E-Cigarettes Went Unchecked in 10 Years of F.D.A. Inaction – The New York Times

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 minute you saw cotton candy flavors — come on,” said Dr. Thomas R. Frieden, the former director of the Centers for Disease Control and Prevention, who had warned since 2013 of the harms to adolescents. “Everything that could have been done should have been done to get them off the market.”

Dr. Hamburg’s F.D.A. suffered an early setback after two e-cigarette companies successfully sued the agency in 2009 for trying to regulate the products as drugs. The F.D.A. was forced instead to treat them as tobacco products under the newly passed Tobacco Control Act, which had less-stringent safety requirements.

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.

In 2017, President Trump’s F.D.A. commissioner, Dr. Scott Gottlieb, granted e-cigarette companies a reprieve of four years before they would have to prove that the public health benefits of their products outweighed the risks. That extension — which Dr. Frieden described as “public health malpractice” — left the door wide open for the surge in popularity of devices such as those made by Juul Labs, the troubled company that now dominates the market.

Meanwhile, the federal government has largely ignored the explosion in vaping THC, the psychoactive ingredient in marijuana, which coincided with either recreational or medicinal legalization in many states. That regulatory dead zone has left public health officials scrambling to track the cause of the vaping-related lung illnesses that have led to at least 29 deaths.

Dr. Ned Sharpless, the acting F.D.A. commissioner, recently acknowledged in a congressional hearing that the agency should have acted sooner. “We’re going to catch up,” he promised.

Last month — facing rising rates of teen vaping and alarm over the lung illnesses — administration officials announced they would finally impose a flavor ban for e-cigarettes.

But the ban has yet to materialize, and industry groups have been fighting it, especially any limits on menthol and mint.

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.

Vaping manufacturers and retailers have opposed more regulations, saying smokers need access to a potentially safer alternative, given that traditional cigarettes kill hundreds of thousands of Americans a year.

“We think that harm reduction, and the potential of harm reduction, for these products cannot be dismissed,” said Brittani Cushman, the board president of the Vapor Technology Association, an industry trade group.

But some public health officials say they doubt Juul and other companies will be able to surmount the regulatory hurdle if teenage use keeps climbing.

The F.D.A.’s lack of action has baffled some families of those who have fallen ill, including Ruby Johnson of Illinois, whose 18-year-old daughter, Piper, nearly died after vaping nicotine and THC.

“If this was romaine lettuce, the shelves would be empty,” she told a House panel last month.

The earliest forms of e-cigarettes arrived in the United States market in 2007 and sought to mimic the smoking experience. The products intrigued many public health experts, who hoped they would wean people off traditional tobacco. They didn’t contain the harmful byproducts and chemicals of cigarettes, although there was little evidence that they were safe.

The F.D.A. was wary. In 2009, the agency declared that the e-cigarettes were illegal drug-device combinations — like a nicotine patch — that had not been approved. The F.D.A. halted imports and warned that they contained toxic chemicals and appealed to young people with flavors like chocolate and mint. E-cigarette companies sued, setting up the first major court fight over vaping nicotine.

The court’s ruling in favor of the industry in 2010 “set the agency back significantly,” said Dr. Joshua M. Sharfstein, who was then the deputy director of the F.D.A. and who left in 2011. The agency’s loss was a harsh reminder of the tobacco industry’s staying power. “It can be very hard for a regulator to address potential risks when there is an aggressive industry on the other side,” he said.

Over the next several years, as the agency slowly developed regulations to oversee all types of tobacco items, including cigars, vaping devices and liquids, “the market became flooded with products that Congress never intended to be on the market at all without F.D.A. review,” said Gregg Haifley, director of federal relations at the American Cancer Society Cancer Action Network.

Vape shops became commonplace, and users experimented with thousands of flavors that were often mixed on store premises or at home.

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 2015, the agency finally sent its proposed rule — for oversight of all e-cigarettes and tobacco products — to the Office of Management and Budget for final approval.

Over that fall and winter, the tobacco and e-cigarette industries made a major push to weaken the regulations, enlisting people like former Senator Mary Landrieu, Democrat of Louisiana, to lobby the Obama administration.

The tobacco and e-cigarette industries overlapped considerably — major tobacco companies like the Reynolds American had begun selling their own e-cigarette products as they sought to replace revenues lost from declining smoking rates. And the nicotine liquids used in vaping are derived from tobacco leaves.

Altria, the nation’s largest tobacco company, threw its weight against a flavor ban. In comments to the F.D.A. on Aug. 8, 2014, it contended that restriction could result in more illicit sales, and that adults also liked fruity and sweet e-cigarette flavors.

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.

And at the Office of Management and Budget, officials hosted dozens of meetings, mostly with industry groups weighing in on the F.D.A.’s 468-page proposal. Some visits were held back to back, with dozens of people — from vape shop owners worried about the economic impact, to product distributors, to public health experts who favored the restrictions — attending the meetings, according to White House records.

“This country is run off the backbone of small business,” read a statement from one entrepreneur, Wade Jordan, who owned vape shops in Bedford, Texas.

One frequent visitor was a familiar face — Andrew Perraut, a former policy analyst who had left the federal budget office in 2014. Federal records show that he represented the budget office in a meeting in April 2014 with Cigar Rights of America, a premium cigar lobbying group.

A little over a year later, in late 2015, Mr. Perraut was back, but this time as a representative of Cigar Rights of America and others, including the e-cigarette company NJoy. Mr. Perraut, now director of public policy at Juul, declined to comment through a Juul spokesman.

When the White House returned the final rule to the F.D.A. in 2016, language for a ban on flavors had been crossed out.

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.”

The agency issued warning letters to companies that sold products that appealed to youth, and began an investigation into whether Juul had illegally marketed to young people and marketed products as smoking cessation devices.

In November 2018, Juul responded by discontinuing sales of most of its flavors to retail shops, with the exception of mint and menthol.

But Juul also brought its lobbyists to the White House numerous times, to argue that restrictions would hurt cigarette smokers who wanted to quit.

“I had to work harder to make the arguments,” Dr. Gottlieb said. “I spilled a lot of blood on this issue.”

Last fall, Juul dispatched the lobbyist Tevi Troy, a former Bush administration health official, and others to make the company’s case at the White House, and tried to temper outrage over whether it had played a role in the rise of youth vaping.

Ms. Talento, the former Trump health adviser, said a generational split became apparent between younger White House health staff members who did not have teenagers, and “the uncool 40-somethings” — like her — who did.

“We were like, ‘It’s not working,’” she said.

“They may have expected a warmer reception,” she said of Juul’s team.

Several federal and state inquiries into its marketing practices have put Juul on the defensive, and it is leaning more heavily on the regulatory expertise of Altria, which has a 35 percent stake in the company. Last month, Juul replaced its chief executive Kevin Burns with a top Altria executive, K.C. Crosthwaite. It has dropped its biggest marketing campaign and said it would discontinue its efforts to overturn an e-cigarette ban in San Francisco.

Soon after Juul stopped stocking retail shelves with its flavor pods, the F.D.A. announced it would require retailers to wall off such e-cigarette products from minors — a watered-down version of more severe actions threatened by Dr. Gottlieb. But those plans have drawn considerable opposition from retailers, conservative groups and businesses.

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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