FDA Plans to Reduce Nicotine in Cigarettes-and Big Tobacco Must Comply

A smoker is seen holding his cigarette during a smoke break outside a building in North Vancouver B.C. Monday Jan. 20 2014

FDA Plans to Reduce Nicotine in Cigarettes-and Big Tobacco Must Comply

A study released Thursday in the New England Journal of Medicine projected that cutting nicotine to a non-addictive level could mean five million fewer smokers in the first year of implementation.

As part of the FDA road map announcement, the agency made a concession on the grandfather date on new tobacco and nicotine products to August 8, 2016.

USA regulators Thursday opened the door to slashing the amount of nicotine in cigarettes in order to make them less addictive, a move that could mean millions fewer smokers in the years to come.

"We're also jump-starting new work to re-evaluate and modernize our approach to the development and regulation of safe and effective medicinal nicotine replacement products, such as nicotine gums, patches and lozenges that help smokers quit", Gottlieb said.

The FDA gained authority over e-cigarettes in 2016, but Gottlieb delayed a deadline for manufacturers to submit their products for review until 2022.

Take the current opioid epidemic, which has reached a fever pitch in the country, ruining millions of lives and now leading to the deaths of more than 60,000 people a year. Smoking causes more than 480,000 deaths each year, despite decades of anti-smoking measures that have pushed the smoking rate to new lows. It's the burning tobacco and other substances inhaled through smoking that cause cancer, heart disease and bronchitis. Those alternative nicotine-delivery products include e-cigarettes or nicotine replacement therapies. But FDA's regulatory efforts have been hampered for years by legal challenges by Big Tobacco companies.

Just recently, the U.S. Food and Drug Administration filed new documents related to a proposal to slash levels of nicotine in cigarettes.

"Altria has already been preparing for any reasonable potential standard, and we plan to participate in every step of this process", said Altria, parent company of Marlboro-maker Philip Morris USA, in a statement. FDA officials are seeking input on what the maximum nicotine level in cigarettes should be and whether such a limit should be implemented all at once or gradually. Genetically engineering a new variety is another possible solution, as is chemically treating plants to remove some of the nicotine.

The Campaign for Tobacco-Free Kids called the FDA plan "bold" and urged the agency to act quickly and set a hard deadline. "The government does have a responsibility to help keep Americans healthier and whatever laws they enact to help people cut down and quit smoking is going to help everybody", said Le.

"The jury is still out on the value of those products as alternatives", Gottlieb said, but he added there are opportunities for other potentially lower-risk products.

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