This article was originally published in The Tan Sheet
Supplement marketer drops appeal of Salt Lake City federal judge's March decision affirming FDA's determination company's Cholestin red yeast rice product is a drug. Firm originally appealed the ruling May 31, but filed a motion to dismiss the appeal Sept. 10, one day before its opening brief was due to be filed with the 10th Circuit U.S. Court of Appeals in Denver. Difficulties in prevailing on appeal, litigation costs contributed to company's decision. Firm introduced a reformulated version of Cholestin in July (1"The Tan Sheet" July 16, In Brief)
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New formulation contains Policor (policosanol), "beeswax-based" proprietary ingredient that inhibits cholesterol synthesis in liver, Pharmanex says July 9. NuSkin Enterprises division removed original red yeast rice-containing Cholestin from market following Utah federal court decision favoring FDA determination the product was a drug because it contained lovastatin, the active ingredient in Merck's Mevacor (1"The Tan Sheet" May 7, p. 15). Once-daily formula developed by Hauser replaces twice-daily red yeast rice dosage and is made with novel PoliSorb softgel delivery system. Thirty-count bottles marked "new and improved" are priced at $39.95
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
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