Public Health

FDA Chief: Please Don't Make Us Regulate Tobacco

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Last week FDA chief Andrew von Eschenbach, who earlier this year expressed concern about legislation that would give his agency regulatory authority over tobacco products, testified against the bill, known as the Family Smoking Prevention and Tobacco Control Act. Von Eschenbach said tobacco regulation does not fit well with the FDA's mission to approve products based on a determination that their benefits outweigh their risks:

FDA cannot "approve" a tobacco product in this context, because there is no scientific context to determine benefit to outweigh the numerous risks. It will be very challenging to transform existing science into a logical regulatory structure. There is little science available to the FDA on which to base decisions on tobacco product standards (such as reducing or eliminating harmful constituents, reducing the amount of nicotine in products, or requiring changes to tobacco product components) or premarket approval.

Von Eschenbach also worried that "associating any agency whose mission is to promote public health with the approval of inherently dangerous products would undermine its mission and likely have perverse incentive effects." For example, "We are concerned that the public will believe that products 'approved' by the Agency are safe and that this will actually encourage individuals to smoke more rather than less." Richard Bonnie, the University of Virginia law professor who chaired the Institute of Medicine's Committee on Reducing Tobacco Use, questioned the basis for this concern, saying, "It seems highly unlikely that such a gross distortion of public understanding could occur when public and private agencies, including FDA itself, are taking aggressive steps to discourage people from using tobacco products and to help people quit."

While I doubt that FDA regulation would lead many people to view cigarettes and other tobacco products as completely safe, it does seem plausible that consumers will tend to view them as less hazardous than they are now. After all, reducing the dangers posed by tobacco products is one of the main rationales for FDA regulation; the FDA is supposed to vet tobacco companies' health claims (one reason Philip Morris, which has been experimenting with safer cigarettes for years, supports the bill). Moreover, the concern that reduced-risk claims, even completely truthful ones, might encourage people to continue smoking is reflected in the bill, which instructs the FDA to take such effects into account when weighing the likely impact of a new product on "the public health." That charge could perversely lead the FDA to keep safer products off the market, depending on its predictions about how current and potential smokers would respond and its assessment of how they otherwise would have behaved. The difficulty of making that call, even leaving aside the ethical problem with substituting a collectivist calculation for the individual judgments of consumers, only reinforces Von Eschenbach's point that the FDA is ill-suited for such a task. 

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  1. Wow…what a terrible idea to use the FDA regulate tobacco products.

    I expect it to be law within the coming 4 years.

  2. We are concerned that the public will believe that products ‘approved’ by the Agency are safe and that this will actually encourage individuals to smoke more rather than less.

    I have the same concern about any drug the FDA approves. Eliminating the FDA is the best solution. Getting the FDA to admit that their approval does not imply 100% safety is a more realistic near term goal.

  3. FDA cannot “approve” a tobacco product in this context, because there is no scientific context to determine benefit to outweigh the numerous risks. It will be very challenging to transform existing science into a logical regulatory structure.

    Hmm, methinks I just won a bet with a very good friend.

  4. “It seems highly unlikely that such a gross distortion […] are taking aggressive steps to discourage people from using tobacco products and to help people quit.”

    This woman is either on crack, or she is anticipating big payouts when people sue the FDA.

  5. Wow, now I’ve seen everything: a bureaucracy that doesn’t want to expand its sphere of influence.

  6. Wow, now I’ve seen everything: a bureaucracy that doesn’t want to expand its sphere of influence.

    Give them time. My guess is they’ll eventually drop their objection with a justification that no one here will see coming. Start looking at field left.

    However, the FDA is correct on this one. They can’t regulate a product which is dangerous… almost by design.

    What would the FDA determine to be a “safe” cigarette? One that doesn’t burn? One that only has less than ‘x’ tar?

  7. Wow, now I’ve seen everything: a bureaucracy that doesn’t want to expand its sphere of influence.

  8. Wow, now I’ve seen everything: a bureaucracy that doesn’t want to expand its sphere of influence.

    Hear, hear.

  9. Wow, now I’ve seen everything: a bureaucracy that doesn’t want to expand its sphere of influence.

    Nah. They’re aiming for prohibition.

  10. It seems to me a very dubious task for the FDA, and a slippery slope, to regulate the advertising practices of an industry. The bill stipulates that they not only fulfill their duties as a health regulator, and as one which guards against false advertising, but most of the powers given to this government body lie in the realm of, if anyone, the FCC (another bloated creature). The size, color, location of advertisements, and the wording, not allowing flavorings … these fall well beyond even the barely acceptable charge of the FDA’s mandated duty.

    To hand over first amendment rights to a public health department in this guise may seem benign enough not to bat an eye over, but the gesture per se suggests that we’ve learned little from those who use the welfare of children to justify the greatest of atrocities to liberty.

  11. Peter: You’re too late. FDA already controls advertising if I’m correct. See: baby formula etc.

  12. there is no scientific context to determine benefit to outweigh the numerous risks

    Now there is: The benefit of more gummint, yay!

  13. One big reason Philip Morris wants the FDA to regulate tobacco is partly because it would potentially preempt more egregious future bans (a la the comment above re: prohibition), and also because it would limit competition via innovation – once the products get regulated, they go ‘BTC’ (behind the counter and unadvertised) and the leading brand (marlboro) basically can set its market share in stone.

    This was mentioned i think in a Reason article last year… or some trade rag i saw

  14. Given that part of the FDA’s mission statement is “protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs”

    And also understanding that the FDA has a history of withholding ‘drugs’ that aren’t proven safe, from the public (and that’s probably a pretty easy argument to make for tobacco/cigarettes), could this be a clever move in the direction of tobacco prohibition?

    I’d like to think we’re still a long way from that, but it’s not as though the government doesn’t have a history of sneaky, underhanded moves to get what it wants (think Marijuana tax act)

  15. Family Smoking Prevention and Tobacco Control Act

    Ha ha ha.
    What, was the “Children Smoking Prevention and Tobacco Control Act” already taken?

  16. I guess the FDA has never heard of consumer surplus…?

  17. Health & Human Services successfully fought against a suit to require FDA to regulate tobacco products in the 1970s.

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