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Buyer
Be Aware
Here
are some facts about dietary supplements:
- Manufacturers
are responsible for making sure that their dietary supplement
is safe. They do not need to register with FDA or get FDA
approval before producing or selling their product. Investigations
into whether a supplement may react poorly in combination
with certain drugs, and in certain people, are not required.
Should numerous reports of a bad reaction surface once a
product reaches the market, the FDA will intervene. Then
it is up to the FDA to show that the product is unsafe.
- Often
some scientific evidence supports a manufacturer's claims
about a given supplement. But the current law allows manufacturers
to make their claims without ever submitting such studies
to the FDA. Manufacturers are required to have substantiating
evidence on hand in case the FDA chooses to investigate.
- Manufacturers
are responsible for ensuring that their product's ingredient
list is accurate. But some supplements have been shown to
contain different amounts of the active ingredient from
bottle to bottle within the same brand. In one case, Aurora
Health Care withdrew its brand of St. John's wort from 70
retail pharmacies in 1999 when a reporter discovered that
the product contained only 5.3% of the amount of active
ingredient claimed on its label.
- The
FDA specifically prohibits manufacturers from claiming that
dietary supplements can treat or prevent actual disease.
Products may only describe ways in which they affect the
body's "structure or function" with statements such as "supports
the immune system." In a new ruling, products can now claim
to treat certain "life stage" conditions, such as acne associated
with adolescence, or morning sickness during pregnancy.
Supplements must carry a disclaimer clarifying that such
statements have not been evaluated by the FDA.
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