Fda May Soon Propose Regulation That Could Ban Many/most E-Cigarette Products, Eliminate Many/most Companies

[Christopher]

This was sent to me today and it's not looking good. Posted by Bill Godshall over on ECF ( Executive Director Smokefree Pennsylvania) Bill is pro e cigarette for those of you that don't know who he is.

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It appears that the FDA may soon (perhaps in the next several weeks or months) follow through with the agency's April 25 stated intent (in red below) to propose a regulation that would apply Chapter IX of the FSPTCA to e-cigarette products (that contain nicotine) and other currently unregulated tobacco products, including: small cigars, large cigars, pipe tobacco, hookah/shisha tobacco, dissolvable tobacco/nicotine products (that aren't smokeless tobacco products), nicotine water, tobacco/nicotine skin cream and patches, non electronic nicotine inhalers, tobacco/nicotine nasal sprays, etc.

April 25, 2011

Regulation of E-Cigarettes and Other Tobacco Products

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.”

June 16, 2011

Sens. Merkley, Brown and 10 other Democrats pressure FDA to reverse ruling that Star's Ariva BDL and Stonewall BDL aren't smokeless tobacco products (as defined by FSPTCA), grossly exaggerate health/safety risks of dissolvable tobacco (that now includes nicotine lozenges), falsely claim products are marketed to youth, call them candy.

New Senator Brown and Senate Colleagues to FDA: It's Time To Close The Door On Tobacco Candy

http://www.ktvz.com/...863/detail.html (6/16/11 Dem Sens. letter to Margaret Hamburg)

Although we recognize that FDA has not yet asserted jurisdiction over the full range of tobacco products potentially subject to regulation under the statute, FDA does have authority over smokeless tobacco products. For this reason, we do not understand why Ariva-BDL and Stonewall-BDL should not be categorized as “smokeless tobacco products” and subjected to immediate FDA regulation. We fear that this action will encourage other tobacco companies to introduce new forms of dissolvable tobacco products in an effort to avoid regulation as smokeless tobacco products, an outcome that Congress intended to prevent. Already, another tobacco manufacturer, R.J. Reynolds, recently reintroduced dissolvable, candy-like Camel products, including Sticks, Strips and Orbs, in Charlotte and Denver. Yet another manufacturer, Altria has debuted its “smokeless tobacco stick” and is test marketing it in Kansas. The recent proliferation of dissolvable tobacco products—which can easily end up in the hands of children—in the marketplace, makes FDA’s decision particularly disturbing.

October 14, 2011

US Senate Democrats Blumenthal, Lautenberg & Brown urge FDA to "swiftly" expand tobacco regulations, falsely accuse tobacco industry of undermining FSPTCA, urge agency to apply Chapter IX to all cigars, pipe tobacco, hookah/shisha, dissolvables, e-cigarettes and other tobacco products, criticize companies for marketing exponentially less hazardous smokefree alternatives to smokers, grossly misrepresent health risks/benefits and marketing of smokefree products.

Senators Send Letter to FDA on Other Tobacco Products

http://www.cspdigita.../tom-letter.pdf (Oct. 14, 2011 letter to Margaret Hamburg from Sens Lautenberg, Blumenthal, Brown)

Now, we respectfully request that FDA build on these successes and move swiftly to issue a strong regulation that would legally treat or deem all tobacco products, including cigars, pipe tobacco, and hookah tobacco and accessories, as subject to the Tobacco Control Act. We appreciate FDA's past work to issue this important regulatin. Now we ask that you provide us with an update on the agency's progress and anticipated timeline for completion of this regulation, commonly known as the "deeming" rule. In addition, we would appreciae the opportunity to discuss the specifics of this new rule with yout, and would also ask that you respond to this letter with a date indicating your availability for such a meeting.

On July 13, 2011, Dr. Lawrence Deyton, Director of FDA's Center for Tobacco Products, met with Senators Blumenthal, Sherrod Brown, and Merkley to discuss FDA's regulatory decision around Star Scientific's products Ariva-BDL and Stonewall-BDL, two recently-developed dissolvable tobacco lozenges. In June, FDA deemed both products to be outside the direct regulatory authority afforded the agency under Chapter IX of the FSPTCA, thus requiring FDA to issue an additional regulation in order to assert authority over such products. While we continue to respectfully disagree with this decision, we were encouraged during this meeting to hear of FDA's commitment to swiftly issue such a "deeming" regulation, and were pleased to hear of an anticipated October release.

November 29, 2011

Cigars | FDA | Obama Administration | Regulations | The Daily Caller

Cigar smokers are mad as hell, and they aren’t going to take it anymore. Faced with an unprecedented assault on their guilty pleasure from President Barack Obama’s Food and Drug Administration, aficionados and industry insiders told The Daily Caller that they’re picking up their torch lighters and revolting.

Usually divided by their preferences for mild, medium and full-bodied smokes, they’re uniting against regulations that threaten to make cigars prohibitively expensive, shut down scores of small cigar shops, jeopardize tens of thousands of jobs and erase the traditionally bright line between Camels and Cohibas.

Cigar lovers are also recruiting members of Congress to defend what public health activists and anti-cancer crusaders see as little more than gentrified cigarettes smoked by economic one-percenters.

“Only a couple weeks remain,” one apocalyptic online pitch warns, “to stop the FDA from ruining cigars.” If that seems like a stretch, don’t bother telling Famous Smoke Shop. The e-tailer has sent 1.7 million emails to customers on its mailing lists, asking them to encourage their representatives in Congress to co-sponsor legislation designed to tie the FDA’s hands.

Cigar industry representatives told TheDC that efforts like this have already generated more than 113,000 messages to Congress.

It’s no surprise, then, that 125 House members and four senators are on board. They include 26 Democrats, along with six of Congress’ 20 physicians and two of its seven nurses — all strange bedfellows for a pro-tobacco law in the making.

Sen. Mary Landrieu, a Louisiana Democrat, announced Wednesday that she will join them. Landrieu chairs the Senate Committee on Small Business & Entrepreneurship, a crucial position from which to influence an issue that affects mostly mom-and-pop retailers.

Cutting an Exception

The Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011 arrived in the House in April and the Senate in August. Much of the domestic cigar supply enters the United States in the Sunshine State, and two Florida legislators — Republican Rep. Bill Posey and Democratic Sen. Bill Nelson — are leading the charge.

The bill’s focus is to carve out an exception for premium cigars in the Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama in 2009.

The Tobacco Control Act (TCA) gave the FDA new authority to regulate tobacco, and the agency has most famously wielded that power by requiring garish photographic warnings this year on cigarette packs. But the law, an FDA spokesperson told The Daily Caller in an email, “also permits FDA to deem other ‘tobacco products’ subject to the TCA’s general controls by regulation.”

The FDA spokesperson explained that a “proposed rule deeming cigars to be subject to FDA’s jurisdiction” could be “finalized” after a public-comment period expires, giving the agency the authority to regulate “any product that meets the definition of a ‘tobacco product’ under the TCA, including cigars, little cigars, and certain novel nicotine containing products (such as certain electronic cigarettes).”

The FDA seems to be taking its longer leash seriously. On three occasions since December 2010, the agency has already put the cigar industry on notice that it intends to propose a rule to “deem cigars subject to the Tobacco Control Act.”

BILL GODSHALL

The reason I stated that an FDA regulation to apply Chapter IX of the FSPTCA to e-cigarettes could ban many/most e-cigarette products (that contain nicotine) is because Section 910 of the FSPTCA could allow the FDA to ban some/many/most/all e-cigarette products that were not available in the US market before February 15, 2007.

Under the provisions of Section 911, manufacturers/importers (of all tobacco products that weren't on the market prior to February 15, 2007) would need to submit an application to the FDA claiming that the product is "substantially equivalent" to another product that was already on the market prior to 2/15/2007, and the FDA would have sole discretion of determining whether the product is or isn't substantially equivalent to the other e-cigarette product.

Aslo, Section 911 would prohibit all e-cigarette manufacturers and importers from truthfully claiming that e-cigarettes are less hazardous than cigarettes, as such a claim would render the product as a "modified risk tobacco product". Section 911 requires any company desiring to make a MRTP claim to apply to the FDA to do so, and the FDA must approve the application.

Many other provisions in Chapter IX would basically require every e-cigarette manufacturer and importer to hire a team of lawyers just to comply with the currently pending provisions (as well as comply with regulations approved in the future).

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Bill is supposed to start collaborating with CAASA to create an action letter as well as some sample letters so we can start email congress, news stations etc. CASSA doesn't directly talk to Vapor Talk but I'll try to post back anything new I come across here. I hope you all will do the same should you come across any new information.

[bzeisman]

there's nicotine water?!? when did that come out?

[Christopher]

there's nicotine water?!? when did that come out?

I'm not sure if it's still out but at one point there was a company selling "nicotine water". It was supposed to be an NRT.

[Viper Ron]

This is where it becomes somewhat unfair, my wife uses no nicotine in any of her juices, never has never will, so the thinking on the FDA that e cigs are nothing but a nicotine inhaler is preposterous! What's next, rock band use the same stuff to create fog in their live show! Ban that too, it's the same stuff used to make juices and is also used in food! Come on FDA do your research and get it right NOT ALL E CIGS USER USE NIC!!!!!!

[Christopher]

It's funny because PG is in MIO flavoring, "Dibs" ice cream and a handful over there products we use and consume daily. Heck, it's even in my Axe hair gel. I wonder just how much PG we've taken in over the years before e cigarettes ever came along.

[Brian]

This could be where big tobacco with it's huge legal staff takes over the ecig market.

[Uma]

"The reason I stated that an FDA regulation to apply Chapter IX of the FSPTCA to e-cigarettes could ban many/most e-cigarette products (that contain nicotine) is because Section 910 of the FSPTCA could allow the FDA to ban some/many/most/all e-cigarette products that were not available in the US market before February 15, 2007."

Back to the non-satisfying wispy days so that we all turn back to cigs. Quite a plan they have there.

Thank goodness for Radio Shack.

[Christopher]

Topic unlocked, sorry about that.

[Rip Topaz]

Well, this sucks. Guess its time to stock up on liquid. There's no way I'm going back to analogs.

[nana]

I agree. I'm not going back either. Not after all this time.

Backups, backups, and more backups!!!

[thearmedvapor]

And this is why I am the armed vapor. Screw this government, Im not going back to cigs, Ill fight first, we all know a revolution is coming sooner than later, and the way things are looking nowadays with this ******** and all the other crap from the Fed its gonna be considerably sooner than later, in addition to stocking up on your liquids, batts, mods and cartos, go ahead and get some extra food and water stashed away and some weapons and ammo too. Long live the Republic, we cant take this crap much more.

[Mark]

Heck, it's even in my Axe hair gel.

There's a joke in there somewhere but I'm not gonna do it.

[Strykker118A]

Just in case when I get paid Im gonna buy 200 bucks worth of cartos and a ton of batteries. Maybe a few gallons of e liquid lol

[Christopher]

There's a joke in there somewhere but I'm not gonna do it.

Shut up mark I still have a little bit of hair!

[Strykker118A]

Im not gonna lie this has me scared to death. I just started getting serious about my vaping and have already spent roughly 500 bucks on ecig stuff and now theyre thinking about eliminating things. I just cant go back to smoking analogs. Its been a little over 2 months without smoking and I feel great! Only thing that helped me was the Ego. No nicotene gum, no patches, no anything was working except this. They need to just leave us alone we arent hurting anybody. They cant complain about the ingredients because they are found in the foods we eat so whats the difference in vaping it? Has me outraged. We all need to get together as a big support group and fight this thing if it comes time. Fight for our healthier lifestyle and our freedom to vape!!!

[mjradik]

We all knew this would come eventually, but I still think it will come later... not sooner.. But the key words here are ...." e-cigarette products (that contain nicotine)" Plain PG/VG can't be regulated. Flavors can't be regulated. Yes nicotine can and will be regulated eventually.. At worst I think this will effect 'pre filled' cartos, and those 'ready to go' e-cigs and brands the most (most of those are crap anyways). I don't think accessoires will be effected to much. Batteries can still be sold, and shoot, empty cartos can be sold has 'hand warmers' or something to get around any bans or taxes. Weed is illegal, and you can still buy bongs and accessories just fine. Prices will go up, and there will be a black market for nicotine, but e-cigs will never go away. This is just my opinion...

[Strykker118A]

That does make sense really. As long as they dont take away cartos and eliquid I think Id be ok. Even if price goes up I dont care as long as they still exist!

[Christopher]

I agree that e cigarettes will not go away. Hardware CAN be regulated as the FDA classifies it as a "drug delivery product".

What it really boils down to is demand. If the FDA regulates it to the point that new consumers disappear the market will shrink. There are only so many current vapers to go around. So if the money isn't there, the suppliers will dwindle.

You'll still most likely be able to order from China but again that depends on what effect the American market has on them. If it causes a large enough drop in cash flow, factories will move to other things. It's not that you WONT be able to get e cigarettes or parts, it's just that the choices and convenience will be much less. Luckily modders will probably step in and you'll have SOMETHING. Just not in the way we see today.

You also have to figure, if they create some type of an import law or fine, let's say $50k. The chances of you getting caught with a few batteries is slim. But, how many are willing to take that risk. Especially after getting a warning letter in the mail. Interesting times no doubt. I do have some speculations as to what will actually happen, but no point in giving new suppliers a head start

[Viper Ron]

Some small legal things are already being put into place!

[kleraudio]

They are not doing this for our health.

Big tobacco is losing a ton of money cuz of this. I'm getting sick and tired of all these lobbyists and politicians making ridiculous laws just to pad their wallets.

It's why we don't have gas free automobiles, oil is waaaaaaayyyy too big a money maker to eliminate.

Same with tobacco, we can't have masses giving up on tobacco and being healthy, there's no tax dollars in that! It's pathetic.

And then they say it's because it's marketed towards kids.... Always a great reason to get the soccer moms and extreme right wingers on board.

If they want to keep America "safe and healthy" why don't they ban automobiles and fast food?

[twelveday]

i hope it doesnt turn out that way. I was way into cars also, and in california you get pulled over for a tiny mod on your car or anything etc etc, or cars that dont pass emissions testing u cant drive, but for some reason its legal for the people who live in states with low population or some random place out in the boondocks its completely legal to drive your 1000hp modded supra on the streets, i just hope i dont have to move to some place where all there is , is cows and cornfields, just to vape =Dlol

[yeahivape]

$$$

[DMIAvaper]

The FDA has been wandering down this road for the last two years. Their agenda is always a clouded one. It is hard to believe that their intentions are genuine when they seem to take arms against the simplest of products with no real data to take such a stance. Please read the following portion of their own mission statement:

Regulatory Requirements

Individual subject safety must be balanced against the potential public health benefits of new therapies

Risk assessment requires sufficiently detailed information regarding:

Product characterization and safety testing

Supportive preclinical or clinical data

Monitoring plan

There seems to be so many circumstances where they don't seem to follow their own rules. There is absolutely no data that they have offered to support any kind of ban of electronic cigarette technology. At most there might be justification to put some kind of label on these products like they force the herbal medicinal industry to do saying something like, 'these statements have not been evaluated by the Food and Drug Administration, this product is not intended to diagnose, treat, cure, or prevent any disease'.

[Breal]

The FDA has been wandering down this road for the last two years. Their agenda is always a clouded one. It is hard to believe that their intentions are genuine when they seem to take arms against the simplest of products with no real data to take such a stance. Please read the following portion of their own mission statement:

Regulatory Requirements

Individual subject safety must be balanced against the potential public health benefits of new therapies

Risk assessment requires sufficiently detailed information regarding:

Product characterization and safety testing

Supportive preclinical or clinical data

Monitoring plan

There seems to be so many circumstances where they don't seem to follow their own rules. There is absolutely no data that they have offered to support any kind of ban of electronic cigarette technology. At most there might be justification to put some kind of label on these products like they force the herbal medicinal industry to do saying something like, 'these statements have not been evaluated by the Food and Drug Administration, this product is not intended to diagnose, treat, cure, or prevent any disease'.

Let's hope that is all they will require.

[Soberrider]

Big tobacco companies, (nicotine)drug makers, and the government tax money (from tobacco) are all against the e-cig. Guess we'll have to see what happens. Whatever happens I'll still win.