FDA Vape Deadline Passes, Many Products Now Subject to Enforcement Action

A court-ordered deadline for “premarket” review of vaping products that contain nicotine passed this month without the Food and Drug Administration (FDA) approving any of the millions of applications it has received. As a result, the agency has announced that every vaping product sold in the US is subject to enforcement action at the discretion of the agency.

The deadline was set in response to an anti-vaping lawsuit. Since that time one year ago, the FDA had received over 6.5 million applications for “new tobacco products” from over 500 manufacturers. Most of the applications are for vaping devices or liquids.

The FDA has claimed that it has acted on “about 93% of the total timely-submitted applications,” because ¾ of those applications were from just one manufacturer and the response was for the FDA to say they were incomplete, that number is misleading. Furthermore, later that month, the FDA issued 55,000 “marketing denial orders” (MDOs) rejecting “flavored” vaping products due to perceived or actual youth use of related products.

Tobacco harm reduction advocates argue that this rationale suggests bias against flavored e-liquids which are enormously popular among people trying to quit smoking. It also suggests that to meet the FDA’s requirements, even small businesses would have to invest in expensive scientific research to disprove that same bias.

In total, the FDA has issued 132 MDOs for over 946,000 flavored vaping products. However, it has still not acted on applications from big companies like Juul.

Many people argue that the FDA should ban all flavored vaping products because they appeal to youth. However, this overlooks the fact that they appear to appeal to everyone, as former smokers prefer them by a large margin, and banning them might ironically cause more smoking.

According to the Tobacco Control Act, however, a manufacturer must show more than that its products being safer than combustible cigarettes. They must prove a public health benefit to the FDA and demonstrate that the benefit outweighs any potential harm—including any caused by youth vaping flavors.

In truth, this is simple, because compared to smoking cigarettes, the health hazards of nicotine itself are minimal, and most youth who vape frequently are former or current smokers themselves. Much like with other over-hyped “problems,” there is little evidence suggesting, let alone proving, that flavored vapes are a “gateway” to smoking for youth.

Nevertheless, this newly shifted burden placed on companies by the FDA’s inaction should eliminate all but the largest companies with the most resources. Hopefully, this will not lead to black market products—especially since this was the real cause of the vaping scare in 2019.

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