PharmaRoth Labs Inc (ROTH)

[sweetlou]

"A denial..note the work "violates". Sorry if the facts hurt"

I'm going to place some comments in italics to emphasize several important phrases directly from your post which I will assume is taken without modification from the FDA response letter to ROTH.

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.
because it is authorized for investigation as a new drug, note also substantial clinical investigations...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.
in other words it is not grandfathered as a food or supplement, so if you want to apply as a drug it is subject to the provisions of the Act. CDER administers that process and the contact information is listed
.
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. Introduction
of a new drug into interstate commerce 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.
they said it appears to be a drug, can't sell in US without approval, and we didn't look at the safety information submitted
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).

FDA did not consider whether exemptions apply and you can't assume based on this response that selling it in the US is ok. It may violate another section of the law. Any can read for themselves and see that the response is a matter of fact statement that Sucanon is a drug, has undergone substantial publicly disclosed clinical evaluation, and since it is considered a drug, can't be sold in the US without going through a new drug application. There is no rebuke or taking to task or taking issue with a future press release as you have implied.