Republicans reacted in surprisingly muted fashion yesterday after FDA chief Scott Gottlieb proposed a bold and striking change for a conservative member of President Trump’s administration, announcing that he’s setting in motion new regulations to make cigarettes less addictive.
Enacting the standards could take years, but Gottlieb kicked off the rulemaking process by unveiling an “advance notice of proposed rulemaking” that will be published today in the Federal Register. The FDA chair's move would make the United States the first country to limit the nicotine content of cigarettes — and it is also the biggest tobacco crackdown by far in the near-decade since Congress passed a law allowing the government to start regulating such products.
The FDA will have to answer scads of questions on its plans as the agency seeks input from the industry, health advocates and other stakeholders — such as exactly how high nicotine levels can be and whether the limits should be enacted gradually or all at once. Yesterday, officials pointed reporters to new data finding that slashing nicotine levels to 0.4 milligrams per gram of tobacco filler could push the U.S. smoking rate down to 1.4 percent from 15 percent, a projection Gottlieb also touted:
Today’s milestone places us squarely on the road toward achieving one of the biggest public health victories in modern history. If implemented, lowering nicotine in cigarettes to minimally or nonaddictive levels could save millions of lives: https://t.co/4kPZMsh9Tx pic.twitter.com/WLNSB3Bguu— Scott Gottlieb, M.D. (@SGottliebFDA) March 15, 2018
Per @US_FDA estimates in @NEJM from one possible policy scenario, limiting nicotine in cigarettes could have a major impact on smoking rates & could prevent more than 8 million deaths from tobacco by the year 2100: https://t.co/LNgQ3iEiIQ pic.twitter.com/o9QNZbqbCA— Scott Gottlieb, M.D. (@SGottliebFDA) March 15, 2018
But Republicans in Congress, even those most deeply involved in health-care police, had little to say yesterday. The surprise move by Gottlieb, who is quickly becoming known as one of the most energetic regulators in the Trump administration, could put them in an awkward position.
Altria Group, the parent company of the massive tobacco company Philip Morris, heavily favors Republicans in its election spending. In the 2016 cycle, more than three-quarters of its total spending went to GOP candidates or committees, according to the website Open Secrets. Its top recipient was the Congressional Leadership Fund, a super PAC that helps elect Republicans to the House.
Staff for House Ways and Means Chairman Kevin Brady (R-Tex.) and Sen. Lamar Alexander (R-Tenn.), chairman of the Health, Labor, Education and Pensions Committee, didn’t respond to requests for comment on the FDA chair's move.
A GOP aide to the House Energy and Commerce Committee, chaired by Rep. Greg Walden (R-Ore.), said they’re supportive of the agency’s “public, inclusive process for determining innovative ways to potentially save millions of lives." But the aide urged agency leaders to collect feedback from a wide array of stakeholders.
“In order to be confident federal laws and regulations acknowledge the latest scientific data, lawmakers and agency leaders must hear from current and former tobacco users, doctors, researchers, industry as well as any other groups, like employers, who experience both the direct and indirect impacts of combustible tobacco use,” the aide said.
Democrats offered a swifter and more enthusiastic reaction. Top Energy and Commerce Democrat Frank Pallone (N.J.) called Gottlieb’s proposal a “promising step forward” that “could help prevent the next generation from becoming addicted to cigarettes.”
Sen. Patty Murray (Wash.), the top Democrat on the Health, Education, Labor and Pensions Committee, said she’s “hopeful” the FDA will move swiftly toward a “strong rule that brings us in the right direction of reducing nicotine levels, making tobacco products less addictive and protecting our children.”
“The science has been clear for decades — we need to take action to prevent children from becoming addicted to nicotine and protect them from the serious health hazards that come with it,” she said in a statement.
The Family Smoking Prevention and Tobacco Control Act — the law Congress passed and President Barack Obama signed in 2009 — stops short of allowing the FDA to ban smoking or nicotine outright. But the agency does have broad leeway to control how products are made and advertised.
The FDA notice posting today will be open to comments for 90 days, my colleague Laurie McGinley reports. Other critical questions to be addressed include the potential for illicit trade in high-nicotine cigarettes and whether addicted smokers would compensate for lower nicotine levels by smoking more. After the comment period ends, officials will decide whether to move forward with a formal proposal.
Gottlieb had hinted at potential aggressive action last summer, when he announced the agency would pursue a comprehensive tobacco and nicotine plan in an effort to avert millions of tobacco-related deaths. Smoking is at an all-time low in the United States, and tobacco use among young people is also at historically low rates. Still, smoking causes 480,000 deaths annually in this country, Laurie notes.
“We’re taking a pivotal step today that could ultimately bring us closer to our vision of a world where combustible cigarettes would no longer create or sustain addiction — making it harder for future generations to become addicted in the first place,” Gottlieb wrote yesterday.
The Scientific American's Dina Fine Maron:
FDA's Mitch Zeller (tobacco czar) says cigarettes are the only product that, when used as intended, mayl kill half of all users prematurely. Capping nicotine lvls could help agency says. But so many unanswered ?s: what should lvl be? how measure it? will it spark illicit trade?— Dina Fine Maron (@Dina_Maron) March 15, 2018
The New York Times's Margot Sanger-Katz:
The focus is on “combustible” products, which, presumably, will have ripple effects in other nicotine-containing products, including e-cigarettes.— Margot Sanger-Katz (@sangerkatz) March 15, 2018
A senior fellow at the Consumer Choice Center criticized the FDA's move, saying the proposal puts policy before science:
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AHH: On Monday, the White House plans to roll out more detailed proposals for taking on the nation’s opioid crisis, a senior official told NBC News. The plan is expected to call for tougher penalties, potentially including the death penalty for traffickers, along with changes to treatment and recovery policies and programs for those struggling with addiction.
Trump is expected to announce the plan during a visit to New Hampshire, which has the third-highest drug overdose rates in the country. “We have six billion dollars in short term funding to work with" the senior official said, referring to the level of opioids funding Congress has set aside for the upcoming omnibus spending bill.
The White House has already hinted at how it would like that $6 billion to be used in its budget request last month. But the plan scheduled for release Monday will paint a fuller picture of the ways in which Trump and his appointees want to spend the funds.
OOF: A new study finding more Americans are exercising but the obesity rate continues to grow is the latest evidence that exercise doesn't help with weight loss as much as we'd once thought (or perhaps hoped!). Last year, 53.8 percent of Americans met recommended physical activity guidelines, up from just 41 percent who met the guidelines in 2005, according to the National Center for Health Statistics. Yet 31.4 percent of people older than 20 were obese in 2017, a big increase over 19.4 percent who were obese in a 1997 version of the study.
The figures don't indicate exactly who is working out more — obese Americans or those who don't qualify as obese. But CDC scientists noted to the Hill that experts believe a healthy diet is more important to weight loss than going for a jog. “A dietitian will tell you that nutrition is 70 percent of what contributes to weight loss,” said Tainya Clarke, a health statistician at the center. “Obesity is the result of complex interactions.”
OUCH: The lawsuits are piling up against a San Francisco fertility clinic where thousands of frozen eggs and embryos were possibly destroyed in a storage tank that malfunctioned. Jonathan and Megan Bauer, a couple who lost all eight embryos they were keeping at the center, announced a lawsuit yesterday, the AP reports. Their lawyer Adam Wolf said Megan Bauer was set to undergo an implantation in April using embryos the couple had stored for several years. Wolf said the couple are now in their late 30s and aren't sure they can afford additional fertilization procedures.
“Our clients’ embryos as well as their dreams of future children were irrevocably destroyed,” Wolf said. The Post's Ariana Eunjung Cha reported Wednesday on a class-action lawsuit against Pacific Fertility Center.
—Yesterday, VA Secretary David Shulkin sought to downplay reports of his ouster from the department, telling lawmakers he has no intention of leaving his role. “I came here for one reason and that is to improve the lives of veterans,” Shulkin said during a hearing before a House Appropriations subcommittee.
Our colleague Lisa Rein scooped yesterday that President Trump is eyeing Fox News personality Pete Hegseth, who is a conservative voice on veterans’ policy, to replace Shulkin. Lisa writes Hegseth “has railed against Shulkin and members of Congress in both political parties for their moderate approach to offering veterans access to private doctors.”
The White House did not explicitly say whether Shulkin would remain in his gig, however. White House press secretary Sarah Huckabee Sanders said the administration “has a large number of individuals” working to help veterans through the VA. "We are continuing to review if there are anything that we can do to improve on that system. And if we make changes, we will let you know,” she told reporters, adding "every day we're looking at how we can better the system, whether it's through policy changes or personnel changes, not just at the top level, but across the board."
During the hearing, Shulkin acknowledged reports by The Post and others that he's being heavily undermined within his own agency, describing the situation as a recent “distraction.”
“I’ve publicly acknowledged that the distraction that has happened that you’ve talked about is something that I deeply regret,” Shulkin said. “And I’ve made it clear to everybody in my department that I have no tolerance for anything other than the business that have to do for VA. I believe that we are getting back on track with that, and I’m going to do everything I can to keep our focus on the work that we have to do because there’s a lot of work to do, as you mentioned, that impacts people’s lives.”
—In his own appearance on Capitol Hill, HHS Secretary Alex Azar declined to say whether he would fire Scott Lloyd, director of the Office of the Refugee Resettlement, for allegedly blocking immigrant minors in government custody from getting abortions. Abortion-rights groups and several Democrats have focused their fire on Lloyd, demanding HHS let him go.
“I’m going to just ask you flat out, Mr. Secretary, when will you fire Lloyd?” Rep. Rosa DeLauro (D-Conn.) asked Azar in an appropriations hearing.
"This is simply not an issue of Mr. Lloyd," Azar responded. "This is the statutory obligation of the director of the Office of Refugee Resettlement to coordinate and improve the care of placement of these minors, including providing for serious medical services to them.”
“So you’re not going to do that and you’re going to put their health in jeopardy?” DeLauro asked again about firing Lloyd. Azar mostly dodged the question. “I certainly appreciate any concerns you have, but I do want to make very clear this is not about Mr. Lloyd. This is about long-standing policy and procedure of the Department of Health and Human Services," he said.
Activists and lawmakers delivered a petition with more than 250,000 signatures calling for Lloyd’s removal. The petition was signed by groups including the Center for American Progress Action Fund, the National Latina Institute for Reproductive Health, NARAL Pro-Choice America, Planned Parenthood Action Fund and Physicians for Reproductive Health, among others.
“Blocking young immigrant women from abortion care is a shocking abuse of power from Trump appointee Scott Lloyd,” Rep. Jan Schakowsky (D-Ill.), who is involved with the petition, said in a statement following the hearing. “He clearly thinks he is above the law—but he isn’t. We won’t allow these egregious actions under our watch. I’m proud to join the call for his removal.”
--A few more good reads from The Post and beyond:
- Kaiser Family Foundation holds an event on the status of recovery in Puerto Rico and the U.S. Virgin Islands following Hurricanes Irma and Maria on March 19.
Police release surveillance video from Parkland school massacre:
Here's how Trump's supporters explain away his language:
Democrat Conor Lamb was attacked as a "Pelosi liberal" during the campaign, but now Republicans are calling him "conservative:"