A Federal District Court in Utah on Wednesday ordered the
US Food and Drug Administration (FDA) to lift its ban on the
importation of red yeast rice that is used in the manufacture
of Cholestin, a dietary supplement used to manage cholesterol
levels.
Judge Dale A. Kimball ruled that Cholestin is not a drug
and can be sold by its manufacturer, Pharmanex, as a dietary
supplement. The FDA had asserted that that Cholestin was a
drug because it contains mevinolin, a constituent of red yeast
rice that is chemically identical to lovastatin, the active
ingredient in the cholesterol-lowering drug, Mevacor.
Last May, the FDA banned importation of the red yeast rice.
However, as reported by Reuters Health on June 18, Judge
Kimball issued a preliminary injunction against the FDA's
ban.
"This decision also reflects that good science, while
contributing to the health of Americans, does not transform a
natural health supplement into a drug," said Bill McGlashan,
president of Simi Valley, California-based Pharmanex.
According to a statement issued by the company, the FDA had
not questioned the safety of the supplement during the course
of litigation.
Jonathan Emord, an attorney for the American Preventive
Medical Association, a trade group that represents dietary
supplement manufacturers, said that the ruling is "an
important decision because it limits the ability of the FDA to
wrongfully contend that statements of nutritional support are
unapproved health claims."
He told Reuters Health in an interview on Thursday that the
court had correctly rejected the FDA's assertion that the
mention of a cholesterol-lowering effect on Cholestin's label
implied a health claim.
The court reasoned that since cholesterol levels fluctuate
naturally in people, a statement that the product can lower
cholesterol does not necessarily imply that the product can
prevent atherosclerosis.
Emord noted a court decision from last month that ordered
the FDA to allow the use of disclaimers on dietary supplement
labels. As reported by Reuters Health on January 20, the US
Court of Appeals for the District of Columbia Circuit had
ruled that the FDA's regulations that prohibit claims of
benefits of nutrients were invalid because they violated the
First Amendment to the Constitution.
"What was a high, impenetrable wall is now porous,"
according to Emord. He said that the two court decisions would
likely result in a flood of health information that the FDA
had previously prevented from reaching consumers.
Copyright ©1998 Reuters
Ltd..
