Kuala Lumpur, 28 May 2025 — In a regulatory filing to the US’ Securities and Exchange Commission on 22 May, Ispire Technology Inc, a Nasdaq-listed e-cigarette and cannabis vape company based in the United States, announced that it was on-route to becoming the recipient of the first federal nicotine manufacturing license in Malaysia. This would enable Ispire Malaysia Sdn Bhd based in Johor, to have full authorization for export, import, and production of nicotine products.

“This is a whiplash moment,” stated Azrul Mohd Khalib, Chief Executive of the Galen Centre for Health and Social Policy. “Just last week, Health Minister Datuk Seri Dr. Dzulkefly Ahmad, Dr. Noraryana Binti Hassan, Deputy Director of the Disease Control Division at the Ministry of Health, and Dr. Murallitharan Munisamy, Chairman of the Malaysian Council for Tobacco Control, received the World Health Organization’s (WHO) highest award in recognition of their contributions to tobacco control efforts at the 78th World Health Assembly in Geneva, Switzerland. Now we suddenly have this news. Replacing cigarette manufacturing facilities and tobacco plantations with nicotine vape and vaping hardware factories was not likely what WHO had in mind.”

“This is a worrying development and there are a number of questions which require serious answers. The Malaysian Investment Development Authority (MIDA) requires applicants to obtain a ‘No Objection Letter (NOL)’ from the host state government, in this case Johor, prior to an interim letter of manufacturing licence being issued. Did the Johor State Government unknowingly approve the establishment of a major manufacturing facility run by a US-based company which not only produces vaporisers, cartridges, pod systems, disposables, and batteries for vaping nicotine, but which are also used for cannabis vaping?” Azrul asked.

“Who and when was the nicotine vape manufacturing license allegedly approved at the federal level?”

By the end of this year, according to the company’s March 2025 report to investors, the total capacity of the Senai facility will reportedly reach 61 million devices or 107 million pods per month, with up to 70 production lines. “This is a major manufacturing facility for e-cigarettes and vaping products.”

“Even if only the vapor hardware such as vaporisers used for cannabis vaping are being manufactured at the Senai facility, the Johor and Federal governments must ask themselves a fundamental question: Are they comfortable with Malaysia being known as one of the world’s leading manufacturers and exporters for e-cigarettes and vaping hardware for nicotine and cannabis?” Azrul asked.

“This action runs contrary to the Johor state government’s own actions in 2016 which were way ahead of its time, banning retail business licences for vape and e-cigarettes, almost a decade before the current demand for states to do so.”

“Another issue which needs clarity is the company describing itself in Malaysia as a manufacturer of electronic medical devices. This is a highly regulated space for which this country maintains among the highest regulatory quality standards in the Asia region. The Medical Device Authority (MDA), a federal statutory agency under the Ministry of Health, has never declared vape products, nicotine or otherwise, as medical devices. This claim will certainly cause confusion and undermine Malaysia’s regulatory policies in this area.

“Most countries around the world are moving towards curtailing and reducing the prevalence of smoking, vaping, and nicotine addiction among its population,” emphasised Azrul.

“The WHO award was given in recognition of tireless efforts to protect future generations from the threat of nicotine addiction and tobacco-related diseases. With developments such as this, Malaysia could be at risk of being perceived as going against that commitment and unravelling decades of progress and sacrifice.”

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References:

1. Ispire Technology Inc. Announces Approval of Interim License for Manufacturing of Nicotine Products in Malaysia, 22 May 2025. https://www.sec.gov/Archives/edgar/data/1948455/000121390025047377/ea024338901ex99-1_ispire.htm

2. Ispire Technology Inc. Announces Opening of New ISO- and GMP-Certified Malaysia Manufacturing Facility, 5 February 2024. https://ispiretechnology.com/pages/ispire-technology-inc-announces-opening-of-new-iso-and-gmp-certified-malaysia-manufacturing-facility

3. Investor Presentation – March 2025. https://cdn.shopify.com/s/files/1/0678/8058/3490/files/ISPIRE-Investor-Presentation-03132025.pdf?v=1743725369

4. Ispire Technology Inc. Earns ISO Certifications for its Malaysia Manufacturing Facility, 4 January 2024. https://ispiretechnology.com/pages/ispire-technology-inc-earns-iso-certifications-for-its-malaysia-manufacturing-facility