OK Girls and Boys!
Lets look at the other side of the coin and that's the deeming with respect to Synthetic NIC. Credit to Professor Kent C for his exstratct from the final:
"(Comment 164)
Some comments sought clarification as to FDA's authority over e-liquids
that do not contain nicotine or other chemicals derived from tobacco plants and those e-liquids
that contain nicotine derived from a nontobacco source (e.g., eggplants or tomatoes). Others
claimed that FDA does not have regulatory authority over e-cigarettes that are refillable and do
not contain nicotine, but does have authority over e-liquids if the liquid contains nicotine. Yet,
some said that e-liquids used in e-cigarettes should have an entirely new classification, because
use of the words "tobacco product" in marketing materials would cause undue confusion for
consumers.
pg257
(Response) As stated in section 201(rr) of the FD&C Act, the definition of "tobacco
product" includes any product made or derived from tobacco, including any component, part, or
accessory of a tobacco product. An e-liquid made or derived from tobacco meets this definition
and, therefore, is subject to FDA's chapter IX authorities.
E-liquids that do not contain nicotine
or other substances derived from tobacco may still be components or parts and, therefore, subject
to FDA's tobacco control authorities, if they are an assembly of materials intended or reasonably
expected to be used with or for the human consumption of a tobacco product and do not meet the
definition of accessory.
Source:
Deeming Regulations have been released!!!!
Another interesting member post about an interview with Next Generation Labs at:
Deeming Regulations have been released!!!!
EDIT: Looks like fertile ground for a court case on either the final rule or the drug pathway. Which of course brings into question the realities (not the validity of the claim) of weather a given plaintiff has very very deep pockets to fight. That's 6 or 7 figures over the course of perhaps years! I could be wrong but I see no indication that the current producers of Synthetic NIC have deep pockets.