Pharmanex Suspends U.S. Sales of Cholestin

PROVO, Utah--Pharmanex said it has suspended U.S. sales of its Cholestin product pending the outcome of discussions with the Food and Drug Administration (FDA). Paula Morrow, senior director of public relations for the company, confirmed the sales suspension after a court ruled that FDA's decision to regulate Cholestin as a drug, not a dietary supplement, was lawful.
U.S. District Court Judge Dale Kimball, who in 1998 ruled that FDA's decision to regulate Cholestin as a drug was unlawful, came back April 6 with a reversal of that position. After the 1998 decision, FDA appealed to the 10th Circuit Court of Appeals, which found in July 2000 that Kimball's ruling was incorrect and remanded it back to the district court for reconsideration.
In this latest court review, Kimball examined whether FDA was arbitrary and capricious in determining thatPharmanex, in manufacturing and marketing Cholestin, was actually manufacturing and marketinglovastatin; and that lovastatin had not been "marketed as a dietary supplement or as a food" prior to its 1987 FDA approval as a new drug for Merck & Co.
In Kimball's discussion, he noted that Pharmanex contended that its manufacturing processes and marketing do not emphasize lovastatin content. FDA, however, stated that traditional red yeast rice, the "dietary ingredient," has in many studies been shown to not contain significant amounts oflovastatin. In Pharmanex's patented manufacturing process, FDA noted the process yielded a high amount oflovastatin.
"In light of the standard of review applied to FDA's factual determinations, this court cannot conclude that FDA's factual findings on this issue were arbitrary and capricious," Kimball wrote. "Rather, there is evidence in the record that a reasonable mind might accept as adequate to support FDA's conclusion."
Because the decision applies specifically to the Cholestin supplement, and not red yeast rice as a supplement in general, it is difficult to anticipate possible implications. "On its face, the decision is fairly narrow," said MarcUllman, partner in Ullman, Shapiro & Ullman, a law firm specializing in the dietary supplement field. "However, I wouldn't be surprised if FDA took a broader view and looked at the manufacturing processes and patent claims."
At press time, Pharmanex had not issued a formal statement. Morrow noted that the company was in ongoing conversations with FDA and could not comment while still in negotiations. Pharmanex is a division of Nu Skin Enterprises, a global direct-marketing company with revenue of almost $880 million in 2000.
For more information, visit www.fda.gov.