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Melaleuca Replenex halt cartilage degeneration claim draws FDA warning letter.

This article was originally published in The Tan Sheet

Executive Summary

MELALEUCA REPLENEX HALT CARTILAGE DEGENERATION CLAIM DROPPED following a July 3 FDA warning letter that deems the product an unapproved new drug. Promotional materials for Melaleuca's Replenex dietary supplement carry claims that use of the product results in "Halting and possibly reversing the process of articular cartilage degeneration," according to the warning letter. Other Replenex claims cited by the agency are: "An alternative in the treatment of degenerative joint disease or common osteoarthritis" and "Address the underlying cause -- not just the symptoms -- of osteoarthritic joint pain." The warning letter resulted from an inspection of the firm's manufacturing facilities Feb. 6-11.





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