FDA issues notice on animal-derived thyroid products

Yesterday, the FDA sent a letter to manufacturers, distributors, and importers of products containing natural desiccated thyroid extract (NDT/ADT), including API used in compounded forms and commercial products like porcine thyroid, stating that these products are unapproved biologics and will be subject to enforcement.

The FDA has indicated it will exercise 12 months of enforcement discretion to allow patients time to transition to FDA-approved therapies.

APC is actively evaluating the letter and considering appropriate legal strategy. We will keep members informed.

Stay tuned for updates.