On June 10, 2026, the Natural and Non-Prescription Health Products Directorate (NNHPD) announced the development of two new Natural Health Product (NHP) monographs for Black Cumin (Nigella sativa) and Tongkat ali (Eurycoma longifolia). Industry stakeholders are invited to provide feedback on the proposed monographs during a 30-business-day consultation period, which closes on July 22, 2026.
The proposed Black Cumin monograph applies specifically to fixed oil preparations derived from the seeds through pressing or solvent extraction. Essential and volatile oil preparations produced through distillation are excluded from the scope of the monograph. Several pre-cleared claims are proposed, including antioxidant support, liver function support, maintenance of healthy low-density lipoprotein (LDL) cholesterol and triglyceride levels, and general health support claims. While the NNHPD reviewed evidence related to Nigella sativa‘s effects on glucose metabolism and blood sugar management, it determined that the available evidence was not sufficient to support the inclusion of these claims at this time.
The proposed Tongkat ali monograph is limited to standardized preparations derived from the root, including dry extracts, decoctions, and concentrates. Companies attesting to the monograph and meeting the specified daily dose requirements will be able to access pre-cleared claims related to male sexual health, including support for sexual interest and the promotion of testosterone production.
These new monographs provide an opportunity for manufacturers to streamline licensing for products containing these ingredients while benefiting from a range of pre-cleared claims.
If you have questions about the proposed monographs, would like assistance preparing consultation comments, or are interested in adding new pre-cleared claims to an existing NPN through an amendment, contact one of our regulatory consultants today.
Blog Author
Joanna Chudyk, M.Sc.
Joanna Chudyk is a Principal Regulatory Affairs Consultant with expertise in natural health products, non-prescription drugs, food regulations, and pest management compliance. With a strong scientific background in food safety and quality assurance, she brings specialized regulatory knowledge across a wide range of product categories.
