When weighing the specific findings presented
here, or those related to other alternative pharmacotherapies,
there are other issues that clinicians
should consider. Key among them is that the
regulations that govern the manufacture and sale
of dietary supplement products are less restrictive
than those overseeing the manufacture and sale of
conventional antidepressants.147 It was only
relatively recently (June 2007) that legislation was
enacted that requires dietary supplement manufacturers
to verify the identity, purity, strength, and
composition of their products. Many consumers, as
well as more than a third of physicians in one
survey (37%),148 are unaware that the safety and
efficacy of dietary supplements are not systematically
evaluated before they hit store shelves.
Generally these products routinely enter the U.S.
marketplace without undergoing FDA review,
because they are considered food supplements
under the provisions of the Dietary Supplement
Health and Education Act (DSHEA) of 1994.
DSHEA limits FDA’s ability to regulate their
manufacture and marketing. As a result, unsubstantiated
claims of effectiveness are commonly
implied in product messaging, as is a lack of
balanced information pertaining to the potential
for side effects. Until the recent implementation of
the Dietary Supplement Nonprescription Drug
Consumer Protection Act (January 1, 2008), there
was no provision under any law or regulation that
the FDA enforced that required a marketer of a
dietary supplement to disclose to FDA (or to
consumers) any important safety information
regarding their product. As a result, it is conceivable
that adverse effects associated with dietary
supplement use have been historically underreported
and underestimated. It has been estimated
that FDA learns of fewer than one percent of
adverse events involving these products.149
Contributing factors to such under-reporting
include physicians often being unaware that their
patients are using dietary supplements150,151 and
that general practitioners are not familiar with the
risk profiles of CAM therapies.1