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Re: Thales622 post# 16252

Tuesday, 01/07/2014 7:29:57 AM

Tuesday, January 07, 2014 7:29:57 AM

Post# of 30990
I bolded part of your post below. I didn't realize that it had been approved, not just applied for. I consider that good news.

Dino

"http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm379639.htm#
"In addition, your Anatabloc and CigRx products contain anatabine as a dietary ingredient. While anatabine has been authorized as an investigational new drug, it is also considered a new dietary ingredient, which is subject to premarket approval. To date, a premarket notification has not submitted to FDA, for your products containing anatabine; therefore, they are deemed to be adulterated. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act."

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