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What are the legal implications of using 150000 Puffs products in different countries?

As a supplier specializing in high-puff vaping products with a 150,000-puff design, I get asked one question more than any other by potential partners, regulators, and even customers: “What are the legal hoops we have to jump through to sell these across borders?” For context, our 150,000-puff devices aren’t the same as the 500-puff disposable vapes most people are used to—they’re rechargeable, long-lasting, and packed with e-liquid, built for heavy users or vapers who prefer fewer device changes. But that extended lifespan changes everything when it comes to global tobacco and vaping regulations. Over the past five years, I’ve spent countless hours navigating paperwork, meeting with local regulators, and learning that a product that’s perfectly legal in one country can be banned in the next. Let’s break down the legal implications of these devices in key markets, the gaps that trip even experienced suppliers up, and what that means for anyone looking to work with a vendor like ours. 150000 Puffs

First, it’s critical to understand that 150,000-puff products fall into a regulatory gray area for many governments, because most existing vaping rules were written for smaller, disposable devices. For example, when the EU updated its Tobacco Products Directive (TPD 2) in 2021, it set a maximum e-liquid capacity for open-system vaping devices at 2ml per refill and a maximum puff count of 10,000 puffs for disposables. Our 150,000-puff devices are way over both thresholds—so in theory, they’re not allowed in any EU member state. But that’s not the full story: member states can apply for temporary exemptions for “innovative” products that meet strict safety standards, and a few have done so. Last year, we worked with a partner in Lithuania to get an exemption for our 150,000-puff model after we submitted third-party test data showing our e-liquid is free of harmful additives like diacetyl, and the battery has overcharge and temperature controls that meet EU safety norms. The process took 12 months, required updating our manufacturing traceability system to meet EU’s track-and-trace rules, and cost nearly $80,000 in testing and legal fees. But the exemption is valid for three years, and it lets our partner sell the devices to adult vapers 18 and older. What’s frustrating is that not all EU member states have adopted this exemption—Germany, for example, still enforces the 10,000-puff limit for disposables, so our products can’t be sold there legally without applying for a separate national exemption, which is a whole new, lengthy process.

Moving to North America, the rules are even more fragmented. In the United States, the Food and Drug Administration (FDA) regulates all vaping products under its Center for Tobacco Products (CTP). Back in 2020, the FDA issued a flavored vaping product ban that excluded only tobacco and menthol flavors, but then it relaxed rules for “substantial equivalence” (SE) applications for new products. For our 150,000-puff devices, SE approval is non-negotiable—selling them without it is a federal offense that can result in fines of up to $10,000 per violation, and even criminal charges if regulators prove you marketed to minors. We submitted our SE application in 2022, along with over 5,000 pages of data on nicotine content variability, heavy metal leaching from the device’s components, and user safety (like warnings about not overcharging the battery). The FDA’s review process took 18 months longer than we expected, and we had to revise our device’s design twice to meet new FDA requirements for child-resistant packaging that’s compatible with adults’ use. In Canada, the rules are stricter: Health Canada has banned all vaping devices with more than 10ml of e-liquid, and our 150,000-puff devices hold 80ml. That means they’re effectively banned in Canada right now, with no path to an exemption for large-capacity devices as of 2024. A lot of suppliers have tried to sneak these devices into Canada as “nicotine pouches” or other untaxed products, but Health Canada’s border agents now scan all vaping shipments with specialized equipment that can identify e-liquid and device puff counts, so that’s a risky practice we never recommend.

Asia is another market where the rules change drastically from one country to the next, and it’s where we’ve seen the most confusion for new partners. In the United Arab Emirates (UAE), the Ministry of Health and Prevention (MOHAP) has specific regulations for vaping products with over 10,000 puffs: they’re classified as “medical devices” if they contain nicotine, so we had to register our product with the UAE’s Medical Device Licensing Department (MDLD) and provide proof of nicotine purity. The approval process took six months, and we had to add Arabic-language warning labels that are twice as large as EU labels. In China, the home of most vaping manufacturing, the National Medical Products Administration (NMPA) regulates vaping products starting in 2022, and 150,000-puff devices are allowed only if they meet strict safety and labeling standards—China actually has a larger market for long-puff devices than many Western countries, because vapers there prefer devices that don’t need frequent refills. But in Singapore, vaping is almost entirely banned for recreational use, with only a tiny number of medical exemptions for patients who can’t use nicotine replacement therapy. Our 150,000-puff devices would never be allowed for sale in Singapore, even if we applied for a medical license, because the government’s policy is to discourage vaping entirely. We learned that the hard way in 2021, when a partner tried to ship a small batch of our devices to Singapore as “personal use”—Singapore’s customs seized the shipment, fined the partner $5,000, and banned them from importing any vaping products for five years. That’s a mistake we never let new partners make now.

One of the biggest legal risks we see for 150,000-puff suppliers is the lack of uniform global standards, which means that even if a product is legal in three countries, it could be banned in a fourth for a rule that doesn’t make sense on paper. For example, Australia’s Therapeutic Goods Administration (TGA) classifies all nicotine-containing vaping products as prescription-only medical devices, so our 150,000-puff nicotine devices can only be sold to patients with a doctor’s prescription, and only through licensed pharmacies. Non-nicotine versions of the same device are unregulated in Australia, though, as long as they meet safety standards. That means a partner can import our non-nicotine 150,000-puff devices for sale to adults, but not the nicotine version. In contrast, New Zealand recently proposed a “smokefree generation” law that would ban the sale of all nicotine vaping products to anyone born after 2008, so even if we got approval there, we could only sell to a tiny cohort of vapers. Another gap is tax laws: many countries have specific excise taxes for vaping products with over a certain number of puffs, and some classify them as tobacco products rather than consumer electronics, which means they’re taxed at much higher rates. In the UK, for example, vaping products are taxed at 5% of their retail price, but devices with over 50,000 puffs are taxed at 20% because they’re considered “long-term smoking substitutes.” That’s a cost that has to be factored into pricing, or you’ll end up selling at a loss.

I know a lot of suppliers try to cut corners here—sending products to countries without approval, mislabeling devices to avoid tax, or lying about puff counts to get through customs. But as someone who’s built a business on compliance rather than cutting corners, I can tell you that the risks aren’t worth it. We’ve had two shipments seized over the years, but both were because of paperwork errors, not intentional non-compliance, and we fixed the issues and got the shipments released. The suppliers who cut corners end up with their products banned, fines, or even being blacklisted from importing into certain countries. Just last year, a competitor of ours in China was fined $2 million for selling 150,000-puff devices in the EU without the required exemption, and they were banned from all EU markets for three years. That’s a death sentence for a supplier whose main market is Europe.

So, what does this mean for you, if you’re looking to work with a 150,000-puff product supplier? First, don’t assume that a product legal in one market is legal in another. Second, always ask for proof of regulatory approval for the specific countries you’re targeting, not just general compliance certificates. Third, work with a supplier that has a dedicated legal and compliance team that knows the rules of each market, not just a sales team that only cares about closing deals. At our company, we have a full-time team of three lawyers who specialize in vaping regulations across 12 key markets, and we update our compliance playbook every six months when new rules are announced. We also offer pre-approval support for partners who want to sell in new markets, helping them navigate the application process, update their labeling and packaging, and make sure their supply chain meets local rules.

If you’re a retailer, distributor, or brand owner looking to add 150,000-puff products to your lineup, the last thing you want is to get hit with a huge fine or have your entire inventory seized because you didn’t do your homework. We’ve spent years building our regulatory framework to make this process easier for our partners, and we’re always happy to walk through the specific rules for your target markets, share our compliance documents, and answer any questions you have. Whether you’re looking to sell in the EU, North America, Asia, or beyond, we can provide customized solutions that meet all local legal requirements, while also delivering a high-quality, reliable product your customers will love. Don’t risk cutting corners on compliance—reach out today to discuss your needs, and let’s make sure your next product line is both profitable and legal.

Razz Bar References:

  1. European Commission. (2021). Tobacco Products Directive (TPD 2): Amendments for Innovative Vaping Products. Brussels: Directorate-General for Health and Food Safety.
  2. U.S. Food and Drug Administration. (2023). Substantial Equivalence (SE) Application Guidelines for New Tobacco Product Variations. Silver Spring, MD: Center for Tobacco Products.
  3. Health Canada. (2024). Vaping Products Regulations: Large-Capacity Device Restrictions. Ottawa: Health Canada.
  4. Ministry of Health and Prevention (UAE). (2023). Medical Device Registration Guidelines for Nicotine-Containing Vaping Products. Abu Dhabi: MOHAP.
  5. Australian Department of Health and Aged Care. (2022). TGA Classification of Vaping Products: Prescription vs Over-the-Counter. Canberra: Therapeutic Goods Administration.

Hongkong Voles Technology Co., Ltd.
As one of the most professional 150000 puffs enterprises in China, we have world-leading production equipment and strong manufacturing capabilities. Please feel free to wholesale bulk high quality 150000 puffs in stock here from our factory. Contact us for more details.
Address: Room 302, Tower A, Liangao Business Building, Bao’an District, Shenzhen City
E-mail: sales02@volestech.com
WebSite: https://www.joylifevape.com/