Both Congress and the FDA have done a horrible job specifying or, more accurately, failing to specify to what extent (if at all) PVD hardware might fall under the FDA's regulatory authority. Some attempts on ECF to paraphrase how the statute and the proposed regulations define "tobacco products" have not been accurate. So, it's important to first look at the exact language before trying to figure out what a "tobacco product" is. Here is the statutory definition:
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) DEFINITION OF TOBACCO PRODUCTS.—Section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended
by adding at the end the following:
‘‘(rr)(1) The term ‘tobacco product’ means any product made
or derived from tobacco that is intended for human consumption,
including any component, part, or accessory of a tobacco product
(except for raw materials other than tobacco used in manufacturing
a component, part, or accessory of a tobacco product).
‘‘(2) The term ‘tobacco product’ does not mean an article that
is a drug under subsection (g)(1), a device under subsection (h),
or a combination product described in section 503(g).
‘‘(3) The products described in paragraph (2) shall be subject
to chapter V of this Act.
The terms "component," "part," "accessory" are not defined.
The FDA has made an attempt to interpret what these words mean (I've bolded the most relevant portions):
FDA considers accessories of
proposed deemed products to be those
items that are not included as part of a
finished tobacco product or intended or
expected to be used by consumers in the
consumption of a tobacco product, and
we expect that they will not have a
significant impact on the public health.
In addition, FDA considers accessories
to be those items that may be used in
the storage or personal possession of a
proposed deemed product. Therefore,
items such as hookah tongs, bags, cases,
charcoal burners and holders, as well as
cigar foil cutters, humidors, carriers,
and lighters would be considered
accessories and would not fall within
the scope of this proposed rule. Section
201(rr) of the FD&C Act (21 U.S.C.
321(rr)), as amended by the Tobacco
Control Act, defines the term ‘‘tobacco
product’’ to mean ‘‘any product made or
derived from tobacco that is intended
for human consumption, including any
component, part, or accessory of a
tobacco product (except for raw
materials other than tobacco used in
manufacturing a component, part, or
accessory of a tobacco product).’’ 1
Products that meet the statutory
definition of ‘‘tobacco products’’ can
include currently marketed products
such as certain dissolvables, gels,
hookah tobacco, electronic cigarettes,
cigars, and pipe tobacco. Components
and parts of tobacco products, but not
their related accessories, would also be
included in the scope of this proposed
rule. Components and parts are
included as part of a finished tobacco
product or intended for consumer use in
the consumption of a tobacco product.
Components and parts that would be
covered under this proposal include
those items sold separately or as part of
kits sold or distributed for consumer use
or further manufacturing or included as
part of a finished tobacco product. Such
examples would include air/smoke
filters, tubes, papers, pouches, or
flavorings used for any of the proposed
deemed tobacco products (such as
flavored hookah charcoals and hookah
flavor enhancers) or cartridges for ecigarettes.
The proposed rule also deems
any future tobacco products that meet
the statutory definition of ‘‘tobacco
product’’ except accessories of such
product to be subject to FDA’s
authorities under chapter IX of the
FD&C Act. For example, FDA envisions
that there could be tobacco products
developed in the future that provide
nicotine delivery (e.g., via dermal or
buccal absorption), similar to currently
marketed medicinal nicotine products,
but which are not marketed for
therapeutic purposes. would be ‘‘tobacco products’’ and
subject to FDA’s chapter IX authorities
should the deeming rule be finalized.
So is an empty tank a "component, part or accessory"? An atomizer? A mod? How does a mod with a tank screwed onto it differ conceptually from a pipe?
The statutory definition of "tobacco product" doesn't provide clear answers to these questions. The FDA's inclusion of cartridges for electronic cigarettes appears to be based on the mistaken assumption that all such cartridges are pre-filled. This is evidenced somewhat by the fact that the FDA's other examples of "components and parts" appear to be consumable goods. Pipes aren't mentioned, nor are atomizers, tanks and mods. From reading other sections of the statute, it seems likely that "components" refers to such things as additives, e.g., flavorings and other things that are added to the tobacco itself.
As I've said before, the statute wasn't written with e-cigarettes in mind. It specifically addresses analog cigarettes, cigars, little cigars, snuff, chewing tobacco, all other kinds of smokeless tobacco, loose and roll-your-own tobacco, and so forth. There is nothing in the statute to suggest that Congress gave even a passing thought to e-cigarettes/PVDs. The FDA is now trying to fit a square peg into a round hole.
It is entirely possible that a federal court looking at the statute would determine that the definition of "tobacco product" doesn't cover things like mods, tanks and the like. After the comment period is over, the regs are finalized, and after whatever administrative processes are exhausted, it will be possible to litigate this issue before the regulations go into effect.
