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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