An unclear path: the latest on DTE

We’ve received a number of questions from members about FDA's August 5, 2025 letter on animal-derived thyroid (ADT) products. The biggest concern: Do pharmacies or distributors face an impending deadline to stop dispensing desiccated thyroid extract (DTE) products?

The short answer is … we don’t know. The regulatory landscape remains, shall we say, unclear. That 2025 letter did not establish a formal enforcement deadline. Instead, the agency simply said that there would be “adequate time to transition patients to an FDA-approved thyroid hormone replacement product.”

Fast forward to March 2026, when FDA announced that it expected to issue ADT guidance for industry before August 2026. As of today, July 31, that guidance has not been released.

All this means that we don’t know if or when there will be an enforcement deadline for pharmacies or distributors that distribute DTE. As we said, unclear.

For patients who rely on individualized thyroid therapy, our position at least is clear: Continuity of care remains an important consideration — perhaps the most important consideration — while FDA’s long-term regulatory approach is being developed.