A vape manufacturer cannot challenge a Maryland federal judge’s ruling that tightened a deadline for vape companies to submit premarket applications to the U.S. Food and Drug Administration (FDA), the Sixth Circuit Court of Appeals found.

Vapor Stockroom, a major retailer of vape pens, e-liquids, and other vape merchandise sued the FDA last year after U.S. District Judge Paul W. Grimm imposed a 10-month deadline for vape companies to submit their premarket tobacco applications.

The FDA classified e-cigarettes as tobacco products in 2016 and imposed new regulations over the largely unregulated vape industry in 2018 in response to the youth vaping epidemic. One of the regulations required vape makers and importers to submit applications for premarket review to the FDA before marketing new tobacco products.

The FDA initially gave vape companies a two-year deadline of Aug. 8, 2018, to submit the applications before legally selling new vape products. In August 2017, the FDA responded to industry pressure and extended the deadline to August 2022 for most vape products.

Last year, however, a number of public health groups took efforts to tighten the FDA deadline — a push fueled by the outbreak of vaping-related lung injuries that sickened thousands of people and killed nearly 70 people in 2018-2019. The efforts led to a ruling in July of last year by U.S. District Judge Paul W. Grimm of the U.S. District Court for the District of Maryland imposing a new, accelerated 10-month deadline. The decision followed an earlier ruling that found the FDA had overstepped its authority when it extended the deadline in 2017. The FDA subsequently proposed Judge Grimm’s 10-month order, rejecting a 120-day deadline sought by health advocates because it was too short and might overwhelm the FDA.

Law 360 reported the FDA’s generous extension to 2022 “defeated the purpose of the Tobacco Control Act, allowing unapproved tobacco products to be made and sold and aggravating public health problems surrounding the vaping trend among young people, Judge Grimm said in his order.”

Vapor Stockroom sued the FDA in response to the ruling, saying it was unable to meet the accelerated deadline. The Sixth Circuit rejected the company’s appeal on Oct. 6

.

We're here to help!

At Clark & DiStefano we are attentive, always focusing on the needs of our clients. We develop strategies that are tailored to each individual case, and we treat our clients as strategic partners in achieving a common goal. We endeavor to think outside of the box and formulate cost-effective strategies. Lastly, we believe in prompt communications with clients so they have predictability for reserve setting and sufficient time for studied pre-trial evaluations and recommendations.