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In 2009, Congress enacted legislation giving the Federal Food and Drug Administration the power to regulate tobacco products, including the manufacture, marketing, distribution and product standards for cigarettes, cigarette tobacco, rolling tobacco and smokeless tobacco products. The agency then extended its authority to all tobacco products, including electronic cigarettes.
Regulation of nicotine content is included in FDA standards for tobacco products.
The FDA has recently issued a notice specifying its intention to propose rules to obtain information to consider when developing a maximum nicotine product standard. The idea is to reduce the level of nicotine in cigarettes to minimal levels of dependence or not. The law has not given the FDA the power to prescribe a nicotine level of zero.
The FDA has been slow to enact tobacco regulations due to political pressure, slow federal bureaucracy, and legal challenges faced by the tobacco industry. So it is rather surprising that the FDA has so early regulated the nicotine content of cigarettes. A daring and radical move that I thought would not take place for many years.
Nicotine, at levels commonly found in tobacco products, is not particularly toxic. It is the other 7,000 chemicals in tobacco, 70 of which are carcinogens, that cause smoking-related diseases that kill nearly half a million people each year in the United States. It is the addictive component of nicotine that promotes smoking and perpetuates the resulting diseases.
Nicotine is a drug that is highly addictive and cessation is extremely difficult, as everyone knows. More than half of smokers try to quit each year, but only 4-5% of smokers succeed. There are still 40 million Americans addicted to tobacco, many of them desperately. Children who start smoking can become regular smokers after only 100 cigarettes have been smoked. And like any good addictive drug, tolerance to the effects of nicotine is growing rapidly.
FDA believes reducing nicotine to minimal or non-addictive levels of dependence could reduce the number of youth switching from smoking to regular use, improve smoking cessation success in adults, and reduce relapse rates . In addition, the decision to smoke would be a decision of free will rather than being largely pre-empted by addiction.
It has been estimated that by reducing nicotine to a minimal level, 5 million adult smokers would quit in the first year of application and 33 million avoid becoming regular smokers. This would reduce the prevalence of adult smoking from 15% today to an impressive 1.4%. percent.
There are many research questions to answer. What is the optimal maximum nicotine concentration that would not support tobacco addiction? Should the nicotine content be regulated only for cigarettes or for all combustible tobacco products? People could migrate to other tobacco products to maintain their habits. Should nicotine be reduced gradually or at one time? There is some evidence that an optimal single reduction might be more effective in reducing smoking, although I suspect it is not politically acceptable.
Should smokers dealing with low-nicotine cigarettes simply smoke more to achieve the desired nicotine intake? Surprisingly, some evidence suggests that this does not usually happen. And would it create an illicit market for conventional nicotine cigarettes?
The regulation of nicotine addiction in tobacco could significantly improve the health of the country. The main objective of the FDA is to reduce the use of combustible tobacco, by far the most harmful, even if it results in increased use of less toxic, non-combustion tobacco products, including electronic cigarettes.
It would be a game changer.
Richard Feldman, M.D., is a family physician in Indianapolis and former state health commissioner for Indiana. Send your comments to [email protected].
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