60 Degrees Pharmaceuticals Signs FSU Patent License for Australian Chestnut Extract Supplement

A New Dietary Ingredient Notification dispute is shaping the near-term regulatory path for 60 Degrees Pharmaceuticals, which has secured an exclusive patent license from Florida State University to scale extraction and purification of castanospermine from Castanospermum australe seeds for non-prescription use. The license enables large-scale production, but commercial entry into the U.S. dietary supplement market remains contingent on resolving outstanding FDA feedback.

The FDA issued a Non-Notified Letter in response to the company's NDIN filing, citing insufficient "other safety information" to establish the safety of the proposed use. A formal meeting between 60 Degrees Pharma and the Agency is scheduled for July 1, 2026, after which the company intends to submit a revised NDIN. For regulatory affairs leads, the sequence illustrates a recurring friction point: botanical compounds with traditional food histories do not automatically satisfy the evidentiary threshold FDA applies under the NDIN pathway.

Castanospermine, the principal active component of Australian Chestnut Extract, has been documented in scientific literature as a modulator of carbohydrate metabolism at low doses, affecting glycogen and glucose markers. At higher doses in animal models, immunomodulatory effects have been observed across several therapeutic areas. The compound's dual profile, metabolic at low doses and immunomodulatory at high doses, is likely to inform the safety data package the company will need to construct for the revised submission.

Castanospermum australe is cultivated in Queensland, New South Wales, Florida, Hawaii, and California, and its processed seeds carry a documented history as a traditional food source in Australia. That ethnobotanical record may support, but will not substitute for, the clinical and toxicological data FDA expects under 21 CFR Part 190 governing new dietary ingredients. Regulatory teams navigating similar supplement-to-drug adjacent pathways should note that traditional use data typically functions as contextual evidence rather than standalone safety justification in NDIN reviews.

60 Degrees Pharmaceuticals, best known for ARAKODA (tafenoquine), its FDA-approved malaria prevention product, is extending its portfolio into the botanical supplement space through this FSU collaboration. The outcome of the July 1 meeting and the content of the revised NDIN will determine whether the company can advance toward a compliant U.S. market entry for Australian Chestnut Extract.

Source: 60 Degrees Pharmaceuticals via GlobeNewswire, June 11, 2026.