show the hazards associated
with the use of the said nutritional supplement.
FDA regulation of nutritional supplements can
be initiated in the form of studies, reviews,
reports, scientific literature, and public comments.
This was what happened in 1997, when the FDA proposed
to limit the amount of ephedrine alkaloids (also
known as ephedra, Chinese ephedra, Ma huang, and
epitonin) in dietary supplements, as it was found
to cause a range of side effects such as dizziness,
nervousness, changes in heart rate and blood pressure,
chest pain, stroke, hepatitis, seizure, psychosis,
and even death. For more information on other
potentially dangerous dietary supplements, you
can visit the FDA website.
2. Product information
FDA regulation of nutritional supplements also
includes, to an extent, the monitoring of the
truthfulness of label claims. FDA regulation of
nutritional supplements requires that the labels
of dietary supplements include the statement of
identity, the net quantity of contents, the structure-function
claim: "This statement has not been evaluated
by the Food and Drug Administration.
This product is not intended to diagnose, treat,
cure, or prevent any disease," the directions
for use, the Supplement Facts panel (includes
serving size, amount, and active ingredient),
the other ingredients in descending order of predominance
and by common name or proprietary blend, the name
and place of business of manufacturer, packer
or distributor, and the address to write to for
more product information.
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