Nicotine pouch safety and compliance

Nicotine pouches are currently regulated under General Product Safety Regulations (GPSR) 2015, and companies need to ensure the products they are selling have been evaluated for safety under that. Also as legislation tightens around the marketing and sale of nicotine pouches, manufacturers and retailers must stay ahead of the curve to remain compliant. Under the forthcoming Tobacco and Vapes Bill, nicotine pouches will no longer fall solely under GPSR. Instead, they’ll be classified specifically as nicotine products, ushering in stricter requirements for safety, quality, and labelling.

At ADACT Medical, we help manufacturers and retailers navigate these regulatory changes with clarity. Based on our understanding of upcoming international standards, here’s what pouch producers need to know—and act on:

 1. Ingredient Safety and Toxicological Assessment

All ingredients, including flavourings, must be disclosed and assessed via a Toxicological Risk Assessment (TRA). Only ingredients approved for oral use, food, or medicinal products should be used. Nicotine must meet pharmaceutical-grade purity (BP, EP, USP).

 2. Contaminant Screening

Expect rigorous screening for heavy metals (like arsenic, cadmium, and lead), mycotoxins (such as aflatoxins), and other carcinogenic compounds.

 3. pH and Water Activity Control

Maintaining a stable pH helps prevent tooth demineralisation and ensures nicotine delivery. Water activity should be monitored to minimise microbial risk and maintain shelf life..