07/10/2018 - Vapor Industry Strikes Back at FDA With Multiple Lawsuits

Vapor Industry Strikes Back at FDA with Multiple Lawsuits

Just as the FDA faces various lawsuits from the premium cigar industry, the vape category is also legally challenging the controversial deeming rules as well with multiple lawsuits worth following and watching.

There are several lawsuits challenging the U.S. Food and Drug Administration classifying vapor products as being the same as tobacco products. Jen Hoban et al., v. United States Food and Drug Administration, et. al involves Hoban, the owner of Masterpiece Vapors, The Plume Room, J.H.T. Vape and Lakes Vapor Supply suing the FDA, Dr. Scott Gottlieb, and Secretary of Health and Human Services Alex Azar. Filed in January 2018 by Hoban, the lawsuit centers on how the deeming rule violates the First Amendment and that the “Modified Risk Statement” of the Tobacco Control Act needs to be set aside. Hoban also argues that vaping products are not similar to tobacco products but regulating them all the same creates “burdensome regulatory requirements including a ban on truthful speech unless the speaker obtains government pre-approval for each statement.”

On April 13, 2018, the FDA filed a motion requesting that the lawsuit be transferred from Minnesota to a D.C. Federal Court, saying that this move would help “prevent the unnecessary expenditure of judicial resources, avoid wasteful and duplicative litigation, and avert the possibility of inconsistent judgments.” A hearing to consider transferring the case was held on June 12, 2018.

Another case being heard is Moose Jooce, et al. v. Food & Drug Administration et al., vape shop owner Kimberly Manor’s lawsuit argues that the deeming regulations could put her out of business. Since she is no longer allowed to tell her customers about the benefits of vaping and how it could be considered a safer alternative to smoking traditional tobacco products the products she sells must receive FDA approval, undergoing an expensive pre-market approval process that must be completed by 2022. Manors sells her own e-liquid products and even though there’s no tobacco in the products, she was forced to register as a tobacco manufacturer, per the deeming rule. Manors reported that she will have to pay $500,000 for a pre-market tobacco product application (PTMA). The motion for summary judgment could be heard as soon as mid-August though the case is expected to be extended through at least November 2018.

Another lawsuit that was filed in January 2018 is Rave Salon Inc. v. FDA, another case that accuses the FDA of violating the business’ First Amendment rights by requiring the to receive FDA-approval before conveying any e-cigarette or vapor marketing health benefit-related claims. It also, like the other lawsuits, brings into question the FDA’s deeming rule’s restrictive nature.

One parallel these lawsuits share with those being filed by the premium cigar industry is that the FDA has responded to many with an attempt to consolidate these cases into one case that they want transferred to U.S. District Court in D.C. Their argument for consolidation often is the similarity of the lawsuits and arguing that multiple lawsuits are a waste of resources and the claims of each are repetitive in nature and should be streamlined in response.

While FDA commissioner Scott Gottlieb has appeared willing to reevaluate the government’s relationship with vaping as a means to get people to stop smoking traditional tobacco products, the issue of underage vape use has been a sticking point for the government in recent months. In a speech delivered to the Tobacco Regulatory Science Meeting held in White Oak, Maryland, on June 18, 2018, Gottlieb made the following comments:

“No child should use any tobacco product. We’ve seen cigarette use decline among kids, while e-cig use has grown sharply. This is happening even as overall rates of tobacco use among kids has declined, according to recent data. This is still not acceptable, even if the trends are moving in a more positive direction of reduced overall use of tobacco products. Even if kids are using ENDS instead of cigarettes — and that migration in part accounts for the decline in youth cigarette use — that’s still not an acceptable trade. Parents who see their children using e-cigs and say, “well at least my child isn’t smoking,” should take no comfort. No child should be using any tobacco product. These products are addictive. That’s why we’ve launched a broad campaign to target youth access to e-cigs, and the retailers and manufacturers that make that access possible. We announced some additional enforcement actions against retailers on Friday. And we have both civil and criminal work underway in this area.”

These lawsuits, like those filed by cigar and pipe tobacco businesses, will likely continue and will undergo many twists and turns before any resolution comes of them. If the past year has been any indication, legal challenges may be the last line of defense many vapor and tobacco businesses have against an all-out infiltration of government regulation and control.

For all the latest legislation and FDA news impacting the tobacco and vapor industries, click here.

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