Tobacco and Vapes Bill

Written evidence submitted by Broughton Life Sciences Ltd. (TVB36)

Summary 

 

1 Broughton Life Sciences ("Broughton") is an independent Contract Research Organisation with over 15 years of experience working with nicotine products, including Nicotine Replacement Therapies (NRTs). As an MHRA GMP-inspected facility, we are dedicated to ensuring product safety, quality, and regulatory compliance through rigorous scientific and manufacturing standards.

Executive Summary 

 

2 Nicotine products, including both pouches and vaping devices, present significant potential as harm-reduction tools for adult smokers transitioning away from combustible tobacco products. However, achieving public health goals requires robust regulation and enforcement to ensure product safety, quality, and appropriate consumer use. This response focuses on four primary recommendations: establishing a maximum nicotine limit of 20 mg per pouch for nicotine pouches, establishing standards for nicotine pouch ingredients and labelling, adopting enhanced standards for the manufacturing and testing of nicotine products in the UK, and exempting Heated Tobacco Products (HTPs) from the increasing age restriction due to their relative safety profile.

Broughton's Response 

 

The Potential of Nicotine Products as Harm-Reduction Tools 

3 Nicotine pouches and vaping devices offer non-combustible alternatives for adult smokers aiming to reduce or quit tobacco use. Their discreet nature and reduced harm compared to cigarettes make them an essential part of harm-reduction strategies. These products significantly reduce exposure to harmful chemicals found in combustible tobacco.

4 Heated Tobacco Products (HTPs) have been scientifically shown to reduce exposure to harmful and potentially harmful chemicals compared to combustible cigarettes. For example, studies demonstrate that HTPs emit significantly lower levels of toxicants, such as carbon monoxide and nitrosamines, than traditional cigarettes. This reduced risk is reflected in the Modified Risk Tobacco Product (MRTP) designation granted by the US Food and Drug Administration (FDA) for certain HTPs.

5 Evidence indicates that adult smokers using nicotine pouches experience lower cravings compared to other smoking cessation tools and provide a substantially lower health risk to users in comparison to inhaled products. However, without current regulations, we are starting to observe the risks of high-strength products in "youth appealing" packaging and flavours.

6 Adopting appropriate regulations will ensure these products fulfil their potential while minimising risks, particularly among non-smokers and youth. Striking the right balance between accessibility for smokers and preventing initiation by non-smokers is crucial.

Establishing a Maximum Nicotine Limit for Nicotine Pouches 

7 It is recommended that the UK government set a maximum nicotine limit of 20 mg per pouch, as outlined in the British Standards Institute’s (BSI) PAS 8877:2022, "Tobacco-free oral nicotine pouches – Composition, manufacture and testing – Specification."

8 The 20 mg nicotine cap ensures effective nicotine delivery for adult users while reducing the risk of misuse or accidental exposure.

9 Other jurisdictions, including Germany, have implemented similar caps, highlighting global alignment on this issue. The German Federal Institute for Risk Assessment (BfR) recommends limiting nicotine content to 16.67 mg/g (circa 20 mg per pouch) to ensure consumer safety and to prevent overconsumption, particularly among inexperienced users.

10 Research consistently demonstrates that higher nicotine concentrations are associated with increased risks of dependency and adverse health effects. Excessively high levels of nicotine in pouches may also increase the likelihood of misuse, particularly among individuals not accustomed to such doses.

Applying Ingredients and Labelling Standards to Nicotine Pouches 

11 Ingredients: The composition of nicotine pouches should adhere to rigorous safety and quality standards to ensure consumer safety. PAS 8877 provides a robust framework for regulating ingredients, requiring:

· Full Ingredient Disclosure: Manufacturers should disclose all components, including quantities and identification numbers such as CAS numbers, to facilitate toxicological assessments.

· Prohibition of Harmful Substances: Ingredients classified as carcinogenic, mutagenic, or toxic to reproduction under the Globally Harmonized System (GHS) should be excluded. The presence of toxicologically undesirable constituents as impurities must be restricted to levels deemed acceptable through a documented risk assessment.

· Ingredient Quality/Purity: Nicotine and other ingredients must meet pharmaceutical-grade specifications, ensuring consistent quality and safety. For example, pouch materials in contact with the product should comply with food-grade standards under European Regulation (EC) No. 1935/2004.

12 These measures will help mitigate health risks, ensuring nicotine pouches are both effective and safe for consumer use.

13 Product Presentation: The presentation of nicotine pouches is critical in ensuring appropriate use and reducing appeal to unintended audiences. Drawing from the MHRA's guidance on electronic cigarettes and refill containers, the following principles should be applied to pouches:

· Clear and Informative Labelling: Packaging must include accurate information about nicotine content, a complete list of ingredients, and any allergens present. Warnings such as "This product contains nicotine, which is a highly addictive substance" should be prominently displayed.

· Child-Resistant and Tamper-Evident Packaging: To prevent accidental ingestion, all packaging must be child-resistant and include tamper-evident features.

· Avoidance of Misleading Branding: Product names, designs, and marketing materials must not suggest medicinal benefits, health advantages, or lifestyle appeal. Imagery and terminology that could attract youth should be strictly avoided.

Enhancing Manufacturing and Testing Standards 

14 Implementing stringent manufacturing and testing standards is essential to ensure product safety and quality. These standards should apply to both nicotine pouches and vaping devices. PAS 8877:2022 provides comprehensive guidelines on the composition, manufacture, and testing of tobacco-free oral nicotine pouches, including:

· Ingredient Disclosure: Mandating full disclosure of ingredients to inform consumers and regulators.

· Restricted Substances: Prohibiting harmful additives to reduce health risks.

· Quality Assurance: Ensuring consistency in nicotine content and product integrity.

15 Aligning with the MHRA's advice on due diligence for electronic cigarette devices and refill containers further strengthens regulatory oversight. Key recommendations include:

· Toxicological Risk Assessments: Conduct thorough evaluations to identify potential health risks associated with product use.

· Basic Principles of Good Manufacturing Practice (GMP): Implementing basic GMP principles to ensure consistent product quality and safety without mandating full GMP compliance, including the requirement for routine Quality Control Testing, creation and retention of Batch Manufacturing Records and the determination of the product's Shelf Life via appropriately defined Stability Studies.

16 Adherence to these standards will mitigate risks associated with product contamination, inconsistent nicotine delivery, and the presence of harmful substances.

Strengthening Enforcement Mechanisms 

17 Establishing regulations without effective enforcement mechanisms renders them ineffective. It is imperative to develop a robust framework that includes:

· Regular Inspections: Conducting routine audits of manufacturing facilities to ensure compliance with established standards.

· Market Surveillance: Monitoring products available in the market to identify non-compliant items.

· Penalties for Non-Compliance: Implementing fines, product recalls, or other penalties to deter violations.

18 Collaboration with industry stakeholders, public health organisations, and consumers is vital to ensure the effectiveness of these enforcement strategies. A coordinated approach will help maintain market integrity and consumer trust.

Exempting Heated Tobacco Products (HTPs) from the Age Restriction 

19 The proposed age restriction, which bans tobacco product sales to individuals born on or after 1 January 2009, should not apply to Heated Tobacco Products (HTPs).

20 HTPs have been recognised as a safer alternative to traditional combustible cigarettes, with studies showing significantly reduced exposure to harmful chemicals. The FDA's MRTP designation for specific HTPs highlights their potential as harm-reduction tools. For instance, an independent analysis found that HTP use resulted in 90% lower levels of toxicants compared to cigarette smoke.

21 Applying the age restriction to HTPs may inadvertently drive younger users to more harmful combustible products, undermining public health objectives. A nuanced approach that recognises the relative safety of HTPs is essential to prevent unintended consequences.

22 The UK Government should consider the scientific evidence supporting HTPs and their role in reducing harm for current smokers. Creating exemptions for these products while maintaining strict marketing restrictions can help achieve public health goals without stigmatising safer alternatives.

Recommendations 

 

23 The UK government should:

· Establish a maximum nicotine limit of 20 mg per pouch for nicotine pouches.

· Apply rigorous standards to nicotine pouches, ensuring:

o Full ingredient disclosure and the exclusion of harmful substances as outlined in PAS 8877.

o Compliance with pharmaceutical-grade purity requirements and food-grade material standards for pouch components.

o Clear and informative labelling, child-resistant packaging, and avoidance of misleading branding, e.g. in line with MHRA presentation guidance for vaping products.

· Mandate adherence to manufacturing and testing standards outlined in PAS 8877:2022 and MHRA due diligence guidelines for both nicotine pouches and vaping devices.

· Exempt Heated Tobacco Products (HTPs) from the increasing age restriction due to their recognised harm-reduction potential.

· Develop a robust enforcement framework to ensure compliance.

6 January 2025