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December 8, 2020

Biden’s Health Team and Vaping: What Do We Know?

President-Elect Joe Biden named several key members of his healthcare team Monday, and although there is still one major position to be filled that could affect vaping (FDA commissioner), we decided to go over the appointees and consider how they might matter to the vaping debate and future policy. We’ve also discussed how some of the FDA possibilities might fit in.

HHS secretary: a surprise choice

Biden has chosen California Attorney General Xavier Becerra to lead the Department of Health and Human Services. The HHS secretary oversees the FDA, CDC, National Institutes of Health (NIH), and the Centers for Medicare and Medicaid Services (CMS). HHS has a budget of more than $1 trillion—the largest of any cabinet department—and more than 80,000 employees.

Becerra is a somewhat odd choice for the job. His history as a 12-term Congressman representing Los Angeles and as California’s Attorney General since 2017 doesn’t include much experience with healthcare issues. As a prominent Hispanic political leader, he ticks an obvious box for Biden—but New Mexico Governor Michelle Lujan Grisham would also have been popular among Latinos, and she has extensive healthcare policy experience and the benefit of having run a state government.

In fact, Lujan Grisham—who supported and signed a compromise vaping bill in New Mexico that did not include a flavor ban—was a frontrunner for the job until last week, when news leaked that she had turned down an offer to be Interior secretary. Other names that were mentioned as possibilities—Rhode Island Gov. Gina Raimondo and former Obama Surgeon General Vivek Murthy—probably would have been much worse for vaping than either Lujan Grisham or Becerra. (Murthy wound up being tapped for an encore stint as Surgeon General.)

Becerra has only a minor history with vaping since becoming California’s top law enforcement official, but he seems generally opposed. He filed comments with the FDA supporting a flavor ban except for products able to prove an “overall public health benefit,” and also backed the FDA scheme to reduce nicotine in cigarettes below addictive levels (which would actually require non-combustible nicotine products like vapes to be available for smokers). He has also indicated support for an online sales ban of all tobacco products.

Becerra recently filed a brief defending the California Assembly’s ban on all flavored tobacco products (including vape products) against a lawsuit brought by tobacco companies. (Attorneys General are always expected to defend state laws against challenges, so don’t make too much of this.) And last year Becerra filed a lawsuit against Juul Labs, charging the San Francisco-based vape company with marketing and selling its products to minors.

Becerra was a surprise as HHS nominee. His name had circulated as a possible Biden choice for Attorney General, or as a Senate replacement for Kamala Harris (California Gov. Gavin Newsom will appoint someone to serve the balance of Vice President-Elect Harris’ Senate term).

Becerra’s most important job at HHS, if he is approved by the Senate, will be to coordinate the federal response to the coronavirus pandemic, along with COVID “czar” Jeffrey Zients (who, like Becerra, has no medical background), National Institute of Allergy and Infectious Diseases Director Anthony Fauci (who will also serve as chief medical adviser to Biden), new CDC Director Rochelle Walensky, and Surgeon General Murthy.

In fact, the coronavirus crisis is likely to be the main focus of every HHS agency for the foreseeable future. Expanding COVID testing and distributing vaccines will be full-time jobs for the administration’s health team. While the FDA Center for Tobacco Products’ work will not be interrupted by the pandemic, it’s unlikely that the HHS secretary will have time to put his thumb on the scale of vaping regulations (even if he’d like to). That doesn’t mean that an FDA commissioner dedicated to anti-nicotine ideology won’t do that, of course—but Becerra himself is unlikely to take his eye off the coronavirus ball for the next two years, assuming his nomination is confirmed by the Senate.

CDC director: a respected infectious disease expert

Biden will replace current CDC Director Robert Redfield with Rochelle Walensky of Massachusetts General Hospital and Harvard Medical School. Like Drs. Redfield and Fauci, Walensky is an infectious diseases expert, specializing in HIV/AIDS. She will be tasked with leading the agency during the COVID crisis, and rebuilding its reputation.

Researching Walensky, I could find nothing on vaping issues at all, and no obvious connections to the Bloomberg Philanthropies tobacco policy empire (aside from receiving her medical degree in the early 1990s from Johns Hopkins University, which later received billions from alumnus Michael Bloomberg), which is the source and funding mechanism for most prohibitionist anti-nicotine activism.

That may be good or bad. It may be beneficial that she has no preconceived ideas about vaping, and might be persuaded that a practical harm reduction approach could work. But it’s just as likely that her lack of knowledge or interest in e-cigarettes will mean the existing staff at the CDC Office on Smoking and Health will continue to run their operation without substantial input or oversight.

It was CDC’s deliberate misinformation during last year’s outbreak of vaping-related lung injuries that led to dozens of deaths and thousands of hospitalizations. The source of the outbreak was black market THC oil that was diluted with vitamin E acetate, but the agency persisted in warning Americans about the risk of using “e-cigarettes,” which is a term users apply only to nicotine vaping products.

Surgeon General: everything old is new again

Vivek Murthy will return as Surgeon General, but the job will be expanded to include substantial responsibilities as part of the coronavirus response team. He has been a co-chair of Biden’s COVID advisory group, and was rumored to be under consideration for HHS secretary. However, Murthy has no administrative experience.

Murthy, a Harvard-trained doctor, originally held the Surgeon General job for just over two years under President Obama, and was dismissed in 2017 by President Trump, who replaced him with Jerome Adams, the former Indiana State Health Commissioner (appointed by then-Indiana governor Mike Pence). Murthy was nominated in 2013 by Obama, and finally approved by the Senate more than a year later.

He is famous in the vaping community for the report issued during his tenure titled “E-Cigarette Use Among Youth and Young Adults.” Of course, the SG had no part in creating the document or the accompanying website, which was put together largely by the CDC Office on Smoking and Health. But Murthy promoted the effort with zeal, and used his position to inflame opinions as vaping slid inevitably into the “youth epidemic” years.

Assuming he is confirmed by the Senate (his first approval was rocky), Murthy’s second go-round as SG will likely be dominated by the HHS response to the coronavirus crisis. But he may also wind up as point man on vaping for Becerra, especially if the FDA commissioner isn’t especially interested in the topic.

FDA commissioner: two frightening possibilities

Update Jan. 14
President-Elect Biden has named longtime FDA administrator Janet Woodcock to serve as acting FDA commissioner until a permanent appointment is made.

The job most likely to directly impact vaping and tobacco policy is FDA commissioner, and Biden has yet to announce a nominee. Rumor has it that two frontrunners for the job are Josh Sharfstein and David Kessler, and neither would probably be good for vapers or the vaping industry.

Josh Sharfstein

Sharfstein, a Harvard-trained pediatrician, was an Obama-appointed FDA principal deputy commissioner when the agency was seizing e-cigarette shipments from China in 2009, which led to the lawsuit challenging the agency’s ability to regulate vaping products as drugs or drug devices. If NJOY hadn’t pursued that legal challenge to the end, the American vaping market would not have existed. Sharfstein was often the face of the FDA’s opposition to vaping, defending the agency’s actions and exaggerating the risks of e-cigarettes.

While Sharfstein may sometimes say things like, “Unlike combustible tobacco products, if appropriately regulated, ecigarettes have the potential to help save the lives of many Americans,” he generally advocates the same strategies supported by anti-vaping leaders like Matthew Myers of Campaign for Tobacco-Free Kids: banning flavors and advertising, and raising taxes. He has spoken and written often on the issue, usually to brag that he had raised the alarm early and wasn’t listened to.

Sharfstein has also served as Baltimore’s health commissioner, and later held the same job for the state of Maryland. Since 2014, he has served as an associate dean at the Johns Hopkins Bloomberg School of Public Health. He is familiar and friendly with all of the key players in the Bloomberg Philanthropies anti-tobacco universe.

If Sharfstein becomes FDA chief, he is not likely to miss his second bite at the vaping apple. Expect him to push the Center for Tobacco Products to impose exacting standards for PMTA approval and to reject flavored vaping products altogether. He would likely also welcome new and tougher laws from Congress on flavors and online sales.

David Kessler

Kessler is a pediatrician and a lawyer, and served as FDA commissioner for both George H. W. Bush and Bill Clinton. After leaving the FDA, he was dean at both the Yale and University of California-San Francisco medical schools. He is currently serving as a co-chair on Biden’s COVID-19 Advisory Board.

Kessler was a central figure in the events now referred to as the Tobacco Wars. At FDA, Kessler investigated the tobacco companies, and eventually attempted to regulate cigarettes as a drug, leading to a lawsuit—FDA v. Brown & Williamson Tobacco Corp.—which made its way to the Supreme Court. In 2000, the FDA lost the case by a single vote. (Later the FDA would be given regulatory authority over tobacco by Congress in the 2009 Family Smoking Prevention and Tobacco Control Act, which was compromise legislation supported by both tobacco giant Philip Morris and anti-smoking advocates like Matthew Myers.)

Kessler is seen as a hero by anti-tobacco activists, and he is likely to apply his beliefs about the tobacco industry to the vaping market too. For example, he would like to keep vaping products behind pharmacy counters, and like HHS nominee Becerra, he is a proponent of reducing nicotine content in cigarettes, as former FDA commissioner Scott Gottlieb proposed in 2017.

Kessler has said as recently as 2019 that he doesn’t believe the FDA will approve any nicotine salt-based vaping products, blaming Juul for poisoning the well. “I don’t see with the record that has been created today and with the explosion in youth use, that this is an industry that under the current model has any certainty,” he told CNBC.

“Kessler and Sharfstein both appear to believe that vaping products are a societal evil that can only be addressed by prohibitionist policies,” says American Vaping Association President Gregory Conley.

“Of the two very bad choices,” Conley added, “Kessler is the most dangerous, as his reputation of fighting the tobacco industry in the 1990s will always be brought up favorably by the news media and policymakers alongside his actions on vaping.”

Other possible choices

There have been many names floated for the FDA position. Sharfstein is clearly a favorite, but so were several people who didn’t get the HHS top job. Biden seems willing to make surprising choices, and he might do the same at the FDA.

Luciana Borio, a former assistant FDA commissioner and another member of Biden’s COVID-19 task force, is a name mentioned frequently. Another top possibility is current PDA principal deputy commissioner Amy Abernethy. And some observers think Biden might leave current FDA Commissioner Stephen Hahn in place. However, Hahn recently told reporters he hasn’t been in contact with the Biden transition team.

Senate confirmation

All of the jobs mentioned here, except CDC director, require Senate confirmation, and may face a tough road—as will Biden’s choice for Office of Management and Budget director, the current Center for American Progress president Neera Tanden. (The OMB plays an important role in the White House. It analyzes and approves rules developed by executive agencies like the FDA, and serves as a check on those agencies. For example, it was President Obama’s OMB that prevented the FDA from banning flavored vaping products in the Deeming Rule.)

HHS nominee Xavier Becerra has no medical or healthcare background, and as California Attorney General has defended the Affordable Care Act, which is despised by Republicans. Surgeon General candidate Vivek Murthy barely got approved the first time around, and will probably face the same skepticism over his gun control stance this time, with less margin to lose votes.

FDA commissioners are often challenged in Senate confirmation hearings, but if Biden chooses David Kessler in particular, the hearings would likely be explosive. Although he was originally appointed by a Republican president, Kessler is seen as anti-free enterprise, and his nomination might entail objections from conservative and moderate Democrats as well as Republicans.

Unless Democrats prevail in both Georgia runoff elections in January—a long shot—Republicans will maintain a Senate majority, and they will probably use that power to challenge some of Biden’s cabinet nominees and the non-cabinet health positions that require approval. Republican senators won’t try to derail all of Biden’s choices, but they will probably target a few to shut down, including Tanden and possibly Becerra.

Will the Biden administration wage war on vaping?

Biden is a Democrat, and Democrats have proven to be more likely to support restrictive laws and regulations on vaping, which many of them consider a plot by tobacco companies to ensnare a new generation of customers. They don’t like tobacco companies—but most of them don’t really understand the vaping issue enough to take informed positions. Instead, they simply put their trust in the established anti-smoking groups, like Tobacco-Free Kids and the American Academy of Pediatrics, because they see those groups as noble warriors against the evil tobacco industry.

Biden doesn’t seem to have any particular axe to grind with vaping. If you eliminate a nonsensical comment made early this year referring to vaping and the “EVALI” lung injuries, he has no record on the topic at all. Not a single article I’ve read about Biden’s health care priorities (and I’ve read a lot of them) has even mentioned vaping. That doesn’t mean an adviser won’t convince him it’s important, as HHS Sec. Alex Azar convinced President Trump to ban flavors in 2019. But right now, it’s not a priority—or even a side issue—and it’s unlikely to become one at least until the coronavirus pandemic is over.

The pandemic has probably hastened the decline of vaping as a major issue, but even without COVID, moral panics can’t sustain their momentum forever. With the departure of “EVALI,” and a 29 percent decline in youth vaping this year, it may have lost some of its cachet. Of course, Matthew Myers and the Bloomberg-funded vaping opponents will do everything they can to keep the issue alive. But for the most part, serious health policy people have bigger fish to fry right now.

That’s probably a double-edged sword. If anti-vaping groups can’t get what they want in Washington, they’ll press state and local governments to take action. That means we can expect a tsunami of flavor bans next year in state legislatures and city councils, which ultimately are just as damaging as federal action.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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Todd
Todd
1 month ago

Just wait until some loser gets the bright idea that vaping can carry the coronavirus and infect people. And runs with it.

Kath
Kath
1 month ago

Thank you for wrangling all the summaries on the potential trajectories of the nominations/appointments in regards to THR legislation.

I am hopeful that the growing body of data on Covid-19 & the prophylactic property of nicotine & the ACE2 receptor & the release of You Don’t Know Nicotine will nudge things in a positive way in 2021.

Ed B
Ed B
1 month ago

Well said Jim.But I feel it will be a few years before Biden or any state or governments will push vaping bans.Yes some already have done so but with the pandemic plus everything else that’s raging across the world vaping is probably the furthest thing from their immediate to do list. Stay safe and happy holidays to you

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