Thursday, April 02, 2020 9:12:13 AM
from FDA "In summary, the ingredient "Dried root radix Trichosanthes" for which you have submitted a
notification is not a dietary ingredient under the Federal Food, Drug,
and Cosmetic Act.
is prohibited under 21 U.S.C. 355(a) prior to approval
of an application under subsections (b) or (j) of21 U.S.C. 355. In addition, because the
Agency concluded that "Dried root radix Trichosanthes" is excluded from the definition of a
dietary supplement, FDA did not review evidence of safety information that you submitted for
this substance.
Accordingly, this response should not be construed to be a statement that a
dietary supplement containing "Dried root radix Trichosanthes", if introduced or delivered for
introduction into interstate commerce, would not also violate section 301 (11).
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