Departing Commissioner Scott Gottlieb merits praise for his willingness to wield the U.S. Food and Drug Administration’s power to prevent new generations from getting hooked on nicotine. While it’s a shame that Gottlieb isn’t staying on to see his actions through, his exit should not diminish or slow the FDA’s commendable crackdown on the targeting of young people by e-cigarette manufacturers.
Gottlieb announced last week that he is resigning for family reasons after spending two years at the FDA’s helm. Appointed by President Donald Trump, his tenure was a welcome surprise and his exit, a disappointment. There were initial concerns that Gottlieb, a physician who was once a resident fellow at the conservative American Enterprise Institute think tank, would weaken the agency’s oversight as he carried out White House aims to loosen federal regulations. Trump was blunt about Gottlieb’s mission, saying he was sent there to “cut red tape.”
But Gottlieb clearly recognized the public health responsibilities of his new position. He used his office to energetically spotlight the nation’s opioid epidemic and the high cost of prescription drugs and to develop pragmatic policies in response. Among them: wielding his agency’s resources to intercept opioid shipments into the United States. Another: smartly carrying out the “cut red tape” agenda by working to streamline generic drug approvals to provide lower-cost alternatives to brand-name medications.
But Gottlieb likely will be best remembered for recognizing a growing public health threat — the dramatic rise in e-cig use by teenagers, an epidemic with health risks that users and parents don’t fully appreciate yet. E-cig products include Juul and other electronic devices that deliver a smokeless hit of nicotine, a powerfully addictive chemical that may affect adolescent brain development and lead users of “vaping” devices to turn to traditional tobacco products. While e-cigs are believed to be less harmful than regular cigarettes, the vapor inhaled may also contain harmful chemicals and heavy metals.
E-cig use began escalating well before Gottlieb took office but took a dramatic turn on his watch. “From 2017 to 2018, current e-cigarette use — defined by use on at least one day in the past 30 days — by high school students increased 78 percent, from 11.7 to 20.8 percent, accounting for a troubling 3.05 million American high school students using e-cigarettes in 2018,’’ according to an FDA statement on data gathered by the Centers for Disease Control and Prevention. “In addition, the proportion of current e-cigarette users in high school who reported use on 20 days or more in the past 30-day period increased from 20 percent to 27.7 percent between 2017 and 2018.”
Gottlieb responded last September by warning e-cig manufacturers that the FDA would take action if the industry didn’t move quickly to keep these products out of underage hands. He followed up in November with steps to ban the sale of specific vaping products clearly aimed at young users — such as those with candy and fruit flavors — in convenience stores and some other retail settings. Even though key manufacturers had voluntarily suspended sales of flavors like this, their efforts were begrudging. The FDA ban will prevent the industry from selling them again once the spotlight wears off.
Gottlieb also merits credit for allowing some flavored vaping products, such as those with tobacco flavors, to remain on the market. This action generated criticism from anti-smoking groups but recognized the role that vaping products may have in helping older cigarette smokers kick the habit, or at the least move to a less harmful e-cig product. Less reasonable was a move by the agency under Gottlieb to delay other critical e-cigarette regulations until the early part of the next decade. This was a mistake. Still, other measures Gottlieb took, such as early steps to regulate and reduce the amount of nicotine in traditional cigarettes, strengthen his record.
The Trump administration is already facing pressure to replace Gottlieb with someone friendlier to the vaping industry. That would be a mistake. Gottlieb has put in place a foundation to protect teens from nicotine, an addiction that will last a lifetime for far too many. Finding a replacement who will build upon this is not only the right thing to do, but a timely antidote to growing concerns about the industry ties of other Trump appointees.