Regulatory Flexibility: Why the FDA Needs Discretion—and Why Congress Won't Give It
The FDA's tobacco regulatory framework is rigid—every product must go through the same PMTA process, regardless of risk. Regulatory flexibility—distinguishing between products based on risk—would save lives. Congress would need to change the law.
A nicotine pouch that is substantially equivalent to an already-authorized product should not need the same million-dollar PMTA as a novel heated-tobacco device. A vaping product with temperature control (reducing thermal degradation) should be regulated differently from one without. **The FDA's regulatory framework treats all products as equivalent—and the equivalence creates barriers that protect the most harmful product (cigarettes) from competition. Regulatory flexibility—distinguishing between products by risk—requires congressional action. Congress has not acted.**
