Hopefully CASAA consulted with an attorney before making that list. I can see where it would be very easy to turn that last statement into regulating PVs as they do inhalers or other NRTs. While volume of replies is certainly imperative in any request for comment prior to rulemaking by a federal agency, the content of those replies is just as important.
Actually that last statement is precisely an argument
against the FDA's current position regarding the ecig as a drug/device combination, requiring prior approval under Chapter V of the FD&C Act .
The new tobacco legislation (now a new chapter of FD&C Act) does contain a new category of "modified risk" tobacco products. Here is their definition in the new law:
SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.
(a) IN GENERAL.No person may introduce or deliver for
introduction into interstate commerce any modified risk tobacco
product unless an order issued pursuant to subsection (g) is effective
with respect to such product.
(b) DEFINITIONS.In this section:
(1) MODIFIED RISK TOBACCO PRODUCT.The term modified
risk tobacco product means any tobacco product that is sold
or distributed for use to reduce harm or the risk of tobacco-
related disease associated with commercially marketed tobacco
products.
(2) SOLD OR DISTRIBUTED.
(A) IN GENERAL.With respect to a tobacco product,
the term sold or distributed for use to reduce harm or
the risk of tobacco-related disease associated with commer-
cially marketed tobacco products means a tobacco
product
(i) the label, labeling, or advertising of which rep-
resents explicitly or implicitly that
(I) the tobacco product presents a lower risk
of tobacco-related disease or is less harmful than
one or more other commercially marketed tobacco
products;
(II) the tobacco product or its smoke contains
a reduced level of a substance or presents a
reduced exposure to a substance; or
(III) the tobacco product or its smoke does
not contain or is free of a substance;
(ii) the label, labeling, or advertising of which
uses the descriptors light, mild, or low or similar
descriptors; or
(iii) the tobacco product manufacturer of which
has taken any action directed to consumers through
the media or otherwise, other than by means of the
tobacco products label, labeling, or advertising, after
the date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act, respecting the product
that would be reasonably expected to result in con-
sumers believing that the tobacco product or its smoke
may present a lower risk of disease or is less harmful
than one or more commercially marketed tobacco prod-
ucts, or presents a reduced exposure to, or does not
contain or is free of, a substance or substances.
***************************************
(g) MARKETING.
(1) MODIFIED RISK PRODUCTS.Except as provided in para-
graph (2), the Secretary shall, with respect to an application
submitted under this section, issue an order that a modified
risk product may be commercially marketed only if the Sec-
retary determines that the applicant has demonstrated that
such product, as it is actually used by consumers, will
(A) significantly reduce harm and the risk of tobacco-
related disease to individual tobacco users; and
(B) benefit the health of the population as a whole
taking into account both users of tobacco products and
persons who do not currently use tobacco products.
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1256enr.txt.pdf (quote is from pages 37 and 38)
While the FDA may well not willingly back down from its position classifying ecigs as drug device products, it is still to be hoped that Judge Leon's decision in the SE & Njoy case may force it to do so. Thousands of comments urging the FDA in that direction certainly would be helpful as well; at the very least it would do no harm.