Enzymatic Therapy
This article was originally published in The Tan Sheet
Executive Summary
Labeling, catalog and Web site claims that the supplement firm's glucosamine sulfate products "may be useful in the treatment of osteoarthritis" make them "new drugs" that cannot legally be marketed without an approved NDA, FDA says in a May 5 warning letter. In addition, the agency notes the Green Bay, Wisc.-based firm's nasal decongestant products containing pseudoephedrine "are subject to final rules covering [OTC]... drug products," may not legally be marketed without an approved NDA and are misbranded because the labels lack adequate warnings. The agency also expresses concerns about several other catalog and Web site promotional materials, including references to FDA registration that "creates an impression of official approval and is misleading"
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