An Open Letter to KKM

What KKM Must Do

KKM Must Stop Treating Different Products, Substances and Crimes as One Problem

There is a fundamental difference between an adult smoker switching to a regulated nicotine product, a schoolchild buying a cheap disposable, a patient inhaling an illicit THC cartridge, a criminal filling cartridges with synthetic drugs, and a lawful retailer selling commercially manufactured nicotine e-liquid.

Yet public messaging repeatedly compresses these different products, users and crimes into one word:

This is not a harmless simplification. It conceals causation, assigns guilt by device category and produces rules aimed at the wrong products and people. Different risks require different evidence, laws and enforcement.

For Adult Smokers, the Relevant Comparison Is Smoking, Not Clean Air

For an adult smoker, comparing vaping with clean air is a rhetorical distraction. The clinically relevant question is whether switching completely from combustible cigarettes reduces exposure and improves the chance of remaining smoke-free.

Vaping is not risk-free. The absence of combustion does not make it harmless, but it changes the nature and level of exposure. A major UK evidence review found significantly lower exposure to many harmful substances from vaping than from smoking, while also finding similar or higher exposure than using no nicotine product and emphasising uncertainty about long-term effects. 21

The Cochrane living review, including evidence published up to 1 March 2025, found high-certainty evidence that nicotine e-cigarettes improve smoking-cessation rates compared with nicotine-replacement therapy. It estimated that 8 to 11 of every 100 people using nicotine e-cigarettes might stop smoking for at least six months, compared with about 6 of 100 using nicotine-replacement therapy. 1

This evidence does not make vaping harmless. It makes one point unavoidable: KKM cannot honestly dismiss nicotine vaping as having no legitimate role in smoking cessation.

Before switching from cigarettes, I visited government clinics approximately once every two or three months because of recurring sore throats. During nearly 20 years of vaping, I estimate that I have sought treatment for the same problem no more than ten times.

This letter is also grounded in lived Malaysian experience. Personal experience is not a clinical trial, but policy that refuses to hear former smokers while claiming to act for them is incomplete.

A Policy That Ignores Adult Smokers Fails the Public-Health Test

Malaysia still has a substantial smoking problem. GATS Malaysia 2023 reported that 19.0% of adults currently smoked tobacco, while 5.8% currently used electronic cigarettes and 3.9% concurrently smoked and used electronic cigarettes. 20

These figures make the policy obligation clear. Malaysia must prevent youth uptake while helping adult smokers stop inhaling combustion. The preferred outcome is no smoking and, where possible, no nicotine. For smokers who use vaping as harm reduction, the immediate objective must be complete replacement of cigarettes, not indefinite dual use. A policy that drives even some former smokers back to cigarettes cannot be celebrated as a public-health success.

KKM Must Publish a Usable Clinical Pathway for Adult Smokers

Harm-reduction evidence does not mean retailers should make medical claims or advertise a product as an approved treatment.

However, KKM's 2026 nicotine-dependence management protocol has expanded its clinical scope to include electronic cigarettes or vapes and heated tobacco products. 17

KKM must publish a clinician-led pathway for adult smokers who have been unable to quit through conventional methods. It should explain the available options, prioritise complete cessation of cigarettes, monitor concurrent smoking and vaping, support eventual nicotine reduction where appropriate, and actively prevent relapse to smoking.

KKM cannot include vaping within clinical nicotine-dependence management while publicly treating every vape product as an undifferentiated threat. Clinical policy and public messaging must be coherent.

KKM Must Publish the Full Methodology Behind the RM369 Million Projection

KKM has repeatedly cited a projected annual treatment cost that could reach approximately RM369 million by 2030. A figure of this scale is being used to support major restrictions, yet it is not self-explanatory.

Earlier parliamentary material described RM369 million as a figure that treatment costs could reach annually by 2030 if no firm action were taken. It is a projection, not necessarily an audited amount already spent by government hospitals today. 2

KKM must publish the assumptions, patient count, cost per case, indirect-cost components, diagnostic criteria, substance classification and sensitivity analysis used in the calculation.

1. Is RM369 million actual expenditure, projected expenditure or a combined economic estimate?
2. How many confirmed patients were included?
3. How many cases involved nicotine liquid only?
4. How many involved THC, synthetic cannabinoids, ketamine, mushroom extracts or unidentified substances?
5. How many products were recovered and tested?
6. How many cases relied mainly on a patient saying that they had vaped?
7. How many products came from lawful retailers, and how many came from informal or criminal sources?

Until that material is published, the figure must be presented strictly as a projection. It should not be used as settled proof against every nicotine product, every lawful operator or every adult user.

KKM Must Not Use EVALI as a Blanket Indictment of Nicotine Vaping

EVALI describes lung injury associated with recent use of a vaping device. The term does not, by itself, identify what substance was inside the device.

A cartridge may contain conventional nicotine liquid, THC oil, synthetic cannabinoids, vitamin E acetate, ketamine, methamphetamine or an unidentified mixture. These substances do not become chemically identical merely because they were inhaled through similar hardware.

KKM's own quick reference notes that the CDC case definitions were developed for surveillance and that testing is often used to exclude other diagnoses rather than conclusively identify the chemical cause.3

Without chemical identification, converting an EVALI classification into evidence against commercial nicotine e-liquid is not scientific attribution. It is guilt by association.

The United States EVALI Evidence Cannot Be Selectively Quoted

The CDC found that 82% of hospitalised EVALI patients reported using THC-containing products. It also stated that vitamin E acetate was strongly linked to the outbreak and warned particularly against THC products obtained from informal sources.4

A case-control analysis detected vitamin E acetate in the lung fluid of 94% of 51 EVALI patients and in none of 99 healthy comparison subjects. Earlier testing had detected it in all 29 samples examined.5

The CDC did not claim that every case was conclusively explained by vitamin E acetate. That qualification matters. But any public narrative that erases the high prevalence of THC use, informal sourcing and vitamin E acetate is equally misleading and cannot justify blaming ordinary commercial nicotine e-liquid.

Patient Statements Cannot Replace Toxicology

Some EVALI patients said they had not used THC products. The CDC later reported that nine of eleven such patients had THC or THC metabolites detected in lung fluid. The CDC also acknowledged recall problems, social-desirability bias and the possibility that patients did not know what their cartridges contained.6

This matters even more in Malaysia. A patient who admits using a THC cartridge or another illegal drug may fear police involvement, prosecution, family consequences or social judgment.

A patient saying “I vaped” proves that a device was used. It does not prove what was inside the device.

That creates a clear evidentiary problem. Some Malaysian patients may disclose vaping while concealing, misremembering or simply not knowing the illegal substance involved. This is an inference, not proof that every patient concealed drug use. It is nevertheless more than enough reason to reject chemical blame based only on an unverified statement.

KKM must publish separate categories for confirmed nicotine cases, confirmed THC cases, confirmed synthetic-drug cases, products containing oils or vitamin E acetate, counterfeit or modified products, unidentified mixtures and cases based mainly on unverified patient reports.

Drug-Laced Cartridges Are Drug Crimes, Not Evidence Against Lawful Nicotine Products

Malaysian authorities have reported seizures of large quantities of suspected drug-laced vape products involving synthetic drugs, THC, mushroom extracts and other psychoactive compounds.7 Police have also identified products marketed under misleading names that allegedly contained synthetic cannabinoids.8

These are drug crimes committed through a delivery device. The correct response is to identify the substance, trace the supply chain, freeze criminal proceeds, prosecute manufacturers and distributors, and close any retailer knowingly involved.

If a criminal mixes drugs into a commercially sold drink, the drink itself is not the cause of the crime. If a criminal places drugs inside a cartridge, the problem is the drug and the criminal supply chain.

KKM must not use crimes committed with vape hardware as a pretext to punish every lawful nicotine product sold through similar hardware. Illegal drug cartridges do not represent adult vapers, commercial nicotine e-liquid or compliant businesses.

The Current Registration Structure Protects Large Balance Sheets More Than Consumers

KKM's framework imposes an official RM5,000 fee for each product type or variant, together with laboratory analysis and supporting documents. KKM's FAQ describes the official fee as one-off while the product's defining characteristics remain unchanged. 9

The problem is cumulative scale. Differences in flavour, smell, size, composition, ingredients, manufacturing process or manufacturing location may create separate variants. Businesses also report laboratory and documentation expenses beyond the official fee.

Safety testing is legitimate. A system that only large corporations can realistically afford is not proportionate safety regulation. It is a market-entry barrier that can eliminate compliant SMEs while leaving illicit demand untouched.

Compliance Must Be Strict, Verifiable and Realistically Achievable

If KKM wants every product tested, it should reduce or subsidise fees for SMEs, group products sharing the same base formulation, cap charges across a flavour range, reduce costs where formulations remain unchanged, conduct random surveillance testing and severely punish false documents.

KKM should recognise equivalent reports from reputable accredited laboratories and require additional local testing only where evidence is incomplete. 10

Compliance that responsible SMEs cannot reach is not effective safety regulation. It is market exclusion, and market exclusion creates space for sellers who do not register, test or recall anything.

Tax Policy Must Not Make Smoking the Easier Choice

Malaysia already taxes e-cigarette liquid or gel by volume. The Excise Duties Order 2025 lists a duty of RM0.40 per millilitre. 23

Taxes and fees must reflect relative risk. If regulation makes cigarettes cheaper, easier to obtain or more commercially viable than regulated non-combustible alternatives, it defeats its own public-health purpose.

Vape excise revenue should not disappear into general revenue while KKM cites vaping-related costs. A defined share should be publicly reported and ring-fenced for independent testing, youth prevention, smoking-cessation services, enforcement against illegal drug cartridges, battery recycling and subsidised SME compliance.

KKM Must Prove That the 15 ml Rule Delivers a Net Safety Benefit

Malaysia's packaging rules limit bottled e-liquid to 15 ml, while cartridges and disposable pods are separately limited under the packaging schedule. 11

Bottle capacity is one risk variable, not the whole safety equation. It does not automatically prove that 15 ml produces the best overall result once handling, repeated openings, extra containers, consumer behaviour and waste are counted.

Dividing 60 ml into four bottles creates four containers, four caps, four seals, four labels and more handling. If each container is a potential access opportunity, the net effect must be measured rather than assumed.

KKM must publish the assessment showing why 15 ml is safer overall than a larger bottle using certified child-resistant closures, tamper-evident seals and strict labelling. Without a published net-safety analysis, the rule looks like an arbitrary packaging mandate that raises cost and waste without proven overall benefit.

Regulate Packaging Performance, Not Bottle Size Alone

Child-resistant packaging should be governed by recognised performance standards, not marketing claims from a particular bottle manufacturer. ISO 8317:2015 specifies performance requirements and test methods for reclosable packages designated as resistant to opening by children. 12

No closure is completely childproof. Adults must close products correctly and store them out of reach. Where serious harm occurs because a caregiver recklessly leaves nicotine accessible to a child, the individual circumstances should be investigated and proven negligence addressed.

The law should regulate packaging performance, secure storage and accountability. Bottle size alone is not a substitute for certified closures, clear warnings and responsible handling.

Protect Children by Targeting the Products That Make Access Easy

Underage vaping is a serious problem. The NHMS 2022 adolescent survey reported that 14.9% of Malaysian adolescents surveyed were current e-cigarette or vape users, with many beginning before age 14. 14

Earlier systems required a reusable device, tank, batteries, coils, cotton, liquid and technical knowledge. Cheap disposable and prefilled products removed those barriers. They are small, immediately usable and easy to hide.

KKM cannot design youth policy around assumptions. It must publish local device-specific data. Until then, price, concealability and immediate usability are the clearest practical risk factors and must be treated as such.

Target Cheap Disposables and Prefilled Products Before Adult Refillable Systems

KKM must publish local data showing which devices minors actually use. International data provides a warning: in the United States in 2024, 55.6% of student e-cigarette users reported most often using disposables, while only 7% most often used tank or mod systems. 15

If child protection is the immediate objective, beginning with complex refillable systems used by long-term adults reverses the policy logic unless Malaysian data proves those systems are the main youth product.

KKM should act first against single-use disposables and cheap prefilled products, set minimum prices and strict nicotine and capacity limits, prohibit toy-like designs, require serialised traceability and impose severe penalties for sales to minors.

Ban Youth-Directed Marketing, Not Adult Choice Without Evidence

KKM should ban cartoons, school-related imagery, toy-like packaging, misleading health claims and flavour names clearly designed to attract minors. That is targeted child protection.

However, non-tobacco flavours are also widely used by adults, including former smokers who vape exclusively. An international adult survey found that non-tobacco flavours were common among regular adult vapers and warned that restrictions could affect people trying to quit or remain abstinent from smoking. The study did not prove that every flavour causes cessation. 22

Before any blanket flavour ban, KKM must publish an impact assessment covering youth use, adult switching, relapse to smoking, illicit supply and the toxicological profile of individual flavouring chemicals. A blanket ban without that assessment would be policy by assumption.

The Online-Sales Ban Removes Traceability Instead of Creating Control

KKM's enforcement guidance prohibits online sales of vape products and electronic liquid. 9

A regulated online transaction creates an audit trail: verified identity, date of birth, address, payment record, invoice, product history, courier tracking and proof of delivery. An illegal seller in a private group may record none of it.

The problem is not e-commerce. The problem is unverified e-commerce. KKM should regulate identity, checkout and delivery instead of driving transactions into channels it cannot see.

Replace the Online Ban With Mandatory Digital KYC and Adult Delivery

KKM should replace the online ban with mandatory identity verification and verified adult delivery for every licensed online retailer.

1. Require a valid MyKad, passport or other approved government identification.
2. Extract only the information necessary for verification, including name, identification number and date of birth.
3. Conduct a live face scan with liveness detection.
4. Match the live face against the identification photograph.
5. Reject underage applicants and require identity verification before checkout can be completed.
6. Retain encrypted audit records securely and in compliance with Malaysian data-protection law.
7. Require re-verification when suspicious activity is detected.
8. Require verified adult receipt, identification checks and proof of delivery.
9. Prohibit unattended delivery.

KKM should conduct controlled test purchases. Any retailer that bypasses KYC or knowingly sells to a minor should face immediate suspension, major fines and prosecution.

KKM should regulate the checkout, identity and delivery chain, not surrender adult demand to invite-only groups and anonymous sellers. A licensed website is easier to identify, audit, suspend and investigate than a private seller operating in hidden channels. 13

Prohibition Does Not Remove Demand. It Hands Demand to the Black Market

Prohibition does not eliminate demand. It changes who supplies it.

When lawful products become unaffordable, unavailable, impossible to register or prohibited through traceable channels, some users return to cigarettes while others move to private groups, counterfeit products, illegal sellers or unidentified liquids. A policy that assumes compliance and ignores substitution is not a serious market-impact assessment. 13

A legal market can be tested, licensed, audited, recalled and punished. The black market cannot be recalled, and its sellers have no incentive to follow nicotine limits, age restrictions or product standards.

Do Not Criminalise Adults for Choosing a Non-Combustible Nicotine Product

As of 1 August 2026, KKM had publicly discussed phased restrictions covering the sale and use of open-system vape products. 16

Adults should not be criminalised merely for possessing or using a regulated non-combustible nicotine product. Criminal enforcement should focus on illegal supply, sales to minors, adulterated products, drug syndicates, false documentation and non-compliant commercial sellers.

If KKM proceeds with product restrictions, it must provide reasonable transition periods, clear notice and genuine cessation support. It must not create criminals overnight out of adults whose conduct was previously lawful.

Closing Shops Is Not a Public-Health Outcome

Closing shops is not a health outcome. Reducing legal sales is not automatically harm reduction.

KKM should publish regular measurements of adult cigarette-smoking prevalence, complete switching, complete nicotine abstinence, concurrent smoking and vaping, relapse to cigarettes, youth use by device category, illegal-product seizures, hospital toxicology findings and market displacement.

KKM must publish a before-and-after regulatory impact assessment covering smoking relapse, youth access, illicit trade, enforcement cost, consumer prices, SME closures, packaging waste and electronic waste, followed by public reviews after 12 and 24 months.

Safety Requires Privacy, Product Standards, Recalls, Valid Evidence and Waste Controls

KYC data protection

• Collect only data necessary for age and identity verification.
• Encrypt identity and biometric data, prohibit marketing reuse and set strict retention and deletion periods.
• Restrict access, audit vendors and require data-breach notification under Malaysian requirements. 18

Product standards and recalls

• Require accurate nicotine labelling and a permitted tolerance from the stated concentration.
• Set prohibited-ingredient and contaminant limits, including appropriate testing for heavy metals, carbonyls, microbial quality and adulterants.
• Require leak resistance, child-resistant closures, tamper evidence, battery and charging protections, manufacturing quality systems and batch records.
• Maintain a public registration database, adverse-event reporting, rapid recall powers and consumer complaint channels.

Hospital and enforcement evidence

• Recover and seal products where possible, preserve chain-of-custody records and use accredited laboratories.
• Test for nicotine, THC, synthetic cannabinoids, oils and other adulterants.
• Publish anonymised aggregate findings and preserve samples for independent retesting where appropriate.

Batteries, electronic waste and fire risk

• Treat disposable vapes as electrical waste, require retailer take-back and establish safe collection and recycling.
• Publish fire and disposal guidance for lithium batteries. 19

A Ban Must Not Be Announced First and Justified Later

A ban must not be announced first and justified later. Before introducing major restrictions, KKM must publish the consultation paper, regulatory-impact assessment and evidence matrix explaining why each measure was selected.

• Publish meeting dates, stakeholder categories, declared conflicts of interest and written submissions.
• Include public-health specialists, toxicologists, cessation clinicians, paediatric experts, adult former smokers, consumer representatives, enforcement agencies, privacy specialists, environmental experts, SMEs and lawful industry operators.
• Publish reasons for accepting or rejecting major proposals.
• Provide clear technical standards, recognised laboratories, application service standards and an appeal process.
• Allow a reasonable transition period, address existing compliant stock and avoid retrospective punishment.
• Review the policy publicly after 12 and 24 months against predefined health and enforcement outcomes.

Industry must not control the process. But excluding former smokers, consumers, SMEs and people with operational knowledge also produces rules that are expensive, impractical and easier for illegal sellers to evade.

What Evidence-Based Regulation Should Actually Look Like

Blanket Prohibition Is Not a Substitute for Regulation

This letter is not asking KKM to step back from public health. It is demanding that KKM stop using blanket prohibition as a substitute for precise, accountable regulation.

Publish the evidence. Separate nicotine from THC, synthetic drugs and unidentified mixtures. Treat drug syndicates as drug syndicates. Protect children by targeting the products, prices, marketing and sellers that make access easy.

Give adult smokers accurate relative-risk information and a clinical route towards complete cessation of cigarettes. Keep lawful activity inside traceable channels. Make safety standards demanding but achievable. Measure whether policy reduces smoking and harm, not merely whether it reduces legal sales.

KKM's current direction should be reversed before it removes traceable channels, criminalises adult users and expands the market for sellers who ignore every rule. Regulate the real risk. Prosecute the real offender. Do not punish lawful adults for crimes they did not commit.