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FDA Commissioner's 180 On Vaping

FDA Commissioner's 180 On Vaping



FDA Commissioners 180 On Vaping

When Scott Gottlieb was appointed as the head of the U.S. Food and Drug Administration last year, the vaping industry breathed a small sigh of relief. What more could they ask for than a doctor and free market Republican who had once owned a financial interest in a vape company?  

The hope was he’d consider the harm reduction potential of e-cigs compared to smoking and take a lighter hand in the regulation of vapor products, which is part of the FDA’s purview. However, after being appointed Commissioner, Gottlieb wasn’t quite the ally the industry was hoping for. Under his watch, the administration labeled underaged vaping an ‘epidemic’ and threatened a nationwide ban of all flavored cigalikes and e-liquids as well as online sales of e-cigs altogether.  

In a relatively short period of time, Gottlieb went from being an investor in vaping to cracking down on the industry. How did this dramatic turnabout come about? In this article, we’ll lay out an overview of his career and posit what could have lead to his change in heart.

Before being appointed Commissioner, Gottlieb was a general physician, trained at New York’s Mount Sinai School of Medicine, though his career has also included policy advising and venture capital investing. His Commissioner appointment wasn’t his first stint in government. The New Jersey native worked for the FDA from 2005 to 2007 under the George W. Bush administration.

After leaving the FDA, Gottlieb exhibited receptiveness to the vaping industry in a few ways. He was a fellow on the board of the American Enterprise Institute, a conservative think tank that generally takes a pro-vaping stance.  He also partnered at New Enterprise Associates, the largest venture capital firm in the world when he joined back in 2007. There, he served as an active investing partner in the firm's healthcare division. One of his investments was in a vaping retailer. From 2015 to 2016, Gottlieb was a director of Kure Corp., a Charlotte, North Carolina-based firm that distributes vapor products to boutique brick-and-mortar vape shops. Gottlieb has said his yearlong stint as a Kure director was borne from his interest in developing “lower-risk” tobacco products, according to a report in the Wall Street Journal.  

Throughout the confirmation hearing to be Commissioner, he was asked about potential conflicts of interest due to his ties to vaping. He defended his affiliation, saying that harm reduction policies are an effective way to combat public health dangers such as tobacco and opiate use. He also promised to sell off his stake Kure Corp. to avoid conflicts.

He emphasized during those hearings that he understood the conflict between e-cigs helping adults quit smoking and their popularity among young people. He made it clear he would “not countenance a rise in adolescent smoking rates.”

So net-net, his appointment by President Donald Trump in 2017 seemed to signal the government’s stance toward vaping might be more conciliatoryopen to the technology’s potential harm reduction while ensuring a whole new generation didn’t get hooked on nicotine.

Notably, Gottlieb made a major decision that seemed friendly to the industry when he pushed enforcement of vapor-specific “Deeming Regulations” back from 2018 to 2022. By holding off on enforcing the regulations, he extended a temporary lifeline to thousands of vapor product suppliers who might have been forced out of business by the costs required to comply with the regulations. Gottlieb stated the change would allow more time for product innovations that could make e-cigs less prone to abuse by young people while also helping adult smokers quit cigarettes.  

But the decision inflamed health groups that believed it was too lenient on the vaping industry. Several companies sued the FDA, charging that by delaying the regulations, it was allowing new cigalikes into the market that were just as appealing to young people as JUUL, which has come under fire for its popularity among young people.

So what essentially happened was that some companies took advantage of the respite and defied enforcement by, in the eyes of the FDA, promoting their products to teenagers. “In my view they treated these issues like a public relations challenge rather than seriously considering their legal obligations,” Gottlieb said.

At the same time the vaping industry was seen as running amok, Gottlieb was understandably becoming increasingly concerned with underage vaping, especially as studies and press reports began more clearly confirming teen vaping rates were soaring.  

“The troubling reality,” tweeted Gottlieb, “is that e-cigarettes are the most commonly used tobacco product among youth. Preventing youth from initiating the use of any tobacco product, including e-cigs, is critical.”

The commissioner also began expressing concern about the role e-liquid flavors play in appealing to youth. In February 2018, he tweeted support for a flavor ban, partially blaming sweet, fruity flavors for the rise in underaged vaping.

Gottlieb’s rhetoric about underaged vaping continued to escalate. In May, Gottlieb and the FDA the agency sent forty “warning letters” to e-cig leader JUUL Labs, other brands, online retailers, and brick-and-mortar shops around the country in an effort to crack down on underaged vaping. The FDA’s most serious move to date was a surprise inspection of JUUL headquarters in which it seized thousands of pages of documents related to its investigation into whether the startup marketed its products to teens.

These aggressive actions seem tied to the preliminary findings from the government’s latest National Youth Tobacco Survey. The report has not yet been released, but early data leaked to the Wall Street Journal showed a dramatic surge in underage use. In its report, the WSJ said vaping had risen in popularity among teenagers and high schoolers by 75 percent from 2017 to 2018 alone.

These numbers are likely what prompted Gottlieb to label teen vaping “an epidemic.”  For context, the FDA in the past has labeled opiates, obesity, and tobacco as epidemics. Often this didn’t happen until after the agency came under criticism for not reacting quickly enough to those public health threats. In fact, before he held the post of Commissioner, Gottlieb had been known to criticize the FDA for moving too slowly.

But now it looks like Gottlieb wants to help vaping companies move more quickly.  A week after making the statement on flavors, Gottlieb said he’s open to fast-tracking FDA reviews for new vapor products if they can help prevent underage use. This development could result in the quick approval of a next-generation JUUL product, which features Bluetooth capabilities to disable it from being used by anyone except the person whose smartphone is paired up with it. Another innovation could be a geofencing component to prevent the device from being used on school grounds.

Gottlieb’s willingness to cut the red tape for e-cig brands that are truly working to keep e-cigs out of young people’s hands is a good sign. It indicates he’s addressing concerns from teachers and parents, but also willing to be reasonable with vaping brands that want to help prevent underage use.

Perhaps all the saber rattling was designed to get the industry in line. It seems to be working.