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A bad start doesn’t necessarily mean a bad future

The American tobacco policy has been suffering critics since the deeming regulations have been released, last May. Updates and justifications have been made by the FDA but its main weakness, the fact that it may lead to the collapse of the independent vaping sector, have still not be fixed.

The Federal agency in charge of this regulation is being legally challenged by manufacturers and associations, which freezes most of the administrative procedures that may be required to consider the evolution of this market. At least it steamed out the fervor of the smallest companies, already lead to closing doors, but did not prevent the biggest ones to take over marketing opportunities.

This uncertainty also lead different states to propose their own legislation of vaping products, sometimes clumsy but most of the time with disastrous consequences on the market.

Considering the change that currently operates in the US bureaucracy, Clive Bates, David Sweanor and Eli Lehrer believe that it is time to make serious propositions to get out of this critical situation.

The fundamental change required is to embrace and maximise the huge opportunity of vapor and other low-risk nicotine products, while keeping a sense of proportion about minor risks. C. Bates, D. Sweanor, E. Lehrer

No cost and all benefit for the country!

The e-cigarette that has been thought as a consumer product to be an alternative to combustible tobacco for smokers who want to quit or reduce their smoking, a disaster that costs the world economy about US$1.4 trillion per year [1]. The authors warn the officials that about 9 million vapers already took action to protect their health, at no cost for the country, and are blocked in their effort.

In a short report, they make a 8-point proposition to reshape the federal strategy:

  1. Seize the huge opportunity presented by low-risk nicotine products. Revolutionize tobacco and nicotine policy, reduce healthcare spending and improve health by exploiting the very large difference in risk to human health caused by combustible and smoke-free products. Make appointments and provide direction and funding to embed this in federal agencies such as FDA, CDC, NIH and Office of the Surgeon General as well as the highest levels of the Department of Health and Human Services. It requires 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 US vapor industry by crudely designed and wholly inappropriate regulation. The following approaches are an urgent response:
    1. Put the implementation process on hold and quickly pass legislation that changes the Tobacco Control Act predicate date to 8 August 2016 for nicotine products that do not contain tobacco.
    2. Replace the costly, opaque and politicized product-by-product authorization regime with a standards-based regime where it is clear what is required of manufacturers (recommendation 3).
    3. Add a range of interim safeguards concerning common ground issues such as battery and fluid safety if a standards regime will take time to agree. These should be applied by Congress in the instrument it uses to affect the changes above.
  3. 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 a further public health benefit test unnecessary.
  4. Use new labels to inform consumers about relative risk. Using its rulemaking powers, 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, non-misleading communications.
  5. Stop using the public health test to protect the cigarette trade. The public health test in the Tobacco Control Act does not protect the 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 risk to individual users, not unknowable post-market population effects.
  6. Restore honesty and candor to public health campaigns. Require FDA, CDC and other relevant federal agencies to act to bring public perceptions closer to reality, for example to set a goal that by 2020 at least 75% of Americans believe that e-cigarettes, smokeless tobacco and heated tobacco products are, correctly, each ‘very much less harmful’ than cigarettes. This could be realized through enabling language and funding included in the President’s Budget Proposal or by Executive Order.
  7. Refocus tobacco science on the public interest not bureaucratic expansion. Overall, the imperative is to change the incentive structures in tobacco-related research to stress objectivity in the public interest, not to justify expanded bureaucratic intervention.
    • • Congressional oversight hearings should examine the state of tobacco science,
    • • FDA/CTP should commission replications, counterfactuals, quality reviews and contrarian analysis to challenge its own thinking,
    • • CDC should commission tobacco use surveillance but outsource conduct and analysis to independent third parties and practice open data principles,
    • • NIH should produce guidelines on conduct and reporting of tobacco-related research (e.g. inclusion of comparisons with smoking, materiality of risk, not drawing policy conclusions),
    • • Encourage establishment of a “Center for Nicotine and Tobacco Science in the Public Interest” to act as a defender of the public interest.
  8. Challenge vapor and smokeless prohibitions under WTO rules. The United States should initiate complaints under World Trade Organization agreements about wholly unjustified prohibitions of low risk nicotine products in jurisdictions outside the United States. This would give a win-win for public health and American exporters, while challenging the negligence of the World Health Organization and some of its member states.

Extracts from the executive summary.

In this interview with AEI Resident Scholar Sally Satel, Clive Bates discuss the FDA’s regulations, common arguments against vaping, and how vaping can actually benefit smokers.


[1] Goodchild M., Nargis N., Tursan d’Espaignet E. (2017) Global economic cost of smoking-attributable diseases. tobaccocontrol-2016-053305.doi:10.1136/tobaccocontrol-2016-053305


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