Ryan Spak: FDA must do better for smokers trying to quit

I’m a businessman and a real estate developer, so I’m no stranger to overcoming obstacles. But one of my biggest achievements has nothing to do with the business world — it was quitting smoking.

I’m confident that anyone who’s done it will agree. It’s a habit that’s hard to leave despite knowing the health risks. What finally worked for me was having a better option — something that provided the nicotine I wanted without the deadly smoke that comes from burning tobacco.

That’s the thing many people don’t understand — it’s the smoke from cigarettes, not nicotine itself, that leads to the serious health problems such as cancer, chronic obstructive pulmonary disease (COPD) and heart disease. The U.S. Food and Drug Administration has studied this and acknowledges some products are far less harmful than combustible cigarettes. That includes heated tobacco products (HTPs), nicotine pouches and certain e-cigarettes.

Despite years of progress, nearly half a million Americans die every year from smoking-related diseases. Cigarette smoking stubbornly remains the leading cause of preventable disease and death in our country, and smoking accounts for hundreds of billions of dollars in health care spending and lost productivity every year. Smoking cigarettes not only is costing Americans their lives, it’s hurting our pocketbooks and impacting our economy.

However, for reasons that defy common sense, the FDA’s Center for Tobacco Products (CTP) is dragging its feet in authorizing reduced-risk options, standing in the way of broader access for adults who want to switch to these better alternatives. That has to change if we want more Americans to be able to leave cigarettes in the past, just like I did.

Since 2009, more than 26 million tobacco product applications, which include reduced-risk smoke-free alternatives, have been submitted for FDA review. Fewer than 20 of those have been authorized because of systemic dysfunction within the CTP. Even though federal law says the agency must review applications within 180 days, the process routinely drags on for years.

The CTP was established to advance a harm reduction strategy that recognizes a continuum of risk in tobacco products, with cigarettes being the most dangerous by far and scientifically backed smoke-free products providing a significantly better alternative. By providing adults who smoke with better options, this approach can reduce death and disease tied to cigarette smoke. Unfortunately, government incompetence and red tape have created a bottleneck that prevents more smoke-free products from reaching more smokers.

Pennsylvania’s congressional leaders should be demanding answers. Sens. John Fetterman and Dave McCormick have an opportunity to push the FDA to follow the law, speed up its reviews and focus on science rather than politics.

As someone who stopped smoking cigarettes thanks to smoke-free alternatives, I know how powerful these products can be to help leave cigarettes behind. But too many smokers aren’t getting the chance to find that out for themselves. Until the FDA reforms its broken system, public health gains will continue to fall short of what’s possible. That’s something policymakers can — and must — change.

Ryan Spak is the founder of Philadelphia-based Spak Group, a real estate development firm, and Project Rehab, which helps property owners remediate distressed properties.