Fontem claims the device is not compatible with third-party pods, saying 'use of blu rechargeable devices with other brands may cause malfunctions and will void your warranty.' But although the manufacturer does not approve, it is pretty easy to open a myblu pod and refill it with an e-liquid of your choice. Perhaps the FDA was concerned that myblu could be used with e-liquids made by other companies that offer a wider variety of flavors.

How can it be that allowing the marketing of Vuse Solo, Logic Power, and Logic Pro is 'appropriate for the protection of the public health,' while allowing the marketing of myblu is not? Yet both of those things ostensibly are true of the myblu products that the FDA rejected. The Vuse and Logic products are 'closed system' devices, meaning they cannot be refilled with e-liquids made by other companies, while the cartridges and capsules that the FDA deemed acceptable contain nicotine solutions that taste like tobacco. The approval of Vuse Solo, Logic Power, and Logic Pro was consistent with the FDA's bias against e-liquids in flavors other than tobacco, which it worries are too enticing for teenagers, although they are also highly popular among adults. Myblu's share of the underage market seems to be tiny. The second-most popular was Vuse (10.5 percent), followed by SMOK (8.6 percent), Juul (6.8 percent), and Suorin (2.1 percent). The most popular brand by far, mentioned by about 27 percent of respondents, was Puff Bar, which makes disposable e-cigarettes. According to the most recent National Youth Tobacco Survey, disposable e-cigarettes are more popular among teenagers than vaping devices with prefilled or refillable pods, which in turn are more popular than mods or tank systems. The latter concern is puzzling on its face. The FDA says the applications for Fontem's products were rejected partly because the company failed to present 'sufficient evidence regarding design features, manufacturing, and stability.' But the FDA also says 'the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth.' Myblu is made by Fontem US, a division of Imperial Tobacco. The FDA also approved tobacco-flavored cartridges/capsules for those devices while rejecting applications for other flavors. Out of all those products, the FDA has granted marketing orders for just two device brands: Vuse Solo, which was approved last October, and Logic, which was approved in March.

The agency now claims to have 'completed the review of and made determinations on more than 99 percent' of the products whose manufacturers sought approval. Although the FDA was supposed to act on those applications by last September, it missed that court-ordered deadline. As of September 9, 2020, the deadline for seeking 'premarket' approval, it had received some 6 million applications-one for every permutation of devices and e-liquids that manufacturers sought to introduce or keep on the market. The FDA seems determined to ban nearly every vaping product currently available in the United States. The FDA concluded that allowing the sale of the myblu products would not be 'appropriate for the protection of the public health,' which illustrates how nebulous that standard is and how arbitrarily the FDA applies it.

The decision, which the FDA announced last Friday, affects one of the leading e-cigarette brands and does not bode well for smokers who have switched to vaping or might be interested in doing so.

The Food and Drug Administration (FDA) recently issued 'marketing denial orders' (MDOs) for the myblu vaping device and several of its tobacco-flavored proprietary pods.

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