Public submission from the World Vapers’ Alliance to the Estonian

Government

About the World Vapers’ Alliance

The World Vapers’ Alliance (WVA) amplifies the voices of vapers worldwide and empowers

them to make a difference in their communities. Our members are vapers associations and

individual vapers from all over the world. More information can be found on

www.worldvapersalliance.com

About this consultation and why the World Vapers’ Alliance is responding to it

The World Vapers' Alliance (WVA) welcomes the opportunity to comment on the draft

amendments to the Tobacco Act published for consultation. WVA is an international consumer

advocacy organisation representing the interests of smoke-free nicotine product consumers,

including users of nicotine pouches, vaping products and heated tobacco alternatives. We

engage with regulators across the EU and beyond to promote evidence-based,

risk-proportionate frameworks that support adult smokers in moving away from combustible

tobacco.

We support the Ministries' objective of ensuring nicotine pouches and herbal heated products

are placed on the market safely and responsibly. However, several elements of the draft raise

serious concerns, which we set out below.

How to read this document:

We respond to the main regulatory changes presented in the draft amendment proposal

separately.

1. Consultation timeline

A comment period of seven days for a legislative package of this scope and complexity falls well

short of what sound regulatory practice requires. The proposal touches product formulation,

flavour composition, distance-selling rules and a new penalty regime with fines of up to

€200,000 — matters that warrant proper technical and economic assessment by affected

businesses, retailers and consumer groups.

We respectfully request that the Ministries extend the consultation period to allow

stakeholders to submit substantiated, evidence-based input, consistent with Estonia's own

good legislative practice and the principles of proportionality and stakeholder engagement that

underpin EU better-regulation standards.

2. Maximum nicotine concentration (4 mg/g)

The proposed limit of 4 mg/g represents a reduction of roughly 80% from the de facto market

standard limit of 20 mg per pouch that has been applied. We would encourage the Ministries

to reconsider the basis for this figure and its likely consequences:

● Consumer switching: Adult smokers who have moved to nicotine pouches typically do

so because the product delivers nicotine at a level that satisfies cravings previously met

by cigarettes. A limit set well below what many former smokers currently use risks

making pouches a less effective substitute, with some consumers reverting to smoking

rather than switching to a lower-strength product.

● Risk-proportionate regulation: Nicotine pouches contain no tobacco leaf and produce

no combustion or aerosol; nicotine intake, not the delivery format itself, drives the

relevant risk profile. A blanket concentration cap that does not distinguish between

initiation-oriented and cessation-oriented use may be a blunter instrument than

product standards addressing packaging, marketing and age verification.

● Displacement to unregulated channels: Experience in other EU markets that have

imposed strict nicotine caps shows that a significant share of demand for

higher-strength products migrates to cross-border purchasing and unregulated online

sellers, undermining both the public health objective and the enforcement regime the

draft seeks to strengthen.

We recommend that any limit be set on the basis of a transparent impact assessment,

informed by actual consumer usage data in Estonia and comparative evidence from other

markets, rather than a single fixed figure applied uniformly across all product categories

covered by the draft (pouches, strips, sprays, heated nicotine sticks and heated herbal sticks),

which differ materially in how nicotine is absorbed and used.

3. Flavours: tobacco/menthol-only and the positive list

Restricting permitted flavours to tobacco and menthol, via a positive list of 16 tobacco-related

and 8 menthol-related substances, is a substantial narrowing relative to the current

unrestricted market. We would raise the following points for the Ministries' consideration:

● Role of flavours in switching: Available evidence on smoke-free nicotine products

indicates that flavour variety is a key factor in adult smokers' decisions to switch away

from cigarettes and to sustain that switch. Removing non-tobacco, non-menthol

flavours outright, rather than regulating their marketing and availability to minors, risks

reducing the appeal of the smoke-free category specifically for the adult population it

is meant to serve.

● Evidentiary basis: We would welcome clarity on the domestic data underpinning the

proposed restriction — in particular, evidence of youth uptake of flavoured pouches in

Estonia specifically — so that the measure can be assessed as proportionate to a

demonstrated risk rather than precautionary by default.

We would encourage the Ministries to consider a narrower alternative — for example,

retaining a broader flavour palette subject to strict age-verification controls — as a

proportionate means of addressing youth-appeal concerns without foreclosing a tool that adult

consumers use to move away from smoking.

4. Enforcement and penalties

● Purchaser liability: Extending penalties to individual purchasers engaging in prohibited

distance sales is disproportionate. Enforcement resources are generally better directed

at non-compliant sellers and platforms than at consumers, who in a cross-border digital

market may not always be able to determine the compliance status of a given seller.

● Scope of "prohibited distance sales": We would ask the Ministries to clarify precisely

which distance-selling activities are captured, given the cross-border nature of

e-commerce within the EU single market and the need for the regime to be workable

in practice.

5. Entry into force

We note the proposed entry into force of 1 January 2028, which allows a reasonable lead time

for the market to adjust. We would ask that the final legislation include explicit transitional

arrangements — in particular a sell-through period for compliant stock already on the market

— so that legitimate businesses are not penalised for products lawfully placed on the market

under the current voluntary regime.

6. Conclusion

WVA supports a clear, enforceable statutory framework for nicotine pouches and herbal heated

products, and we recognise the legitimate public health objectives behind this draft. We would

ask the Ministries to: (i) extend the consultation period; (ii) base the nicotine concentration

limit on a transparent, evidence-based impact assessment rather than a fixed reduction from

current market practice; (iii) reconsider the flavour restriction in light of its effect on adult

smokers' ability to switch, or adopt a less restrictive alternative; and (iv) refine the enforcement

provisions so that penalties fall proportionately on non-compliant sellers rather than

consumers.

We would welcome the opportunity to discuss these points further with officials from both

Ministries, and we are glad to share supporting evidence on consumer switching behaviour and

comparative regulatory experience from other markets.

The World Vapers’ Alliance is committed to supporting effective harm reduction policies and is

ready to collaborate with the Estonian Government to achieve shared public health goals.

A comprehensive review of the literature can be found in our Vaping and Harm Reduction Fact

Sheet here: https://worldvapersalliance.com/harm-reduction-vaping-fact-sheet/

For any questions or comments, please contact the submitter of the response.

Public submission from the World Vapers’ Alliance to the Estonian

Government

About the World Vapers’ Alliance

The World Vapers’ Alliance (WVA) amplifies the voices of vapers worldwide and empowers

them to make a difference in their communities. Our members are vapers associations and

individual vapers from all over the world. More information can be found on

www.worldvapersalliance.com

About this consultation and why the World Vapers’ Alliance is responding to it

The World Vapers' Alliance (WVA) welcomes the opportunity to comment on the draft

amendments to the Tobacco Act published for consultation. WVA is an international consumer

advocacy organisation representing the interests of smoke-free nicotine product consumers,

including users of nicotine pouches, vaping products and heated tobacco alternatives. We

engage with regulators across the EU and beyond to promote evidence-based,

risk-proportionate frameworks that support adult smokers in moving away from combustible

tobacco.

We support the Ministries' objective of ensuring nicotine pouches and herbal heated products

are placed on the market safely and responsibly. However, several elements of the draft raise

serious concerns, which we set out below.

How to read this document:

We respond to the main regulatory changes presented in the draft amendment proposal

separately.

1. Consultation timeline

A comment period of seven days for a legislative package of this scope and complexity falls well

short of what sound regulatory practice requires. The proposal touches product formulation,

flavour composition, distance-selling rules and a new penalty regime with fines of up to

€200,000 — matters that warrant proper technical and economic assessment by affected

businesses, retailers and consumer groups.

We respectfully request that the Ministries extend the consultation period to allow

stakeholders to submit substantiated, evidence-based input, consistent with Estonia's own

good legislative practice and the principles of proportionality and stakeholder engagement that

underpin EU better-regulation standards.

2. Maximum nicotine concentration (4 mg/g)

The proposed limit of 4 mg/g represents a reduction of roughly 80% from the de facto market

standard limit of 20 mg per pouch that has been applied. We would encourage the Ministries

to reconsider the basis for this figure and its likely consequences:

● Consumer switching: Adult smokers who have moved to nicotine pouches typically do

so because the product delivers nicotine at a level that satisfies cravings previously met

by cigarettes. A limit set well below what many former smokers currently use risks

making pouches a less effective substitute, with some consumers reverting to smoking

rather than switching to a lower-strength product.

● Risk-proportionate regulation: Nicotine pouches contain no tobacco leaf and produce

no combustion or aerosol; nicotine intake, not the delivery format itself, drives the

relevant risk profile. A blanket concentration cap that does not distinguish between

initiation-oriented and cessation-oriented use may be a blunter instrument than

product standards addressing packaging, marketing and age verification.

● Displacement to unregulated channels: Experience in other EU markets that have

imposed strict nicotine caps shows that a significant share of demand for

higher-strength products migrates to cross-border purchasing and unregulated online

sellers, undermining both the public health objective and the enforcement regime the

draft seeks to strengthen.

We recommend that any limit be set on the basis of a transparent impact assessment,

informed by actual consumer usage data in Estonia and comparative evidence from other

markets, rather than a single fixed figure applied uniformly across all product categories

covered by the draft (pouches, strips, sprays, heated nicotine sticks and heated herbal sticks),

which differ materially in how nicotine is absorbed and used.

3. Flavours: tobacco/menthol-only and the positive list

Restricting permitted flavours to tobacco and menthol, via a positive list of 16 tobacco-related

and 8 menthol-related substances, is a substantial narrowing relative to the current

unrestricted market. We would raise the following points for the Ministries' consideration:

● Role of flavours in switching: Available evidence on smoke-free nicotine products

indicates that flavour variety is a key factor in adult smokers' decisions to switch away

from cigarettes and to sustain that switch. Removing non-tobacco, non-menthol

flavours outright, rather than regulating their marketing and availability to minors, risks

reducing the appeal of the smoke-free category specifically for the adult population it

is meant to serve.

● Evidentiary basis: We would welcome clarity on the domestic data underpinning the

proposed restriction — in particular, evidence of youth uptake of flavoured pouches in

Estonia specifically — so that the measure can be assessed as proportionate to a

demonstrated risk rather than precautionary by default.

We would encourage the Ministries to consider a narrower alternative — for example,

retaining a broader flavour palette subject to strict age-verification controls — as a

proportionate means of addressing youth-appeal concerns without foreclosing a tool that adult

consumers use to move away from smoking.

4. Enforcement and penalties

● Purchaser liability: Extending penalties to individual purchasers engaging in prohibited

distance sales is disproportionate. Enforcement resources are generally better directed

at non-compliant sellers and platforms than at consumers, who in a cross-border digital

market may not always be able to determine the compliance status of a given seller.

● Scope of "prohibited distance sales": We would ask the Ministries to clarify precisely

which distance-selling activities are captured, given the cross-border nature of

e-commerce within the EU single market and the need for the regime to be workable

in practice.

5. Entry into force

We note the proposed entry into force of 1 January 2028, which allows a reasonable lead time

for the market to adjust. We would ask that the final legislation include explicit transitional

arrangements — in particular a sell-through period for compliant stock already on the market

— so that legitimate businesses are not penalised for products lawfully placed on the market

under the current voluntary regime.

6. Conclusion

WVA supports a clear, enforceable statutory framework for nicotine pouches and herbal heated

products, and we recognise the legitimate public health objectives behind this draft. We would

ask the Ministries to: (i) extend the consultation period; (ii) base the nicotine concentration

limit on a transparent, evidence-based impact assessment rather than a fixed reduction from

current market practice; (iii) reconsider the flavour restriction in light of its effect on adult

smokers' ability to switch, or adopt a less restrictive alternative; and (iv) refine the enforcement

provisions so that penalties fall proportionately on non-compliant sellers rather than

consumers.

We would welcome the opportunity to discuss these points further with officials from both

Ministries, and we are glad to share supporting evidence on consumer switching behaviour and

comparative regulatory experience from other markets.

The World Vapers’ Alliance is committed to supporting effective harm reduction policies and is

ready to collaborate with the Estonian Government to achieve shared public health goals.

A comprehensive review of the literature can be found in our Vaping and Harm Reduction Fact

Sheet here: https://worldvapersalliance.com/harm-reduction-vaping-fact-sheet/

For any questions or comments, please contact the submitter of the response.