Synthetic nicotine for pouches, e-liquids, heated products and NRT

ESSENZ supplies (S)-nicotine as the free base, in 25 kg drums. Manufacturers dose it directly or turn it into nicotine salts in their own process. Whatever the product, three things travel with every lot: a consistent assay, a known impurity profile and documents a regulator will accept.

Nicotine pouches

In a pouch, nicotine is absorbed onto a plant-fibre filler with flavours and other ingredients. Pouch makers look for a consistent assay from lot to lot, so the nicotine content of the finished product stays on target, and for a clean, documented impurity profile. Because synthetic nicotine involves no tobacco leaf, some brands describe their pouches as tobacco-free nicotine (TFN) products; check the rules on such descriptions in each market where you sell.

E-liquids

E-liquids use nicotine as the free base or as salts made with organic acids. In the EU, nicotine-containing liquids may contain at most 20 mg/mL of nicotine². In the United States, e-liquids made with non-tobacco nicotine, including synthetic nicotine, have been subject to the FDA's tobacco product requirements since 14 April 2022¹. In both cases manufacturers need full documentation of the nicotine they use.

Heated products

Heated products that deliver nicotine need the same basics as other applications: a nicotine of known identity and assay, a documented impurity profile, and a supplier who can deliver the same specification lot after lot.

Pharmaceutical nicotine replacement therapy (NRT)

In gums, lozenges, patches and sprays, nicotine is the active substance of a medicine. It has to comply with the pharmacopoeia³ and be made under GMP, and the medicine's marketing authorisation sets further documentation requirements. Our nicotine is manufactured at a GMP-certified partner site; talk to us about the documentation your filing needs.

What to ask any nicotine supplier

• A certificate of analysis for every lot, with assay, impurities and enantiomeric purity.
• The specification, the safety data sheet and nitrosamine testing data.
• Capacity and lead times: ours is up to 10 t a month, with samples from 10 g within two weeks.
• Access for an audit of the manufacturing site; ours is open to clients under NDA.