FDA Regulation of Nutritional Supplements

Under the Dietary Supplement Health and Educationstroke, hepatitis, seizure, psychosis, and even death.
Act of 1994 (DSHEA), manufacturers of nutritionalFor more information on other potentially dangerous
supplements are responsible for ensuring that theirdietary supplements, you can visit the FDA website.
products are safe before they are marketed.2. Product information
Manufacturers of nutritional supplements do not needFDA regulation of nutritional supplements also
to provide information to the Food and Drugincludes, to an extent, the monitoring of the
Administration Board, before they can get a producttruthfulness of label claims. FDA regulation of
out on the market. They also do not need thenutritional supplements requires that the labels of
board's review and approval of the supplement'sdietary supplements include the statement of
ingredients before selling these products.identity, the net quantity of contents, the
FDA regulation of nutritional supplements is differentstructure-function claim: "This statement has not
from those covering "conventional" foods and drugbeen evaluated by the Food and Drug Administration.
products; it takes on a post-marketing responsibilityThis product is not intended to diagnose, treat, cure,
by way of monitoring safety and product information.or prevent any disease," the directions for use, the
1. Monitoring safetySupplement Facts panel (includes serving size,
FDA regulation of nutritional supplements involvesamount, and active ingredient), the other ingredients
monitoring the safety of a supplement product thatin descending order of predominance and by common
is out on the market. Before the FDA can takename or proprietary blend, the name and place of
action to restrict the use of a nutritional supplement,business of manufacturer, packer or distributor, and
it has to show the hazards associated with the usethe address to write to for more product
of the said nutritional supplement.information.
FDA regulation of nutritional supplements can be3. Best practices
initiated in the form of studies, reviews, reports,FDA regulation of nutritional supplements also includes
scientific literature, and public comments. This wasestablishing good manufacturing practices, or GMPs,
what happened in 1997, when the FDA proposed tofor manufacturers of nutritional supplements. To be
limit the amount of ephedrine alkaloids (also known assure that the ingredients packed inside the marketed
ephedra, Chinese ephedra, Ma huang, and epitonin) innutritional supplement product are the right
dietary supplements, as it was found to cause aingredients and amount, choose a manufacturer that
range of side effects such as dizziness, nervousness,is GMP-compliant.
changes in heart rate and blood pressure, chest pain,