September 7, 2016

Stanton A. Glantz, PhD

WHO issues new report on e-cigs; contains cautious read of science and sensible policy recommendations

The WHO recently released “Electronic Nicotine Delivery Systems and Electronic Non-Nicotine Delivery Systems (ENDS/ENNDS)” in anticipation of a discussion of these issues at the Seventh Conference of the Parties, which will be held in India in November 2017.  The report has a cautious summary of the current state of the science and a set of very sensible regulatory options, all of which should be implemented now.
 
People can read the report for the details on the science summary, but the single most important statement is
 

The magnitude of these risks is likely to be smaller than from tobacco smoke, although there is not enough research to quantify the relative risk of ENDS/ENNDS over combustible products. Therefore, no specific figure about how much “safer” the use of these products is compared to smoking can be given any scientific credibility at this time. Existing modelling studies indicate, however, that in order for there to be a potential population-wide net health benefit from ENDS/ENNDS at present usage rates, these products would need to be at least three times “safer” than cigarettes. [citations deleted]

 
Here are the regulatory options, quoted verbatim and in full:
 
REGULATORY OPTIONS
 
28. The following is a non-exhaustive list of options that Parties might consider in accordance with their national law, in order to achieve the ENDS/ENNDS objectives set out in the COP 6 decision on ENDS/ENNDS.
 
29. Objective: prevent the initiation of ENDS/ENNDS by non-smokers and youth with special attention to vulnerable groups. Although the debate about whether the use of ENDS/ENNDS is a gateway to smoking is unresolved, preventing this eventuality requires making the initiation and persistence of smoking as difficult as possible. Parties that have not banned the importation, sale, and distribution of ENDS/ENNDS may consider the following options:
 
a. Banning the sale and distribution of ENDS/ENNDS to minors;
b. Banning the possession of ENDS/ENNDS by minors;
c. Banning or restricting advertising, promotion and sponsorship of ENDS/ENNDS (see FCTC/COP/6/10 Rev.1);
d. Taxing ENDS/ENNDS at a level that makes the devices and e-liquids unaffordable to minors in order to deter its use in this age groupvii. In parallel, combustible tobacco products should be taxed at a higher level than ENDS/ENNDS to deter initiation and reduce regression to smoking;
e. Banning or restricting the use of flavours that appeal to minors;
f. Regulating places, density and channels of sales; and
g. Taking measures to combat illicit trade in ENDS/ENNDS.
 
30. Objective: minimize as far as possible potential health risks to ENDS/ENNDS users and protect non-users from exposure to their emissions.
 
a. Parties that have not banned the importation, sale, and distribution of ENDS/ENNDS may consider the following options to minimize health risks to users:
i. Testing heated and inhaled flavourants used in the e-liquids for safety, and banning or restricting the amount of those found to be of serious toxicological concern such as diacetyl, acetyl propionyl, cinnamaldehydes or benzaldehyde;
ii. Requiring the use of ingredients that are not a risk to health and are, when allowed, of the highest purity;
iii. Regulating electrical and fire safety standards of ENDS/ENNDS devices;
iv. Regulating the need for manufacturers to disclose product content to government;
v. Regulating appropriate labelling of devices and e-liquids;
vi. Requiring manufacturers to monitor and report adverse effects; and
vii. Providing for the removal of products that do not comply with regulations.
 
b. Parties that have not banned the importation, sale, and distribution of ENDS/ENNDS may consider the following options to minimize health risks to non-users:
i. Prohibiting by law the use of ENDS/ENNDS in indoor spaces or at least where smoking is not permittedviii;
ii. Requiring health warnings about potential health risks deriving from their use. Health warnings may additionally inform the public about the addictive nature of nicotine in ENDS; and
iii. Reducing the risk of accidental acute nicotine intoxication by a) requiring tamper-evident/child resistant packaging for e-liquids and leak-proof containers for devices and e-liquids and b) limiting the nicotine concentration and total nicotine amount in devices and e-liquids.
 
31. Objective: prevention of unproven health claims being made about ENDS/ENNDS. Parties that have not banned the importation, sale, and distribution of ENDS/ENNDS may consider the following options:
 
a. Prohibiting implicit or explicit claims about the effectiveness of ENDS/ENNDS as smoking cessation aids unless a specialized governmental agency has approved them;
b. Prohibiting implicit or explicit claims that ENDS/ENNDS are innocuous or that ENDS are not addictive; and
c. Prohibiting implicit or explicit claims about the comparative safety or addictiveness of ENDS/ENNDS with respect to any product unless these have been approved by a specialized governmental agency.
 
32. Objective: protect tobacco control activities from all commercial and other vested interests related to ENDS/ENNDS, including interests of the tobacco industry. Parties, including those that have banned the importation, sale, and distribution of ENDS/ENNDS, may consider the following options:
 
a. Raising awareness about potential industry interference with Parties’ tobacco control policies;
b. Establishing measures to limit interactions with the industry and to ensure transparency in those interactions that do take place;
c. Rejecting partnerships with the industry;
d. Taking measures to prevent conflicts of interest for government officials and employees;
e. Requiring that information provided by the industry be transparent and accurate;
f. Banning activities described as “socially responsible” by the industry, including but not limited to activities described as “corporate social responsibility”;
g. Refusing to give preferential treatment to industry; and
h. Treating State-owned industry in the same way as any other industry.
 
The full report is available here.
 

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