|| Pharmanex, Inc.
was seeking a court declaration that the claims the company made for its
cholesterol-lowering supplement, Cholestin™, are allowable under DSHEA.
Pharmanex filed a motion to voluntarily dismiss the action May 8, after,
the FDA filed a motion to dismiss the complaint because the matter was
"not ripe for review." Pharmanex had filed the suit in a Salt
Lake City court after FDA informed the company that it might pursue regulatory
action against the product as an unapproved drug. According to Pharmanex,
the FDA's assertion that Cholestin is a drug "arbitrarily ignores
the undisputed evidence presented to the FDA by Pharmanex that that Cholestin
satisfies the statutory requirements of a dietary supplement under DSHEA."
Cholestin, a dietary supplement made from red yeast (Monascus purpureus)
fermented on rice, has been in stores since January.