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Sunday, March 11, 2018 8:15:30 AM
From FDA "In addition, your Marketwired September 26, 2013, press release reported
that Sucanon (the trade name for your dietary supplement containing the new dietary
ingredient) is a treatment for Type II diabetes.2 A product intended for use as a drug within
the meaning of21 U.S.C. 321(g)(l)(B) is subject to regulation under the drug provisions of
the Act. You should contact. FDA's Center for Drug Evaluation and Research (CDER), Office
ofCompliance, 10903 New Hampshire Avenue, W05 1-51 85, Silver Spring, MD 20993-0002."
AND..
"because there is inadequate information to provide reasonable assurance that the new dietary ingredient does not present a significant or unreasonable risk of illness or injury."
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