Chris Herbert, a clerk at Avail Vapor's shop in its Midlothian headquarters, samples one of the company's products. (Photo by Sarah King)
At midnight on July 19, the FDA closes a 90-day public comment period on the role flavorings play in the initiation and patterns of tobacco use among youth and young adults. The rapidly changing market may be responsible for marrying two River City nicotine giants -- one well established and the other a rapidly expanding newcomer -- in light of U.S. Food and Drug Administration Commissioner Scott Gottlieb’s new Youth Tobacco Prevention Plan rolled out in April.
The public comment period followed a notice of proposed rule-making that could limit flavorings in e-liquids, with the FDA citing a sharp increase in teenagers’ use of vapor products containing nicotine. According to the 2017 National Youth Tobacco Survey conducted by the Centers for Disease Control and Prevention, more than 80 percent of youth and young adults indicated that the first tobacco product they used was flavored. A total of 2.1 million middle and high school students reported using e-cigarettes in the survey.
“These figures are particularly concerning because youth exposure to nicotine -- whether it comes from a cigarette or e-cigarette -- affects the developing brain and may rewire it to be more susceptible to nicotine addiction in the future,” Gottlieb says in a June statement.
A regulation that limits flavors in vapor products could have a significant impact on operations of Chesterfield County-based e-liquid manufacturer and distributor Avail Vapor, which sells products in flavors such as blue raspberry, “mama’s key lime pie” and sweet mint gum.
Despite the FDA’s concern about flavored vaping products appealing to young consumers, Avail CEO James Xu maintains that his company’s mission has always been to help the adult smoker quit. Xu says vaping helped his wife -- a cardiology nurse at the University of Virginia Medical Center -- to quit smoking. And yet, federal regulations do not allow the company to share such stories due to lack of scientific evidence surrounding the industry.
“We can't make any health claims or smoking cessation claims because the FDA has not deemed it a harm reduction product,” Xu says. “Even Scott Gottleib has said that a new product like vaping -- short term it looks very promising, but we still don't know the long-term effects because nobody knows … [so] the FDA doesn't even allow us to repost our customers' testimony because then you basically take a position of endorsing that and you're making a health claim.”
Even so, Xu maintains there is a stark difference between tobacco and nicotine -- despite vapor products falling under the purview of the FDA’s Center for Tobacco Control. Nicotine, Xu says, is what “hooks you,” but it’s the tar that “kills you.”
Despite hurdles the company faces -- most recently, the flavoring debate -- as a shifting market economy intersects with the slower-moving nature of the federal bureaucracy, Avail has expanded to more than 100 stores in 12 states since opening its first location five years ago in Carytown.
“So right now the industry has grown so fast, and quite honestly I think [the FDA] is trying to play catch-up and understand the industry,” says Maggie Gowen, the public relations manager for Avail and executive director of the Global Vaping Standards Association (GVSA). The trade association formed a coalition to encourage public comment from adults who transitioned from smoking cigarettes with the help of e-liquid flavored products.
Another obstacle for companies such as Avail developed in August 2016, shortly after the FDA assumed regulatory authority over the industry, when the agency effectively put on hold the release of any new vapor products or e-liquids that did not previously exist. In other words: the agency slammed the brakes on any new competition entering the marketplace, as well as on the introduction of product innovations and improvement of safety features.
In Gowen’s role with the Global Vaping Standards Association, she has met with federal officials on several occasions to advocate for more robust safety standards and manufacturing regulations. She explains this while striding through Avail’s Midlothian headquarters, where a fraction of the space is dedicated to a retail store with an open floor plan. The store offers customers a glimpse inside the lab where liquids are created under the watchful eye of what the company describes as doctorate-holding chemists.
The lab at Avail Vapor's corporate headquarters in Chesterfield County. (Photo by Sarah King)
She explains that all liquids are mixed inside International Organization for Standardization (ISO) Class 6 clean rooms -- a self-imposed manufacturing regulation, since none are imposed by the FDA. Change is on the horizon, however.
Since the Center for Tobacco Control assumed regulation of the vaping industry in 2016, the FDA has been taking an increasing active role, Gowen says. “They’re taking the youth access piece of it extraordinarily [seriously], they’re being very proactive on that. It’s a huge concern for them.”
And perhaps rightfully so: Gottlieb only announced the formation of the new initiatives aimed at youth prevention after issuing 40 warning letters this spring to retailers for selling Juul products -- small vaping devices that look like USB flash drives -- to minors, beginning in late April. The products, which contain the equivalent amount of nicotine to a pack of cigarettes inside each flavored “pod,” have soared in popularity among teens. The phenomenon has spawned a slew of news reports about exasperated school administrators, parents and students “who can’t stop” using Juul.
“When it comes to flavors in non-combustible products like electronic nicotine delivery systems or e-cigarettes, we recognize the issue involves additional considerations,” Gottlieb says in a statement. “The troubling reality is that e-cigarettes are the most commonly used tobacco product among middle and high school students, and flavors are identified as one of the top three reasons for use.”
The inquiry into Juul comes several years after the company entered the marketplace. The product was initially engineered by two graduate students at Stanford University who intended to use the device to vape cannabis, Xu explains, noting that his company was initially uninterested in acquiring Juul.
The FDA had also recently issued 13 warning letters to companies selling e-liquids -- commonly referred to as ‘”juice” -- with labeling or advertising that resembles kid-friendly food products such as apple juice boxes, candy such as Warheads or other treats, like cookies. Aside from misleading marketing and labelling practices to arguably entice underage youth, the practice could be potentially lethal.
“The apple juice box packaging and the e-liquid inside it actually smell like apple juice,” Federal Trade Commissioner Maureen Ohlhausen said in a news conference with the FDA. “Given the significant number of serious child poisonings due to ingestion of liquid nicotine, marketing these products in such a matter could present an unwarranted risk to health and safety.”
Meanwhile, the FDA issued another advanced notice of proposed rulemaking to curtail the levels of nicotine in combustible tobacco products (cigarettes and cigars) to nonaddictive levels -- a move that would affect leading U.S. cigarette manufacturer Altria Group, Inc. -- parent company of Philip Morris USA and popular brands such as Marlboro cigarettes, Skoal smokeless tobacco and Nu MarkTen e-cigarettes.
Last year, Altria announced its undisclosed amount of minority investment in Avail -- a move that may seem odd for a company actively seeking FDA approval of its own e-cigarette variations and devices. Altria also is responsible for the FDA having oversight of the tobacco industry in the first place, after years of lobbying Congress.
“We began this journey more than 15 years ago when we made the bold decision to pursue federal legislation to grant the FDA jurisdiction over tobacco,” Altria President Martin Barrington said in opening remarks to investors in November 2017. “Legislation that was required to establish the possibility of bringing innovative, reduced-risk products to market.”
And yet, the company’s investment in Avail was by no means nearsighted.
“We’ve gained a better understanding of the vape store channel and adult open-system vapers, and have access to extensive data around adult vaper purchasing patterns,” Jody Begley, Altria’s senior vice president of tobacco products, told investors. “Through their retail stores, we’ve also learned a great deal about educating adult tobacco consumers about new products -- insights Altria’s companies can apply to other areas of their reduced-risk portfolios going forward.”
In 2018, Altria spent upwards of $2 million on lobbying Congress Juul Labs notched in at $120,000. Among the top congressional recipients of tobacco industry funds in 2017-2018 was Democratic Sen. Tim Kaine who received $51,525, followed by Republican Sen. Thom Tillis of North Carolina with $48,950, according to the Center for Responsive Politics, which tracks contributions to candidates.
The FDA will need to take time to respond to the public comment period and examine the data, research, science and subjective evidence presented before the agency. FDA administrators and company heads alike have expressed uncertainty as to how long this process may take, or what the outcomes and/or findings may be.
Commissioner Gottlieb, however, has made one thing clear with regard to youth market.
“The blitz continues.”
