If you make, import or sell nicotine pouches in Pakistan, one document sits behind most of the regulatory discussion: PS 5468-2020, the Pakistan Standard for tobacco-free oral nicotine products. It is the PS 5468 nicotine pouch standard that buyers, regulators and retailers increasingly ask about, and it is the benchmark any future compulsory certification would rely on. This guide explains what the standard covers, what it asks of a product, where its legal status stands, and how a business can prepare.
Quick answer: PS 5468-2020 is the Pakistan Standards and Quality Control Authority (PSQCA) standard titled “Nicotine Containing Tobacco Free Oral Product”. It covers pouches and similar products placed in the mouth, and sets requirements for ingredients, nicotine content, labelling and product information. Public reports describe a nicotine limit of up to 20 mg per pouch. As of the latest reports we could verify, the standard had been approved but was still voluntary, while the government considered making it compulsory through a statutory order. Check the current status with PSQCA before relying on either position.
What is PS 5468-2020?
PS 5468-2020 is a national standard published by PSQCA. Its title, “Nicotine Containing Tobacco Free Oral Product”, describes exactly what it covers: products that contain nicotine, contain no tobacco leaf, and are designed to be used orally, with nicotine absorbed through the lining of the mouth. The white pouches placed under the upper lip are the typical example.
Like other Pakistan Standards, PS 5468 is a technical document. It describes what a compliant product should look like and how it should be labelled. On its own, a standard does not create a legal obligation. It becomes compulsory only when the government adds the product to PSQCA’s compulsory certification list through a statutory regulatory order (SRO). That distinction matters for nicotine pouches, as explained below.
Which products are in scope?
| Product | Covered by PS 5468? |
|---|---|
| Tobacco-free nicotine pouches placed in the mouth | Yes, this is the core scope |
| Other tobacco-free oral nicotine products used the same way | Generally yes, if nicotine is absorbed orally |
| Nicotine products licensed as medicines or medical devices | No, these follow drug or device rules |
| Oral tobacco products such as naswar or snus containing tobacco | No, they are not tobacco-free |
If your product is marketed as a cessation aid or makes therapeutic claims, it may fall under the Drug Regulatory Authority of Pakistan instead. Our guide to DRAP medical device registration explains how that regime works.
What does PS 5468 require?
PSQCA’s public summary says the standard gives guidance on ingredient requirements and nicotine limits, and covers product information, labelling and certification. Reporting on the standard adds detail: ingredient disclosure, a nicotine limit of up to 20 mg per pouch, labelling guidelines and child safety warnings.
Ingredient requirements
Manufacturers are expected to know and disclose what goes into each pouch, typically plant-based fibres, fillers, flavourings, sweeteners, pH adjusters and the nicotine source. In practice this means a full bill of materials, supplier specifications and certificates of analysis for each ingredient.
Nicotine content per pouch
The reported limit of 20 mg of nicotine per pouch is the figure most businesses ask about. Your declared strength, your production tolerance and your laboratory results all need to sit comfortably inside it. A product that tests close to the limit leaves no margin for batch variation, so we recommend checking several production batches rather than one sample.
Labelling and product information
Labels are where most compliance gaps appear. Expect to show the nicotine content, the ingredients, manufacturer or importer details, batch and date information, and required warnings, including child safety messaging. Because the exact wording and layout rules sit in the standard itself, buy the current copy from PSQCA and check your artwork against it before printing.
Testing and certification
Conformity is shown through testing at a recognised laboratory and, if PSQCA certification is sought, a factory and quality system assessment. If your lab partner is accredited by the Pakistan National Accreditation Council, results carry more weight. Our guide to ISO 17025 lab accreditation in Pakistan explains why accreditation matters.
Is PS 5468 mandatory in Pakistan?
This is the question we hear most often, and the honest answer is that it depends on the date you are asking. Here is the timeline that has been publicly reported.
| Date | Development |
|---|---|
| 2020 | PS 5468 drafted and approved as a Pakistan Standard |
| October 2024 | Industry requested that the standard be made mandatory |
| June 2025 | The National Standards Committee recommended mandatory status |
| August 2025 | A stakeholder meeting did not reach consensus after objections from the health ministry, and the matter moved towards cabinet-level approval |
As of those reports, PS 5468 remained voluntary, with the Ministry of Science and Technology working on an SRO that would bring nicotine pouches under PSQCA’s compulsory certification marks scheme. Separately, the federal health ministry has told the National Assembly that nicotine pouches are non-tobacco products outside its regulatory mandate, and an April 2026 regulatory overview described them as consumer products that fall outside Pakistan’s smoking ordinance.
Rules in this area are moving. Before you launch a product or sign a supply contract, confirm whether an SRO has been issued and from what date it applies. CEC tracks these notifications for clients as part of our nicotine pouches certification service.
Why comply voluntarily now?
Even while the standard is voluntary, aligning with it has practical benefits:
- Faster transition. If certification becomes compulsory, products already tested and labelled to PS 5468 can move quickly instead of being withdrawn for relabelling.
- Buyer and retailer confidence. Distributors and large retailers increasingly ask for test reports before listing a product.
- Export readiness. Several markets now regulate nicotine pouches, and a documented specification makes foreign approvals easier.
- Fewer surprises at port. Importers with a clear specification and test file are better placed if customs or PSQCA ask for evidence.
How to prepare your product for PS 5468
- Buy the current copy of PS 5468 from PSQCA and confirm the latest amendment.
- Compare your formulation, nicotine strength and packaging against each clause.
- Collect ingredient specifications and certificates of analysis from every supplier.
- Test several production batches for nicotine content and other parameters at a recognised laboratory.
- Revise label artwork, warnings and product information before the next print run.
- Put a documented quality system in place, often aligned with ISO 9001, so batch records support your results.
- Monitor PSQCA notifications for any SRO that makes certification compulsory.
Each step is easier with the right company and tax registrations already in place. Our pages on SECP corporate services and ISO certification cover those foundations, and our PSQCA product certification page explains how PSQCA licensing works across product categories.
Frequently asked questions
What is PS 5468?
PS 5468-2020 is the Pakistan Standard for nicotine containing, tobacco-free oral products, published by PSQCA. It covers products such as nicotine pouches and sets requirements for ingredients, nicotine content, labelling and product information.
What is the nicotine limit per pouch under PS 5468?
Public reporting on the standard describes a limit of up to 20 mg of nicotine per pouch. Confirm the exact requirement and test method in the current copy of the standard before setting product strengths.
Is PS 5468 mandatory in Pakistan?
As of the latest reports we could verify, PS 5468 had been approved but remained voluntary, while the government considered an SRO to make certification compulsory. Check with PSQCA for the current position before launch.
Does PS 5468 apply to naswar or snus?
No. PS 5468 covers tobacco-free products. Oral products that contain tobacco are outside its scope.
Do nicotine pouch labels in Pakistan need warnings?
Reporting on PS 5468 says it includes labelling guidelines and child safety warnings. The exact wording and placement should be checked against the current standard.
How CEC can help
Connect Engineers & Consultants helps manufacturers, importers and private label brands assess products against PS 5468, coordinate laboratory testing, review labels and prepare for PSQCA certification. See our nicotine pouches certification in Pakistan service for the full scope.
Planning a nicotine pouch launch or import? Talk to our compliance team before you print packaging or ship stock.
This article is general regulatory information, not legal advice, and it is not a recommendation to use nicotine products. Nicotine is addictive. Regulatory requirements for nicotine products in Pakistan may change, so confirm current rules with PSQCA and the relevant authorities before acting.
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