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Amlactin 12% ammonium lactate cream, lotion appropriately marketed as cosmetics.

This article was originally published in The Rose Sheet

Executive Summary

AMLACTIN 12% AMMONIUM LACTATE LOTIONS MARKETED APPROPRIATELY AS COSMETICS, Upsher Smith Labs (Minneapolis) maintains in response to a recent warning letter from FDA declaring the topical lotion and cream to be unapproved new drugs. The company conveyed its position to the agency in an Aug. 24 letter. Following a review of Amlactin labeling and promotional materials, FDA informed Upsher Smith in an Aug. 5 warning letter it believes the products are intended for the "cure, mitigation, treatment or prevention of disease" or "to affect the structure or any function of the body." However, the company does not plan to modify its product formulations and maintains its marketing claims are appropriate for a cosmetic moisturizer.
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