FDA planning to lower nicotine in cigarettes

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Today, the FDA issued an advanced notice of proposed rulemaking to lower nicotine in combustible cigarettes to minimally or nonaddictive levels. This new regulatory step, according to the FDA, will advance a comprehensive policy framework that could help avoid millions of tobacco-related deaths across the country.

"Tobacco use also costs almost $300 billion a year in direct health care and lost productivity".

Tobacco products remain the only legal consumer products that are lethal when used as directed.

"We see a historic opportunity here to potentially more rapidly migrate cigarette users into products that are modified-risk", Gottlieb said, adding that "the jury's still out" on whether e-cigarettes present a net gain to public health. And there's still the question of whether such a rule should be implemented immediately or gradually. In the statement as well, the FDA has accepted that if the steps are implemented, it will result in increasing the number of people who quit smoking (in US) by around 5 million in just one year. Extend this to 2100, and 33 million people - particularly young adults, where the addition most frequently takes hold - would have been prevented from becoming regular smokers. The analysis suggests that by slashing nicotine levels smoking rates could drop from the current 15 per cent to as low as 1.4 percent. "It is a public health urgency to move forward rapidly". It's the burning tobacco and other substances inhaled through smoking that cause cancer, heart disease and bronchitis.

The agency is asking for public comment on several aspects of the issue.

Applications for newly regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, must be submitted by August 8, 2021, and applications for non-combustible products, such as e-cigarettes, must be submitted by August 8, 2022. Per the pre-rule abstract on OMB, Office of Information and Regulatory Affairs' (OIRA) website, the "Kid-Appealing Flavors in Tobacco Products..."

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Mitch Zeller, director of the FDA's Center for Tobacco Products, suggested that this round of tobacco regulation would focus primarily on combustible tobacco products, which he called the most risky mechanism for the delivery of nicotine.

The agency published its formal notice online Thursday to begin regulating nicotine in what's expected to be a multi-year process littered with potential obstacles.

A concern some have raised is the prospect of smokers simply upping their consumption of cigarettes to get their nicotine fix, but the paper addressed that.

"We'll also advance key parts of our tobacco plan very soon", he said. These "provisional" products can remain on the market unless the FDA finds them not substantially equivalent. The FDA is now reviewing the iQOS application. Strasser said. "How quickly do you move to reach the new standard of nicotine content?"

If put in place, it could save millions of lives throughout the world that are being destroyed by addiction to nicotine.

In 2016, more than two million U.S. middle and high school students used e-cigarettes in the past 30 days, including 4.3 percent of middle school students and 11.3 percent of high school students, compared with 3.2 percent of United States adults. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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