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Designer Drug
THG
The Food and Drug Administration (FDA) has recently been
made aware of a substance called tetrahydrogestrinone (THG),
which is reportedly used by athletes to improve their
performance. Based on the agency’s analysis of this
product, the FDA has determined that THG is an
unapproved new drug. As such, it cannot be legally
marketed without FDA approval under the agency’s
rigorous approval standards that are meant to ensure
that drugs sold to American consumers are safe and
effective.
The FDA is concerned about the marketing and use of this
unapproved product and is working with other Federal law
enforcement agencies to aggressively engage, enforce,
and prosecute those firms or individuals who
manufacture, distribute, or market THG. “Our mission is
to protect the American public from this potentially
harmful product,” said John Taylor, FDA’s Associate
Commissioner for Regulatory Affairs.
In the meantime, the FDA is warning consumers that while
little is formally known about the safety of this drug,
its structure and relationship to better known products
leads the FDA to believe that its use may pose
considerable risks to health. Although purveyors of THG
may represent it as a dietary supplement, in fact it
does not meet the dietary supplement definition. Rather,
it is a purely synthetic “designer” steroid derived by
chemical modification of another anabolic steroid that
is explicitly banned by the U.S. Anti-Doping Agency.
The use of THG by athletes as an alternative to other
banned anabolic steroids was recently brought to light
by the U.S. Anti-Doping Agency. The substance is closely
and structurally related to two other synthetic anabolic
steroids, gestrinone and trenbolone. Anabolic steroids,
which build muscle mass, can have serious long-term
health consequences in men, women, and children.
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