FDA Regulation Threatens Cigarette Alternatives

Jacob Sullum | April 1, 2009

This evening the House of Representatives is expected to approve a bill authored by Rep. Henry Waxman (D-Calif.) that would let the Food and Drug Administration regulate tobacco products. The bill, which is supported by Philip Morris but opposed by its smaller competitors, is also supported by the leading anti-smoking groups but opposed by some of their smaller competitors. Recently the dissenters in the anti-smoking movement have been highlighting one of the bill's major flaws: It would grandfather in all current cigarettes (except for those with politically incorrect flavors) while making it virtually impossible to introduce and promote safer alternatives.

One of those alternatives is snus, Swedish-style oral snuff, the health risks of which are negligible compared to those of cigarettes. The Waxman bill would not ban snus, but it would prohibit manufacturers from informing consumers about oral snuff's dramatic safety advantages. Another cigarette alternative, one that probably would be kept off the market altogether under the bill's regulatory standards, is electronic cigarettes, battery-powered devices that deliver odorless nicotine vapor instead of smoke, avoiding all the hazards associated with tobacco combustion products. Sen. Frank Lautenberg (D-N.J.) wants the FDA to take electronic cigarettes off the market "until they are proven safe." Even if the FDA does not ban e-cigarettes under its existing drug authority, their manufacturers probably would not be able to meet the test established by the Waxman bill for products that compete with cigarettes.

One anti-smoking group that supports snus, e-cigarettes, and other harm-reducing alternatives to standard cigarettes is the American Association of Public Health Physicians (AAPHP), which says (PDF):

A variety of non-pharmaceutical alternative nicotine delivery products are already on the market or in various stages of development and market testing. These include sticks, strips, orbs, lozenges and e-cigarettes. The information available suggests risk and benefit profiles similar to widely accepted pharmaceutical nicotine replacement products.

Holding the snus and alternative nicotine delivery to the research standards of pharmaceutical products would cost the manufacturers millions of dollars per product and would deny current smokers the benefits of these products for a decade or more. Furthermore, such studies probably could not be conducted at current American academic centers because Institutional Review Board (IRB) guidelines would likely prohibit case/control studies on products with no therapeutic benefit. Thus, the seemingly reasonable research standards in the Waxman bill would likely result in a de-facto ban on all such products. AAPHP therefore favors the research guidelines from the Buyer bill [alternative legislation introduced by Rep. Steve Buyer (R-Ind.)].

Since both the Waxman and the Buyer bills would approve currently marketed cigarettes, the most hazardous of all tobacco products, the standard for lower risk products for use by current smokers should be the hazard posed by cigarettes, not a pharmaceutical safety standard.

Bill Godshall of Smokefree Pennsylvania (who alerted me to the AAPHP statement), tobacco policy blogger Michael Siegel (who clued me in to the e-cigarette controversy), and the American Council on Science and Health also worry that FDA regulation could stifle the market for cigarette alternatives. I explain why the Waxman bill is bad for smokers here, here, and here. I discuss snus here, here, and here.

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NolongerTofuSushi|4.1.09 @ 1:20PM|#

Is the new big federal cigarette tax, that is supposed to begin today, real or a hoax?

anon|4.1.09 @ 1:27PM|#

"The bill, which is supported by Philip Morris but opposed by its smaller competitors"

No shit, you say

|4.1.09 @ 1:30PM|#

The bill, which is supported by Philip Morris but opposed by its smaller competitors,

tells me all I need to know to oppose this bill.

edwards|4.1.09 @ 1:36PM|#

Given the scientific data supporting the statement that smokeless tobacco is 98% safer than cigarettes, it's truly appalling that the majority of the public health community so irrationally rejects the switch-to-smokeless (switchtosmokelesss.com, switchtosnus.com) tobacco harm reduction argument. There are, after all, LIVES at stake! (Oh, but they're SMOKERS' lives... never mind.)

Zeb|4.1.09 @ 1:36PM|#

Shit like this proves that the anti-tobacco crowd is made up of a lot of unpleasant mean-spirited people for whom hatred of tobacco and those who enjoy it outweighs all reason. If they were serious about public health results they would be pushing the use of things like snus and electric cigarettes as alternatives to smoking.

|4.1.09 @ 1:36PM|#

Is the new big federal cigarette tax, that is supposed to begin today, real or a hoax?

It's real. Keeping in line with Obama's pledge not to raise taxes on those earning less than 250K, the poor and middle class are exempt.*

* There's your April fools joke.

Kolohe|4.1.09 @ 1:42PM|#

Representative Waxman is an unparalleled tool. I do not understand why liberals like him so much. He opposed public transporation for his district in an archetypical example of limosine liberal Nimbyism. More importantly to the body politic, over several years of two different decades, he has wasted irreplacable resources by using his Chairmanship of the govt oversight committee to grandstand every random ass thing rather than overseeing government. And then everyone's surprised with govt malfeasence.

Ska|4.1.09 @ 1:43PM|#

That must make a pack of smokes in NYC cost $11.

Allan|4.1.09 @ 1:43PM|#

To answer sushi's question, it is for real. The tax increase occurring today is part of the SCHIP that Obama signed into law earlier this year, and was vetoed by former president Bush twice(IIRC, correct me if he did only veto it once) in the last 2 years:
http://ryorevolution.com/ryo-schip-table.html
http://www.ttb.gov/main_pages/schip-summary.shtml

Thanks very much to Jacob for writing this article, as this is another great reason why Congressmen and Senators should take another look at the FDA tobacco regulation bill. Too bad it'll more than likely fall on deaf ears to those who already favor it, though....

|4.1.09 @ 1:44PM|#

Shit like this proves that the anti-tobacco crowd is made up of a lot of unpleasant mean-spirited people for whom hatred of tobacco and those who enjoy it outweighs all reason.

Puritanism: The haunting fear that someone, somewhere, may be happy.

Henry Louis Mencken (1880-1956)

|4.1.09 @ 1:45PM|#

Waxman, besides being one of the ugliest fuckers to ever walk the planet (looking at him makes me physically ill), is a shithead extraordinaire. I just want some fuckbag Democrat lickspittle to defend Waxman and tell me how Democrats are for the poor. Really, someone try it.

|4.1.09 @ 1:48PM|#

Epi, I've always been of the belief that Waxman is the spitting image of one of the Morlocks from the George Pal version of The Time Machine

Peppered Ayn|4.1.09 @ 1:50PM|#

"Shit like this proves that the anti-tobacco crowd is made up of a lot of unpleasant mean-spirited people for whom hatred of tobacco and those who enjoy it outweighs all reason."

So you are okay with a sidewalk covered in cigarette butts being replaced with a sidewalk covered in snus spit?

Gross is gross.

|4.1.09 @ 1:52PM|#

I must be mis-reading this story. It can't possibly be true that a Democrat controlled Congress is preparing to pass legislation that would entrench major corporations and protect them against smaller competitors?

And that Big Nanny in Washington is entrenching old-style cigarettes against safer alternatives?

That would unpossible in the Age of Obama, so what am I missing?

|4.1.09 @ 1:54PM|#

Smokers should be shot.

So you are okay with a sidewalk covered in cigarette butts being replaced with a sidewalk covered in snus spit?

Thus does Peppered Ayn demonstrate her ignorance of snus. One of the great things about snus is that it does not require its users to expectorate.

NolongerTofuSushi|4.1.09 @ 1:56PM|#

No wonder the electric cigarette is on the block to b banned. It has LED at the lit end! Breathing led can't be good for you.

Just look at the picture if you don't believe me.

JKAF

Ranilen|4.1.09 @ 1:57PM|#

One of my friends just started using one of those e-cigs to quit smoking last week. It's pretty cool, he can even smoke it indoors with smoke-allergic people.

Ironically, he is from New Jersey.

|4.1.09 @ 1:58PM|#

So you are okay with a sidewalk covered in cigarette butts being replaced with a sidewalk covered in snus spit?

Tobacco laced spittle gets washed away by the rain and is quickly biodegradable. Filtered cigarette butts take years to degrade and clog wastewater treatment plants.

I'll go with the spit.

Zeb|4.1.09 @ 2:06PM|#

So you are okay with a sidewalk covered in cigarette butts being replaced with a sidewalk covered in snus spit?

Yes, but I'd rather see a mix of the two.

Al Capone|4.1.09 @ 2:09PM|#

Smokers should be shot.

Bring it, bitch.

mark|4.1.09 @ 2:09PM|#

So, write my representative, as always? Or is there someone more influential I should get in touch with?

Cool Cal|4.1.09 @ 2:11PM|#

An occasional smoker, I grew up in Jersey (back then, you could smoke in Jersey restaurants for Christ sake!) and got the first part of Lautenberg's reign. Now I live in Waxman's district (where incidentally, he has yet to be challenged - what the fuck?). There is some Kafkaesque poetry to this, my being seemingly followed by a network of douchebag civil servants. But seriously, I abhor the idea of actively campaigning for politicians, but the fact that Waxman has been Commissar of Beverly Hills for this long is inexcusable. Someone at least has to run against him. Is there not a sizable majority or even minority in these parts that thinks this mustachioed busy-body shitbird scumbag fucknut should be greeting seniors on the day shift at Lawry's by now.

|4.1.09 @ 2:15PM|#

Allowing these alternatives on the market would give people the false impression that tobacco can be completely harmless. Smokers reinforce the idea that smoking is deadly, thus getting more people off tobacco.

|4.1.09 @ 2:18PM|#

Waxman has the looks of a greek god. And the dems are for the poor. Really.

I'm not surprised. Smokers kick off earlier, saving Social Security and medicine bundles; they pay more in taxes with "real" cigaretes.
Newer, safer, alternatives are blocked. I'm surprised Waxman didn't say it was "win-win" for all involved (unless he did, I didn't RTFA)

|4.1.09 @ 2:19PM|#

J sub D | April 1, 2009, 1:30pm | #

The bill, which is supported by Philip Morris but opposed by its smaller competitors,

tells me all I need to know to oppose this bill.

He had me at Henry Waxman.

|4.1.09 @ 2:23PM|#

Waxman has the looks of a greek god.

If that Greek God is Hephaestus, then yes.

NolongerTofuSushi|4.1.09 @ 2:26PM|#

"Thus does Peppered Ayn demonstrate her ignorance of snus. One of the great things about snus is that it does not require its users to expectorate."

Typical. Stupid. Cunt.

Dan|4.1.09 @ 2:28PM|#

This isn't about safety - it is about taxes. They have a nice cigarette tax going, and all these alternatives are going to make it really hard form 'em.

NolongerTofuSushi|4.1.09 @ 2:30PM|#

@Al Capone

Is it true you only had one ball?

|4.1.09 @ 2:32PM|#

Yes, but it was gigantic.

|4.1.09 @ 2:34PM|#

NolongerTofuSushi|4.1.09 @ 2:36PM|#

"Yes, but it was gigantic."

Got any pictures of it?

|4.1.09 @ 2:38PM|#

I wanna try an e-cig, but hell I can't even switch to another brand of the real things.

|4.1.09 @ 2:39PM|#

Oh my. Lovely Juanita has once again tortured my heart by her presence.

Love hurts, love scars,
Love wounds, and marks,
Any heart, not tough,
Or strong, enough
To take a lot of pain,
Take a lot of pain
Love is like a cloud
Holds a lot of rain
Love hurts, ooh ooh love hurts

|4.1.09 @ 2:40PM|#

If that Greek God is Hephaestus, then yes.

Good one, Epi. Happy April Fools' Day!

The bill, which is supported by Philip Morris but opposed by its smaller competitors, is also...

...written by Philip Morris to protect Philip Morris. Prove me wrong and I'll STFU on this subject.

J sub D, can you stick something in Jaunita's mouth once and for all, please.

NolongerTofuSushi|4.1.09 @ 2:40PM|#

"Oh my. Lovely Juanita has once again tortured my heart by her presence."

She has a big butt. I love that.

dhex|4.1.09 @ 2:49PM|#

so e-cigs are basically vaporizers for tobacco?

|4.1.09 @ 2:52PM|#

dhex,

It vaporizes liquid nicotine in a cartridge, not just, uh, anything you can jam in it.

|4.1.09 @ 3:20PM|#

There have been studies done on Electronic cigarettes, the FDA is just ignoring this. This is ridiculous, these devices could save millions of lives. Sen. Frank Lautenberg also wanted to ban Bikini Waxes. This just tells you how ridiculous this guy actually is. Hes older then dirt and needs to step down. He has no clue about Electronic cigarettes but yet he wants to ban them. People need to speak up for there rights and stop letting the government run there lives. IM OUTRAGED!!!!!!!!!!

SpongePaul|4.1.09 @ 3:27PM|#

cigarette price in MS which only has an 18 cent state tax this morning 4.25-4.40 cheapies by carton went from 14.99 to 22.99 malboro camel etc carton 42-45 a week ago cheapies 1.99 per pack malbro etc 2.50-3 depending on location.
Oh and the E cigarettes should be legal, but that wont stop me from slapping the Smug out of someone if they "puff" on one and then try to give me a health lecture

|4.1.09 @ 3:32PM|#

For the record, Frank is eighty-fucking-five years old. Waxman is a relatively young sixty nine.

Given that re-election is almost a sure thing for congresscritters, if you want to put upper age limits on office holders (or term limits) in the constitution, I'm with you.

Robert Byrd, Jesse Helms, Strom Thurmond. Need I say more?

|4.1.09 @ 3:33PM|#

Oh yeah. Ted fucking Kennedy.

dhex|4.1.09 @ 3:39PM|#

"It vaporizes liquid nicotine in a cartridge, not just, uh, anything you can jam in it."

oh, well, huh.

cigarettes in nyc vary from 9 something to 11 something a pack already, depending on where you are. if i hadn't quit i'd be pissed all to hell and back.

SpongePaul|4.1.09 @ 4:07PM|#

The fun thing about a cig tax increase is that it is counter productive. When you make a large jump like has happened today. One thing is sure to happen. the marginal and poor will either cut back lessing taxes, or there will be an economic hole where the money they would have spent now goes to the tax. now the middleclass and the rich, well the same effect. the overall end result is that no matter how high taxes go, revenue has a set point. for people will not pay above X for Z. if the taxes creep up, then this phenomanon is eased by time. a rapid increase in a sin tax, leads to a rapid decrease in use. thus causing less tax money to come in. AND WTF is anyone doing using a non accountable tax to fund things that need steady funding, huh! STUPID FEDS

SpongePaul|4.1.09 @ 4:09PM|#

btw i smoke a half a pack to a pack per day. you can belive that i switched to a cheaper brand and have cut back to 5-10 per day. take that feds, i smoke the indian non taxexed cigs on my boat though, heck in a weekend in the ocean i can cut through 2-4 packs in 2 days. depending on weather and fish.

BakedPenguin|4.1.09 @ 4:17PM|#

cigarettes in nyc vary from 9 something to 11 something a pack already...

That has to be a huge incentive for smuggling. It's not even a full day's drive from VA or NC to NYC, and a truckload of smokes bought @ < $3 a pack and sold @ say, $6 a pack would reap a nice profit.

Of course, the threat of 2-5 years (or whatever) in Ossining definitely mitigates the attractiveness of that arrangement somewhat.

|4.1.09 @ 4:44PM|#

E-cigarettes are more than just suspect. Looks like they could be highly toxic -- poisonous. The American Cancer Society, Cancer Action Network, American Heart Assn and American Lung Assn -- all agree that electronic cigarettes should be pulled off the market. The World Health Organization says they may be highly poisonous and that the product-makers are committing fraud by using the WHO logo and name in advertising and packaging. The makers of e-cigs claim that they are safe but have absoluely no scientific studies to back up their claims. No evidence. No proof. Just their word "believe us, so we can make money."

Ethic Soup blog posted an excellent article on the subject at:

http://www.ethicsoup.com/2009/03/hey-hey-fda-whaddaya-say-are-ecigarettes-safe-eh.html

The cost of stopping your cigarette habit does not have to be breathing toxic poisons into your lungs from a pretend cigarette!

|4.1.09 @ 5:28PM|#

So the Indian smoke shop cigs aren't subject to the increase? Ah! I finally found something useful about living in Oklahoma.

|4.1.09 @ 5:37PM|#

Sharon, you have it backwards. There's absolutely no scientific basis showing how e-cigs are poisonous - that's your conjecture from the politically motivated statements from various organizations.

Furthermore, what you think smokers should and shouldn't do is irrelevant to the discussion of the legality of the devices.

|4.1.09 @ 6:11PM|#

FDA has said in the past that they saw no reason to regulate e-cigarettes. It is the politicians that are getting money from the taxes and Big tobacco, of course they want to see e-cigs gone. Big Pharma has a huge interest in the quit-smoking drugs. I use a Torch electronic cigarette and my husband uses a Torch e-pipe and e-cigar. All of the issues have been addressed, no tobacco, no tar, no carcinogens,
nothing ignited. No smell, first or secondhand smoke. No butts or ash. I get the nicotine that I want and I save money...and here come the politicians to strong-arm FDA.
For more info. www.torchcigarettes.com

|4.1.09 @ 6:13PM|#

Rising taxes on cigarettes and other tobacco products create revenue for State and Federal Government. Of course, if us folks have the option of a very safe nicotine replacement, we may live healthier lives. But oh the money they would lose. So of course squash it until they can impose an equally unfair tax on these products.

|4.1.09 @ 7:11PM|#

From what I understand, an ecigarette cartridge contains propylene glycol and nicotine. Propylene glycol is FDA approved for use in food, cosmetics and medicines, and is listed as an additive in cigarettes at Phillip Morris's website.

It appears to me that this debate -reduced to it's simplest form - is about a device that allows smokers to mimic the act of smoking while inhaling two products that are already widely in use, elminates many other unhealty chemicals they are currently using on a daily basis, while totally eliminating the issue of second hand smoke. Beyond that, it is all semantics as to whether the product can legally be marketed as a 'smoking cessation device'.

I just don't see what the issue is here.

I think there is a segment of society that is so rabidly anti-tobacco that if someone were to offer a fresh ear of corn as a workable substitute, they would form an anti-corn committee in order to address the possibility of kernels getting stuck in people's teeth.

Seriously, do we not have bigger fish to fry in this country? Personally, I'd much rather see our legislators focusing on more immediate problems.

|4.1.09 @ 9:06PM|#

"The World Health Organization says they may be highly poisonous"

No one from the WHO has ever said that. Please get your facts straight before spouting such asinine reasoning. What was said was that more testing needs to be done to validate their effectiveness in smoking cessation.

http://www.who.int/mediacentre/news/releases/2008/pr34/en/index.html

|4.1.09 @ 9:26PM|#

The problem is that we have large groups of uneducated people who see something different and 'unnatural' and somehow assume that is it somehow nefarious. It doesn't take that long to actually find out what is in the stuff and studies that show the inherent safety or risk out of the parts which make up the whole. But most of these people are uneducated for a reason, they are just too lazy to do the work so they pass off actually looking critically at something off to those that have a vested interest into one side or another of the problem. It would take less then 5 minutes the realize that there has been no study showing any permanent negative health repercussions to using electronic cigarettes that is not from the already readily available nicotine itself, and at least one study showing the potential as a highly effective smoking cessation aid. But all that doesn't really matter because they have made up their mind before even before they even look at any evidence. Welcome to the American Inquisition.

|4.1.09 @ 9:31PM|#

Oh and one more thing:
"Ethic Soup blog posted an excellent article on the subject at:

http://www.ethicsoup.com/..."

According to the byline you posted the story. It's typically bad form to spam your blog and just silly to spam it and then act like it was some else's work while having your name on the byline.

|4.1.09 @ 11:08PM|#

My oldest brother has been a 3 pack a day man for 33 years. He started using the E-cig 6 weeks ago. Hos raspy cough is gone. He feels better, more energy, looks better etc. He can do it inside at work and he is saving a shitload of money.
These politicians should slide a blunderbuss up their ass till they choke and pull the trigger.

Steve Hartwell|4.2.09 @ 12:14PM|#

US Senator Lautenberg, the guy who kick started this global ambush on E-cigs a few weeks ago, by demanding the US FDA do what Health Canada has done. Let's expose the underside of that Lautenberg turd and we find that Lautenberg is joined at the hip with the Robert Wood Johnson Foundation, which is Johnson & Johnson's NGO, and the main source of funds for global anti-smoking, to the tune of over $ 440 MILLION so far, while of course it's 'parent' makes BILLIONS from their various anti-smoking products. Johnson & Johnson also owns Pfizer, the maker of the Nicotine Inhaler. Now - it turns out that Lautenberg has approved numerous gov't grants to RWJF over the years, and, received campaign donations from the same people. Meaning - those most against the Electronic Cigarette are the very same people who will lose the most because of Electronic Cigarettes, and the very same people behind the global anti-smoking and anti-ecigs campaigns. What really pisses me off is that the global so-called news industry refuses to report these facts. - Steve Hartwell -
www.tobaccosmokersofcanada.ca - Toronto, Canada

|4.2.09 @ 1:13PM|#

New Zealand Health has conducted detailed research into the safety of a typical representative eCig liquid which can be found here: http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf

Green Smokes|4.2.09 @ 9:27PM|#

This is ridiculous! Electronic cigarettes contain water, nicotine, propylene glycol (which is a safe food additive which can be found in everything from ice cream to food coloring), and flavoring. Regular cigarettes contain over 4000 harmful chemicals and cancer-causing carcinogens, but the product they want to ban is the e-cigarette? My e-cigarette has saved my health and the health of those around me (since there's no second-hand smoke)! What a joke...

I found this blog that helped me figure out which brand of e-cigarette I should buy. If you're considering switching over, I hope this page helps you like it helped me:

Green Smokes

And here are some videos with information about how e-cigs work:

HealthySmokes' Youtube Channel

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