The Food and Drug Administration funds and certifies cigarettes

Reprinted from internal sources

With how the news is moving these days, it’s easy to miss the drama unfolding in the world of tobacco. Over the course of this year, the Food and Drug Administration announced a plan to reduce nicotine in all cigarettes, ban all menthol cigarettes entirely, and decline a request from Juul to sell their products, only to get around and suspend that ban as the company appealed the decision. All of this was overshadowed by the fact that US health agencies funded research trials of two low-nicotine (VLN) cigarette products — one of which is menthol — that have gone on to receive FDA approvals as low-risk products. .

It is astonishing that the Food and Drug Administration and other agencies have spent $100 million from US taxpayers to develop evidence of the safety and efficacy of combustible cigarettes. Worse, these agencies then used insufficient evidence to justify their endorsement as low risk, and required labels to claim marketing “helps smoke less” on cigarette packages.

This is a wrong way to make the United States smoke-free.

But the Food and Drug Administration (FDA) doesn’t seem to be concerned. Instead, it seems to conclude with some magical thinking that individuals will stop smoking after using VLN cigarettes because low nicotine will reduce their addiction. Indeed, VLNs are likely to exacerbate misperceptions of risk among consumers. Nicotine is not the biggest problem. The combustion of burning tobacco is the most harmful to health. In other words, the Food and Drug Administration approved the combustible cigarettes it helped develop while rejecting more than 99 percent of vapor products from the market that did not.

Combined with efforts to reduce nicotine in all cigarettes, this amounts to a blanket ban as most brands will be removed from the market for non-compliance. But the FDA-approved VLN brands will remain. The type of political maneuvering and dealing refers to a non-competitive behaviour, in which the government tries to select winners and losers.

History has shown us time and time again that bans never work — whether it’s with alcohol, opioids, or flavored e-cigarettes. Furthermore, FDA-funded research to understand the acceptance of VLNs showed that an immediate decrease in nicotine resulted in more significant withdrawal symptoms and increased the likelihood that smokers would seek alternative sources.

Since the launch of the first commercially successful e-cigarettes, it has evolved and grown in a dramatic way. By 2014, the British Medical Journal documented an estimated 460 different e-cigarette brands that delivered nicotine without the harmful effects of smoking. Researchers have confirmed that e-cigarettes pose a continuum of risks, comparing them to nicotine patches used to quit smoking. Because e-cigarettes mimic a smoking ritual, they have proven to be practical smoking cessation tools for adult smokers. Even the Centers for Disease Control states that “frequent use of e-cigarettes is associated with greater smoking cessation than less frequent use.” A reasonable way to reduce adult smoking is to increase the availability of these products.

The Food and Drug Administration would do well to recognize this evidence for a smoke-free United States. It could start by updating the National Tobacco Control Strategy – one that was published over a decade ago and doesn’t even mention vaping. The FDA’s comprehensive tobacco and nicotine regulation plan should also be updated. Created in 2017, it includes a mix of strategies to reduce youth use, address racial justice and eliminate smoking. However, like the National Tobacco Control Strategy, it does not take e-cigarettes as a smoking cessation tool. The FDA could also learn a bit from comprehensive, evidence-based tobacco control strategies in other countries such as the UK or New Zealand, which have labeled what a smoke-free society means to their residents.

It is important to remember that no tobacco product is safe. Those who smoke cigarettes are encouraged to use alternatives such as low-risk nicotine products (such as e-cigarettes) as they have become necessary to help adult smokers stay away from deadly combustibles. Banning vaping while increasing the number of low-nicotine combustible cigarettes is as counterproductive as it is political. No need for that.

Mazen Saleh

Mazen Saleh is the Policy Director for the Integrated Damage Reduction Program at the R Street Institute.

Mazen holds a Bachelor’s degree in Liberal Arts from Georgetown University and a Master’s degree in Global Health from University College London.

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