FDA targ­ets cigarettes to widen its fight against addiction in US

Bloomberg

Eight years after it was given the power to meaningfully change smoking in America, the US Food and Drug Administration (FDA) moved to do so.
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.
The move shocked Washington and Wall Street, sending tobacco stocks reeling. It’s also the latest sign that Gottlieb, appointed by
US 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 on 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 vigour.”
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 on 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 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.