Bringing Common Sense to Tobacco Control Policy

What the Administration Can Do Right Now to Jump Start Progress Toward a Post-Cigarette America

The new administration is moving fast on a wide array of initiatives to reshape government approaches to issues big and small. President Trump often refers to these measures as a “revolution of common sense,” underscoring his view that much of what he’s trying to do is about smart policies and ambitious goals that help the American people. Now that he’s in office beginning the process of installing new leadership at federal agencies and mapping out his administration’s policy agenda for the coming four years, it is a natural opportunity to “think big” about the future. Here is a big thought, rooted in common sense: let’s make cigarettes obsolete.

There is no such thing as a truly clean slate when it comes to policymaking - certainly not on an issue with so many entrenched issues and deeply held beliefs as tobacco control policy.

Nevertheless, this year feels like the possibility space is wider than it has been in a long time.

The new administration has pledged to rethink the nation’s approach to public health and has the opportunity to build upon the first Trump administration's efforts. Specifically, revisiting the 2017 Comprehensive Plan for Tobacco and Nicotine Regulation, rooted in the crucial distinction between nicotine’s addictive properties and the lethal health impacts of combustible tobacco use. The science continues to build around the value of alternatives to combustible cigarettes. And the need for change is right there in front of us every time we walk into a convenience store and see the shelves packed with illegal products from China.

So, with that in mind, what can the new administration do starting immediately to put America on a better course? Here are four ideas worthy of consideration:

1. In with the Authorized, Out with the Illegal: It’s past time to bring law & order to the marketplace. The President took a big step forward when he announced the closing of the “de minimis loophole,” which allowed smugglers to ship illegal vapes into the US disguised as innocuous consumer packages. Now, all imports from China are subject to customs inspection and it should be made abundantly clear to U.S. Customs and Border Protection (CBP), as well as wholesalers, retailers, and nicotine users what products can and cannot be imported and sold legally in the U.S. The president can give authorities the power to clear the shelves of the more than 60,000 illegal disposable vapor products that have flooded into the US, mainly from China, and instruct the FDA to replace them with a wide array of scientifically-validated, authorized products. Doing so will preserve adults’ freedom to choose from a compelling selection of alternatives while restricting the prevalence of products with flavors, packages and features that are clearly intended to attract those underage.

2. Reform the Review Process: The FDA must commit to a rational and efficient process for reviewing applications for innovative alternatives to cigarettes. Despite the FDA having the authority to authorize new reduced-risk products, only 34 vaping products have received marketing authorizations through the PMTA process to date. The path forward requires streamlining the authorization process while maintaining rigorous standards. The process should be based on clear product standards and guidance, with the goal of introducing science-backed, legal, reduced-risk nicotine products that give adult smokers the widest array of compelling options to help them switch. For example, clear product standards for product performance based on chemistry, toxicology and engineering, would bring clarity and speed to the process. Rigorous marketing and sales standards would similarly pave the way to clarity and speed while ensuring that youth prevalence, now at historic lows, can be minimized. Finally, rather than amorphous predictions of possible future unintended consequences, clear standards, coupled with more active surveillance, would fulfill the statutory mandate to address the risks and benefits to public health. These measures are well within the agency’s authority and should be deployed urgently.

3. The Truth About Smoking Alternatives: President Trump should empower smokers to make informed decisions about their health. Most adult smokers express an interest in quitting combustible cigarettes, with over half wanting to pursue less harmful nicotine options. The overwhelming scientific consensus is that such alternatives exist, and the FDA has so found. But, the current narrative around ENDS and their risk as compared to combustible cigarettes, is misleading and must be corrected to give American smokers the whole truth. The FDA has the power to point millions of smokers in the direction of a less harmful alternative and the potential to eradicate the combustible cigarette - they just need to acknowledge and act upon it.

4. Empower Rather than Politicize: The President can give substance to this commitment by empowering the Center for Tobacco Products (CTP) to make science-based decisions without political interference. Too often politics and bureaucracy have overshadowed the scientific process - leading to indecision, inaction or worse. Hard-working civil servants at the CTP sometimes feel their work is being leveraged for political goals rather than public health goals. To get back on track, the Trump administration must allow CTP to standardize compensation with other FDA centers as established under the 21st Century Cures Act - this could increase morale and retention - and align the workforce with the core mission, empowering employees to champion products that reduce harm without political interference.

By launching his second term with strong, decisive action, President Trump can flip the script on smoking in the U.S. with a common sense approach. We can go from a federal policy that is confusing and confounding to one that has a clear purpose and an aligned strategy - all of it pointed toward the North Star of getting as quickly as possible to the end of combustible cigarettes in our country. The longer the new administration waits to act, the greater the risk of inertia settling in and vested interests undermining progress. There is no better time to start than right now.