Wednesday, May 25, 2016 10:36:13 AM
In summary, the ingredient "Dried root radix Trichosanthes" for which you have submitted a new dietary ingredient notification is not a dietary ingredient under the Federal Food, Drug, and Cosmetic Act. Moreover, the product to which you refer in your submission appears to be a drug under the Act and thus subject to the regulatory requirements of drugs.
Here is the link to the complete letter.
https://www.regulations.gov/#!documentDetail;D=FDA-2014-S-0023-0011
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