As FDA Contemplates Strict Vaping Regulations, Lives Hang In the Balance

Amazing Vapes is a small e-cigarette shop nestled between Conyers and Covington, Georgia. Opened in 2014 by Elizabeth Langbecker, the retailer is one of many that serve Metro Atlanta. Sadly the livelihoods of Mrs. Langbecker and her staff (including store manager Magen Moore) are threatened, along with the health of Amazing Vape customers, by overreaching bureaucrats at the Food and Drug Administration (FDA).

In a relatively short time, the e-cigarette and vaping industry has rapidly changed. “The products are better and we’re expanding on flavors all the time,” Ms. Moore said on a rainy day last month. “Lower nicotine content has happened throughout the years. Most premium juices don’t go up higher than six milligrams now. A lot of people have access to juices with lower nicotine rather than starting off super high. It’s helping with nicotine craving better than when someone starts off with a juice that has a stronger nicotine level.”

The delivery systems have also improved. “Everyone used to start on little basic pens. Those aren’t even our top seller anymore,” she explained. “People like sub-ohm now. They’re getting a more airy feel, and they’re dropping the amount of nicotine they consume more quickly.”

Although Amazing Vapes has grown and is offering a wider range of juices to satisfy just about everyone’s pallet, Ms. Moore believes that there is another purpose to what she does for a living.

“Our role is to help people get off cigarettes, to give them healthier alternatives, and make them more comfortable with it. We like to give people as much information as possible so they know exactly what they’re getting into,” said Ms. Moore. “If you don’t have that information then you don’t know about vaping, you don’t know how it works, and it’s not going to help you.”

But the livelihoods of workers at Amazing Vapes, along with the employment of thousands more at thousands of other similar businesses across the country, have been threatened by the Food and Drug Administration (FDA).

In May 2016, the FDA published a regulation, known as the “Deeming Rule,” through which it claimed authority to regulate e-cigarette products; otherwise known as electronic nicotine delivery systems (ENDS). Although the FDA claimed that action was needed to clamp down on minors’ access to e-cigarettes, the regulation was sweeping. Any e-cigarette product on the market on February 15, 2007  -- meaning virtually all of them, including juices, although they do not contain tobacco -- would be subject to FDA approval.

Without question, these costs would put a severe strain on the industry; likely driving the vast majority of manufacturers and retailers, including Amazing Vapes, out of the market. Pre-market approval would cost between $117,486 and $466,563 per product. The FDA claims that the cost is “not in the millions of dollars described by some others.” Of course, the costs of compliance are often underestimated because regulatory obfuscation and other uncertainty dramatically increase the real cost of bringing products to market

“Honestly, [the FDA regulation] was a let down. Finally something comes out that’s healthier and better for people, and you want to shut it down?” Ms. Moore complained.

There have been developments since the regulation was published. While it was supposed to take effect in August 2018, the e-cigarette industry was given a reprieve in July 2017 when the FDA delayed major parts of the regulation for several years. Other aspects of the rule like addictiveness warnings, ingredient listing, and tobacco health documents have either gone into effect or will be going into effect soon.

Since the delay was announced, FDA Commissioner Scott Gottlieb has made a series of concerning statements. Last month, Commissioner Gottlieb said, “[W]e may take steps to curtail the marketing and selling of flavored products. We’re now actively evaluating how we’d implement such a policy.”

Flavored juices are an important part of the industry. Various companies, as well as retailers like Amazing Vapes, produce flavored juices for ENDS. Flavors range from basic ones like menthol to cinnamon to cereal flavors like Fruit Loops and Cap’n Crunch to donut flavors. There are also higher quality premium juices of all varieties. Commissioner Gottlieb is considering regulating flavors - which manufacturers, retailers, and users fear will be tantamount to a ban - to discourage minors from using e-cigarettes or vaping.

Ms. Moore and Amazing Vapes believe that a flavor ban would destroy the industry, leaving those who used ENDS and flavored juices in order to stop smoking with substantially fewer choices.

“The vaping industry would go away fast if the FDA banned flavors. Over half of the people who come in want to get off cigarettes because they don’t want the taste. They want to get away from it,” said Ms. Moore. “They want a fruit flavor or a custard flavor. Something that actually tastes and smells good.”

But the FDA and small businesses like Amazing Vapes are only a couple of players in this debate over how to regulate the e-cigarette and vaping industries. Often lost in all this regulatory overreach is the voice of the user. This can't be minimized. 

Andy Allen, a 50-year-old Metro Atlanta resident and former smoker, believes he added years to his life because he discovered vaping.

“For years I tried to quit smoking. I smoked from age 12 to age 47. There were times I smoked almost three packs a day. I had an outdoors job for most of the time, so I was able to smoke whenever I wanted,” Mr. Allen explained. “Finally, in December 2015, I felt so unhealthy that I had to finally try something I had heard about for a while, and that was vaping.”

Mr. Allen called a friend who connected him with Amazing Vapes, and the staff helped him choose what ENDS to purchase, and find out what juices he liked. He was skeptical, having tried nicotine gum and patches. But after a few days, he began feeling healthier.

“It was much easier to go up and down stairs again without being completely winded and exhausted. I was so thankful I had finally found harm reduction that gave me so much relief from the chemicals of combustible cigarettes.”

Like Ms. Moore, the ability to offer a variety of flavors was helpful to Mr. Allen, who has not smoked a cigarette in nearly three years. “If my only choices were tobacco flavors, I would just keep smoking combustibles. E-juice flavors are definitely an essential part of my not smoking almost three years.”

While the FDA ponders how strictly to regulate the e-cigarette and vaping industry, livelihoods and lives hang in the balance as bureaucrats decide whether to severely limit available choices in the market. But if the FDA goes too far, the agency would likely push people to return to smoking, with all the negative health consequences that would come with it.