The U.S. Food and Drug Administration is taking the first steps toward what could become government-mandated standards to reduce nicotine levels in cigarettes.
The federal agency has had the authority to regulate tobacco products since 2009, and it announced last year it would explore putting limits on nicotine, the addictive agent in tobacco.
While the FDA cannot require that nicotine be removed from cigarettes, the agency said Thursday it will seek scientific and public input for a rule-making process that could set maximum nicotine amounts as a way to make cigarettes less addictive.
“This would make it harder for future generations of vulnerable teens to become addicted in the first place, and it would allow more currently addicted smokers to quit or completely switch to potentially less harmful products,” FDA Commissioner Scott Gottlieb said during a news conference.
The FDA is opening a 90-day public comment period on the proposed rule-making, and officials said they would evaluate the input and determine what steps to take next. Comments can be submitted starting Friday at www.federalregister.gov.
It is unclear whether the FDA will ultimately set rules, and how long that might take. The process will involve navigating some complex scientific issues, including what maximum level of nicotine would be most effective. The standards would not affect non-combustible tobacco products.
Altria Group Inc., the Henrico County-based parent company of top U.S. cigarette maker Philip Morris USA, said Thursday that the FDA’s action is “a request for information, not a proposed rule, and is the first step in a multi-year process that will require the agency to examine and resolve many complex issues.”
Any nicotine standards would need to be part of a “comprehensive package” that would include steps to encourage the development of less harmful products, the company said. “Altria has already been preparing for any reasonable potential standard, and we plan to participate in every step of this process,” said Murray Garnick, Altria’s executive vice president and general counsel.
Limiting the nicotine in conventional cigarettes could lead tobacco companies to put more emphasis on development of alternative products, such as electronic cigarettes and vaping products, said Steve Marascia, director of research at Capitol Securities Management in Henrico County. Marascia said the rule-making process “will not be done quickly.”
In a note to investors, tobacco industry analyst Bonnie Herzog of Wells Fargo Securities LLC also predicted “a long, multi-year process.” Any final rules could end up facing legal challenges, she said.
“While we think there is a sense of urgency at the FDA, we still believe it will take four to five years before any potential changes are implemented, given the sheer complexities and risks involved,” Herzog wrote.
Among the issues the FDA must consider are the possible unintended consequences. For instance, reducing nicotine might cause smokers to compensate by smoking more, and regulations might lead to an illicit market for higher-nicotine cigarettes.
The FDA also said it will consider the “technical achievability” of reducing nicotine. Reductions might be achieved through tobacco blending, cross-breeding of plants, genetic engineering, chemical extraction and agricultural practices, the agency said. The FDA also has to consider how quickly any rules could be implemented, and it will seek information on the costs, including costs to tobacco farmers.
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