Replies to post #11040 on PharmaRoth Labs, Inc. (ROTH)

[old biohf guy]

This is where you are wrong and it shows the need to pay close attention to what you read.

Roth applied for approval as a nutritional supplement, not for approval as a drug.

By God, please go back and reread very carefully and completely.

[sweetlou]

Now we’re actually getting somewhere. Your very own post that takes a portion of the FDA letter is included below. It shows that Sucanon, which contains Tricosanthes:
1. Is not approved as a supplement because it is a drug for which substantial clinical investigations have been instituted “
2.If one reads FDA’s language carefully, one would note that “FDA did not consider whether Section 301(11) or any of its exemptions apply to dietary supplements containing dried root radix Tricosanthes”
3. FDA says separately in the same response letter that the safety information on Sucanon was not reviewed because Sucanon is considered a drug not a supplement. Their statement is very similar to the statement in #3 above, namely that FDA did not consider whether the interstate commerce provisions apply to a supplement, since Sucanon is not considered a supplement.

Here is your post in its entirety for information:

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).