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Re: Jayyy post# 5507

Wednesday, 05/25/2016 10:36:13 AM

Wednesday, May 25, 2016 10:36:13 AM

Post# of 13735
ok....here is the actual FDA language (from the middle of page 2) cut and pasted here without modifications, editing, deletions or changes, but I did highlight the key phrase

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