There's a change in the air.
Vaping is now federally regulated by the Food and Drug Administration, the government agency announced Thursday. The long-anticipated final regulations were officially revealed, including prohibiting the sale of e-cigarettes to people under the age of 18, banning free samples of e-liquids, and maintaining a pivotal grandfathering date that the vaping community says will seriously threaten the industry.
The rules are the final step in a nine-step process to bring e-cigarettes and other vaping products under the FDA's purview. Now, the FDA can enforce rules governing everything from manufacturing, to labelling, to distribution of vaping products. Manufacturers will now be required to report all ingredients and their facilities will be subject to health and safety standards. Vape shops will need to check photo ID and will no longer be able to let customers sample products before buying. The rules go into effect in 90 days.
"This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated," Mitch Zeller, director of the FDA's Center for Tobacco Products, said in a press release. "The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced. Ultimately our job is to assess what's happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA."
Some of these rules—like not selling to those under 18—were already in place in a lot of states, but the manufacturing side of the industry had very little oversight until now. The changes will mean the FDA can prevent the sale of products made in garages and kitchen sinks, and will ensure customers can be confident that what they're getting inside a bottle is what it says on the label.
However, the rules keep in place a grandfathering date for existing products that were on the market as of February 15, 2007. That means that any product that wasn't on the market before that date now has two years to complete a lengthy, costly application process. In the new rules, the FDA estimates this process will take companies 1,500 hours to complete, for each individual product, plus an additional 200+ hours to do an environmental assessment—a time and cost constraint that the industry worries could choke out companies. Since the vaping industry really only started to emerge around 2006 and 2007, the vast majority of products currently on the market came out after that date.
"The FDA now estimates that filing a PMTA will take over 1,700 hours per product, which brings the estimated cost for a single application up to over a million dollars [based on previous FDA cost estimations]," said Gregory Conley, the president of the American Vaping Association, a nonprofit advocacy group. "This gigantic price tag is affordable to Big Tobacco companies, but small and medium-sized businesses will be crushed. This is not regulation, it is prohibition that will cost lives, kill jobs, and further entrench America's largest cigarette companies."
There are bills currently being considered in Congress to change this date to protect the industry from this one requirement, but it's yet to be determined if they'll actually be successful.
The rules also put limitations on the kinds of vaping products that are likely to get approved. Right now, more experienced vapers often build their own devices by combining different pieces to create a custom box mod, but the FDA notes it "expects that it may be difficult for manufacturers to make the showing necessary to meet the statutory standard, given the great extent of possible variations in combinations of hardware components, if all are considered and sold separately. Thus, with respect to apparatus, FDA expects that manufacturers will be most successful where authorization is sought for entire delivery systems, rather than individual components."
In other words: If manufacturers want a hope of keeping products on the market, they're going to have better luck building closed, cookie-cutter devices, rather than continuing to sell the pieces to let vapers build their own custom model.
The new rules mark a monumental jolt to the vaping industry. While regulation was inevitable—and actually is welcome by most of the industry—some of the rules may be too strict for many start-up vape companies to survive.