PharmaRoth Labs, Inc. (ROTH)

[Jayyy]

Really-they applied and application was DENIED!!! Are these fraudsters selling into the USA? No--BANNED.

In addition, it is possible that a recently enacted law may affect the legal status of dietary
supplements containing "Dried root radix Trichosanthes". Section 301 (11) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331 (11)) prohibits the introduction or delivery for
introduction into interstate commerce of any food (including a dietary supplement) that
contains a drug approved under 21 U.S.C. 355, a biological product licensed under 42 U.S.C.
262, or a drug or a biological product for which substantial clinical investigations have been
instituted and their existence made public, unless one of the exemptions in section 301(11)(1)(
4) applies. In our review of your notification, FDA did not consider whether section 301(11)
or any of its exemptions apply to dietary supplements containing "Dried root radix
Trichosanthes". 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).