FDA Approves more Heated TobaccoProducts and Rejects more E-cigarettes

The US Food and Drug Administration (FDA) has approved three heated tobacco(HNB herbal heatsticks) products made by Philip Morris International (PMI), foreign media reported. The agency issued a marketing Authorization Order (MGO) for three tobacco-flavored heating sticks – Marlboro West Coconut, Marlboro Bronze and Marlboro Amber – all of which can be used with PMI’s IQOS devices.


In 2019, the FDA authorized IQOS and some other Marlboro heating sticks through its Premarket Tobacco Products Application Process (PMTA), in which PMI had to show that the products were suitable to protect public health – in short, that they were more likely to help adults who smoke switch to safer alternatives(HNB tabak manufacturer) than expose a new generation to nicotine. The agency also granted the company the ability to make some revised risk statements in 2020.


Heated Tobacco products (HTPS) heat tobacco sticks(Heated Tabac supplier) without burning them to produce inhaled vapor.


HTP has become popular in other parts of the world and shows compelling potential as a harm reduction option.


Most notably, cigarette sales in Japan have fallen by nearly 43 percent over the past decade, following the launch and popularity of the HTP. This is despite the fact that the Japanese government is largely hostile to tobacco harm reduction (THR); Nicotine e-cigarettes, for example, are actually illegal. Critics of mainstream tobacco control – who generally support prohibition-focused measures – point to Japan as a potential, if limited, model. South Korea has followed suit, and while Taiwan has just banned vaping, it has left HTPs alone.


Although the additional IQOSMGO will add to the small supply of safer nicotine substitutes authorized by the U.S. FDA, they are also a reminder that the PMTA process favors well-funded manufacturers, mainly with ties to the tobacco industry.


Despite this, none of the flavored vape products produced by anyone received MGO. The IQOS announcement comes just days after the FDA rejected two menthol e-cigarettes from RJReynolds’ steam company Vuse. That left THR advocates and industry observers wondering whether the agency would authorize a flavored nicotine replacement product.

Currently, IQOS is not available in the US: Altria began selling the device on a limited basis in 2019, but a patent dispute with RJReynolds halted any sustained rollout. Then, last October, PMI spent $2.7 billion to wrest back the rights to commercialize IQOS in the United States from Altria and announced plans to start manufacturing the product in the country.


The launch is now set for mid-2024 as tobacco giants continue to focus on the market for safer nicotine replacements, particularly in the United States. PMI also took a step closer to sole ownership in November by taking over a majority stake in SwedishMatch, makers of the popular oral nicotine pouch Zyn, for $16 billion.


Meanwhile, small and medium-sized vapor manufacturers – most of which have been rejected for PMtas – continue to fight any hope of MGO in court.