Since their debut in the UK in 2019, nicotine pouches have seen a remarkable rise, with usage doubling from 2020 to 2024, according to industry data. These small, oral nicotine products have gained traction as an alternative to smoking, but their rapid growth has exposed significant regulatory challenges. As demand continues to climb, Broughton, an analytical and consultancy firm, has identified five critical areas where manufacturers frequently fall short of compliance. Addressing these issues is essential to ensure consumer safety and avoid severe penalties.
Inadequate hazard labelling poses risks. Nicotine is classified as acutely toxic under the CLP Regulation (EC) No. 1272/2008, requiring clear hazard statements on packaging. Failure to comply can lead to safety risks and regulatory action. Companies found guilty of non-compliance may face unlimited fines, with the severity of the violation determining the penalty. In extreme cases, individuals responsible could face up to two years in prison, either alongside or instead of a fine. Manufacturers are also encouraged to follow voluntary guidelines, such as BSI PAS:8877, which offer detailed recommendations on composition, manufacturing, and labelling to enhance product safety.
Missing product information undermines traceability. The General Product Safety Regulations (2005) mandate that nicotine pouches include the manufacturer’s details, batch numbers, and disposal instructions. Omitting this information hampers traceability and jeopardizes consumer safety. Without proper identification, tracking and resolving quality or safety issues becomes difficult, potentially leading to legal repercussions. Clear, comprehensive labelling is crucial for compliance and maintaining consumer trust, ensuring products can be managed effectively throughout their lifecycle.
Misleading imagery increases safety concerns. Some nicotine pouches feature packaging resembling sweets or fruit, creating a risk of accidental consumption, particularly by children. This violates the General Product Safety Regulations (2005), which require products to be designed and packaged to avoid significant risks, especially to vulnerable groups. Such imagery not only undermines the product’s intended use but also attracts regulatory scrutiny for failing to meet consumer protection standards. Manufacturers must ensure packaging clearly distinguishes nicotine pouches from edible items and is inaccessible to children.
Misclassification leads to regulatory errors. Many manufacturers incorrectly assume nicotine pouches fall under the Tobacco Products Directive (2014) or the Tobacco and Related Products Regulations (2016) due to their nicotine content. In reality, they are governed by the General Product Safety Regulations (2005), unless medicinal claims, such as smoking cessation, are made, which would place them under the Medicines and Healthcare products Regulatory Agency (MHRA). This misclassification can result in non-compliance with safety requirements, as the GPSR stipulates that products must present no risk or only minimal risks under normal use.
Non-compliant labelling and missing Safety Data Sheets (SDS) create gaps. The General Product Safety Regulations (2005) require clear ingredient lists, allergen declarations, hazard symbols, and instructions for safe use and disposal. But many manufacturers fail to provide SDS to retailers, complicating efforts to verify compliance with classification, labelling, and packaging regulations. Without SDS, critical details like nicotine content, allergens, and hazardous chemical warnings cannot be confirmed, jeopardising consumer safety and regulatory adherence. Transparent documentation is vital to ensure products meet health and safety standards.
The surge in nicotine pouch popularity underscores the need for stringent compliance. Broughton emphasizes that its analytical testing, toxicology, and consultancy services can help manufacturers identify risks early and streamline market entry. With unlimited fines and potential imprisonment at stake, adhering to regulatory requirements is non-negotiable. As the market expands, manufacturers must prioritise accurate labelling, clear product information, and proper classification to protect consumers and safeguard their brands. By addressing these compliance challenges, the industry can sustain its growth while ensuring safety and trust.
