Eight tobacco harm reduction proposals for the federal government

The attached policy study was co-authored by R Street President Eli Lehrer and David Sweanor, professor at the University of Ottawa’s Center for Health Law.

In 2015, 36.5 million Americans, or 15 percent of U.S. adults, combined to smoke 264 billion cigarettes. Cigarette smoking causes more than 480,000 deaths each year in the United States – more than HIV, illicit drugs, alcohol, motor vehicles and guns combined. Smoking-related illness in the United States costs more than $300 billion annually, including nearly $170 billion for direct medical care for adults and more than $156 billion in lost economic productivity. Smoking creates a massive health and economic burden.

Yet despite very large expenditures and sweeping federal powers, perverse tobacco policy is failing the American public and will soon destroy thousands of small and medium-sized businesses that are part of the solution, not part of the problem. The vast majority of health harms attributed to smoking arise from burning tobacco cigarettes and inhaling the smoke into the lungs, not from nicotine use. The 2014 Surgeon General’s Report confirmed: “Death and disease from tobacco use in the United States is overwhelmingly caused by cigarettes and other burned tobacco products. Where there is no combustion—as with smokeless tobacco, e-cigarettes and other vaping products or heated tobacco products—the risks of nicotine use inevitably will be much lower (representing from 2 percent to 10 percent of the risk of cigarettes) because the physical processes are so different. None of these products are perfectly safe, as very little is, but they are very much safer.

These products with radically reduced risk create opportunities for major health and economic gains through substitution. However, U.S. policy has actively denied and stymied this opportunity:

To address these policy failures, we suggest eight proposals for discussion, summarized below and set out in concise briefing form in the subsequent sections. The proposals are as follows:

  1. Seize the huge opportunity presented by low-risk nicotine products. Revolutionize tobacco and nicotine policy, reduce health-care spending and improve health by exploiting the very large difference in risks to human health that stem from combustible and smoke-free products. Make appointments and provide direction and funding to embed this approach in federal agencies, such as the Food and Drug Administration, Centers for Disease Control and Prevention, National Institutes of Health and Office of the Surgeon General, as well as at the highest levels of the Department of Health and Human Services. This will require a concerted approach on many fronts.
  2. Cancel the FDA deeming rule before it destroys the U.S. vaping market. An emergency response is required to prevent the near complete and needless destruction of the U.S. vapor industry by crudely designed and wholly inappropriate regulation. The following approaches should be part of this urgent response:
  1. Establish a standards-based regime for low-risk nicotine products. Regulate low-risk tobacco and nicotine products by setting product standards (chemical, mechanical, thermal, electrical) that reduce individual risk to users while promoting innovation and ensuring the products are an attractive alternative to smoking. These standards would ensure average exposures were at least 90 percent lower than smoking and would make further public-health-benefit tests unnecessary.
  2. Use new labels to inform consumers about relative risk. Using its rulemaking powers, the FDA should allow manufacturers to apply an accurate harm-reduction message to all non-combustible tobacco or nicotine products: “This product presents substantially lower risks to health than cigarettes,” or other truthful and non-misleading communications.
  3. Stop using the public health test to protect the cigarette trade. The public health test in the Tobacco Control Act does not protect public health, but it does protect the cigarette trade from competition. It should not be applied to non-combustible tobacco or nicotine products.  These should be evaluated according to their product characteristics and risks to individual users, not unknowable post-market population effects.
  4. Restore honesty and candor to public-health campaigns. Require that the FDA, CDC and other relevant federal agencies act to bring public perceptions closer to reality. Set a goal that, by 2020, at least 75 percent of Americans believe that e-cigarettes, smokeless tobacco and heated tobacco products are, correctly, each “very much less harmful” than cigarettes. This campaign could be realized either through enabling language and funding included in the president’s budget proposal or by executive order.
  5. Refocus tobacco science on the public interest, not bureaucratic expansion. Overall, the imperative should be to change the incentive structures in tobacco-related research to stress objectivity in the public interest, not to justify expanded bureaucratic intervention.
  1. Challenge vapor and smokeless prohibitions under World Trade Organization rules. The United States should initiate complaints under WTO agreements about wholly unjustified prohibitions of low-risk nicotine products in jurisdictions outside the United States. This would represent a win-win for public health and American exporters, while challenging the negligence of the World Health Organization and some of its member states.

Image by totojang1977

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