WHO report on e-cigarettes

Late last August, shortly before I left for vacation the WHO released its report on e-cigarettes (with WHO calls Electronic Nicotine Delivery Devices, ENDS), Electronic nicotine delivery systems.  At the time I was too busy to put out a blog post highlighting the report, so am adding one now.  It continues the WHO's policy of basing its recommendations on the scientific evidence.
 
Here are the policy recommendations:
 

SPECIFIC REGULATORY OPTIONS
 
39. In order to achieve the general regulatory objectives mentioned above, Parties that have not banned the sale of ENDS could consider the following non-exhaustive list of regulatory options, on the understanding that the advisability and feasibility at country level of each of these options will depend on a complex set of country-specific factors, including the existing regulatory frameworks and the legal exigencies of the regulatory process.
 
40. Health claims. Prohibit manufacturers and third parties from making health claims for ENDS, including that ENDS are smoking cessation aids, until manufacturers provide convincing supporting scientific evidence and obtain regulatory approval. The regulatory standard for cessation claims and approval as cessation aids should remain an appropriate body of evidence, based on well-controlled clinical trials. For ENDS products to be approved for smoking cessation by the suitable regulatory agency, the appropriate balance should be reached between providing accurate scientific information to the public about the risks of ENDS use and its potential benefits as compared with smoking. This balance can only be determined through scientifically tested audience messaging.
 
41. Use of ENDS in public places. Since the reasonable expectation of bystanders is not a diminished risk in comparison to exposure to second-hand smoke but no risk increase from any product in the air they breathe, ENDS users should be legally requested not to use ENDS indoors, especially where smoking is banned until exhaled vapour is proven to be not harmful to bystanders and reasonable evidence exists that smoke-free policy enforcement is not undermined. If smoke-free legislation is not fully developed according to Article 8 of the WHO FCTC and the guidelines for its implementation, this should be done as soon as possible.
 
42. Advertising, promotion and sponsorship. Given that the same promotional elements that make ENDS attractive to adult smokers could also make them attractive to children and non-smokers, Parties should contemplate putting in place an effective restriction on ENDS advertising, promotion and sponsorship. Some forms of ENDS promotion, however, may be considered acceptable by Parties if empirical evidence shows that ENDS might play a role in helping some smokers to quit without leading to increased ENDS use by minors and non-smokers who otherwise would not have used nicotine.
 
43. Any form of ENDS advertising, promotion and sponsorship must be regulated by an appropriate governmental body. If this is not possible, an outright ban on ENDS advertising, promotion and sponsorship is preferable to the implementation of voluntary codes on ENDS marketing, given the overwhelming evidence that similar codes for tobacco and alcohol products have failed to protect young people from such advertising.
 
44. Advertising, promotion and sponsorship of ENDS with or without nicotine, must, at a minimum:
(a) state clearly whether the product contains nicotine or may be used with nicotine solutions;
(b) not make them appealing to or target, either explicitly or implicitly, non-smokers or non-nicotine users, and must therefore indicate that ENDS are not suitable for use by people who do not currently consume tobacco products;
(c) not make them appealing to or target, either explicitly or implicitly, minors, including through the selection of media, location or the context in which they appear or through imagery that promotes sexual or sporting prowess;
(d) never promote ENDS for non-smokers, and their use should not be portrayed as a desirable activity in its own right;
(e) encourage smoking cessation and provide a quitline number if one exists;
(f) contain nothing that could reasonably be expected to promote the use of tobacco products, such as:
(i) the appearance or/and use of tobacco products;
(ii) the use of any brand name, design, colour, emblem, trademark, logo or trade insignia or any other distinctive feature that might be associated by the audience with a tobacco product;
(iii) the use of the words e-cigarette, electronic cigarette, or any other descriptor that might reasonably be expected to create confusion with the promotion of cigarettes and other combustible tobacco products;
(iv) showing ENDS products in ways that could reasonably be expected to promote tobacco products, including images of tobacco-like products;
(g) not contain health or medicinal claims, unless the product is licensed for those purposes by the appropriate regulatory agency. Electronic cigarettes and other nicotine-containing products should be presented only as an alternative to tobacco, and should include warnings that dual use will not substantially reduce the dangers of smoking;
(h) not undermine any tobacco-control measure, including by not promoting the use of ENDS in places where smoking is banned;
(i) include factual information about product ingredients other than nicotine and in a way that does not distort evidence of risks;
(j) not link these products with gambling, alcohol, illicit drugs or with activities or locations in which using them would be unsafe or unwise.
 
45. Advertising, promotion and sponsorship of ENDS that contain nicotine or may be used with nicotine solutions must:
(a) clearly state the addictive nature of nicotine and that these products are intended to deliver nicotine;
(b) Prohibit suggestions that ENDS have positive qualities as a consequence of the addictive nature of the product.
 
46. All authorized forms of ENDS advertising, promotion and sponsorship must be cleared by the appropriate authority prior to publication/transmission in order to proactively prevent inappropriate marketing, and then be monitored to assess compliance.
 
47. Protection from vested commercial interests. Transparency should be required from ENDS and tobacco companies advocating for and against legislation and regulation, both directly and through third parties. No matter what role the tobacco industry plays in the production, distribution and sale of ENDS, this industry, its allies and front-groups can never be considered to be a legitimate public health partner or stakeholder while it continues to profit from tobacco and its products or represents the interests of the industry. Article 5.3 of the WHO FCTC should be respected when developing and implementing ENDS legislation and regulations.
 
48. Product design and information. ENDS should be regulated to:
(a) minimize content and emissions of toxicants;
(b) ensure use of nicotine of pharmacological quality, when nicotine use is intended;
(c) standardize nicotine delivery at levels known to the consumers;
(d) minimize acute nicotine toxicity;
(e) impede product alteration to use of other drugs;
(f) ban ENDS solutions with fruit, candy-like and alcohol-drinks flavours until empirical evidence shows that they are not attractive to minors;
(g) require manufacturers and importers to disclose to governmental authorities information about the contents and emissions of ENDS; and
(h) require registration of manufacturers and importers with governmental authorities.
 
49. Health warnings. ENDS health warnings should be commensurate with proven health risks. In this regard, the following risk warnings could be considered: potential nicotine addiction; potential respiratory, eyes, nose and throat irritant effect; potential adverse effect on pregnancy (due to nicotine exposure).
 
50. Surveillance and monitoring. Governments are recommended to use or strengthen their existing tobacco surveillance and monitoring systems to assess developments in ENDS and nicotine use by sex and age.
 
51. Sale to minors. Retailers should be prohibited from selling ENDS products to minors, and vending machines should be eliminated in almost all locations.

 
Not surprisingly, the WHO has been attacked by e-cigarette enthusiasts.  The repport has also attracted support from several public health authorities, including
 

• European Public Health Association
• The Lancet
• BMJ
• Italian ISS (equivalent of US NIH)