FDA DSHEA "article" interpretation in Cholestin case "contrary" to statute -- Pharmanex.
This article was originally published in The Tan Sheet
Executive Summary
DSHEA "ARTICLE" INTERPRETATION BY FDA IN CHOLESTIN DECISION is "contrary to the statutory text" of the Dietary Supplement Health & Education Act, which incorporates an "established and authoritative prior interpretation" and "would produce absurd results," Pharmanex argues in a June 1 memorandum filed in Salt Lake City federal court. The company maintains the DSHEA provision excluding from dietary supplement status "an article that is approved as a new drug" does "not apply" to Cholestin, which is marketed as a dietary supplement for healthy cholesterol.