What is the FDA Deeming Rule?
The new FDA deeming rule may just end up being the end of vaping as we know it.
From the early days, the burgeoning vaping industry was basically the wild, wild west — a largely unregulated boom of new flavors, companies, and devices. And in 2016, the FDA expanded its definition of tobacco products to include e-cigarettes, cigars, and hookah — giving the agency complete regulatory powers over the vaping industry. Originally, the FDA planned to require any vaping products, including e-juice and e-cigarettes, on the market as of August 8, 2016 to undergo costly and extensive product reviews.
How costly and extensive? The agency estimates the product reviews required under the FDA deeming rule will cost vaping companies anywhere from $117,000 to well over $400,000 – per product. That’s more money than many small vaping startups make in a year.
Originally, the deadline for compliance was August 8, 2017. Vaping products on the market prior to February 15, 2007 are exempt due to a grandfather clause, but any new products created, and older products that have been modified, are required to undergo the FDA’s review. That’s pretty much everything. All your equipment. Nearly every flavor you love. And unlike the FDA’s deadline for compliance, only an act of Congress can change the “grandfather” rule date.
The FDA deeming regulation has the potential to wipe out the vaping industry as we know it.
Bring on the Lawsuits
Not surprisingly, the vaping industry banded together to fight the FDA’s new rule, and a bevy of lawsuits were filed in federal court — including these three from Pacific Legal Foundation, and another by Nicopure, which was initially denied and is now under appeal — making the claims that the deeming rule itself is unconstitutional, and disputing the concept that a product that contains no tobacco can be classified by the FDA as a tobacco product, among others.
Your Favorite Flavors are Safe. For Now…
The agency then announced a new, extended deadline for compliance with the FDA deeming rule, to August 8, 2022. It means your favorite flavors and boutique vaping companies are safe for the time being.
And, as late as last week, the FDA announced steps aimed at making it easier to bring NRT (Nicotine Replacement Therapy) products, which include vaping products, to market more rapidly. This move, signals that the agency may be softening its stance on vaping and e-cigarettes.
It’s Not Over Yet
Anti-vaping advocates, including Campaign for Tobacco-Free Kids, American Lung Association, American Cancer Society, American Heart Association, Truth Initiative, American Academy of Pediatrics, Democracy Forward, and numerous individual pediatricians are hitting back hard and suing the FDA for dragging its feet and extending the deadline on the regulation of e-cigarettes and certain tobacco products, claiming that vaping is a public health risk.
A number of the FDA’s rules regulating the e-cigarette industry, such as nicotine warning labels and age verification requirements, have already gone into effect. These are positive steps, aimed at informing the consumers and preventing kids from using products meant for adults.
And as CNBC reported, “Manufacturers are also still required to request and receive approval in order to sell products that weren’t on the market before Aug. 6, 2018.”
For the moment, your favorite e-liquids, e-cigarettes, and boutique vaping companies are in the clear. But beware, the Vapocalypse may be coming — unless we fight now.