On Wednesday, The FDA announced its most bold and stringent regulatory actions to date for the vape industry. The agency released an official statement on their website, much of which echoed sentiments made by commissioner, Scott Gottlieb, in a speech the same day. The speech is also available on the FDA site in full, but I will try to break down some of the more salient points.
FDA Takes Major Action
“We sent more than 1,100 warning letters to stores for the illegal sale of e-cigarettes to minors. In addition, we issued another 131 civil money penalties to stores that continued to violate the restrictions on sales to minors,” the agency bluntly stated. They are also communicating with companies like Juul Labs to determine if the companies are allowing online bulk sales that the FDA says should be an obvious indicator of intent to resell (likely to minors). The warnings and penalties come on the heels of what Gottlieb continues to call an epidemic of teen vape use. “Hindsight, and the data now available to us, reveal these trends. And the impact is clearly apparent to the FDA,” the commissioner said.
Gottlieb noted that he used the term epidemic thoughtfully, yet explicitly, as he believes no term better describes the rampant trend of underage vaping. The onus, he argued, is in the hands of manufacturers and retailers. The vape industry “treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate, and the existential threat to these products,” he said.
This is not the first time this year the FDA issued warnings to vape product manufacturers. The industry has had its proverbial feet held to the fire since late last year. Twice this year alone, the agency has stepped in and issued warnings and fines to vendors or manufacturers believed to be contributing directly to this purported epidemic.
Forty vendors received citations in April this year for selling e-cigarette products to minors. Products like whipped cream flavored juice in what looks like a can of real whipped cream, or apple vape juice packaged to look like literal apple juice were obviously problematic. Those items have all been removed from market.
In May, seventeen different vendors were warned that their products resembling candies and foods that may attract kids needed to be pulled from shelves. All seventeen companies complied. Some municipalities and local governments did not wait for the FDA to address concerns like youthful advertising and marketing, banning flavored e-juices and other such seemingly ‘kid-friendly’ vape products before the FDA took action.
The FDA’s Role in Regulation
The FDA assumed regulatory oversight and authority over e-cigarettes only recently. And the agency announced their ‘comprehensive plan’ to regulate tobacco alternatives only last year. They have been slow to act on properly managing tobacco alternatives since they took control of market compliance. Gottlieb acknowledged that current efforts were not enough, and that the FDA would need to step up their authority over the e-cigarette market. “We need a regulatory process that requires product applications to show that the marketing of the product is appropriate for the protection of the health of the overall population. And we need a regulatory process that keeps these same electronic cigarette products out of the hands of youth,” he said in his speech.
Gottlieb went on to say he believes the FDA needs to evaluate the way e-cigarette companies are marketing their products before products are approved for sale, not just the content of the products. But such a stringent and in depth process has already proved too much for the agency to handle. The FDA has not approved any of the over 300 Pre-Market Tobacco Applications they have received since instituting their current market regulations. Businesses currently manufacturing and selling e-cigarettes are allowed only to do so because they have been given an extension to submit their materials for review. In the commissioner’s speech, he announced the agency has revisited that decision, instead giving manufacturers a mere 60 days to offer “robust plans” on how they will combat teen use of their products.
Criticized for Inaction
Even in his own speech, the FDA commissioner seems to question whether they themselves could have done more to correct the current climate of e-cigarettes in the hands of youth. “For instance, what if we hadn’t extended the compliance dates for filing applications for e-cigs on the market when the deeming rule went into effect,” Gottlieb questions. “While the statute places the burden on manufacturers to show with scientific evidence that the public health standards in the law are met, we also understood that many manufacturers were new to regulation. And many novel products were already on the market,” he continued, claiming there was little the agency could reasonably have done at the time.
They appear to be overcorrecting, and folding to public outcry based on media portrayal of this so-called ‘epidemic.’ A former FDA associate commissioner and current health care lawyer, Marc J. Scheineson told the New York Times that he sees the agency using current public opinion and bullying tactics to force manufacturers into “voluntary compliance.”
Some think the FDA could already have managed the supposed epidemic they face. “[T]hey could be so much more effective by following the regulatory plan that had been ready to put into place and that the commissioner postponed,” National Center for Health Research, Diana Zuckerman, told the New York Times. Others, like Michelle Minton of the Competitive Enterprise Institute, have offered similar critique of the FDA’s responsibility for the very problem they seem so fervently (and suddenly) addressing.
Is It A Problem?
Why is the FDA taking such hardlined action now? A number of news outlets continually report vaping (specifically ‘Juuling’) has become an enormous teen trend over the last year or so. Stories abound of the problems faculty and administration face in middle and high schools across the country. Students use vapes discreetly, blowing vapor into sweatshirts or backpacks. The lack of tobacco odor and flash drive appearance make devices easy to conceal.
But, how prevalent is this supposed rampant teen vape use? According to recent CDC data, vaping among underage groups has been on a steady decline after reaching its peak in 2015 (when the FDA initially took control over vape regulation). As is typical of trends, since the hype peaked, it has considerably subsided. In 2015, over 20% of high school students reported using e-cigarettes. That number was a remarkable 11.3% by 2016. Last year’s National Youth Tobacco Survey showed that 11.7% of teen reported vape use, a moot change.
Whatever ‘epidemic’ the FDA says it is combating, the numbers do not reflect the commissioner’s outrage and persecutory speech. Vape manufacturers should expect more trouble with marketing and manufacturing in the near future.