Recommendations

The FCTC must seize this opportunity to drastically reduce harm

Recognition of oral nicotine as one of the least harmful nicotine-based products

The harm reduction concept is endorsed in Article 1 of the World Health Organization Framework Convention on Tobacco Control (FCTC). This concept should be expanded and amplified to include recognition of and support for proportionate, risk-based regulation of oral nicotine.
Tobacco and nicotine products should be placed on a continuum of harm, from the most harmful of combusted tobacco to much lower harms of smoke-free nicotine delivery with or without tobacco, including oral nicotine and NRT.
For net public health benefit, the trend towards switching from high-risk smoking tobacco products such as cigarettes to low-risk smoke-free products such NONDS should be accelerated.
Accurate risk communication: Consumers and the public, as part of their basic human rights, must be accurately educated about the relative harms of nicotine- containing products relative to smoking.

It is a priority that the marketing and promotion of smoke-free oral nicotine products should not target youth. If this principle is not respected, the category is unlikely to be allowed to grow.

No marketing to children

Oral nicotine advertising, packaging, flavour names, promotional gifts, activities and events should be directed only to adults.
Age verification needs to be put in place.

Preferred regulatory framework

Regulation should be risk-based, proportionate and recognising of the harm reduction potential of smoke-free oral nicotine products compared to smoking tobacco products.

Differentiation should be made between smoking tobacco products and smoke-free products such as Oral Nicotine Delivery Systems (ONDS).
Recognise that flavours are integral to the appeal of smoke-free alternatives, such as ONDS, and an essential part of the proposition to smokers to try switching and remain smoke-free.
The policy for use of smoke-free nicotine and tobacco products in public spaces: In the absence of evidence of a plausible material risk to bystanders arising from ONDS, smoke-free ONDS should be allowed for use.
Labelling should convey accurate but not exaggerated information, to explain relative risk.
Products should meet specific safety standards for packaging and ingredients. There are established and recommended standards for smoke-free ONDS to draw on.

Responsible risk communication

All state and non-state actors should be encouraged to employ Accurate Risk Communication of the ONDS category.

Product Standards

Products should meet specific safety standards for manufacturing, mixing, processing, packaging, labelling and ingredients. In addition, product standards for novel smoke-free alternatives such as ONDS should provide assurance to regulators and consumers on scientific studies on toxicity, addictiveness and attractiveness, in particular as regards its ingredients analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perception.

Robust research

Development of a comprehensive research agenda for the ONDS category, in order to grow the evidence base with regard to the safety, efficacy (for tobacco cessation) and quality.

NICOTINE

Nicotine research should be central to establishment of an evidence base for this category, including safety, pharmacokinetics and possible side effects in ONDS.
Post-marketing surveillance should be in place to monitor potential nicotine overdoses.

EPIDEMIOLOGY

Epidemiology is considered the most reliable method for assessing the long-term risk. As this is a new category, epidemiological data need to be collected from the onset.

TOXICANTS

Whereas the toxicants in cigarette smoke are responsible for most of the harm related to smoking, it is imperative for the ONDS research agenda to take a balanced approach in seeking to ensure product safety while enabling and encouraging adult smokers to switch to potentially reduced risk nicotine alternatives. This would include the measurement of the following:
Toxicant release: Amount of certain potentially harmful chemicals that are released when product use is simulated.
Toxicant exposure: Amount consumers are exposed to when they use the product.
Toxicant risk: Effect these exposures have on the chances of developing a related disease.

BIOMARKERS

A very important area of research in tobacco and nicotine. Biomarkers help measure the biological impact of an exposure to a product and its ingredients. Various biomarkers need to be studied, including:

Biomarkers of Biological Effect (BoBE): The effects that chemicals in ONDS have when inside the body, should be measured – e.g. blood pressure.
Biomarkers of Exposure (BoE): Determined by measuring the metabolic byproducts of ONDS in blood, breath, saliva or urine.

NICOTINE UPTAKE BETWEEN DIFFERENT PRODUCTS

Comparisons between smoke-free oral nicotine products and other tobacco products (e.g. cigarettes).
When comparing smoke-free oral nicotine products to cigarettes, the mistake should not be made to compare the total amount of nicotine in the pouch, with the amount of nicotine measured in the emissions from a cigarettes.

SOCIAL SCIENCES & CONSUMER UNDERSTANDING

Market research on the preferences of various consumer groups, including young people and current smokers; risk/benefit analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perception.