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Cholesterol claims for supplements supported by Novartis in comments to FDA.

This article was originally published in The Tan Sheet

Executive Summary

CHOLESTEROL CLAIMS FOR SUPPLEMENTS AIMED AT NON-HYPERCHOLESTEROLEMICS are not disease claims, Novartis maintains in Dec. 24 comments to FDA. "It is incorrect that all claims to lower cholesterol imply treatment of the disease hypercholesterolemia, because non-hypercholesterolemic individuals may also wish to lower their cholesterol levels," Novartis states. The comments respond to tentative conclusions by the agency that cholesterol reduction statements for Cholestin, marketed by Pharmanex as a dietary supplement, constitute unapproved new drug claims. The agency expects to reach a final conclusion in the near future.
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