Public Health

FDA Will Regulate Tobacco Products (But Don't Tell Consumers)

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Today, as expected, the Senate overwhelmingly approved a bill authorizing the Food and Drug Administration to regulate cigarettes and other tobacco products. The bill, the subject of my column this week, has already been approved by the House, and President Obama is eager to sign it. For reasons why he shouldn't be, see the column and this blog post, which includes links to earlier coverage. Today I also taped a Marketplace commentary for NPR on the subject.

One interesting change between the House and Senate versions of the bill has to do with the censorship provision I mentioned in the column. The House version prohibits manufacturers from making "any statement directed to consumers through the media or through the label, labeling, or advertising that would reasonably be expected to result in consumers believing that the product is regulated, inspected or approved by the Food and Drug Administration, or that the product complies with the requirements of the Food and Drug Administration, including a statement or implication in the label, labeling, or advertising of such product, and that could result in consumers believing that the product is endorsed for use by the Food and Drug Administration or in consumers being misled about the harmfulness of the product because of such regulation, inspection, or compliance."

Apparently someone realized how absurd it was to try to stop manufacturers from telling consumers that tobacco products are now regulated by the FDA and comply with its requirements, two points that are indisputably true and in any event will be matters of common knowledge. The Senate version of the bill instead bans "any statement or representation, express or implied, directed to consumers through the media or through the label, labeling, or advertising that is false or would reasonably be expected to mislead consumers into believing that the product is approved by the Food and Drug Administration, or that the Food and Drug Administration deems the product to be safe for use by consumers, or that the product is endorsed by the Food and Drug Administration for use by consumers, or that is false or would reasonably be expected to mislead consumers regarding the harmfulness of the product because of the Food and Drug Administration's regulation or inspection of it or because of its compliance with regulatory requirements set by the Food and Drug Administration."

But the revisions do not address the central problem, which is that FDA regulation of tobacco products is inherently misleading, promising safety improvements it won't deliver. Even if the Senate version of this provision ends up in the final law, the FDA could still plausibly argue that a completely truthful statement such as "this product is regulated by the FDA" would "reasonably be expected to mislead consumers regarding the harmfulness of the product." The plausibility of that argument reflects the ineffectiveness of FDA regulation, not the sneakiness of the tobacco companies.

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  1. Looks like the market knows what this is all about.

  2. I am a little confused. With all the medications that have come on the market then been pulled off because of dangerous side effects that nobody knew about, who still beleives that FDA regulation means something is safe?

  3. Today I also taped a Marketplace commentary for NPR on the subject.

    It’s a common mistake, but “Marketplace” is not an NPR show–even though it runs on many, many NPR affiliates. It had been distributed by Public Radio International, and is now produced and distributed by American Public Media.

  4. How is it that the FDA can regulate something that is neither a food, nor a drug, nor intended for any medical or nutritional purpose? The only common points I can find are that tobacco is vegetable matter and that all uses of tobacco, of which I am aware, involve putting it into the body in some way — sniffing, smoking, chewing, etc.

    Is the FDA now to be the agency in charge of telling us what otherwise legal substances we can or cannot put into our bodies; are they now to be the champions of the purity of our precious bodily fluids?

    You say the Senate approval was “overwhelming,” Jacob? I hope that the American people can be at least as overwhelming in kicking these clueless rascals to the curb.

  5. Perhaps they need to change the name of the FDA to the DSA (Dangerous Substance Administration). (Or possibly an entirely new regulatory board, haha). That would possibly alleviate some confusion consumers may/will have. It would also set the stage for regulation of marijuana, cocaine and heroin, and all those damned designer drugs, if they were to become legal.

  6. JAM – While I don’t agree with the FDA regulation of tobacco, nicotine is definitely a drug.

  7. How is it that the FDA can regulate something that is neither a food, nor a drug, nor intended for any medical or nutritional purpose?

    Whatever the legislature tells them to. FDA already regulates lasers whether for medical purposes or otherwise, because Congress required that too. “Cosmetics” isn’t part of FDA’s name, either. BFD.

    nicotine is definitely a drug.

    Depends on its intended use. When it’s in an insecticide product, it’s regulated by EPA under FIFRA. The att’y gen’l could make it a DEA-controlled substance too, because although the CSA exempts tobacco, it doesn’t exempt nicotine per se from scheduling as a DEA-controlled substance.

  8. How is it that the FDA can regulate something

    Stop right there.Enough said.

    Tobacco is definitely a “drug” in the same sense that khat,opium or marijuana is. It is a processed plant material that contains psychactive chemical(s).

    “Cosmetics” isn’t part of FDA’s name, either.

    They regulate dental floss too.

  9. When it’s in an insecticide product

    Wasn’t that linked to the disappearance of honey bees?

  10. Never mind, answered my own question.

  11. FTA:

    And it could reduce the amount of nicotine, perhaps to a point where tobacco is no longer addictive and smokers who want to quit can break free more easily.

    Won’t the nicotine-addicted just smoke more to compensate, with even more health damage?

  12. So anyone think the BATFE regs will go away?

  13. Papaya,

    Won’t the nicotine-addicted just smoke more to compensate, with even more health damage?

    Look, you’re trying to reason with people who have the same mindset that increasing potency of marijuana (allowing users to smoke less) is a bad thing. Bottom line; “Don’t bother me with facts, I’ve made up my mind”. I suspect a large number of these people think that “The Flintstones” was a documentary.

    … Hobbit

  14. # SIV | June 11, 2009, 9:02pm | #
    ## How is it that the FDA can regulate something

    # Stop right there.Enough said.

    #Tobacco is definitely a “drug” in the same
    # sense that khat,opium or marijuana is.
    # It is a processed plant material that contains
    # psychactive chemical(s).

    I already conceded the plant part, but the point was that tobacco’s intended use is neither medicinal nor nutritional. At present, it is considered as a poison. Is regulating known poisons part of the FDA’s charter?

    To Robert: I don’t think that the FDA should be regulating cosmetics, but at least their intervention there is in the name of protecting people from the harmful effects of substances that are expected to be “safe.” One doesn’t expect or desire cosmetics to contain toxins, carcinogens, etc. But by now, pretty much everyone has been exposed to the fact that smoking is bad for you. Don’t (or shouldn’t) Americans enjoy the liberty of introducing harmful substances into their bodies if they wish? If the FDA or some other government agency has effectively sounded the alarm and gotten the word out, shouldn’t that be the end of it, as far as they are concerned? At some point, shouldn’t government step back and allow citizens to live their own lives?

    Also, Robert, were you aware that the FDA can regulate iPods and other personal music players, because those players can 1) be used for therapeutic purposes (biofeedback, and the like) and 2) overly-loud sounds reproduced by such devices can cause damage to the ears? I actually read the relevant law and “guidance” on this a couple of years ago, and was shocked at the agency’s reach.

    Is this kind of government control over the options available to citizens consistent with a “free country”? If so, by what reasoning? If not, what can we do about it?

  15. Just about every drug, be it medicinal or recreational, is a poison. The way most people use tobacco, it is a recreational drug. What is the point your nit-picking semantics?

  16. @James Anderson Merritt – “If not, what can we do about it?”

    Vote them ALL out of office.

  17. Tobacco is on its way to becoming a gateway drug. A gateway to forcing socialized healthcare for treatment of lung cancer, when addicts and their lawyers start whining, ” I thought it was safe because it was regulated.”, then the libtards will say, “Well, ok.”

  18. I was a little troubled by this quote from Dick Durbin: “Joe Camel has been sentenced and put away forever.” Yes, I realize that he was just using rhetoric. But, uh, Dick? The legislature can’t “sentence” anybody. That would be called a bill of attainder, which is specifically forbidden by the Constitution. It just makes me a little nervous when politicians don’t just display ignorance and overstep their authority, but speak proudly about doing it.

  19. I was aware that FDA had been asked for guidance concerning “brain machines” that aren’t much more than iPods, etc. It wasn’t clear what the agency’s reach would be, so someone asked for the guidance so they wouldn’t be blindsided by a future agency interpret’n.

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