WMA Statement on Electronic Cigarettes and Other Electronic Nicotine Delivery Systems

Adopted by the 63^rd WMA General Assembly, Bangkok, Thailand, October 2012 and
revised by the 74th WMA General Assembly, Kigali, Rwanda, October 2023

PREAMBLE

Electronic cigarettes (e-cigarettes) and other electronic nicotine delivery systems (ENDS) are products designed to deliver nicotine to a user in the form of an aerosol. These products are usually composed of a mouthpiece, a rechargeable battery-operated heating element, a replaceable cartridge that contains liquid nicotine and/or other chemicals, and an atomizer that, when heated, turns the contents of the cartridge into an aerosol. This aerosol is then inhaled by the user and exhaled. These products are often made to look like other tobacco-derived products like cigarettes, cigars, pipes, toys and electronics that appeal to young people. They can also be made to look like everyday items such as pens and USB memory sticks. ENDS and their risks are outlined in more detail in the WMA Statement on Health Hazards of Tobacco Products and Tobacco- Derived Products.

Nicotine exposure, no matter how it is delivered, can affect brain development and lead to addiction. No standard definition of e-cigarettes exists, and manufacturers use different designs and different ingredients. Quality control processes used to manufacture e-cigarettes are substandard or non-existent, and few studies have been done to analyze the level of nicotine delivered to the user and the composition of the aerosol or vapor produced. Unknown amounts of nicotine are delivered to the user, and the level of absorption is unclear, leading to potentially toxic levels of nicotine in the system, especially in children, adolescents and young adults. E-cigarettes and ENDS may also contain other ingredients toxic or carcinogenic to humans including delivery solvents, propylene glycol, glycerin, pulegone, formaldehyde, acetaldehyde, acrolein, and heavy metals, such as chromium, copper, zinc, tin and lead.

Manufacturers and marketers of e-cigarettes and ENDS often claim that use of their products is a safe or safer alternative to smoking cigarettes, particularly since e-cigarettes and ENDS they do not produce carcinogenic smoke. However, no studies have conclusively determined that the aerosol is not toxic or carcinogenic. There is some evidence of a risk of carcinogenicity of the respiratory tract due to long-term, cumulative exposure to nitrosamines and to acetaldehyde and formaldehyde. As with tobacco products, the safest option is to abstain from using e-cigarettes and ENDS.

Evidence already exists that e-cigarettes and ENDS are harmful and not safe.  Risks include:

• appeal to children, adolescents and young adults, through packaging and marketing designed to appeal to these age groups, and especially when flavors like strawberry or chocolate are added to the cartridges. These factors can increase nicotine addiction among young people, and may be a gateway to experimenting with other tobacco products. Packaging and marketing targeted to young people has contributed to the dramatic increase in e-cigarette and ENDS use which in some regions is more popular than tobacco smoking.
• the belief promoted by manufacturers that these devices are acceptable alternatives to scientifically proven cessation techniques, when neither their value as therapeutic aids for smoking cessation nor their safety as cigarette replacements is established. Evidence reveals that these products are harmful to health and not safe. In addition, evidence on the use of ENDS as a way to decrease tobacco use in adults is inconclusive;
• inconsistent and unknown dosage, manufacturing processes, and ingredients, including the potential for abusing or manipulating the product, e.g., by adding cannabis, and simultaneous use with other tobacco products (dual or poly use);
• high potential of toxic exposure to nicotine by children, either by ingestion or dermal absorption from contents of a nicotine cartridge, because the cartridges and refill liquids are readily available over the Internet and are not always sold in child resistant packaging;
• worse clinical outcomes in patients with the SARS-COV2 virus who also use e-cigarettes.

RECOMMENDATIONS

1. That e-cigarettes and ENDS be subject to the WHO Framework Convention on Tobacco Control, and to jurisdictional smoke-free laws and regulations.
2. That the manufacture and sale of e-cigarettes and ENDS be subject to national regulatory bodies as either a new form of tobacco product or as a drug delivery device. At a minimum, regulations should address maximum strength of nicotine fluids, tank size on vaping devices, product labeling, and child-resistant packaging. This recommendation also applies to devices using synthetic nicotine.
3. That clinical testing, large population studies and full analyses of e-cigarette ingredients and manufacturing processes be conducted to determine their level of risk, viability, and efficacy as tools for tobacco cessation.
4. That e-cigarettes and other ENDS should never be marketed as a valid or efficacious method for smoking cessation without validated clinical research that is assessed by appropriate regulatory bodies. In all other instances, plain package marketing should be required, in accordance with the WMA Resolution on Plain Packaging of Cigarettes, e-Cigarettes and Other Smoking Product.
5. That the sale, marketing, distribution, and accessibility of e-cigarettes and other tobacco products to children and adolescents be prohibited.
6. That the production, distribution and sale of flavored e-cigarette cartridges and candy products that depict or resemble tobacco products be prohibited.
7. That the sale of e-cigarettes and ENDS via the internet be prohibited in order to prevent access to these products by minors.
8. That physicians, pediatric practitioners and dentists inform their patients of the potential risks of using e-cigarettes and ENDS, e.g., addiction, cardiovascular disease, lung disease, impact on brain development due to nicotine, physical injuries, etc., even if regulatory authorities have not taken a position on the efficacy and safety of these products.
9. That the WMA and its members support further research on the harmful effects of e-cigarettes and ENDS, especially in children, adolescents and young adults.