PharmaRoth Labs, Inc. (ROTH)

[Jayyy]

FDA denial:
FDA has carefully considered the information in your notification and other published reports
and determined that "Dried root radix Trichosanthes" is excluded from the definition of a
"dietary supplement" under 21 U.S.C. 321 (ff)(3)(B)(ii), because it is an article authorized for
investigation as a new drug for which substantial clinical investigations have been instituted
and the existence of this investigation as an investigational new drug has been publicly
disclosed. ' Moreover, FDA does not have any information that indicates that "Dried root
radix Trichosanthes" was legally marketed as a dietary supplement or as a food prior to
October 15, 1994. 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.