Read the full remarks below as prepared for delivery:

Good afternoon. I’m Robyn Gougelet, Vice President of U.S. Regulatory Affairs at Juul Labs. On behalf of the Company, I appreciate the opportunity to address the important question of how to spur meaningful innovation to reduce death and disease caused by combustible cigarettes.

Ending smoking requires an all-of-the-above approach. This includes increasing access to proven pharmacotherapies, new medicinal options, behavioral support, and access to products that deliver nicotine without smoke regulated by the Center for Tobacco Products (CTP).

This includes Electronic Nicotine Delivery Systems, or ENDS, more commonly known as e-cigarettes, like the JUUL System.

At Juul Labs, our mission is to transition the world’s billion adults who smoke away from combustible cigarettes, eliminate their use, and combat underage usage of our products. And we believe our products are benefiting public health. Over two million adults who smoke have switched using JUUL. This includes many individuals with no intention to quit who ended up switching completely, also known as “accidental switching.” 

The premise is simple: as adults who smoke try e-cigarettes, they begin to substitute vaping for smoking if they find them to be satisfying alternatives. Over time, we see increased smoking abstinence. 

The success that we have seen with JUUL products in the real world is likely due to the superior delivery of nicotine compared to nicotine replacement therapies (NRTs) coupled with similar rituals to smoking. 

It may also be due to a different mindset than smoking cessation. 

With NRTs and other pharmacotherapies, people who smoke must be committed to quit – completely, abruptly, immediately, and forever. It requires them admitting they need medical help, and many people who smoke do not see themselves as sick. Any slip – a cigarette while out with friends or during a stressful time – is seen as a failure. Over 90% of these lapses lead to relapse.

With JUUL, there does not need to be a defined goal. This appears to be a promising intervention occurring in the commercial nicotine space for adults who smoke who would otherwise not quit using nicotine. 

Last week’s commentary in Annals of Internal Medicine by senior leaders at FDA and NIH highlights the public health potential of e-cigarettes. The authors note: “many adults who smoke have used e-cigarettes to quit smoking.” We also appreciate their overview of the requirements of the clinical development program for a medicinal inhaled nicotine product.

From our perspective, barriers created by FDA’s Center Center for Drug Evaluation and Research (CDER) prevent us from pursuing a medicinal product. The substantial pre-clinical assessments required for inhaled nicotine products before they can even be subjected to clinical trials are particularly cumbersome. 

Pre-clinical burdens for novel compounds are understandable and appropriate in the new drug context. But this situation is admittedly unusual. 

E-cigarettes have been used by millions of adults who smoke and have already demonstrated superior effectiveness for smoking cessation. The Cochrane review did not find evidence of substantial harms, though more data are needed to assess longer term risk.  

Although this situation is unique, it is important to consider the urgent need to appeal to the 28 million Americans who smoke. As we contemplate the public health burden of combustible cigarette use, and the wealth of real-world evidence on e-cigarettes, we urge CDER to be more flexible in its requirements.

It is important to note, as a potential sponsor of such a program, we must consider risks, including delays in the development of cytisine, and the lack of approval for a nicotine mouth spray already approved in dozens of countries. Given the significant resources we would need to invest in this program, the systemic risks are sobering.  

Were FDA to revise these pre-clinical requirements, or even consider shifting some of them to later in the development program, Juul Labs would be in a much stronger position to allocate the resources necessary to pursue such a program. Absent substantial changes to these requirements, a smoking cessation indication through CDER is not tenable as compared to other steps we are taking to reduce the burden of smoking.

Thank you.

Read Robyn’s additional thoughts on this topic in her recent LinkedIn article HERE.

It is widely understood that the best option for adult smokers to reduce the risks to their health from combustible cigarettes is to quit tobacco and nicotine products altogether. However, for adult smokers who have not successfully quit, noncombustible products, such as electronic nicotine delivery systems (ENDS), or vapor products, can provide adult smokers a potentially less harmful alternative and off-ramp from combustible use.

A growing body of scientific evidence has shown just that. Real-world data and evidence demonstrate that ENDS products are viable alternatives for adult smokers, displace cigarette sales and use, and could have a significant public-health benefit.

In a new white paper entitled “The Real-World Impact of ENDS for Adult Smokers: Tobacco Harm Reduction Through Real-World Data and Evidence,” Juul Labs has reviewed and compiled the latest science and evidence demonstrating the positive real-world impact of ENDS products for adult smokers based on four key lines of evidence: 

• Market data demonstrating faster-than-anticipated declines in cigarette sales as a result of increasing ENDS availability;
• Population surveys demonstrating adult smokers transitioning and completely switching from combustible cigarettes to ENDS products;
• Economic data demonstrating ENDS products as substitutes to combustible cigarettes; and
• Population models indicating reductions in tobacco-related death and disease as ENDS use increases.

This white paper is intended for members of the scientific and public health communities, regulators, and policymakers. This information is not for advertising or promotional purposes and is not intended for a consumer audience. 

To read the full white paper, visit the Juul Labs Science website.