DescriptionDHEA is a supplement with a long history of
controversy. In the 1980s it was promoted by supple-
ment makers as a ‘‘miracle’’ product that would
improve athletic performance, build muscle, burn fat,
restore sexual potency, and prevent aging. Many of
these claims are still made by supplement makers
today. In 1985, the Food and Drug Administration
(FDA) banned DHEA for sale in the United States
because of its potential for abuse and the high risk of
serious side effects. DHEA was also banned by several
sports organizations including the International
Olympic Committee and the National Football
League. However, in 1994, the United States Congress
passed the Dietary Supplement Health and Education
Act (DSHEA). Under this law, DHEA met the defi-
nition of a dietary supplement and could once again be
sold without a prescription in the United States.
DSHEA regulates supplements such as DHEA in
the same way that food is regulated. Like food manu-
facturers, manufacturers ofdietary supplementsdo not
have to prove that their product is either safe or effec-
tive before it can be sold to the public. Manufacturers of
conventional pharmaceutical drugs, however, must
prove both safety and effectiveness in humans before
a new drug is approved for use. With dietary supple-
ments, the burden of proof falls on the FDA to show
that the supplement is either unsafe or ineffective before
it can be restricted or banned. Information about a
supplement’s safety and effectiveness is normally gath-
ered only after people using the product develop health
problems or complain that the product does not work.
In the mid-2000s, there was pressure to reclassify
DHEA as a hormone and ban its over-the-counter
sale, but dietary supplement manufacturers have suc-
cessfully fought this move. Federal law requires that all
manufacturers of dietary supplements and over-the-
counter drugs report consumer complaints of adverse
events (negative side effects) to the FDA. This makes
accumulating information on the safety of DHEA
faster and easier.
DHEA is produced mainly in the adrenal glands.
These are small, compact hormone-producing tissues
located just above each kidney. The adrenal glands
convert cholesterol into DHEA and release it into
the bloodstream. DHEA is also produced in smaller
amounts by the testes, liver, and possibly the brain.Tablet form of DHEA.(James Keyser//Time Life Pictures/Getty Images. Reproduced by permission.)
DHEA