President Trump can accelerate the U.S.'s economic trajectory by fixing a broken system that prevents American manufacturers and businesses from providing smokers safer products proven to help them quit. Doing so will help small manufacturers, independent distributors, and retail shops from offering smokers lower-risk alternatives.
Streamlining this process will not only save lives, but also allow thousands of locally owned businesses to grow, hire more employees, and compete on a level playing field — helping community economies thrive even as public health advances.
The current regulatory regime, called the Premarket Tobacco Product Applications, is a process mandated by the Food and Drug Administration that leads to approval or non-approval of new technologies that can help smokers quit.
This process includes e-cigarettes, also known as vaping products, nicotine pouches, and heat-not-burn devices (which steam tobacco, rather than burning it). The core mandate of the PMTA is to consider if a product is appropriate for the protection of public health. Because vaping products have been conclusively proven to help smokers quit, under the legal requirements they would fall squarely in the category of appropriate.
Devastatingly for public health, in a process that put politics above science, Biden’s FDA interpreted the PMTA in such a way that has resulted in denial of 99 % of all new products, and the approval of merely 26 e-cigarette products and devices according to the FDA’s own data.
For over five years, conservative groups have been consistently decrying this process, which harms public health while destroying American small businesses, leaving the market dominated by illegal Chinese-made imports.
Yet another key problem with the current system is that each application can cost well over $500,000 — with the average manufacturer or retailer selling dozens, if not hundreds, of different flavors (each at various concentrations). The cost for any business could easily reach into tens of millions of dollars, and these are largely small businesses. There is no way a small business can afford such costs, and promises were made to producers of vaping products that the new Trump administration would fix the problem.
The U.S. vaping industry contributed about $17.5 billion to American economic output and employs 90,000 Americans with $5.5 billion in wages and benefits. Over 150,000 American companies distribute vaping products and rely on this industry to support their customers. These numbers would exponentially increase if federal regulations allowed American entrepreneurs to bring this industry above board. More jobs would be created and investments in the U.S. economy would increase dramatically.
The current FDA framework is unworkable for small businesses and needs clearer guidance and guardrails to ensure transparency and fairness in the approval process. But this goes beyond protecting the vaping industry. This fight is about preserving responsible business practices and ensuring innovation is not stifled by bureaucracy.
This industry is going to exist no matter what. Our choice is whether to regulate and invest in a legal, American-made industry or allow unregulated, foreign counterfeits to flood the market. Foreign counterfeits strip away tax revenue and create an environment without guaranteed product safety.
Once the PMTA regulation is revised, American vaping manufacturers and distributors are prepared to invest billions of dollars into U.S. manufacturing and job creation. With the right, fair regulatory system, the U.S. can bring this industry above board, support widespread job creation, and drive innovation back on U.S. soil, while saving millions of lives in the process.
President Trump campaigned on this reform — promising to “save vaping” and restore opportunity to small entrepreneurs squeezed out by the FDA’s gatekeeping — and now has a real chance to deliver.
