Eight years after it was given the power to meaningfully change smoking in America, the U. Food and Drug Administration moved to do so.
On Friday, the FDA announced it would take advantage of powers in the Family Smoking Prevention and Tobacco Control Act -- a law enacted under a Democratic Congress and then-President Obama -- to cut the level of nicotine in cigarettes to nonaddictive levels.
“A lot of people have been thinking about this for a long time, including experts in the agency, including myself,” FDA Commissioner Scott Gottlieb said in an interview with Bloomberg on Friday.
The move shocked Washington and Wall Street, sending tobacco stocks reeling. It’s also the latest sign that Gottlieb, appointed by President Donald Trump, views his mandate broadly. Gottlieb has taken steps to battle the high cost of prescription drugs and opioid addiction, too, two issues not squarely within the agency’s traditional purview.
“I’ve pledged a deep commitment to taking aggressive steps to address the epidemic of addiction to opioids,” Gottlieb said earlier Friday. “I view our opportunity to confront addiction to nicotine with the same obligation. I’ll pursue efforts to reduce addiction to nicotine with the same vigor.”
Passed by a Democratic Congress and signed by then-President Obama in 2009, the tobacco law gives the FDA “the authority to regulate the levels of tar, nicotine and other harmful components of tobacco products.” Yet until now, that authority hasn’t been so broadly used.
$130 Billion Industry
The move -- which came just hours after the failure of Republicans’ effort to repeal and replace much of the Affordable Care Act -- is likely to upend the $130 billion American tobacco industry and potentially encourage millions of people to quit smoking. It’s also likely to set off a lobbying fight in Washington, even as it pushes the cigarette industry to move faster in the development of new products that rely less on burning tobacco and more on potentially lower-risk technologies like vaping.
At the same time, the agency is making a nicotine-related compromise that has some anti-smoking advocates worried. The FDA said it will push back by five years until 2022 a deadline for electronic cigarette companies to submit applications to the FDA.
“I am concerned by delay in implementing the commonsense rules finalized last year,” Senator Richard Blumenthal, a Democrat from Connecticut, said in an emailed statement about the e-cigarette delay. “By dragging their feet, the FDA risks rolling back the incredible gains we have made to protect a new generation from a lifetime of disease -- and eventual death -- brought on by nicotine addiction and tobacco use.”
Tradeoffs
In a briefing Friday, Gottlieb called nicotine both the “problem” and “ultimately, the solution.” The FDA “must also recognize potential for innovation to lead to less harmful products,” he said.
Gottlieb said the agency needed more time to get the regulations in place to properly oversee newer tobacco products like e-cigarettes while at the same time cutting the addictive nicotine in traditional cigarettes.
“We were thinking about, or thought we could, potentially reduce levels of nicotine to create that inflection point in public health, taking a new balanced approach to new product innovations could make a lot of sense and help people transfer off cigarettes in a world where cigarettes were no longer addictive,” Gottlieb said in the interview.
Gottlieb also said regulators will look at banning menthol and flavored products because of their potential for attracting young people. An administration official said the White House supports the move, and disagreed that it was a break from Trump’s anti-regulation agenda.
“I went through deliberate process,” Gottlieb said in the interview. “We’ve been working on this for a while with the senior leadership of the tobacco center. Our policy understanding is fairly advanced. I’ve briefed all the appropriate people in on it.’
Surprise Move
It still came as a shock to some in Washington and Wall Street.
Representative Robert Aderholt, the Alabama Republican who runs the congressional subcommittee overseeing the FDA budget, said Gottlieb called earlier in the day to give him a heads up on the new policy.
“I’m still trying to get my arms around it,” Aderholt said Friday.
The Center for Tobacco-Free Kids, an anti-smoking advocacy group that’s been active in past tobacco regulatory changes, said it didn’t get a preview of the announcement. Staff were gathered in a conference room watching Gottlieb’s announcement when they got the news, Becky Wexler, a spokeswoman, said via email.
“This was a big surprise and will make it imperative that domestic tobacco companies strive to develop innovative, safer products,” said Jack Russo, an analyst with Edward Jones & Co. who follows the tobacco industry.
Stocks Plunge
Shares of Altria Group Inc., the maker of Marlboro cigarettes, fell 9. Shares of British American Tobacco fell 6. For both companies, it was the biggest one-day drop since 2008.
The timing of the FDA announcement may be particularly painful for British American Tobacco, which just completed its almost $50 billion acquisition of Reynolds American Inc. earlier this week.
The London-based company cited the “attractive” U. market when it sealed the deal, which brought it brands such as Camel and Newport.
While reducing nicotine is bad news for the cigarette business, the impact could be tempered for companies like Philip Morris International Inc. and Altria, which have been putting more emphasis on innovations they say have less health risks. Philip Morris has spent over $3 billion on developing its reduced-risk portfolio.
British American Tobacco’s Reynolds American division said it was encouraged by the move and that the FDA had recognized “tobacco harm reduction policies and the continuum of risk for tobacco products.”
Altria called the move “an important evolution” and said it “intend to be fully engaged throughout this process.”
— With assistance by Erik Wasson.
0 comments:
Post a Comment