The proposed Draft Royal Decree in Spain introduces stringent regulations on vaping products and nicotine pouches.
While framed as public health measures, these policies may inadvertently undermine harm reduction strategies, potentially driving users back to traditional cigarettes instead of safer alternatives.
The draft decree, as currently proposed, risks undermining harm reduction efforts by imposing unfeasible restrictions on vapes and nicotine pouches.
A united and well-coordinated public response is crucial to shape regulations grounded in scientific evidence and aligned with public health priorities.
Below is a detailed analysis of the proposed changes, their implications, and recommendations for public feedback.
Your participation is vital to advocate for fair, balanced, and effective policies that support smokers in transitioning to safer alternatives.
Key Changes for Vapes
Nicotine Dosages and Product Safety
Requirements:
• Devices must deliver consistent nicotine doses under normal use.
• Products must feature child-resistant designs, leak-proof mechanisms, and safe refilling systems.
Concerns:
• Requiring “100% safety” is an unrealistic and unattainable standard. No product can guarantee absolute safety; this ambiguous criterion could lead to arbitrary enforcement.
• While leak-proof mechanisms are a reasonable requirement, overly rigid regulations could stifle innovation and increase product costs, limiting consumer accessibility.
Flavor Restrictions
Requirements:
• E-liquids would be limited to ingredients that produce a “tobacco-like” flavor.
Concerns:
• The lack of clarity on what constitutes a “tobacco flavor” creates regulatory uncertainty for manufacturers.
• If Spain adopts a restrictive whitelist, similar to the Netherlands’ 16-ingredient model, it would drastically reduce product diversity and potentially drive users back to combustible cigarettes.
Key Changes for Nicotine Pouches
Nicotine Content Limit
Requirement:
• Nicotine pouches must not exceed 0.99 mg of nicotine per sachet.
Impact:
• This limit effectively constitutes a de facto ban. Products with such low nicotine levels are neither viable for manufacturers nor appealing to consumers, thereby eliminating this alternative from the market.
Additive Restrictions
Requirement:
• Flavors other than tobacco and additives that enhance nicotine absorption, stimulants like caffeine or taurine are prohibited.
Impact:
• Restricting flavors to tobacco would eliminate most existing products, reducing consumer appeal and likely increasing cigarette consumption.
Broader Implications
These measures could:
• Weaken harm reduction efforts by removing safer alternatives to tobacco.
• Hinder innovation in harm reduction technologies.
• Favor the combustible cigarette market by eliminating its main competitors—vaping products and nicotine pouches.
Ultimately, these policies could discourage smokers from transitioning to lower-risk alternatives, contradicting Spain’s public health objectives.
Recommendations for Public Submissions
It is essential for public input to ensure that the proposed regulations are balanced and evidence-based. Submissions can be sent to informacion_publica@sanidad.gob.es with the subject DG/87/24 APORTACIONES + YOUR NAME by December 13.
Key points to highlight:
1. Emphasize how vapes and nicotine pouches have helped individuals reduce or quit smoking.
2. Question the feasibility of the “100% safety” standard, an unrealistic benchmark with no precedent in product regulation.
3. Advocate for flexible flavor regulations, such as blacklists of harmful ingredients, rather than restrictive whitelists.
4. Oppose the nicotine limit for pouches, highlighting its impracticality and the lack of global precedents.
5. Request clarity on the definition of “tobacco flavor” to avoid regulatory ambiguity.
6. Demand evidence-based policymaking prioritizing public health while respecting adult consumers’ rights.
How to Participate
The organization ANESVAP provides resources to facilitate public participation:
• Public Consultation Guide: Step-by-step instructions.
• Telegram Group: Join here.
• Send testimonies to info@anesvap.es or contacto@elmonovapeador.com.
Amplify your message using official hashtags:
• #MinisterioDelTabaco
• #MeEncantaLaFruta
• #ElVapeoSalvaVidas