Regulatory Transparency: What the FDA Knows—and What It Tells the Public
The FDA makes decisions about nicotine products based on evidence that is largely invisible to the public. The PMTA review process is opaque—the evidence submitted, the analysis conducted, and the basis for decisions are not publicly accessible.
The FDA authorizes a vaping product. The public sees the authorization letter—a brief document summarizing the decision. The evidence on which the decision was based—the manufacturer's application, the toxicological data, the behavioral studies—is not public. **Regulatory transparency is essential for accountability: the public deserves to know why products are authorized or denied, on what evidence, and with what reasoning. The current opacity protects the agency from scrutiny—and denies the public the information needed to evaluate the agency's performance.**
