#parents | #teensvaping | E-Cigarettes Went Unchecked in 10 Years of F.D.A. Inaction

In 2009, not long after Dr. Margaret Hamburg became commissioner of the Food and Drug Administration, a package arrived at her home. Inside was a clunky device called an e-cigarette.

“It was my first exposure to this emerging, new technology,” Dr. Hamburg recalled.

The package was sent by an antismoking activist as a warning about a product that was taking off in the United States. But over the next decade, the federal government — across the span of two presidential administrations — allowed the rise of a largely unregulated industry that may be addicting a new generation to nicotine.

E-cigarettes and vaping devices, with $7 billion in annual sales, have become a part of daily life for millions of Americans. Youth use has skyrocketed with the proliferation of flavors targeting teenagers, such as Bazooka Joe Bubble Gum and Zombie Blood. And nearly 1,300 people have been sickened by mysterious vaping-related lung injuries this year.

Yet the agency has not vetted the vast majority of vaping devices or flavored liquids for safety.

In dozens of interviews, federal officials and public health experts described a lost decade of inaction, blaming an intense lobbying effort by the e-cigarette and tobacco industries, fears of a political backlash in tobacco-friendly states, bureaucratic delays, and a late reprieve by an F.D.A. commissioner who had previously served on the board of a chain of vaping lounges.

The agency then spent five years trying to issue regulations that would survive further legal as well as political scrutiny by a White House that had other priorities, including rolling out the Affordable Care Act.

Then, in President Obama’s last year, the administration rejected a proposal to ban flavored e-cigarettes. It came in the face of fierce lobbying over the tobacco regulations, including by a former senator and by a onetime White House analyst who had represented the Obama administration in the same discussions a year earlier.

Even bigger changes to the e-cigarette industry might be on the way. That deadline Dr. Gottlieb extended has been overturned by a judge, who ordered the F.D.A. to require e-cigarette companies to apply for approval by May, and to submit evidence their products do more good than harm. Last week, Reynolds American began the process, filing its application with the F.D.A. for VUSE, the company’s cartridge-based vaping system that features flavors such as mixed berry, tropical, menthol and others.

One of the tobacco industry’s fiercest critics, Senator Jeff Merkley, Democrat of Oregon, had urged the agency beginning in 2009 to rein in nicotine vaping products, and mentioned allies like Mitchell Zeller, who oversees tobacco at the F.D.A., and who was among the early advocates for a ban on flavors.

Dr. Hamburg, who left the F.D.A. in 2015, said the agency struggled to move quickly to issue the broad regulation for e-cigarettes as well as other tobacco products, including cigars. It was a complex process, she said, given previous court challenges.

“For something so important for health, the delays at H.H.S. and the White House were distressing and confusing — people were getting very frustrated,” she said, and given the expanding industry, “I wanted to get it out, from a reputational point of view and from a morale point of view for F.D.A.”

At the time, the Obama White House and the Department of Health and Human Services were also dealing with mounting Republican opposition to the administration’s signature health care law, the Affordable Care Act, which was passed in 2010 and went into effect in 2014 with an exceptionally bumpy rollout.

In Congress, the tobacco industry lobbied hard against the proposals, using its pull as a major donor to get Republicans and some Democrats to sign on to industry-friendly bills.

Shaun Donovan, the director of the budget agency, and other Obama administration officials, including Kathleen Sebelius and Sylvia Mathews Burwell, both of whom served as secretary of the Department of Health and Human Services during that period, declined to comment. Dr. Robert M. Califf, who had supervised policy on tobacco products at the F.D.A. before becoming commissioner in 2016, said he did not know why the flavor ban had been deleted. However, “I’m sure the small business impact had something to do with it,” he said.

Dr. Hamburg, who had left by then, also said she did not know why it had been deleted.

Some former Obama administration officials said the White House considered the flavor ban too restrictive and that there was no solid evidence that flavored e-cigarettes were harmful. In addition, it would have extended to products like cigars, which was opposed by the industry, as was regulation of premium cigars, which threatened Democrats in tobacco-friendly states like North Carolina and Florida.

One former Obama administration health official, who asked not to be identified because it could jeopardize his employment as a lobbyist, said the political risk for banning flavors seemed too high, given Republican control of Congress. The White House was worried about several Republican proposals that aimed to unravel the F.D.A.’s ability to regulate tobacco products.

“We were very nervous about what would happen if we did this,” the former official said. “Would the Obama ‘nanny state’ criticism come in to play? Not all Senate Democrats were strong champions of those things. There had to be give.”

The rule approved by the White House did set new requirements for the industry, including forbidding sales to minors and mandating the submission of ingredient lists by e-cigarette manufacturers.

In 2017, the vaping landscape shifted again with Mr. Trump’s appointment of Dr. Gottlieb, who had served on the board of Kure, a chain of vaping lounges. Although he divested from Kure when he became the F.D.A. commissioner, Dr. Gottlieb held on to the idea that vaping could help adults quit smoking.

Two months into his new job, he handed the e-cigarette industry the breathing room of a four-year extension to comply with the new rules as part of a broader package that appeared to straddle competing interests. He called for lowering nicotine in cigarettes to render them less addictive, while ensuring access to e-cigarettes and other alternatives for smokers trying to quit.

Then, in 2018, new federal survey data showed that teen vaping had jumped sharply in the past year, driven by the popularity of Juul, and that more than three million American high school students had tried e-cigarettes.

“It was just a horror show,” said Katy Talento, a former top health policy adviser to Mr. Trump on the Domestic Policy Council. After that, she said, “the calculus changed.”

In an interview, Dr. Gottlieb said he then began lobbying the White House and lawmakers to win support for an e-cigarette crackdown.

“I couldn’t outright ban the sale of e-cigarettes in convenience stores, because the law prohibited me from doing that,” he said. “And that’s where the kids were accessing the products.”

Last month, after Dr. Sharpless and Alex M. Azar II, the secretary of health and human services, told White House officials that new figures showed teen vaping had increased again, they said they would draft the proposed ban on most flavored e-cigarettes.

“We can’t allow people to get sick,” the president said, with his wife Melania at his side in the Oval Office. “And we can’t have our youth be so affected.”

Mr. Trump recently tweeted that he liked “the vaping alternative to cigarettes” but wanted to keep young children from using the products.

Some states and cities have stepped in. Massachusetts has halted sales of all vaping products for four months, and other states, including Michigan, Rhode Island, Washington, Oregon and New York, have imposed flavor bans or taken steps to do so. And several major retailers, including Walmart, Walgreens and others, have said they would stop selling e-cigarettes altogether.

Efforts to track the cause of the lung illnesses have been hampered by the fact that THC-based products largely fall into a regulatory vacuum, and relaxed laws in many states have enabled an illicit trade. While marijuana is still illegal at the federal level, nearly three dozen states permit medicinal use, and 11 states and the District of Columbia have fully legalized it.

The F.D.A.’s authority over THC is considered a gray area of law. A handful of cannabis-derived drugs have been approved, and the F.D.A. is talking to other agencies about expanding its reach.

Nearly 1,300 people, disproportionately young, have been sickened from vaping THC, nicotine or both. At least 29 have died.

It often takes a public health crisis for the federal government to enact major change, said Dr. Califf, the former F.D.A. commissioner.

“It has to get bad enough before you can actually get down to what needs to get done,” he said. “And I guess in a way this is an example.”

Julie Creswell contributed reporting.




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