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Pharmanex Inc. withdraws suit against FDA.

 
  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.  
  F-D-C Reports-- "The Tan Sheet," April 14, May 26, 1997.  
 
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