On 2016 Aug 11, Clive Bates commented:

I should add that the authors are writing about the FDA ("FDA" appears 70 times in the paper), yet this work is funded in part by the FDA Center for Tobacco Products. It's no surprise then that it takes a wholly uncritical approach to FDA's system for consumer risk information. Somehow they managed to state:

The authors of this manuscript have no conflicts of interest to declare.

While the funding is made clear, the failure to acknowledge the COI is telling - perhaps a 'white hat bias'?

On 2016 Aug 11, Clive Bates commented:

It may not be what the authors intended, but the paper offers a troubling insight into the ingrained pedantry of a regulatory bureaucracy and how this can obscure the truth and cause harm. The authors have approached their work without considering the wider implications for health of FDA's system for assessing risk communication.

The core weakness in the paper is the assumption that nothing can be true unless the FDA says it is, and that the FDA has a way of efficiently establishing what is true. No evidence supports either contention.

Some observations.

1. The paper was published before FDA had deemed e-cigs to be within its jurisdiction, so the retailers involved were free to make true and non-misleading claims - if they did that, they have not broken any laws.

2. Some of the vendors' claims documented in the paper are reasonable and true and some would benefit from more nuanced language - all are broadly communicating substantially lower risk. This is, beyond any reasonable doubt, factually correct. The makers of these products are trying to persuade people to take on much lower risk products than cigarettes, but the authors and appear to believe this should be prevented. This is indistinguishable from a regulatory protection for the cigarette trade, with all that implies.

3. If the public bodies like CDC and FDA in the U.S. had been candid about these products from the outset instead of creating fear and confusion, vendors would not need to make claims or could quote them as reliable authorities. However, they have not done this in the way that their English equivalents have: see, for example, the Royal College of Physicians [1] and Public Health England [2]. These bodies have assessed the evidence and made estimates aiming to help consumers gain a realistic appreciation of relative risk of smoking and vaping. They estimate that e-cigarette use, while not guaranteed entirely safe, is likely to be at least 95% lower risk than smoking.

4. This contrasts with the FDA route to providing consumers with appropriate risk information - the Modified Risk Tobacco Product (MRTP) application. This approach already appears dysfunctional. It is now two years since Swedish Match filed a 130,000-page application to make a claim for snus (a form of smokeless tobacco) that is so obviously true it does not even justify the wear and tear on a rubber stamp: WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes. If a snus vendor cannot say that, then no claim is possible under this system.

5. In contrast with its reluctance to allow manufacturers to state the obvious, FDA does not subject its own claims or risk communications to the public health test that it requires of manufacturers or vendors. FDA intends to require the packaging of e-cigarettes to carry the following: WARNING: This product contains nicotine. Nicotine is an addictive chemical. But how does it know this will not deter smokers from switching and therefore continuing to smoke? How does it know that it is not misleading consumers by the absence of realistic information on relative risk?

6. FDA (and the authors) take no responsibility for, and show no interest in, the huge misalignment between consumers' risk perceptions and expert judgement on the relative risks of smoking and vaping Only 5.3% Americans correctly say vaping is much less harmful than smoking, while 37.5% say it is just as harmful or more harmful [3] - a view no experts anywhere would support. By allowing these misperceptions to flourish, they are in effect indifferent to the likely harms arising from maintaining that smoking and vaping are of equivalent risk unless FDA says otherwise.

7. It is a perverse system that requires tobacco or e-cigarette companies to go through a heavily burdensome and expensive MRTP process before the consumer can be provided with truthful information about risks. Why should the commercial judgements of nicotine or tobacco companies on the value of going through this process be what determines what the consumer is told? For the most companies, the cost and burden of the process will simply be too great to guarantee a return through additional sales, so no applications will be made and consumers will be left in the dark.

8. The FDA's restriction on communicating true and non-misleading information to consumers is part of the Nicopure Labs v FDA case - the challenge is made under the Constitutional First Amendment protection of free speech. The authors should not assume that the FDA that is acting lawfully, and FDA (and the authors) should have the burden of proof to show a vendor's claim is false or misleading.

To conclude, the authors should return to the basic purpose of regulation, which is to protect health. They should then look carefully at how the legislation and its institutional implementation serve or defeat that purpose. If they did that, they would worry more about the barrier the FDA creates to consumer understanding and informed choice and less about the e-cigarette vendors' efforts, albeit imperfect, to inform consumers about the fundamental and evidence-based advantages of their products.

[1] Royal College of Physicians, Nicotine with smoke: tobacco harm reduction. April 2016 [link]

[2] Public Health England, E-cigarettes: an evidence update. August 2015 [Link]

[3] Risk perception data from the National Cancer Institute HINTS survey, 2015).

On 2016 Aug 11, Clive Bates commented:

It may not be what the authors intended, but the paper offers a troubling insight into the ingrained pedantry of a regulatory bureaucracy and how this can obscure the truth and cause harm. The authors have approached their work without considering the wider implications for health of FDA's system for assessing risk communication.

The core weakness in the paper is the assumption that nothing can be true unless the FDA says it is, and that the FDA has a way of efficiently establishing what is true. No evidence supports either contention.

Some observations.

1. The paper was published before FDA had deemed e-cigs to be within its jurisdiction, so the retailers involved were free to make true and non-misleading claims - if they did that, they have not broken any laws.

2. Some of the vendors' claims documented in the paper are reasonable and true and some would benefit from more nuanced language - all are broadly communicating substantially lower risk. This is, beyond any reasonable doubt, factually correct. The makers of these products are trying to persuade people to take on much lower risk products than cigarettes, but the authors and appear to believe this should be prevented. This is indistinguishable from a regulatory protection for the cigarette trade, with all that implies.

3. If the public bodies like CDC and FDA in the U.S. had been candid about these products from the outset instead of creating fear and confusion, vendors would not need to make claims or could quote them as reliable authorities. However, they have not done this in the way that their English equivalents have: see, for example, the Royal College of Physicians [1] and Public Health England [2]. These bodies have assessed the evidence and made estimates aiming to help consumers gain a realistic appreciation of relative risk of smoking and vaping. They estimate that e-cigarette use, while not guaranteed entirely safe, is likely to be at least 95% lower risk than smoking.

4. This contrasts with the FDA route to providing consumers with appropriate risk information - the Modified Risk Tobacco Product (MRTP) application. This approach already appears dysfunctional. It is now two years since Swedish Match filed a 130,000-page application to make a claim for snus (a form of smokeless tobacco) that is so obviously true it does not even justify the wear and tear on a rubber stamp: WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes. If a snus vendor cannot say that, then no claim is possible under this system.

5. In contrast with its reluctance to allow manufacturers to state the obvious, FDA does not subject its own claims or risk communications to the public health test that it requires of manufacturers or vendors. FDA intends to require the packaging of e-cigarettes to carry the following: WARNING: This product contains nicotine. Nicotine is an addictive chemical. But how does it know this will not deter smokers from switching and therefore continuing to smoke? How does it know that it is not misleading consumers by the absence of realistic information on relative risk?

6. FDA (and the authors) take no responsibility for, and show no interest in, the huge misalignment between consumers' risk perceptions and expert judgement on the relative risks of smoking and vaping Only 5.3% Americans correctly say vaping is much less harmful than smoking, while 37.5% say it is just as harmful or more harmful [3] - a view no experts anywhere would support. By allowing these misperceptions to flourish, they are in effect indifferent to the likely harms arising from maintaining that smoking and vaping are of equivalent risk unless FDA says otherwise.

7. It is a perverse system that requires tobacco or e-cigarette companies to go through a heavily burdensome and expensive MRTP process before the consumer can be provided with truthful information about risks. Why should the commercial judgements of nicotine or tobacco companies on the value of going through this process be what determines what the consumer is told? For the most companies, the cost and burden of the process will simply be too great to guarantee a return through additional sales, so no applications will be made and consumers will be left in the dark.

8. The FDA's restriction on communicating true and non-misleading information to consumers is part of the Nicopure Labs v FDA case - the challenge is made under the Constitutional First Amendment protection of free speech. The authors should not assume that the FDA that is acting lawfully, and FDA (and the authors) should have the burden of proof to show a vendor's claim is false or misleading.

To conclude, the authors should return to the basic purpose of regulation, which is to protect health. They should then look carefully at how the legislation and its institutional implementation serve or defeat that purpose. If they did that, they would worry more about the barrier the FDA creates to consumer understanding and informed choice and less about the e-cigarette vendors' efforts, albeit imperfect, to inform consumers about the fundamental and evidence-based advantages of their products.

[1] Royal College of Physicians, Nicotine with smoke: tobacco harm reduction. April 2016 [link]

[2] Public Health England, E-cigarettes: an evidence update. August 2015 [Link]

[3] Risk perception data from the National Cancer Institute HINTS survey, 2015).