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Reason
Reason
Jacob Sullum

The FDA's Rejection of a Major Vaping Brand Shows It Is Arbitrarily Applying a Nebulous Legal Standard

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. 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 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 FDA seems determined to ban nearly every vaping product currently available in the United States. 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. Although the FDA was supposed to act on those applications by last September, it missed that court-ordered deadline. 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.

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