Regulatory Certainty: What the Industry Needs—and Why It Can't Get It
Nicotine companies need regulatory certainty to invest in reduced-risk products. They can't get it—because the FDA's process is unpredictable, Congress can change the rules, and the political winds shift with every administration.
A nicotine company considering a $500 million investment in a new reduced-risk product needs to know: will this product be authorizeable, or will the rules change before we finish development? **Regulatory uncertainty is a barrier to the investment that the transition away from cigarettes requires. The FDA's PMTA process is slow, unpredictable, and subject to political interference. Congress could change the regulatory framework at any time. The uncertainty doesn't just frustrate the industry—it slows the transition that would save lives.**
