Pg. 32 deeming doc
"Upon implementation of this final rule, currently unregulated tobacco products and future products meeting the definition of "tobacco product" under section 201(rr) (except accessories of newly deemed tobacco products) will be subject to chapter IX of the FD&C Act."
Pg. 260
FDA agrees that there is an expanding market of tobacco products that meet the FD&C Act definition of "tobacco products." However, FDA does not believe it is necessary to define individual categories of tobacco products for purposes of this rule. In fact, by deeming "tobacco products" generally, it will help ensure that novel and future tobacco products are introduced into the market in an appropriate and efficient manner. FDA may issue specific definitions at a later time if it determines that doing so is appropriate.
Pg. 261
Likewise, at least one comment suggested that we establish a definition of "alternative
nicotine product," which would be defined as "any noncombustible tobacco-derived product
containing nicotine that is intended for human consumption, whether chewed, absorbed,
dissolved or ingested by any other means." The comment stated that several States have adopted
variations of this definition and that it would provide necessary clarity.
(Response) For the reasons explained previously, FDA finds that it is not necessary to
add these definitions to the codified for this final rule.
Pg. 256
(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.
(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.
Pg. 258
In addition, some comments stated that FDA has no justification for regulating products simply because they may deliver nicotine. They likened such authority to imposing onerous regulations on caffeine, another plant-derived chemical.
(Response) FDA disagrees. FDA is deeming these products to address public health
concerns (79 FR 23142 at 23148 and 23149). ENDS are tobacco products.
eta: @SeniorBoy composing while you were posting :- )
Last edited:
