Court Backs FDA Check of Cholestin

Tuesday, July 25th 2000, 12:00 am
By: News On 6

DENVER (AP) — The Food and Drug Administration should be allowed to regulate a dietary supplement made from a substance that is chemically identical to the active ingredient in a drug that lowers cholesterol, an appeals court has ruled.

The 10th U.S. Circuit Court of Appeals ruled Friday that a federal court in Utah erred when it said the FDA could not regulate the dietary supplement Cholestin.

The FDA had banned imports of red yeast powder containing mevinolin, which is used to make Cholestin. Because mevinolin is identical to a synthetic drug — sold as Mevacor and prescribed to lower cholesterol — the agency regarded the powder as an unapproved drug.

But U.S. District Court Judge Dale Kimball last year ruled that FDA's ban was illegal under a 1994 federal law because Cholestin clearly fit the definition of ``dietary supplement'' and could not be regulated by the agency as a drug.

Kimball said the law allows FDA to regulate finished products — but not their ingredients — as drugs.

The appeals court disagreed, saying the intent of the law was ambiguous and that to interpret it as applying only to finished drug products ``would be to restrict its scope so as to render it a meaningless limitation.''

The decision sends the case back to district court for decisions on unresolved arguments.