To better understand the many dozens of different Chapter IX provisions/regulations that e-cigarette products (containing nicotine derived from tobacco) and e-cigarette manufacturers and importers would face (if FDA proposes and subsequently approves of a new regulation to apply Chapter IX of the FSPTCA to e-cigarettes (and other currently unregulated tobacco products), I strongly urge everyone to go to
http://frwebgate.access.gpo.gov/cgi...=111_cong_public_laws&docid=f:publ031.111.pdf
mark it as a favorite website (for future reference) and print out the entire 84 pages (of FSPTCA text).
On page 9 of the document, under
Title I - Authority of the Food and Drug Administration, please note that
Section 101(rr)1 defines a "
tobacco product" as "
any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco products". This is the clause cited by Judge Richard Leon when he struck down the FDA's legal authority to regulate e-cigarettes as "drug devices" and ruled that e-cigarettes fit the definition of "tobacco product" in the FSPTCA, and that the FDA had the legal authority to regulate e-cigarettes as tobacco products.
On page 10 of the document, please note that "Chapter IX - Tobacco Products" begins
a continues to at least the end of Section 919 User Fees on page 56.
If the FDA proposes a new regulation to apply Chapter IX to e-cigarettes and other currently unregulated tobacco products, it would do so under the Congressionally granted authority cited in
Sec. 901 FDA Authority Over Tobacco Products
(on page 12) per
Sec. 901(b) Applicability -- This chapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this chapter.
It appears that Chapter IX also includes
Sec. 102 Final Rule beginning on page 56 (which were from 1996 to reduce cigarette and smokeless tobacco sales to minors and reproduced at
FR Doc 2010-6087
Sec. 103 Conforming and Other Amendments to General Provisions on page 59,
Sec. 104, and Sec. 106 on page 67.
Title II - Tobacco Product Warnings; Constituent and Smoke Constituent Disclosure
(beginning on page 68 and going to page 76) is
NOT part of Chapter IX, but rather it amends the FCLAA.
Title III - Prevention of Illicit Trade in Tobacco Products (beginning on page 76 and ending on page 78
is also part of Chapter IX, everything after
Division B - Federal Retirement Reform Act (beginnning on page 78) is not part of Chapter IX.
As you review Chapter IX, please note that the words printed in the margins (e.g. Deadline, Regulations, Notice, Establishment, Effective Date, Publication, Reports, Hearings, etc.) cite the many different regulations, other activities and deadlines that FDA was/is/will be required to fulfill.
After you read through the entire document, I suggest rereading it another half dozen times to better undertand what implications and ramifications could or would occur if FDA proposes and subsequently approves a new regulation (that FDA stated its intent to propose back on April 25) to apply Chapter IX of the FSPTCA (and subsequently of the FDCA) to e-cigarettes and other currently unregulated tobacco products.
Per several comments posted on this thread, please note, however, that the FDA's proposed regulation entitled "Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products" (that was cited by the cigar industry in the article I posted at the beginning of this thread) and at
Regulations.gov
would currently only apply to cigarettes, cigarette tobacco, Roll-Your-Own tobacco, and smokeless tobacco products.
But if the FDA proposed and subsequently finalized a new regulation to apply Chapter IX of the FSPTCA to e-cigarettes and other currently unregulated tobacco products, the proposed regulation "Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products", many other already approved FDA tobacco regulations, and dozens of forthcoming FDA tobacco regulations would ALSO apply to e-cigarettes and other currently unregulated tobacco products (which is why the cigar industry cited that recently proposed regulation (whose public comment deadline is Dec 8).
Per inquiry by sqirl1, although none of the provisions in Chapter IX (if applied to e-cigarettes) would explicitly ban flavored e-cigarette products (as it only bans certain flavorings for cigarettes), its possible the FDA could rule that flavorings used in e-cigarettes not on the market prior to February 15, 2007 are not "substantially equivalent" to flavorings used prior to that date and that they can therefore be banned because they are "New Tobacco Products" unless/until approved by the FDA. Also, Chapter IX gives the FDA the authority to adopt future regulations for tobacco products that could include a ban on certain (or all) flavorings. But even if the FDA banned flavorings in e-cigarettes, the flavorings could be marketed in separate packages (than e-cig products), and then added to various e-cigarette products by consumers. But all of these flavoring ban possibilities (cited in this paragraph) are speculative at this time.