FDA on shaky ground
Clive Bates is director of Counterfactual Consulting. He is a former senior civil servant and was director of Action on Smoking and Health (U.K.) from 1997 to 2003.
The US Food and Drug Administration’s policy shift toward reducing nicotine in cigarettes is likely to attract significant tobacco-industry litigation, according to a Bloomberg News story relayed by the TMA.
In announcing a week ago its Comprehensive Plan for Tobacco and Nicotine Regulation, the FDA said that it would require the reduction of cigarette nicotine deliveries to non-addictive levels if that were found to be technologically and practically feasible.
The Bloomberg piece speculated that the tobacco industry would go to court to stop the FDA from imposing or enforcing its regulatory framework.
The article noted that, according to tobacco lobbyists, the industry could argue that the policy amounted to a de facto ban on cigarettes.
And while a 2009 law gave the FDA the power to regulate cigarettes, it explicitly stated the agency did not have the power to ban them.
Even some anti-smoking advocates think the FDA is on shaky ground with its proposal. “The legal mandate that they have to do this is extremely weak,” Clive Bates (pictured) was quoted as saying. “They say they’re not banning cigarettes, but they are banning cigarettes with any meaningful level of nicotine in them.”
Lastly, the Bloomberg piece noted that FDA Commissioner Scott Gottlieb, who was confirmed in early May, was ‘turning out to be among the most aggressive (and unpredictable) cabinet officials during the early days of the Trump administration’, which favored deregulation.
‘It’s not clear whether Gottlieb personally sought President Trump’s counsel before making the announcement,’ the piece said. ‘An administration official says the White House supports the policy and disagreed that it was a break from Trump’s anti-regulation agenda.’
