Several threads ago, Jacinda wrote
"Thanks for all the info Bill! Although I was wondering if you could clear something up for me? From this statement made by the FDA:
The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
I get the idea that they are going to try to amend the FD&C Act so that the pre-market requirements will apply to e-cigs and other tobacco products. Am I misunderstanding this? Do you think that they won't be able to change it, or are you just saying that currently it doesn't apply to e-cigs? I'm sorry if I'm missing something..."
The FDA stated it "intends to propose a regulation" to extend the many different Chapter IX provisions
http://frwebgate.access.gpo.gov/cgi...=111_cong_public_laws&docid=f:publ031.111.pdf to ALL currently unregulated tobacco products, which includes cigars, pipe tobacco, e-cigarettes, e-liquid, nicotine gums, lozenges, patches, nasal spray, skin cream, water and at least several dissolvables.
But the regulatory promulgation process could take several years, and the Secretary of HHS must determine that any new regulation "would be appropriate for the protection of the public health."
Since there is no evidence that any of these unregulated tobacco porducts (except for cigars and pipe tobacco) have harmed any users, there is really no public health justification for imposing any Chapter IX regulations to e-cigarettes. More importantly, applying some Chapter IX provisions to e-cigarettes and other smokefree alternatives would actually harm public health.
We need to carefully review all of the Chapter IX provisions, and expose/oppose those that could/would actually harm public health if the are applied to e-cigarettes and/or other smokefree alternatives (e.g. the Feb 15, 2007 grandfathering date in
Sec. 910, and the Modified Risk clause that prohibits e-cig companies from truthfully claiming they are less hazardous than cigarettes in
Sec. 911), as well as exposing other Chapter IX provisions that wouldn't benefit public health.
We should assume that CTFK/ACS/AHA/ALA/ALF/AMA and other e-cigarette prohitionists will aggressively urge the FDA to apply ALL Chapter IX provisions to all unregulated tobacco products.
Meanwhile, tobacco harm reduction advocates and the makers and users of currently unregulated smokefree tobacco products will be exposing and opposing the counterproductive and unnecessary regulations in Chapter IX (if they are applied to various unregulated tobacco products).
Since cigars and pipe tobacco are unregulated tobacco products, cigar companies (including Philip Morris and Swedish Match) and pipe tobacco companies also will be exposing and opposing counterproductive and unnecessary Chapter IX regulations (as they apply to cigars and pipe tobacco products).
If PM and Reynolds are planning to market e-cigarettes, they'll also be joinin us in opposing counterproduct and unnecessary provisions in Chapter IX (if applied to e-cigarettes and any other products they are planning to market).
The more vested PM and Reynolds are in e-cigarettes, the more aggressively they will oppose the FDA's forthcoming proposed regs (as they apply to e-cigarettes).