MAHA and Tobacco Harm Reduction in the United States

The U.S. Food and Drug Administration has made slow progress in accelerating the pathway for authorizing safer alternatives to cigarettes. Recently, the FDA indicated that it would fast-track the process for marketing orders for novel tobacco products. Further, the agency continues to crack down on sales of unauthorized products. 

Unfortunately, the process has been mired by changes in the administration, outside influence, and widespread confusion among policymakers on alternatives to cigarettes. If we truly want to accelerate the end of combustible cigarette use in the United States—and Make America Healthy Again—significant reforms must be enacted at the federal level. 

Tobacco harm reduction (THR) is not a new concept. Since the mid-20th century, researchers have sought ways to let adults continue using nicotine without the devastating health effects caused by burning tobacco. In the past two decades, the invention of the modern e-cigarette has transformed THR into a multibillion-dollar global industry, helping millions of adults move away from cigarettes. Like any disruptive innovation, however, THR faces fierce opposition—particularly from public health groups that continue to spread misinformation and slow progress toward a smoke-free future.

A Brief History

The 1964 Surgeon General’s Report on Smoking fundamentally changed the conversation around tobacco. For the first time, a government-sponsored study officially confirmed the link between smoking and cancer. At the time, 42% of American adults smoked daily. In the years that followed, the federal government restricted advertising, imposed excise taxes, and limited where smoking was allowed. These measures worked: By 2023, only 8.4% of adults smoked every day. Still, that figure represents more than 22 million people.

In the 1970s, renowned researcher Michael Russell famously observed that people “smoke for the nicotine but die from the tar.” It is the burning of tobacco—releasing thousands of chemicals, including 69 known carcinogens—that causes disease, not nicotine itself. This insight spurred decades of research into safer nicotine delivery systems. Some companies experimented with charcoal-heated cigarettes in the 1980s with little success. Smokeless products like Swedish snus showed potential, but the real breakthrough came in 2003, when Chinese pharmacist Hon Lik invented the modern e-cigarette.

THR and Smoking Trends in the U.S.

E-cigarettes reached the U.S. market around 2006–2007, and use has since grown rapidly. By 2023, more than 20 million American adults were vaping, many of them former or current smokers. The timing is no coincidence: Between 2007 and 2023, adult smoking rates fell by nearly 40%. Among young adults aged 18–24, the decline was even more dramatic—smoking prevalence plummeted 81.8%, dropping from 30.6% in 2007 to just 5.6% in 2023.

Yet, access to these alternatives remains tightly controlled by the FDA. Since Congress gave the agency authority over tobacco in 2009, and especially after e-cigarettes were deemed “tobacco products” in 2016, FDA regulation has severely limited consumer choice. As of August 2025, the agency has authorized just 39 e-cigarette products, a couple dozen oral nicotine pouches, and only a handful of heated tobacco products. This is wholly inadequate for the 20 million adults who vape and the 30 million who still smoke. Meaningful reform is urgently needed.

Recommendations to RFK for Reforming the FDA to Accelerate THR

Today, every product must secure an FDA marketing order to be legally sold in the U.S. Unless a product can demonstrate “substantial equivalence” to one that was on the market before February 2007, it must undergo the far more burdensome Premarket Tobacco Product Application (PMTA) process.

The PMTA pathway is prohibitively expensive, painfully slow, and has failed to deliver. To date, only 81 products have received PMTA authorization—compared to tens of thousands of combustible (and much more harmful) products approved through the older, less demanding substantial equivalence pathway.

Several reforms could fix this broken system:

• Congress could scrap the Tobacco Control Act altogether, ending the FDA’s control over THR products.
• Lawmakers could update the arbitrary 2007 predicate date to give newer products a fairer, less costly review.
• The FDA could exercise enforcement discretion, focusing on bad actors who sell to minors while allowing responsible companies to serve adult consumers.

Conclusion

If the U.S. is serious about reducing the toll of smoking, THR must be embraced as part of the solution. Other countries—including Canada, New Zealand, and the UK—actively promote smoke-free alternatives. America should do the same. By reforming FDA oversight and expanding access to THR, tens of millions of adults could transition away from deadly cigarettes and toward a healthier future.

Lindsey Stroud is a Visiting Fellow and President and Founder of Tobacco Harm Reduction 101.