Last week, the FDA confirmed it conducted a surprise inspection of e-cigarette manufacture Juul Labs.
According to reports, two FDA inspectors, at times joined by a third official, arrived the morning of September 24 to Juul’s San Francisco office and spent five days reviewing documents and interviewing members of the marketing and enforcement teams. The FDA inspectors took more than 1,000 pages of documents concerning sales and marketing.
But Juul should have seen the inspection coming as it has been in the crosshairs of the FDA’s enforcement arm for quite some time now. This is in part because Juul has become the e-cigarette of choice for underage vapers, with sales reported to increase more than 600 percent in a year to 16.2 million in 2017, according to a Centers for Disease Control and Prevention Report also released yesterday. The Report further noted that by the end of July 2017, Juul represented for almost one in three e-cigarettes in the US, where more than 2 million middle and high school student have now tried Juul. The FDA added that youth vaping skyrocketed 75 percent in just the past year as teens experienced Juul.
So as part of its effort to combat youth use of, and access to, e-cigarettes, the Agency has “made an example” out of Juul. On April 24, FDA issued a press announcement stating, “that the FDA has been conducting a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes – specifically JUUL products – to minors at both brick-and-mortar and online retailers.” During this initial focus on retailers in the spring, the FDA issued 56 warning letters and six civil monetary penalties.
On September 12, the FDA announced its intention to shift its sights further up the distribution chain to the manufacturer and again mentioned Juul by name. And in a letter to the manufacturer dated the same day, the FDA stated that although the Agency deferred enforcement of the premarket review requirement for electronic nicotine delivery system (ENDS) products such as Juul set forth under the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA was reevaluating the enforcement discretion policy.
Less than a week later, the FDA further articulated its concern for e-cigarettes and the increasing youth use, despite their potential benefits for adult users. In a September 18 press release, the agency stated, “[t]o be clear, the FDA remains committed to the idea that e-cigarettes have the potential to help adult smokers transition away from combustible cigarettes. But we may have to narrow the off ramp for adults, to close the on ramp for kids. We make hard tradeoffs all the time. We’ll do it again if we must.”
Juul’s CEO stated in response to the FDA inspection:
We are committed to preventing underage use, and we want to engage with FDA, lawmakers, public health advocates and others to keep JUUL out of the hands of young people. The meetings last week with FDA gave us the opportunity to provide information about our business from our marketing practices to our industry-leading online age-verification protocols to our youth prevention efforts. It was a constructive and transparent dialogue. We've now released over 50,000 pages of documents to the FDA since April that support our public statements. We look forward to presenting our plan to address youth access in the 60-day time frame as outlined by FDA. We want to be part of the solution in preventing underage use, and we believe it will take industry and regulators working together to restrict youth access.
An additional concern that has been raised is that e-cigarettes may be used for other gateway drugs. For example, a new study reported in JAMA found that nearly one in 11 middle and high school students in the US has used cannabis in an e-cigarette, which means 12.4 percent of high schoolers and 4.5 percent of middle schoolers (8.9 percent combined) have ever vaped marijuana.