Melania versus the Vapers

Melania Trump has tended to show interest in children, visiting several detention centers for young migrants even as her husband pushed hardline immigration policies that exacerbated the crisis at the border. She also visited health centers treating infants born to mothers addicted to opioids.

Many of the cases of mystery illness, which has sickened more than 450 and killed at least six people, have been linked to vaped forms of marijuana and black market products — not to e-cigarettes, based on what’s known so far. But the two crises — the illness and teen vaping — collided politically and in the public’s mind, creating an opening for political action.

The new policy announced by Trump will toughen marketing rules the FDA has been developing for e-cigs for months. Manufacturers would have to show their e-cigarettes don’t pose a public health threat. They would also need to demonstrate why e-cigs without the added flavors should stay on the market. Until then, the administration can order all flavored vapors off the market.

Manufacturers might also have to demonstrate how their products could be misused. The agency will examine nicotine content, safety, as well as “tamper proofing on the product and perhaps even retail and channel distribution practices,” Azar said.

The action followed rising pressure from congressional Democrats and a growing number of Republicans critical of the vaping industry’s teen appeal and marketing strategies. They returned from their August recess to more reports of vaping illness and a growing appetite for national standards to replace a state-by-state patchwork as some areas push forward with flavor bans.

They were egged on by former FDA commissioners like Scott Gottlieb, who left the post in April and has grown increasingly critical of industry giant Juul after tobacco behemoth Altria bought a large stake. Gottlieb in June publicly called for his old employer to consider whether easy-to-use cartridge systems like Juul’s should be allowed on the market.

“This problem was largely created by the cartridge based Juul products, in my opinion,” Gottlieb said Wednesday, adding that the administration’s action “will reduce the appeal of these products to children and impact this epidemic.”

Former FDA Commissioner David Kessler last month wrote to senators — and penned a New York Times op-ed — noting that Juul’s chemistry in particular seemed designed to mask nicotine’s harshness and hook new users, much like traditional cigarette makers focused on “smoothness” in years past.

“These are illegal products and should not be on the market without approval from FDA, which they do not have,” Kessler told POLITICO Wednesday. “The increase in youth use and the recent concerns about safety no longer can justify the administration using enforcement discretion to avoid implementing the law.”

The FDA in 2017 pushed a deadline for reviewing e-cigarette products back by four years. A federal court this summer ordered it to require submissions within 10 months, effectively moving the deadline to May 2020. In the meantime, e-cigarettes remain on the market subject to the agency’s discretion.

Juul on Wednesday said it would comply with the new FDA policy when it becomes effective.

Congressional Republicans were largely blindsided by the White House’s move. Most either urged caution as officials try to decode vaping illness or expressed concern about the prospect of sweeping intervention in a legal market that doesn’t appear immediately at fault for the illnesses.

“I haven’t heard of any that’s really been caused by a legal vaping product,” said Sen. Ron Johnson (R-Wis.). “I understand the rationale, but adults might like flavored vaping liquids too.”

The abrupt announcement also left Republicans seeking clarity on whether the administration is seeking a permanent ban or just a temporary halt.

Sen. Chuck Grassley (R-Iowa) confirmed there had been no communication from the White House or federal health agencies, adding. “But that’s okay. I’m just glad they’re taking action.”

However, some Republicans and outside conservative groups have blasted proposed flavor bans and other sales restrictions as overreach that could push former smokers back onto cigarettes.

“It is incredibly discouraging to see an administration that has prided itself in rolling back regulatory red tape now try to run the American people’s lives for them,” said Dan Savickas regulatory policy manager at FreedomWorks, which supports smaller government. “Flavored e-cigarettes have been a vital option for so many Americans who want to quit smoking. Government involvement in this case, as it always does, will cause more harm than good.”

Larger e-cigarette manufacturers are treading lightly, preparing for rough times ahead but — unlike thousands of smaller manufacturers — better equipped to navigate FDA’s requirements and clear the bar to market their products. The Vapor Technology Association, an industry trade group, said that banning flavors would be “a public health travesty” that could turn former smokers back to cigarettes.