FDA to Regulate E-Cigarettes Just Like Tobacco

[Vocalek]

CASAA has an entire section of the web site dedicated to getting forlks to show up, write, or call when legislation is proposed that will impact our access to or use of reduced-harm alternatives. We have had victories on most of these!
CASAA.org

When you sign up for membership (no charge), be sure to provide your contact information and to check the box to receive CASAA alerts and newsletters. We will do our best to keep you in the loop.

CASAA | Member Signup

 

[Vap0rJay]

Well, if that's the case, FDA and other tobacco Control "health officials" world-wide: NOW HEAR THIS!

You have done your best to outlaw to safer alternatives to smoking. You work to keep the fact that there ARE safer alternatives a big fat secret so that smokers can't make informed decisions.

Joshua Sharfstein, Margaret Hamberg, and accomplices: Your 2009 Press Release was so skillfully crafted that smokers who were considering switching to an e-cigarette reacted like this: "Man, those things will give you cancer! They got antifreeze in them! I'm sticking to my regular brand."

Congratulations. I hope you're proud of yourself.

If the CDC has been giving us accurate information about annual US deaths caused by smoking, then you folks are personally responsible for 800,000 of those deaths at this point (2 years * 400,000 deaths). The more smokers you convince to keep smoking, the more blood will accumulate on your hands.

tobacco Companies: Keep up the good work. I see you working to develop lower-risk products. I see you running advertisements suggesting that your smoking customers switch to these products. Bravo!

The Government Agencies, Health Organizations, Pharmaceutical Companies, Medical Community, and tobacco Companies could be working hand in hand to provide effective ways to get smokers to stop inhaling crap.

Instead, the former groups have declared war on the latter group. ECF: The losers in this war are you, me, and everyone you know who smokes or used to smoke.

*End of Rant*

Do you HONESTLY think they care? 800k deaths = job security. World population is booming - we can afford to lose a few. In fact, I wouldn’t be surprised if they have a status quo FOR fatalities due to smoking. Got to keep Pharma in business. There is no money in cures, only treatment. If they truly succeeded, and death rates dropped to insignificant numbers --- they would be unemployed.

Pure speculation of course… but using their own logic, arguments, and line of reasoning --- if it looks like a duck and quacks like a duck, must be a duck

 

[Bill Godshall]

On April 25, the FDA Regulation of E-Cigarettes and Other Tobacco Products
announced that it had agreed to go along with Judge Leon's ruling https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54 prohibiting the FDA from regulating (i.e. banning) e-cigarettes as drug devices.

The legal impact of this means that e-cigarettes, e-liquid, nicotine gums, lozenges, patches, skin creams, nasal sprays, nicotine water (and any other nicotine product that is "derived from tobacco" and is "intended for human consumption") is now an unregulated tobacco product according to federal law (as long as no therapeutic claim is made by the manufacturer/importer).

In that same document, the FDA announced its intent to propose a regulation that would apply Chapter IX of the FSPTCA to all currently unregulated tobacco products (including little cigars, large cigars, pipe tobacco, hookah and the list of nicotine containing products listed in the previous paragraph.

As one who has consistently advocated reasonable and responsible regulations for e-cigarettes (and other tobacco/nicotine products), I don't consider many of Chapter IX provisions to be reasonable or responsible (especially Section 910 that may allow the FDA to ban any/all e-cigarette products that weren't on the market on February 15, 2007, and Section 911 that would prohibit ALL e-cigarette companies from truthfully informing smokers that e-cigarettes pose significantly lower health risks than tobacco cigarettes).

And since there is no evidence that e-cigarettes are being used by youth or that the products are marketed to youth, there is no justification for the FDA to apply the FSPTCA's youth access provisions (that currently apply to cigarettes and smokeless tobacco) upon all e-cigarette vendors. Rather, state laws prohibiting e-cigarette sales to minors are more appropriate, and have already been enacted in a half dozen states.

 

[Bill Godshall]

Vocalek wrote

Congress recognized the importance of offering smokers less hazardous alternatives and therefore set aside a special section in the Family Smoking Prevention and Tobacco Control Act to guide the FDA to identify and approve modified risk tobacco products.


FSPTCA – Section 911

What is a Modified Risk tobacco product? 911 (b)(2)(A)(i)
Presents lower risk of disease
Contains reduced level of or exposure to a substance
Does not contain or is free of a substance

When should Modified Risk products be fast-tracked? 911 (g)(2)(A)
If evidence not available or requires long-term studies
Evidence that is available demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely

It is important to note that the FDA can only approve a Modified Risk tobacco product claim if a company applies to the FDA to make a specific Modified Risk claim for a particular product as compared to another (or other) tobacco product(s).

Since ALL noncombustible tobacco/nicotine products are far less hazardous than cigarettes, the primary reason Section 911 was agreed to by CTFK and Philip Morris in 2004, and included in the FSPTCA was to prohibit, prevent, and to erect potentially impossible hurdles any smokeless tobacco product to be truthfully marketed to smokers as less hazardous alternatives to cigarettes.

Also, Section 911 (and the term Modified Risk tobacco product) only applies to claims by tobacco manufacturers and importers whose products are regulated by Chapter IX of the FSPTCA.

Even if the FDA begins to ethically acknowledge and/or inform smokers or the public that all noncombustible tobacco/nicotine
are far less hazardous alternatives to cigarettes, the FDA won't use the term "Modified Risk tobacco product" to describe smokeless tobacco products, e-cigarettes or any other noncombustible tobacco/nicotine product. Even if the FDA approves an application by a manufacturer/importer to make a Modified Risk claim for a smokeless tobacco product, that would not apply to any other smokeless tobacco product (until/unless another company's MR application was similarly approved by the FDA, but even then it would only apply to a specific claim made by a specific company for a specific product that is compared to another (or other) product(s).

That's why I strongly urge all tobacco harm reduction advocates to NOT refer to smokefree tobacco/nicotine alternatives as "Modified Risk tobacco products". Rather, we should (and are protected by the 1st amendment) simply continue telling the truth about all smokefree tobacco/nicotine alternatives.