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The Health 202: FDA could begin ramping up tobacco regulation efforts


with Paige Winfield Cunningham

The Food and Drug Administration created waves last month when it announced it would ban menthol cigarettes.

But that might be just the start when it comes to tobacco regulation. 

The agency has discussed the possibility of reducing the level of nicotine in cigarettes, a proposal that could have a seismic impact on the tobacco industry and public health.

“Reducing nicotine in cigarettes to nonaddictive levels would bring about the most fundamental change in the tobacco market in history,” said Matt Myers, the president of the Campaign for Tobacco-Free Kids and a proponent of nicotine reduction.

The discussions come amid a growing global push to end tobacco sales.

More than 140 organizations released a letter today calling on governments to begin plans to phase out the sale of all cigarettes. Signatories include the Association of American Cancer Institutes and schools such as the Johns Hopkins Bloomberg School of Public Health.

And New Zealand is soliciting feedback on a proposal that would slash nicotine levels in cigarettes by 95 percent and eventually phase out the legal sale of cigarettes.

“We’ve allowed ourselves to think of tobacco deaths as a normal part of the fabric of society,” said Chris Bostic, the policy director of Action on Smoking & Health, one of the organizers behind the letter. “Over 8 million deaths a year is anything but normal.”

In the United States, the Food and Drug Administration can’t ban cigarettes but it can require companies to lower nicotine levels to minimally addictive levels, as long as it’s not zero. Some experts think that alone would trigger a dramatic reduction in use, especially given that nearly 70 percent of American smokers say they want to quit. 

“The aim of this is basically to reduce or eliminate addiction. What drives cigarette smoking is becoming addicted to smoking,” said Neal Benowitz, a tobacco addiction researcher at the University of California at San Francisco.

FDA acting commissioner Janet Woodcock has confirmed nicotine reduction is “on the table.” 

Woodcock made the comments in a media briefing last month.

An FDA spokesperson confirmed the agency is continuing to review comments it received in response to a 2018 nicotine-reduction proposal put forward under former FDA commissioner Scott Gottlieb. That proposal, which announced that the agency would explore reducing nicotine to minimally addictive levels, stalled after Gottlieb left the Trump administration in 2019, but it could still form the basis for future rulemaking.

It also reflects years of government-backed research into the potential impacts of regulating nicotine levels.

One FDA-funded analysis published in the New England Journal of Medicine in 2018 predicted that lowering nicotine to minimally addictive levels would result in 5 million smokers quitting within a year and 13 million within five years. The smoking rate in the United States, which is currently at 14 percent in U.S. adults, would drop to 1.4 percent by 2060, according to this model. 

Still, it may not be the FDA that needs convincing.

“The issue is not the FDA. The issue is what do the American people want. In America we elect politicians, and they make the decisions. The FDA is a regulatory body,” said Robert Califf, a cardiologist who served as FDA commissioner under President Barack Obama.

Eric Lindblom, a former FDA executive focused on tobacco policy under the Obama administration, says that officials at the agency’s Center for Tobacco Products probably are supportive of nicotine reduction, but “without White House support, the nicotine rule will not happen, regardless of what FDA wants or tries to do.”

And nicotine reduction could be politically tricky.

The tobacco industry spent more than $28 million on lobbying last year. 

Califf, who is supportive of nicotine reduction, cautioned that it would be “politically challenging” and “divisive.” 

He referred to the New Zealand government’s push to eliminate cigarettes: “If you rank countries on a scale of how highly they value individual freedom versus societal good, the U.S. and New Zealand are on very different ends of that spectrum.”

Critics have raised concerns that the policy would create a black market in cigarettes.

Kaelan Hollon, a spokeswoman for the tobacco company Reynolds American, warns of a “high potential for a dangerous illicit market” if the United States bans all but very low nicotine cigarettes while the rest of the world allows higher nicotine content.

Hollon also points out that lower-nicotine cigarettes would not, in themselves, be any safer than regular cigarettes.

Even proponents of nicotine reduction, such as Califf, say that concerns about a black market need to be taken seriously.

“So far in the history of the U.S. in dealing with addictive substances, an illegal market has happened a hundred percent of the time,” he said.

It’s one reason some researchers argue that any policy to reduce nicotine would need to be accompanied by widespread availability of less harmful alternatives, including e-cigarettes.

Still, those in favor say the benefits would outweigh the costs.

About 480,000 Americans die of smoking each year — that’s more than the number of Americans who died of covid-19, the disease caused by the coronavirus, last year.

“A lot of smokers will quit. And the ones that quit completely will have big, big, big health gains, and the ones that switch to e-cigarettes will likely have some substantial health gains,” Lindblom said. “At the same time, any kids still experimenting with cigarettes will not be addicted to nicotine.”

Biden's budget

The White House is expected to leave key health priorities out of its budget plan.

The budget will not include President Biden’s campaign pledge to enact a public option to create a government-run health insurance program, or his pledge to cut prescription drug costs, according to people briefed on the internal matter, The Washington Post’s Jeff Stein and Tyler Pager report

Instead, the administration will focus on trying to pass what is has already introduced. Biden has proposed about $4 trillion in additional government spending along with major tax hikes, and the administration is struggling to advance those initiatives amid internal divisions among Democrats and limited prospects for bipartisan support.

The budget, which will be released on Friday, tells Congress how the president would like to see it spent money and is not binding.

While the administration is not expected to include the health-care priorities in its budget numbers, White House press secretary Jen Psaki said that the budget document will include a call for Congress to enact legislation to reduce drug prices and improve health-care coverage.

Ahh, oof and ouch

AHH: Coronavirus infections dropped below 30,000.

The seven-day average for coronavirus cases on Sunday was 25,679, less than one-tenth of the infection rate during the winter surge and the lowest average since the end of last June, The Post’s Lenny Bernstein and Joel Achenbach report

“The pandemic map remains speckled with hot spots, including parts of the Deep South, the Rocky Mountains and the Pacific Northwest. At the local level, progress against the contagion has not been uniform as some communities struggle with inequities in vaccine distribution and in the health impacts of the virus,” our colleagues write.

But a Covid-19 Community Profile Report released last week showed that the vast bulk of America has “low” or “moderate” viral burden. The 694 counties with “high transmission” is half as many as in mid-April.

A key question is whether smoldering infections in communities with low vaccination rates will flare up in the fall and winter, said David Rubin, director of PolicyLab at Children’s Hospital of Philadelphia, which has been modeling the outbreak for more than a year. 

“If we’re continuing to have disease reservoirs and we have areas with low vaccinations, it’ll hang on until the fall and start to pick up pace again. It’ll find pockets where there are unvaccinated individuals, and have these sporadic outbreaks,” Rubin told The Post.

OOF: A former FDA chief says that children will need to keep wearing masks in schools.

Gottlieb said on CBS’s “Face the Nation” on Sunday that parents of children under 12, who are not yet eligible for vaccines, will need to make individual risk assessments, but that it makes sense for kids to keep wearing masks indoors. He said the Centers for Disease Control and Prevention probably would need to reassess its guidance recommending mask-wearing outdoors at summer camps, The Post’s Amy B Wang writes.

“Wearing masks is difficult in the summertime when it’s hot, and I don’t think that the risk merits that,” Gottlieb said. “But I do think parents need to make an assessment about the risk of the environment. … In a crowded, indoor, stuffy setting, in a classroom, for example, I think having kids continue to wear masks for a period of time is reasonable.”

CDC officials have indicated that they are planning to release updated guidelines for summer camps, schools and businesses. 

OUCH: Flush with federal aid, wealthy hospitals bought up smaller ones during the pandemic.

Federal bailouts cushioned large hospital systems from financial losses and allowed them to continue scooping up competitors and doctors' offices, a spending spree that experts say will lead to more consolidated markets and higher prices, the New York Times’s Reed Abelson reports.

“The buying spree is likely to prompt further debate and scrutiny of the Provider Relief Fund, a package of $178 billion in congressional aid that drew sharp criticism early on for allocating so much to the wealthiest hospital systems, and that had no limits on mergers and acquisitions,” Reed writes.

Hospitals argue that the federal aid played no role in the deals, some of which were in the works before the start of the pandemic. And some major hospital chains have argued that large, consolidated systems were better able to respond to the pandemic.

Still lawmakers are pushing for greater scrutiny into hospital aid, something that could play a factor as the Biden administration determines how to distribute the remaining $25 billion in aid.

More in coronavirus news

A report on sick staff at a Wuhan lab could fuel debates over the origin of the coronavirus.

A previously undisclosed U.S. intelligence report said that three researchers from China’s Wuhan Institute of Virology became sick enough in November 2019 to seek hospital care, the Wall Street Journal reports. The intelligence report provides more detail into events first alluded to in a State Department fact sheet issued in the final days of the Trump administration. The fact sheet said that several researchers in the lab had become sick “with symptoms consistent with both Covid-19 and common seasonal illness.”

“It isn’t unusual for people in China to go straight to the hospital when they fall sick, either because they get better care there or lack access to a general practitioner,” the Wall Street Journal’s Michael R. GordonWarren P. Strobel and Drew Hinshaw write. “Still, it could be significant if members of the same team working with coronaviruses went to hospital with similar symptoms shortly before the pandemic was first identified.”

The report could add fuel to the hypothesis that the pandemic originated when the novel coronavirus leaked out of a lab in China. Many scientists remain skeptical of this theory, however. Current and former officials also expressed differing views on the strength of the evidence included in the U.S. intelligence report.

  • Although many colleges and universities, and some travel companies, have imposed vaccine mandates, other employers have held back, The Post’s Dan Diamond reports.
  • Nursing homes are seeking to dodge wrongful death lawsuits by invoking liability protections extended by Congress and the Trump administration at the start of the pandemic, Politico’s Susannah Luthi and Rachel Roubein report.
  • As a catastrophic coronavirus surge has devastated India’s health-care system, doctors throughout the Indian diaspora, including in the United States, are trying to fill the void from afar, The Post’s Fenit Nirappil reports.

Sugar rush

Fifteen months after the New Orleans’ French Quarter was completely shut down, visitors and music are slowly returning. (Video: Robert Ray/The Washington Post)