WHO issues important call to action on ecigs

The World Health Organization has released a call to action and supporting technical note that provides detailed guidance for countries on how to battle the e-cigarette epidemic. The WHO both supports countries who have prohibited the import and sale of e-cigarettes and provides detailed evidence-based guidance for those who allow sale of e-cigarettes.

• Banning all flavouring agents, including menthol and synthetic menthol analogues
• Prohibiting attractive and/or promotional features related to the presentation and packaging of
• The products, such as colours or colouring properties, attractive descriptors, including names
• Regulating features that enable the user to manipulate the product, post-sale
• Limiting the concentration and quantity of nicotine, to reduce the risk of dependence
• Setting a maximum volume for e-cigarette cartridges, to limit toxicants exposure and use
• Setting a maximum battery power, to limit the influence of power on nicotine and toxicant delivery
• Prohibiting device features that permit transmission of information to and from third parties (including manufacturers), such as connections to smartphone apps, that could be used to collect personal information, details of use topography, or to remotely control the product
• Prohibiting additives that have carcinogenic, mutagenic and reprotoxic properties

The Biden White House should pay particular attention to the first recommendation and lift its blockade on the FDA’s product standards eliminating menthol in cigarettes and menthol and other flavors in cigars.

The WHO is, as far as I know, the first agency to highlight the problems with allowing tobacco companies to monitor and remotely control e-cigarettes (and other electronic nicotine delivery systems). Juul has applied to FDA for authorization for Juul 2, which has such capabilities and is already being sold in England.  While Juul is claiming that this two-way communication can be used to reduce youth use, it gives them tremendous power to manipulate users to increase addiction and sales. FDA and other similar agencies should simply prohibit such two-way communication.

Another important contribution in the Call to Action is making the distinction between e-cigarettes as consumer products and medicines, highlighting the lack of evidence that e-cigarettes, as consumer products have not been shown to help smokers “switch completely.”

Cessation strategies should be based on the best available evidence of efficacy, synergistic with other tobacco control measures and subject to monitoring and evaluation. Based on the current evidence, it is not recommended that governments permit sale of e-cigarettes as consumer products in pursuit of a cessation objective. Any government pursuing a smoking cessation strategy utilizing e-cigarettes should control the conditions under which the products are accessed to ensure appropriate clinical conditions and regulate the products as medicines (including requiring marketing authorization as medicines). The decision to pursue a smoking cessation objective, even in such a controlled form, should be made only after considering national circumstances, along with the risk of uptake and after exhausting other proven cessation strategies. [emphasis added]

Regulatory agencies, including FDA, need to follow WHO’s lead and start making this important distinction. In particular, FDA Center for Tobacco Products should stop using the euphemism “switching completely” to avoid saying “cessation” and until e-cig/tobacco companies win approval from the drug side of the FDA (the Center for Drug Evaluation and Research) to make such claims.

Both documents are important resources that should help governments and health advocates modernize their thinking on e-cigarettes.