President Trump routinely boasts of unshackling the economy by cutting red tape. But one industry may be about to face an onslaught of regulations, as senior members of his administration discuss a crackdown on electronic cigarettes.
The e-cigarette industry grew over the past decade into a significant part of the economy, with billions in annual revenue as large manufacturers and small local shops induced smokers to switch en mass from foul-smelling analog tobacco to vaporized nicotine-laced liquid.
But Trump administration officials are discussing regulations that could sink businesses and substantially alter the industry — a welcome development to health campaigners but an outrage to vaping advocates.
E-cigarette policy has been a battleground for years. Defenders point to studies that indicate e-cigarettes are a less-toxic alternative, and argue they’re an off-ramp from addiction. Public health groups say their popularity risks addicting children.
Now long-simmering debate over flavors and popular vaping models appears to be reaching a head, with Food and Drug Administration commissioner Scott Gottlieb and Health and Human Services Secretary Alex Azar outlining a possible crackdown in the Washington Post this month.
Gottlieb and Azar warned of “an epidemic” of youth use, citing unreleased 2018 data from the the National Youth Tobacco Survey that found a 75 percent jump in use by high schoolers and a 50 percent hike among middle-school students.
The increases are likely to erase drops in youth use in 2016 and 2017, after a 2015 peak, and comes after a September FDA raid of JUUL, which rocketed to market dominance with an e-cigarette that looks like a USB flash drive.
Gottlieb and Azar wrote they are considering forcing flavored liquid to win approval under the pre-market review process — an arduous process through which companies gain permission to sell tobacco products by proving there was a pre-2007 functional equivalent.
Pre-market approval applications for e-cigarettes and flavored liquid were supposed to be due this year, but regulators delayed the deadline to 2022, forestalling a costly compliance burden that small companies say could squeeze them from the market.
In a September interview, Gottlieb threatened cartridge systems with an earlier pre-market review. “In closing the on-ramp to kids, we’re going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs,” he reportedly told staff.
Gottlieb isn’t all talk. Last month, the FDA instructed the five largest manufacturers to submit plans to reduce youth use. This month, the FDA ordered 21 companies to prove that their products were on the market before August 2016, the cutoff date for grandfathered products.
The FDA has options for a crackdown. One is moving up the date for pre-market review applications. Another is proposing a new regulation banning flavors. The FDA took public comments through July on an advanced notice of proposed rulemaking on a potential flavor ban for tobacco. Many adults insist the lure of flavors helped them stop smoking, but health advocates say they entice children.
The buzz has advocates on edge.
“Commissioner Gottlieb seems to be one of the only Trump appointees who is pushing for new government regulation that will shut down small businesses around the country,” said Gregory Conley, president of the American Vaping Association.
Conley said a crackdown risks Trump’s boast about the economic contribution of regulatory relief, recently pegged at $23 billion by the White House Office of Management and Budget.
“It is evident that Commissioner Gottlieb is bound and determined to radically change this market in a way that’s unlikely to be good for public health, and there is a political aspect to this as well,” Conley said. “If President Trump runs for re-election, he’s going to need every vote to win again. Any action that sees many vapor products removed from the U.S. market, that is going to be blamed by current vapers on the administration, not just Commissioner Gottlieb.”
Conley does support a tougher approach toward stores that sell to underage buyers and recommends more undercover operations.
As Trump officials turned up the heat, JUUL hired former White House spokesman Josh Raffel, who worked closely with Trump’s daughter Ivanka and her husband, presidential adviser Jared Kushner.
JUUL hasn’t taken an antagonistic public stance toward regulators, and in a statement expressed interest in working with authorities. “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 company said.
But health advocacy groups see blood in the water after years of inconclusive clashes.
“[Gottlieb’s] actions are a recognition of the seriousness of the problem, and a commitment to the health of Americans,” said Vince Willmore, vice president of the Campaign for Tobacco-Free Kids. “We would like to see the FDA move forward quickly and comprehensively.”
Willmore wants a blanket flavor ban, with a narrow carve-out if companies can show an option helps adults quit.
Erika Sward, an assistant vice president of the American Lung Association, said she’s not sure if Gottlieb will “grab the bull by the horns and go after all flavored products,” but scoffs at suggestions that adults would turn to hazardous homebrews.
“I think it’s very important for the FDA to crack down on products that are addicting another generation,” she said.
