Cigarette smoking is responsible for more than 480,000 deaths every year in the United States. More than 16 million Americans are living with a disease caused by smoking, such as cancer, heart disease, stroke, lung diseases, diabetes, and chronic obstructive pulmonary disease (COPD). What if we could slash these numbers with one simple regulatory change? The U.S. Food and Drug Administration has proposed doing just that. In July 2017, FDA Commissioner Scott Gottlieb announced a new, comprehensive plan that highlighted nicotine as a key cause of addiction and placed it at the center of the FDA’s tobacco regulation efforts. One important part of the plan was the idea of implementing a standard that would limit the level of nicotine in cigarettes, which would make them minimally addictive or nonaddictive.

On March 15, 2018, FDA issued an advance notice of proposed rulemaking (ANPRM) on the topic of implementing that standard. An ANPRM is essentially used to test public opinion, and it isn’t a required part of rulemaking. The ANPRM is sometimes referred to as a “request for comments,” although the public can also submit research and other data. The types of questions the FDA is seeking answers to includes: What maximum nicotine level would be appropriate for the protection of public health? Should a nicotine-related standard be implemented all at once or gradually?  What unintended consequences (like the potential for illegal trade or for smokers to simply smoke more in compensation) might occur as a result?

That same month, an FDA-funded study called  Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States was published in the New England Journal of Medicine. The article points out that while nicotine is not itself responsible for most tobacco-related illnesses, it is the primary thing that makes tobacco so addictive. The idea is that the degree of harm tobacco poses to public health is therefore directly tied to the amount of nicotine it contains. According to the article, 5 million more adult smokers might quit smoking within a year of the rule’s implementation, and by 2100, more than 33 million people would avoid becoming regular smokers.

FDA PROPOSES LIMITS ON NICOTINE

In response to one of the questions up for comment, regarding an immediate versus gradual nicotine reduction, a study was recently released in the Journal of the American Medical Association. Researchers divided the 1,250 participants into two groups – immediate versus gradual – and kept an eye on their cigarette use. The people in the immediate reduction group had a greater reduction in smoke exposure, greater reduction in dependence, and more cigarette-free days. This suggests that at least one part of the plan may be well on its way to being decided.

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