6-methyl-nicotine was invented to circumvent regulations in the face of the demonization of natural nicotine. FIVAPE points out that in France, this molecule is banned in vaping products.
Introduced to the US market in 2023, the 6-methyl-nicotine (or metatin) molecule has spread to countries where vaping and nicotine are strongly demonized, or even banned, notably under pressure from anti-smoking lobbies. It's a way for certain players in these countries to bypass regulations and evade all controls, to the detriment of consumer safety.
In France, the molecule 6-methyl-nicotine is banned in vapour e-liquids. No manufacturer may use it, and no retailer may sell it.
This ban is based on several French and European regulations.
What do we know about 6-methyl nicotine (6-MN / metatin)?
The 6-methyl-nicotine molecule is a synthetic nicotine derivative, modified by a methyl group in position 6 of the pyridine ring. It is not naturally present in tobacco.
6-methyl-nicotine may exhibit increased cytotoxicity, with studies showing1 oxidative stress, suggesting a greater toxic potential than nicotine.
The 6-MN molecule is also said to have enhanced neuronal affinity, i.e. stronger binding to nicotinic receptors, with the risk of an exacerbated addictive effect. However, there is no evidence that 6-methyl-nicotine is any more or less effective than natural nicotine in helping people to stop smoking.
To date, there is no toxicological evaluation of 6-methyl-nicotine (or metatine) in the medium and long term, particularly by inhalation.
In short, this molecule is much less well known than nicotine.
Regulatory analysis: nicotine and nicotine derivatives in the European Directive
European Directive 2014/40/EU (TPD2) does not formally ban synthetic nicotine, but imposes strict notification and assessment conditions. Any molecule that has not been notified and assessed - in particular derivatives such as 6-MN - is de facto banned. Vaping products containing such substances cannot be legally marketed in the European Union.
Presentation and clarification of the position of the Directive and its transposition into French law concerning natural nicotine, synthetic nicotine, and derivatives such as 6-methyl-nicotine:
Molecule | Prohibited by the TPD? | Authorization possible? |
Natural nicotine | No | Yes |
Identical synthetic nicotine (bioidentical) | No | Yes, if notified and assessed |
6-methyl-nicotine (modified derivative) | Not explicitly named | De facto unauthorized (not notified, not assessed) |
Analysis by molecule type :
Natural nicotine: derived from tobacco, it is widely used in regulated vaping products. Its safety is well documented. It is authorized if notified in EU-CEG with the necessary toxicological data.
Identical synthetic nicotine : artificially manufactured but structurally identical to natural nicotine. It may be authorized, provided it is notified to EU-CEG and accompanied by a complete assessment dossier.
6-methyl-nicotine (6-MN / metatine): a modified synthetic molecule, not present in tobacco, and structurally different. It cannot be used in regulated products, as it is neither notified nor evaluated. It constitutes a regulatory bypass and represents a potentially higher toxicological risk.
Legal framework effectively prohibiting 6-methyl-nicotine (6-MN / metatine)
The ban on metatin (or 6-MN) in France is based on several legal frameworks:
Directive 2014/40/EU (TPD2)2 - Article 20 - Ingredients must not present a risk to human health under normal conditions of use. 6-MN or metatine, which has not been evaluated and is potentially toxic, does not comply with this provision.
Notification obligation - Article 20.2 TPD - All ingredients must be notified via EU-CEG with toxicological dossier. 6-MN or metatine has not been notified, and is therefore banned from the market.
Public Health Code3 - Article L3513-7 - Vaping products must not contain substances likely to present a risk to human health. The potential toxicity of 6-MN puts it in this category.
Articles R3515-6 to R3515-8 of the French Public Health Code - require substances to be declared and toxicological analysis to be carried out. As 6-MN is not declared, it cannot be authorized.
Order of May 19, 2016 on the composition of e-liquids4 - Prohibits CMR substances, not evaluated or without justification for use. 6-MN is not evaluated, and therefore de facto banned.
Precautionary principle - Treaty on the Functioning of the EU (TFEU - Article 191) - Where there is scientific doubt about the safety of a substance, a ban is justified. 6-MN falls into this category.
Summary table of regulatory interpretation :
Legal element | Interpretation | Application to 6-MN |
Article 20 TPD | Prohibits non-assessed risk substances | Forbidden |
EU-CEG notification | Mandatory before marketing | Not notified |
Public Health Code (L3513-7) | Ban on hazardous substances | Forbidden |
Order of 2016 | Prohibits non-evaluated substances | Forbidden |
Precautionary principle | Justifies ban without scientific certainty | Applicable |
- Comparative analyses of transcriptome sequencing and carcinogenic exposure toxicity of nicotine and 6-methyl nicotine in human bronchial epithelial cells ? - https://www.sciencedirect.com/science/article/abs/pii/S0887233323001108 ︎
- Directive 2014/40/EU (TPD2) - https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX%3A32014L0040 ︎
- Public Health Code: https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000032786733 ︎
- Order of May 19, 2016 on the composition of e-liquids - https://www.legifrance.gouv.fr/loda/id/JORFTEXT000032547614/ ︎