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The Importance of Cessation Following FDA Regulatory Momentum

Guest Author: Dr. Carolyn Dresler, ASH Volunteer

The FDA has recently made several exciting announcements, proposing new rules and making decisions about tobacco products. For one, JUUL is to be removed from the market, but, unsurprisingly, the industry sued the next day for a ‘stay’. The FDA just closed a comment period for a proposed rule on the removal of menthol from cigarettes. And, the FDA recently stated that they will propose a rule to lower nicotine in cigarettes to non-addictive levels.

All of this is good – particularly for preventing youth from initiating smoking or vaping. But what does it mean for the people who are already addicted to nicotine through these various products? We must increase our supportive efforts to help them quit. We already know that the majority of people who smoke want to quit and that they have probably tried multiple times to quit. Nicotine is just an extremely difficult drug to quit.

So, with all of these rules to make tobacco products less addictive – HOW do we help those already addicted to quit?

Trashing Cigarettes

Helping people quit smoking isn’t technically the purview of the Center for Tobacco Products at FDA – they are supposed to make sure tobacco products on the market are ‘appropriate for public health’; an oxymoronic statement. Despite that, the FDA, at their Center for Drug Evaluation and Research (CDER) is tasked with approving drugs for tobacco cessation. And CDER can only approve what is submitted to them from the pharmaceutical industry.

CDER has no e-cigarettes or smokeless tobacco products ‘approved’ for cessation.

A possible new cessation product is cytisine. This is a drug – an herbal drug – that has been used for decades in eastern Europe. It has been approved in Canada for cessation. But the FDA CDER is requiring a series of new studies, which means they are not expediting the product to market.

Quit lines need more support to help more people quit.  CDC should increase funding for such cessation efforts.

We must ramp up education and cessation intervention for those with a mental health/behavioral diagnosis. We know this population has a very high co-morbid smoking prevalence that cannot be overlooked.

We must increase outreach to our LGBTQ+ community. They also have a higher-than-average smoking prevalence rate – and are targeted by the tobacco industry. We must look for ways to better educate and HELP them quit.

We need to do better with cessation assistance, period. But, with the occurrence of new FDA rules that will eliminate menthol (and hopefully all flavored products) in addition to lowering nicotine levels – we need to prioritize better assistance to help people break their addiction and stay quit.