This Petition demands the FDA revisit its decisions on the dietary supplement Anatabloc. We specifically demand that the FDA recognize anatabine as an article of food present in the food supply in a form in which the food has not been altered.
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Anatabine, the key ingredient in Anatabloc is a small naturally occurring phytochemical found in peppers, tobacco, tomatoes, eggplants, and cauliflower. Anatabine has been consumed by humans in these various plant forms for millennia.
It is impossible to classify any food article with such a common and long history in the human food supply as a “New Dietary Ingredient” (NDI.)
The anatabine citrate found in Anatabloc is not a “chemically altered” form of this common phytochemical. The anatabine molecule is kept whole and intact, as it bonds with the salt citrate to facilitate its extraction.
This small biomolecule cannot be considered a “component of tobacco.”
As chlorophyll-a is a biomolecule in tobacco so is anatabine – and the FDA allows the continued sale of chlorophyll supplements. It is not a “component or part” of tobacco, which by definition would be stem, leaf, flower, seed or root – not a biomolecule.
Further, as evidenced on the National Institutes of Health’s (NIH) National Center for Biotechnology Information (NCBI), an overwhelming number of published peer-reviewed studies on tobacco and its constituent biomolecules, have concluded that anatabine does not contribute to the harmful effects of tobacco.
To rule that anatabine is a form of tobacco is a glaring over-reach on the part of the FDA.
Any and all content on the Anatabloc website found objectionable by the FDA in its ruling that the product was misbranded has been removed by the manufacturer and distributor of Anatabloc, Rock Creek Pharmaceutical (formerly Star Scientific) to the satisfaction of the FDA.
The law states it’s incumbent upon the FDA to determine if a product under its regulatory aegis is in fact dangerous to the public. In the case of Anatabloc, the FDA failed to do that.
However, through technical bureaucratic fault-finding based on invalid arguments it has financially forced the manufacturer of Anatabloc to suspend its sales. In this action, the FDA has denied the very people who it is intended to protect, their right to a safe, natural cost – effective dietary supplement.
With great respect for the enormous mandate imposed on the FDA to protect the health of the American public we ask the FDA to use common sense and compassion in the decisions detailed here above.