What the FDA Can Learn From the UK
COMMENTARY

June 8, 2023by Dave Dobbins
What the FDA Can Learn From the UK
This Thursday, Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md. (Associated Press)

The U.K. government is leading the way in providing life-changing support for smokers by offering vape starter kits and behavioral support to smokers in England. This groundbreaking initiative is a crucial step towards achieving the government’s ambitious target of reducing smoking rates to 5% or less by 2030.

Unfortunately, the U.S. Food and Drug Administration seems to be letting this opportunity pass. While the agency continues to deny authorizations allowing new nicotine products, including many e-vapor products, to be marketed in the U.S., the U.K. has taken a science-based approach to reduce smoking among all age groups. The FDA has even restricted the use of flavored e-vapor products, despite compelling evidence showing that they play a critical role in transitioning smokers to a smoke-free life.

In announcing its initiative, the U.K. Health minister said:

“Up to two out of three lifelong smokers will die from smoking. Cigarettes are the only product on sale which will kill you if used correctly. … We will offer a million smokers new help to quit. We will be funding a new national ‘swap to stop’ scheme — the first of its kind in the world. We will work with councils and others to offer a million smokers across England a free vaping starter kit.”

Meanwhile, here in the U.S., there is a disconnect between science and policy solutions that can help wean adult smokers off cigarettes. Science shows us that nicotine can be delivered in a way that causes far less risk compared to traditional cigarettes. Yet, U.S. lawmakers and regulators are creating barriers and delays that keep new, reduced-risk products from smokers who want them. 

The FDA, which regulates all tobacco products, has a tremendous opportunity to cut through this cluttered debate, promote harm reduction and save lives. 

A recent independent audit of the FDA’s tobacco program by the Reagan-Udall Foundation found the agency lacks vision and has failed to provide adult smokers with regulated, less risky products and to educate smokers on the health benefits of alternative products. To correct this, the agency must take two critical steps.

First, the FDA must quickly bring clarity to the authorization process, so that new products that deliver nicotine without all the toxins from cigarettes can be made available to adult smokers. The FDA often touts that it has denied more than 1.2 million applications for new products to enter the market. Many of these denials are now tied up in litigation because the FDA hasn’t set clear standards or appears to be moving the goal posts. In fact, more products are on the market due to court review than a functional and efficient FDA authorization process. 

Second, the FDA must change its mindset and understand that adults can be trusted with accurate information. What does this mean? Research shows most smokers think nicotine causes cancer and far too many still believe vaping is just as bad as smoking traditional cigarettes. That’s because they mistakenly believe nicotine is what makes cigarette smoking so deadly, rather than the thousands of chemicals that result from burning tobacco.  

While FDA officials have acknowledged a continuum of risk — that is, that not all nicotine products present the same risk — the agency has been hesitant to clearly communicate it to adult smokers. If the FDA were to make it evident for adult smokers that nicotine isn’t the primary cause of smoking-related harm, it would go a long way toward encouraging smokers to switch and have a tremendous impact on public health. The agency’s own research says this. FDA Commissioner Robert Califf often talks about misperception being one of the greatest threats to public health writ large. This is one of them, and many lives are at risk, including the lives of many of my loved ones.

We cannot continue to act as if all nicotine products present the same health risks. Settled science shows they do not. Nor should we embrace outright bans as the most effective strategy to get smokers to quit for good, particularly given the harmful unintended consequences that history has shown us, and which are currently playing out in the states that have moved forward with these misguided proposals.

Like the U.K., with the right strategies in place, we can reduce harm for millions of adult smokers. The FDA can lead the world in tobacco harm reduction. The time to do that is now.


Dave Dobbins is the former chief operating officer of the American Legacy Foundation/Truth Initiative, a leading tobacco control organization. Dobbins began his career as an attorney in private practice doing complex litigation, intellectual property and corporate transactions. A strong supporter of tobacco harm reduction, Dobbins now consults for Altria. Dobbins can be reached on Twitter.

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