Covering Their Butts

Why it's misleading to say the FDA is regulating cigarettes

Jacob Sullum | June 10, 2009

The Family Smoking Prevention and Tobacco Control Act, which the House approved in April and the Senate is expected to approve this week, includes a censorship provision that speaks volumes about the law's effectiveness. It prohibits manufacturers from making "any statement directed to consumers" that "would reasonably be expected to result in consumers believing" a tobacco product "is regulated, inspected or approved by the Food and Drug Administration."

The bill, which President Obama supports, authorizes the FDA to regulate tobacco products. Yet it says "consumers are likely to be confused and misled" if they know the FDA is regulating tobacco products. They might mistakenly believe that FDA regulation makes these products safer, for example, when the opposite is the truth.

It's easy to understand why Philip Morris supported this bill. The market leader can expect to benefit from the limits on advertising and promotion, the regulatory burden on smaller competitors, and the ban on every "characterizing" flavor except the one it happens to use in some of its most successful brands (menthol). But the company may be wrong to believe that FDA regulation will allow it to pursue plans for safer cigarettes.

To introduce a "modified risk product," a manufacturer has to convince the FDA not only that the product will "significantly reduce harm and the risk of tobacco-related disease to individual tobacco users" but also that it will "benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products." Alternatively, if "scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies," the FDA can let a manufacturer advertise reduced levels of certain substances in cigarette smoke, but only if the agency decides it "would be appropriate to promote the public health."

This collectivist standard means the FDA can keep a product off the market even if it is indisputably safer than conventional cigarettes, based on fears that it will attract nonsmokers or smokers who otherwise would have given up tobacco entirely. That same hurdle applies to the promotion of existing products.

Consider snus (Swedish-style smokeless tobacco), which under the new law will continue to carry a warning that it "is not a safe alternative to cigarettes." Although that's literally true, since nothing is 100 percent safe, there's no question that snus is far less hazardous than cigarettes. Yet the FDA is now empowered to prevent manufacturers from saying so, lest consumers make an informed decision to use smokeless tobacco rather than abstaining completely.

Such censorship would sacrifice the lives of current smokers for the sake of a tobacco-free future. Likewise the mandated reductions in nicotine content authorized by the law, which would be aimed at making cigarettes less attractive to nonsmokers.

The predictable result of reducing nicotine content is that people will smoke more to get the dose to which they are accustomed. They will take more puffs, inhale more deeply, hold the smoke longer, or consume more cigarettes. Consequently, they will be exposed to higher levels of toxins and carcinogens.

The authors of the law are familiar with such compensatory behavior. It's the reason they decided to prohibit the use of misleading cigarette terms such as light, mild, and low-tar, which are based on yields delivered to smoking machines rather than people.

Yet the attempt to mandate less addictive cigarettes would be even more dangerous than the industry's practice of reducing nicotine and tar yields simultaneously, since it would increase the tar-to-nicotine ratio. Somehow we're supposed to believe that the government's involvement transforms a life-endangering fraud into a life-saving public health intervention.

Since FDA regulation is apt to make cigarettes more hazardous while impeding competition from safer alternatives, you can begin to see why mentioning it might give consumers the wrong impression. I won't tell them if you don't.

Jacob Sullum is a senior editor at Reason and a nationally syndicated columnist.

© Copyright 2009 by Creators Syndicate Inc.

Comments

Rhywun|6.10.09 @ 7:15AM|#

Smoke 'em while you got 'em.

|6.10.09 @ 7:40AM|#

Science-based my ass.

|6.10.09 @ 7:53AM|#

Wow, that is simply amazing. Another reason to smoke!

RT
www.anonymity.2ya.com

MNG|6.10.09 @ 8:01AM|#

I have to think all this concentration on the goofy way that government has done this dance with cigs (which to a large degree has been due to the enormous influence their makers have in politics) is hand waving to prevent libertarians from thinking about how in the market private actors knowingly and deceptively made fortunes selling a product which was crazy harmful to their consumers. We get told all the time that surely rational businesspersons would never do such a thing and so regulation is not needed. Yeah, right.

MNG|6.10.09 @ 8:03AM|#

Oh, and anonymity-bot, I do hope that Satan will occasionally take a drag on his Kools and blow it in your face while he rapes and devours you for all eternity for the sin plaguing good folk with your spam.

Anonymous|6.10.09 @ 8:11AM|#

hand waving to prevent libertarians from thinking about how in the market private actors knowingly and deceptively made fortunes selling a product which was crazy harmful to their consumers

So? With a miniscule fraction of the money taxpayers provide to government, private firms could be funded to perform studies on foods and drugs.

Of course you're going to assert that these studies should be done, and if they wouldn't (weren't), then that's a market failure up to government to correct. Which would be fine, except that it's fascism (compulsory collectivism featuring state-run business).

Xeones|6.10.09 @ 8:52AM|#

Jeezum crow, is there anything government can't fuck up utterly?

how in the market private actors knowingly and deceptively made fortunes selling a product which was crazy harmful to their consumers

...pretty much all of whom have known for decades that smoking is crazy harmful. My grandparents were referring to cigarettes as coffin nails back in the '50s, for example, and still they smoked 'em. I myself eat a great deal of bacon. Is it bad for me? Most likely. It may even kill me one day. Fuck do i love bacon though, and i'd go Unabomber on anyone who tried to regulate bacon for my own good.

I guess what i'm trying to say is caveat fucking emptor.

MNG|6.10.09 @ 8:57AM|#

"With a miniscule fraction of the money taxpayers provide to government, private firms could be funded to perform studies on foods and drugs."

And of course we can trust the private firms to not be deceptive to consumers in a way that would harm them, just like we could trust private firms not to deceptively sell dangerous products to their consumers...Uh, on second thought!

"fascism"

Alright, time to put this old nag out to pasture. The negative connotation people have about fascism is not the industrial labor policies the Nazis and Mussolini were involved in (but not Franco tellingly) but the forced administration of castor oil, the meeting of political dissent with firing squads, the concentration camps and the warmongering... Libertarians and conservatives take one aspect of fascism they find appalling (industrial policy), associate it with similar modern policy options, and then hope people will associate ALL of the above named aspects of fascism to the proponents of the modern policy. But that dog ain't hunting, it's pretty lazy and transparent...

MNG|6.10.09 @ 9:03AM|#

Xeones

So cig companies did not actively try to deceive their consumers? They did not try to target kids and other often low-information groups? They did not manipulate nicotine levels in the hopes of hooking consumers? Just checking...

And you would last about three weeks under true caveat emptor, so careful what you wish for. I bet at this moment you know very little about the history and reputability of about 95% of the makers of the food and medecine etc., that you have in your home right now. You buy your aspirin, bacon and what not confident that it will not kill you or give you dysentery because you know that shit's been heavily regulated. Fat, protected and happy you can then sit back and bitch abstractly about the evils of overregulation and the the theoretical beauty of caveat emptor...

PR|6.10.09 @ 9:12AM|#

The States Attorney Generals told me they needed the Master Settlement Agreement because the states were paying healthcare costs for smokers. I assume I have insurance by virtue of these additional taxes I have paid or was I misled and confused?

Xeones|6.10.09 @ 9:12AM|#

Wow. Project much, MNG?

|6.10.09 @ 9:13AM|#

MNG:
And of course we can trust the private firms to not be deceptive to consumers in a way that would harm them...

Article:
It prohibits manufacturers from making "any statement directed to consumers" that "would reasonably be expected to result in consumers believing" a tobacco product "is regulated, inspected or approved by the Food and Drug Administration."

MNG, what's the difference here, exactly, besides the fact people are forced to pay for the government alternative to get the same deception at the behest of influential interests?

Dave Krueger|6.10.09 @ 9:24AM|#

Wait a sec. You people must still be under the impression that the First Amendment allows, you know, free speech.

The new reading of the First Amendment is that you are free to say anything that is approved. All other speech has no value.

Personally, I think the government mandated warnings on cigarette packages are a violation of free speech. By god, if limiting your speech is a violation, then telling you what to print is just as much (if not more) of a violation.

Xeones|6.10.09 @ 9:38AM|#

some fed: Government is utterly incorruptible, and everyone in it is a saintly being with every lesser creature's best interests at heart. We should kneel and thank Vishnu that such wisdom is available to create laws and tell us what we can and can't do with our own bodies -- for our own good, of course.

Granite|6.10.09 @ 10:12AM|#

Has there been a first ammendment challenge to crap like this? I mean, I'm ok with the FDA (re: The Government) saying 'Truth in Advertising or we'll bust your ass', and giving them the resources to prove what 'Truth' is, but this is ridiculous.

|6.10.09 @ 10:17AM|#

So the anonymity bot can now do typos in its handle.

I am seriously impressed. Without the ad at the bottom, I would say its close to passing the Turing test.

private actors knowingly and deceptively made fortunes selling a product which was crazy harmful to their consumers.

Its not deceptive if nobody is deceived, MNG.

And I am genuinely curious as to the theory under which the provision of 100% truthful information about FDA oversight is "deceptive."

MNG|6.10.09 @ 10:38AM|#

"what's the difference here, exactly"

Uhh, that one is acting in behalf of the consumers (trying to get them to NOT think they are safe) while the other was not (trying to get them to think they ARE safe)?

"Its not deceptive if nobody is deceived"

And robbery is not wrong if the victim had no money on him...

|6.10.09 @ 11:14AM|#

The way this is being implemented doesn't suggest that the FDA will be acting on the consumers' behalf rather than Phillip Morris's. The whole flavoring issue leaving menthols untouched is pretty revealing in that regard.

But setting cynical assumptions of backroom deals aside for the sake of argument, what would acting in the consumers' interest even look like with cigarettes?

Can cigarettes be made "safe" in the same sense as cat food? Under FDA pressure, can cigarettes be rendered less harmful up to the point where they become acceptable to the FDA for some valid use, as in the case of lethal yet life-saving chemotherapy medications?

Accepting for the sake of argument that cigarette companies aren't behind this whole affair, the remaining party behind this measure are anti-smoking advocates who want prohibition and have drafted the FDA to get there by half-measures and nannying. This is a pretty perverse standpoint from which to argue that anti-smoking advocates are on the side of consumers. What consumer advocate is opposed to consumption itself?

|6.10.09 @ 11:41AM|#

Ummm, right, MNG, all the gov't regulation of cigarettes has totally stopped people from smoking stuff they good and well know is harming their health, right?

RTFA. The FDA is now prohibiting cigarette companies from telling consumers the truth, because some idiots actually think that government regulation of cigarettes will make them safer.

But even Congress knows better than that.

Granite|6.10.09 @ 12:18PM|#

Can cigarettes be made "safe" in the same sense as cat food?

It's nicotine and other nasty stuff. IMHO, FDA would be perfectly within it's powers to inspect the leaf to make sure it doesn't have e-coli growing on it, or that the processing isn't dosing the product with toxins (other than, you know, the tobacco itself).

From that point of view, there is merit in telling companies they can't advertise 'FDA Approved', although that's different from 'FDA Inspected'

|6.10.09 @ 12:42PM|#

It's nicotine and other nasty stuff.

Actually, nicotine is pretty harmless all by itself. That's why you can buy it in gum and patches and whatnot.

Its the other combustion byproducts that are bad for you.

|6.10.09 @ 1:20PM|#

"And robbery is not wrong if the victim had no money on him..."

"Robbery" without taking anything is not a crime. Somebody could come up to me and ask me to have my watch or wallet, and I would just say no. If they assault me, then there's a law against that. If they keep pestering me, there's laws against that. But a "robber" that takes nothing is just an idiot.

|6.10.09 @ 2:43PM|#

The FDA doesn't regulate cigarettes, that's the job of the Bureau of Alcohol TOBACCO and firearms.

The Lurkee-loo|6.10.09 @ 3:17PM|#

I've been looking into switching to e-cigarettes....
Anybody know anything about them?
Do they really work?...

d|6.10.09 @ 3:42PM|#

The bill, which President Obama supports,...

WTF?!!!! Isn't Chairman Obama a smoker himself? He has stooped to an all-time, granny/nanny-vote-grubbing low (well...maybe not, we'll see what he does next).

LarryA|6.10.09 @ 4:31PM|#

And of course we can trust the private firms to not be deceptive to consumers in a way that would harm them, just like we could trust private firms not to deceptively sell dangerous products to their consumers...Uh, on second thought!

See Underwriters Laboratories.

"Robbery" without taking anything is not a crime.

Not under Texas law:

Sec. 29.02. ROBBERY. (a) A person commits an offense if, in the course of committing theft as defined in Chapter 31 and with intent to obtain or maintain control of the property, he:
(1) intentionally, knowingly, or recklessly causes bodily injury to another; or
(2) intentionally or knowingly threatens or places another in fear of imminent bodily injury or death.
Sec. 29.01. DEFINITIONS. In this chapter:
(1) "In the course of committing theft" means conduct that occurs in an attempt to commit, during the commission, or in immediate flight after the attempt or commission of theft.

Most other state laws are similar.

Robert|6.10.09 @ 7:02PM|#

The same bill that authorizes the Food and Drug Administration to regulate cigarettes prohibits manufacturers from telling consumers about FDA regulation,

This has long been true for medical devices.

Baja K|6.11.09 @ 12:27PM|#

1) Search "PNHP New England Journal of Medicine tobacco insurance" for new info on health insurers' multi-Billion dollar investments in cigarette manufacturers. (They also invest in tobacco pesticides, etc.)

2) Here's a ready-made note to perhaps send, quickly, to Senate and House members. All points easily referenced by simple search of the relevant terms.

Dear___________:
RE: S.982 The FDA Tobacco Bill

Please address several significant errors in this legislation.

1) It states that nicotine is harmful. It is not. It is deemed safe in many nicotine delivery products.

2) It allows the FDA to lower nicotine levels. But that is the trick of "lite" cigarette makers for the purpose of prompting more smoking and more sales. Lower nicotine levels also prompt heavier, more-intense, more-irritating puffing.

3) By relegating the farm-related matters to the USDA, the FDA will ignore perhaps the most toxic and carcinogenic cigarette elements, the residues of any of over 400 US Registered tobacco pesticides….some of them being dioxin-delivering chlorine chemicals. The US GAO condemned lax oversight of this area in 2003.

4) By that same USDA situation, the FDA will ignore the carcinogenic nature of PO-210 radiation in tobacco grown with certain phosphate fertilizers.

5) The bill virtually threatens, if not predicts, an escalation of Prohibition-style crimes.

6) Numerous omissions: A reading of the legislation finds nothing specific, or even generally, about the following:
* Added burn accelerants.
* Dioxin-delivering chlorine-bleached cigarette paper.
* Cigarettes made partly or entirely with "tobacco substitute material"---fake tobacco.
* Any risks or harms, proven or likely, from use of plain, unadulterated tobacco.

There are more questionable clauses and phrases, but the above points certainly require some important re-writing, and further study.

|6.11.09 @ 5:06PM|#

Every day I come closer to running around screaming and waving my hands in horror of metastasizing government. Given the FDA's "stellar" (not) record on keeping track of the stuff they already regulate, I don't see how this new ploy makes any difference at all. Apparently they think their stamp of approval means a rodent's derriere difference to we common folk.

IIRC, it was gummint that mandated the labeling of smokes as "light," "low tar" in order to inform consumers.

As noted earlier, we all heard cigs referred to as coffin nails and there was a song w/ lyrics "smoke that cigarette, 'til you smoke yourself to death." We're not uninformed. Many choose to smoke because they (gasp!) enjoy it. Oddly, life expectancy has ramped up and we baby boomers either smoked (1 out of 2 in the 60s) or lived with a smoker.

I bummed a smoke earlier this week at a smoker friendly neighborhood patio bar. It was wonderful. American Spirit, 100% additive free.

Like Prohibition, coming down on smoking like a duck on a June bug creates a healthy black market. I wonder if there's any way to track how much of these buck$ go to terrorist. We I one, I'd surely get into smuggling.

Pigovian taxes haven't cut the smoking rate. There are ample sources of tax free smokes (Am Indian reservations). So far, to my great horror, gummint has banned credit card companies and private delivery services from dealing with reservation sales... however, to my great amusement, the USPS can deliver them and you can place orders through your checking account. Go figure.

Rambling along. Re scientific studies, the EPA edict about the danger of 2nd hand smoke used many studies conducted in Asia involving indoor coal fires (not on my list of safe things to do). Their meta analysis tossed out the gold standard 95% confidence interval and used 90%. I sure don't expect gov studies to be, well, 'fair and balanced.'

I've several friends/neighbors who stop by for a cup of coffee or a drink and a smoke. OK by me.

Dogs, I've gotta stop this. Anyway, smokers have been shown to be more productive than non smokers and those that cavil about 15 minute smoking breaks don't seem to notice all the time they spend chitchatting around the water cooler and office kitchen.

Oh dear, one more thing. No. Two more. I'm so sorry. Anyhooo, Banning smoking in restaurants and other businesses stomps all over property rights. As well, increasingly hermetically sealed homes and buildings create unhealthy indoor air quality whether one smokes or not. And (ta da, I'm done), obesity has ramped up in almost perfect inverse correlation with lower smoking rate. Let's play whack a mole, shall we?

|6.11.09 @ 5:20PM|#

lost in this whole discussion so far is the fact that government makes far more money from tobacco than does private enterprise. add to that the fact that government actively supported and promoted soldiers using tobacco for decades and one has to wonder, again, whether government has another adgenda. like say....POWER.

|6.12.09 @ 12:10AM|#

When the Federal Government nationalizes health care and runs private competition into the ground; through laws that will benefit itself (the government) over private insurers, we will start to see a lot more taxes and regulations on things like- and not so like, cigarettes. Like the "sin" tax on soda pop (i think that may have failed). What I mean is that the government is utterly broke and soon Hussein Obama and the statist Democrats (along with the "new" Republican party) will have completely bankrupted this country. Federal Reserve counterfeiting (9 trillion just since recession started) will cause inflation, making health care prices go up even higher. The federal government then will have to start outlawing consumer products which are harmful (or thought to be) completely to drive down the cost of nationalized health care. So to lower cost the congress will force people to live healthier, force them to eat better, force them not to smoke, force. Do so by making products illegal, by regulating them out of existence, by taxing them out of business. I am surprised I don't hear this fortune told more. America's Destiny awaits.

|6.12.09 @ 11:58AM|#

What "flavored cigarettes"? Other than menthol, all the flavored smokes I can think of are all blunts, which ain't exactly for the tobacco these days...

|6.12.09 @ 2:06PM|#

Andy Durfane:
"the federal government then will have to start outlawing consumer products which are harmful (or thought to be) completely to drive down the cost of nationalized health care. So to lower cost the congress will force people to live healthier, force them to eat better, force them not to smoke, force."

Actually Andy, its health conscious people how are driving up healthcare costs by going to the doctor more often and requesting more medical procedures and prescription drugs of questionable value. Also, long term care for the very old is quite costly and since people are living longer, in part because they have been smoking less, this too is a major reason for the rising costs but nobody wants to talk about the elderly being a burden. So if the government wanted to lower costs, it would encourage people to smoke more and eat more junk food so they would die earlier. When you consider the taxes smokers are already paying, and the fact that they die 5-7 years earlier than an average non-smoker (so they don't collect their full retirement benefits) I would say that smokers are subsidizing the healthy.

|6.12.09 @ 4:18PM|#

What "flavored cigarettes"? Other than menthol, all the flavored smokes I can think of are all blunts, which ain't exactly for the tobacco these days...

Cloves, for example, are the most famous. (And that ban has Indonesia seriously pissed.). Also a host of smaller companies produce various strawberry, chocolate, etc. flavored cigarettes and use organic tobacco and the like. But they're little guys, so they must be crushed just like those evil people at Etsy who might violate the CPSIA.

Essentially, all flavors not sold by Phillip Morris are banned.