FDA Must Maintain Strong Scientific Review Process for New Tobacco Products and Crack Down on Illegal Marketplace to Protect Public Health

Today, the U.S. Food and Drug Administration announced that it plans to evaluate changes to the framework for applications for new tobacco products like e-cigarettes and nicotine pouches to make it easier for them to be sold. While the agency has not fully outlined what changes it may propose, any action that weakens the scientific evidence required or diminishes the review process would undermine the FDA’s regulatory role in protecting public health.

The law requires the FDA to evaluate a number of key pieces of information about a proposed new product, including its components, ingredients, toxicological profile and health impact. It also must consider the risks and benefits to the population as a whole, including users and non-users of tobacco products, particularly youth.

The agency’s review of these products against a rigorous public health standard is critical in balancing two important objectives: providing adults who smoke with access to products that have demonstrated they pose less risk if used exclusively, while preventing initiation among youth and those who don’t already use tobacco or nicotine products.

With more than 24 million U.S. adults who still smoke, there’s a clear need to provide an off-ramp from combustible cigarettes – the leading cause of preventable disease and death. Total cessation is always the goal, but access to FDA-authorized alternatives may play an important role for those unwilling or unable to quit nicotine. Adults who use these products deserve confidence that they have been thoroughly evaluated and are not exposing them to unnecessary or unforeseen health risks.

At the same time, we cannot allow new products to become an on-ramp for addiction among young people and nicotine-naïve individuals. This is critical to ensuring authorized products remain appropriate for the protection of public health, especially as the agency considers a wider variety of flavors and higher nicotine strengths.

Achieving these objectives is made significantly more difficult by today’s largely uncontrolled marketplace. While the potential FDA changes are intended to smooth the process for companies meaningfully participating in the regulatory system, the biggest obstacle is the continued proliferation of products sold by companies that have no intention of complying with the law. 

Nearly 7,500 illegal e-cigarette and nicotine pouch products have flooded the market, exploiting enforcement gaps to continue marketing highly addictive and appealing products with largely untested ingredients that put all consumers at risk. 

The goal shouldn’t be how quickly products can move through the review process. It should be to ensure the FDA has the scientific information necessary to determine whether products meet the public health standard and that products authorized through that process are the only ones available in the marketplace.