SALT LAKE CITY -- In a closely monitored case, a federal judge here has decided against the Food and Drug Administration, Washington, in its attempt to ban a popular natural dietary supplement.
A), the FDA currently has little power to oversee a supplement maker's manufacturing practices or to enforce marketing guidelines -- unless a product is deemed unsafe.
The FDA had sought to prevent Pharmanex, Simi Valley, Calif., from producing its Cholestin-brand cholesterol-maintenance product because it contains mevinolin, a naturally occurring substance found in red yeast powder. The FDA argued that because mevinolin is the active ingredient in a synthetic cholesterol-lowering drug -- Merck & Co.'s lovastatin (brand name Mevacor) -- Cholestin was, in effect, an unapproved drug.
Until the FDA banned the import of the mevinolin-containing powder from China, Pharmanex was producing up to 90,000 Cholestin capsules a day. The product is sold in 35,000 stores across the country.
In issuing a preliminary injunction against the FDA, U.S. District Court Judge Dale Kimball accepted Pharmanex's argument that it would be forced to go out of business if the ban were upheld. He also pointed out that the safety of Cholestin was not in question.
"We are thrilled with the court's decision, and believe it is a reflection of the weakness of the FDA's legal and factual position and the importance of the issues that are at stake in this case," said Bill McGlashan, president of Pharmanex, in a prepared statement. "Natural dietary supplements such as Cholestin play an important role in maintaining and promoting good health in a cost-effective manner, and Congress passed DSHEA to ensure access to these products."
Said an FDA spokeswoman: "The agency will review the court order thoroughly, but at this time we anticipate that we will continue to pursue the case on its merits."