My response to a Swedish public health consultation that included recommended nicotine limits for nicotine pouches. In my view, a nicotine limit of around 20 milligrams per pouch should be set to start with and lowered only if a market survey shows harmful unintended consequences are likely to be negligible or minor and acceptable. In is not inherently more cautious to set a lower limit.
Consultation
Special investigator Inga-Lill Askersjö, Report to the Government of Sweden, Ministry for Health En trygg uppväxt utan nikotin, alkohol och lustgas [A safe upbringing without nicotine, alcohol and nitrous oxide], SOU 2024:23, 25 March 2024 [link][Press release]
Response
A safe upbringing without nicotine, alcohol and nitrous oxide, SOU 2024:23 – Comment by Clive Bates, United Kingdom [PDF] 30 August 2024
Extract
Proposed alternative approach. I would like to suggest a three-part alternative to the proposal made by the special investigator [set a nicotine limit at 12 milligrams per gram]:
- Set a threshold using nicotine mass per serving. A threshold for nicotine content should be set for oral nicotine products. The threshold should be defined as the total nicotine content per serving, not per gram of filler. The latter approach will drive perverse workarounds and does not address safety objectives.
- Set the threshold relatively high initially. The nicotine threshold is set at a relatively high level initially; for example, 20 milligrams per serving. The aim would be to eliminate dangerous rogue products with irresponsibly high levels of nicotine without disrupting the mainstream market that is responsible for Sweden’s success. The Swedish Standards Institute (Svenska Institutet för Standarder) defines a reasonable model for a standard of this nature and sets a threshold of 20 milligrams per serving. It also defines measurement methodology and sets limits for pH and water content. A riskier approach would be to set a standard at a lower maximum nicotine content per serving based on a notional toxicity threshold suggested by Germany’s Bundesinstitut für Risikobewertung, a standard of 16.6mg nicotine per serving.14 Setting any lower threshold increases the risks of adverse consequences (more smoking, illicit trade, workarounds) arising from banning products already used by adult consumers. It is not inherently cautious to set a lower threshold.
- Monitor the development of the market and lower thresholds over time if justified. The impact of the initial threshold should be assessed in a market survey (i.e. what products are available and who is using them), and this would then form the basis for a possible future lowering of the nicotine threshold, providing the Minister is satisfied it will not trigger harmful unintended consequences. Under such a system, the Minister would have powers to set nicotine thresholds through secondary legislation and under conditions specified in the law (e.g. following a market survey).
Such an approach would deal immediately with rogue high-nicotine products with no risk of unintended consequences, provide a basis for a well-managed market, and support future regulatory development based on evolving learning and insight responding to innovation.