The New York Times: Sheila Kaplan and Matt Richtel
Dr. Scott Gottlieb became commissioner of the Food and Drug Administration in 2017 with an ambitious plan to reduce cigarette smoking, a habit that kills nearly half a million Americans each year, by shifting smokers to less harmful alternatives like e-cigarettes.
But he was quickly embroiled in an unexpected crisis: the explosion of vaping among millions of middle and high school students, many of whom were getting addicted to nicotine.
Dr. Gottlieb will depart at the end of this month, following his sudden announcement last week that he would resign, with his plans to toughen regulation of both vaping and smoking unfinished and powerful lobbying forces quietly celebrating the exit of a politically canny administrator who aggressively wielded his regulatory powers.
Opponents are already swooping in, making their case to Congress and reaching out to the White House. A coalition of conservative organizations that oppose government intervention in the marketplace has harshly criticized Dr. Gottlieb’s crackdown on e-cigarettes. Retailers, including convenience store and gas station owners, are on Capitol Hill lobbying against guidelines Dr. Gottlieb proposed on Wednesday to restrict sales of most flavored e-cigarettes to separate adult-only areas and to require age verification of customers.
And major tobacco companies are likely to seize on his departure to try to scuttle his long-term plans to lower nicotine levels in cigarettes to nonaddictive levels and to ban menthol cigarettes, which make up more than a third of the cigarette market and dominate sales to African-Americans. Some longtime officials inside the F.D.A. said privately that they fear these ideas could be delayed indefinitely.
“There have been well-intentioned commissioners before Gottlieb,” said Jonathan Havens, a former F.D.A. tobacco lawyer now in private practice. “But they were not as good at capturing the attention of the nation, of the stakeholders. I think that momentum could very well stall on some of these products, or be lost completely.”
This pivotal moment in regulation of smoking and vaping comes just months after Altria, maker of Marlboro cigarettes and the nation’s largest tobacco company, with a market value of $100 billion, bought a 35 percent stake in Juul, the nation’s dominant vaping company whose valuation soared on the investment to $38 billion.
Juul’s alliance with Altria has given it access to a far more muscular, experienced political player. Altria gave $500,000 to Mr. Trump’s inaugural committee, and spent more than $10 million on lobbying last year, according to the Center for Responsive Politics.
Dr. Gottlieb has expressed anger that Juul and Altria were negotiating their financial deal in secret, while each was making promises to the F.D.A. that he believes the deal broke. The investment in Juul means that Altria, with net sales of cigarettes and other products last year amounting to $25.4 billion, is now selling flavored e-cigarettes, which it had told the F.D.A. it would stop doing, he said.
“Proponents of vaping, who support these companies,” he said in an interview, “ought to realize just how much these companies are putting their short-term business objectives ahead of any long-term goals for these technologies to be effective tools for adult smokers.”
The question is whether Dr. Gottlieb’s successor will continue his policies and enforce them. On Tuesday, Dr. Norman E. “Ned” Sharpless, director of the National Cancer Institute, was named to replace him in an acting capacity and is in the running to succeed him permanently.
Dr. Gottlieb supports Dr. Sharpless, who said he would continue his predecessor’s policies. Alex M. Azar II, secretary of health and human services, said in a statement Wednesday that the administration backs closing off children’s access to e-cigarettes, while making them available to adult smokers trying to quit.
“I’m hearing from people who are gleeful that he’s gone,” Liz Mair, a Republican political consultant who founded Vapers United, a group that supports vaping as a tool to stop smoking, said of Dr. Gottlieb. “I think people who are doing a victory lap right now better watch and see what direction things are moving in. It’s not, ‘Oh, the vaper wars have been won.’ I wouldn’t bank on that.”
Dr. Gottlieb’s decision to leave just as his regulatory efforts on e-cigarettes were coming to fruition has set off speculation that he had lost favor within the administration. Dr. Gottlieb denied that, noting that the administration’s budget includes his request for the e-cigarette industry to pay fees, estimated at $100 million, that would primarily go toward enforcing limits on flavored e-cigarettes to protect teenagers. “What that tells you is I got broad buy-in into that,” he said in an interview.
When he became commissioner in May 2017, his goal was to move smokers to less harmful alternatives, such as e-cigarettes. That July, he allowed e-cigarette companies to keep their vaping devices and nicotine pods on the market for an extra four years before they would have to prove their products would benefit public health.
During that time, the F.D.A. also sought to limit nicotine in cigarettes to encourage smokers to switch to vaping. But his original plan grew untenable as evidence of Juul’s popularity with teenagers mounted.
In an interview, he recalled the morning in August 2018 when Mitch Zeller, the director of the agency’s tobacco control unit, brought him the bad news: Vaping was up 78 percent among high school students and 48 percent among middle school students, with 3.6 million youths reporting they had used e-cigarettes, according to the 2018 National Tobacco Youth Survey.
A few weeks later, Dr. Gottlieb called youth vaping an epidemic, and gave e-cigarette makers 60 days to show how they would curb youth vaping, or risk having their products pulled from the shelves. Juul pulled mango, crème and other flavors off the shelves but continued to sell them on line.
The conservative leaders now fighting restrictions on flavored e-cigarettes include Grover Norquist’s anti-tax group, Americans for Tax Reform, the R Street Institute and the American Legislative Exchange Council Action, a nonprofit. In a letter dated Feb. 4, a coalition of these and 13 other groups urged President Trump to “halt the Food and Drug Administration’s aggressive regulatory assault on businesses who sell and consumers who rely on less harmful alternatives to cigarettes in the United States.”
Both Juul and Altria say they had nothing to do with this message to the president. But in recent years, both companies have donated to Mr. Norquist’s group and to some of the other groups that signed the letter.
In 2017, Altria made contributions to the Goldwater Institute, the Rio Grande Foundation, the R Street Institute, and the Independent Women’s Forum, as well as Mr. Norquist’s group, according to an Altria annual philanthropy report that did not specify the amounts.
And Juul confirmed its contributions to Mr. Norquist’s group, the R Street Institute, where Tevi Troy, Juul’s vice president of public policy, and a friend of Dr. Gottlieb’s, was once a board member, and to ALEC Action. Juul declined to disclose the size of its donations.
Joshua Raffel, a spokesman for Juul, said the company had not asked the conservative coalition to write to the White House, but he acknowledged that one of the company’s lobbyists or consultants might have discussed it with the organizations involved. Juul spokesman, Matt David, said the company backs the restrictions on sales in convenience stores.
“We need category-wide action to further combat youth usage of all e-vapor products,” he said. That includes, Juul said, requiring the age restriction for tobacco and e-cigarette sales to be raised nationwide to 21, a legislative proposal that Dr. Gottlieb has supported.
Public heath advocates remain dubious about Juul’s commitment to curbing teenage use, with some saying the company wants to have it both ways: supporting groups that oppose restrictions on teenage access, while waging a public-relations campaign that it never intended youths to use its product.
Juul has also been ramping up its lobbying operation and political contributions. In 2018, it reported donations to the Democratic and Republican attorneys general associations, the Democratic and Republican governors associations, and other federal and state political committees. Juul’s political action committee and affiliated individuals also gave a total of $215,000 to federal candidates and their committees, according to the Center for Responsive Politics. Juul spent more than $1.6 million on lobbying last year, the center noted.
For years, the tobacco industry has come under fire for marketing cigarettes, especially menthol cigarettes, to African-American communities. Juul appears to be trying to court various groups — perhaps to promote its menthol-flavored e-cigarettes — with various donations. The San Francisco-based company has contributed to the Congressional Black Caucus Foundation, and the National Newspaper Publishers Association, a trade group for African-American owned community newspapers.
The company has also retained lobbyist Chaka Burgess, co-managing partner of the Empire Consulting Group who serves on the governing boards of the black caucus’ foundation and the caucus’ political action committee, and on that of the NAACP Foundation.
Juul has also announced a partnership with the Black Mental Health Alliance, although it declined to give details, as did the alliance. The vaping company said its $35,000 donation to the black caucus’ foundation involved buying a table at an event.
Taking another page from the Big Tobacco playbook, Juul also started JLI Science, a website showcasing Juul-funded research on electronic nicotine delivery system products. The Centre for Substance Use Research, based in Glasgow, Scotland, conducted several studies now listed on the site, including one that says adolescents who had never used an e-cigarette had very low interest in using one in any of Juul’s eight flavors, and another that concluded most adolescents had never heard of Juul.
Representative Diana DeGette, a Democrat from Colorado who now heads a House subcommittee that oversees the F.D.A., said she favors banning the sale of all flavored e-cigarettes. She also said in an interview that she plans to demand marketing documents that Juul submitted to the F.D.A., which has been investigating whether the company deliberately targeted youths.
Senator Charles Schumer, Democrat of New York, said on Sunday in an interview that he would press Dr. Gottlieb’s replacement to follow through on restricting sales of flavored e-cigarettes.
Dr. Gottlieb had planned to ultimately force tobacco companies to cut nicotine to nonaddictive levels, and said in interviews that he believed he had the authority as F.D.A. commissioner to issue such a policy, despite profound cigarette-industry opposition to cutting the ingredient that makes smokers crave their next smoke.
Altria last year told the F.D.A. that it would oppose any effort to reduce nicotine levels in cigarettes, and disputed the agency’s authority to do so. And it maintains two websites that cranked out thousands of virtually identical letters to the F.D.A. against nicotine reduction, signed by smokers.
Dr. Gottlieb had also suggested pursuing a ban on menthol cigarettes, and said that the F.D.A. is now developing that rule, which would need to win White House approval.
In comments on its website, Altria contends that a ban on menthol would damage public tax revenues generated by cigarette sales and lead to illegal black markets.
The American Lung Association often cites a study indicating that more than three-quarters of African-American cigarette smokers said they prefer menthol cigarettes, compared to less than a quarter of white smokers. Menthol cigarettes make up 35 to 40 percent of the market in the United States, according to the Centers for Disease Control and Prevention.
Asked if this effort would continue without Dr. Gottlieb’s leadership, a spokeswoman for H.H.S. declined to comment, but sent links to previous statements in support of the F.D.A.’s tobacco plans.
Dr. Gottlieb has acknowledged it would take years to move a proposed menthol ban forward.
“Big tobacco companies will want to educate whoever takes that position,” said Marc Scheineson, a lawyer who works with smaller tobacco companies. He said that these groups would inevitably try to reverse any move toward a menthol ban, which he called “a Scott Gottlieb priority.”
“He was definitely running this train,” Mr. Scheineson said.
15 March 2019