On October 29, 2021, the U.K agency, Medicines and Healthcare Products Regulatory Agency (MHRA) announced that NHS could soon prescribe e-cigarettes to help tobacco smokers quit, inviting e-cigarette manufacturers to submit products to undergo the same approval process as prescribed medicines. It could make England the first country to prescribe medicinally licensed e-cigarettes. Under such a circumstance, “A medically licensed e-cigarette would have to pass even more rigorous safety checks than those required for them to be sold commercially”, according to BBC.

 

On the same day, the Malaysian government announced to impose excise duty on nicotine vapor products. The managing director of British America Tobacco (BAT) Malaysia, Nedal Salem, said this indicates the Malaysian government is looking to legalize nicotine vapor products: “Regulation will not only allow vape users access to reduced-risk alternatives to smoking, but also ensure the products used are compliant to quality and safety standards.”

 

Meanwhile, in October, the U.S Food and Drug Administration (FDA) has granted marketing orders for Vuse Solo and accompanying tobacco flavored e-liquid pods, making it the first set of e-cigarette authorized for sale by the FDA.

 

From the UK to Malaysia and the U.S, E-cigarette is accepted by more and more health regulators around the world as an effective harm-reduction tool to improve public health.

 

As BAT Malaysia states, regulation could positively accelerate healthy development of the vaping industry for setting higher quality requirements and safety standards for products. Moreover, regulation measures, such as the marketing authorization and prescription evaluation, could be deemed the regulators’ acknowledgement of the products’ public health benefits.

 

Besides, On October 27, Mitch Zeller, director of the agency’s Center for Tobacco Products, said that the FDA’s reviews of tobacco products sold in the U.S “are in final stages”. However, the agency so far has only authorized three products for their substantial evidence of harm reduction while issuing marketing denial orders for 200 thousand products.

 

Vuse is currently in a lead position to pass the Premarket Tobacco Product Applications (PMTA) process. It showcases that the FDA (and perhaps other regulators) is more likely to trust and approve products made by market leaders for assured public health benefits and reliability proved by sufficient scientific data.

 

The FDA’s rigorous requirements for products are also applied to manufacturers. SMOORE, the world’s largest vaping manufacturer, is the strategic supplier of VUSE. It features PMTA-related non-clinical evaluation capabilities, including physical testing, chemical testing and health risk assessment. Moreover, SMOORE’s CNAS tests have also expanded to 134.

 

As the regulatory framework outlines a higher entry barrier for the industry, the global vaping industry will witness a more standardized and concentrated market where industry leaders, such as BAT and SMOORE, will further strengthen their leading positions. Meanwhile, the whole industry and the supply chain will benefit from such a well-regulated and standardized market in turn.