Omni Nutraceuticals
This article was originally published in The Tan Sheet
Executive Summary
Company offers to delete statement "Healthy long-term joint support" from Inholtra Joint Pain, Joint Pain Plus dietary supplement/OTC combo products "if necessary to resolve all issues raised" by FDA, firm tells agency in Feb. 13 letter. Omni also says "active/inactive" distinction FDA made in its Feb. 8 letter is invalid because DSHEA authorizes use of supplements intended to affect structure, function of the body "without subjecting them to regulation as drug ingredients" (1"The Tan Sheet" Feb 18, 2002, p. 7). Company notes it "remains willing to meet with FDA to resolve outstanding issues"...
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