NNHPD Identifies Concerns with Melaleuca Alternifolia

 In Natural Health Products, Regulatory Affairs


Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) recently published a notice which identifies concerns about Melaleuca alternifolia, also known as tea tree, essential oil.

The concern relates to tea tree essential oil on its own as a single medicinal ingredient as well as in formulation with other essential oils.

A total of 39 products connected to 28 NPN licence holders have been identified as part of the concern. The NNHPD will contact these license holders to request that required information be added to their product.

If your company will be impacted, Dell Tech can help. Email Jacqui, Dell Tech’s Director of Regulatory Affairs today for assistance.

All impacted license holders will receive a post-license request notice from NNHPD no later than December 31st, 2023.

A post-licence request notice requires response within 20 calendar days. The NNHPD may take regulatory action per sections 16-18 and 20 if responses are not received by the deadline.

The concern arises from the absence or need for revisions in several risk statements, statements regarding the duration and method of use, and recommendations for product use or intended purpose on the product’s license and its corresponding label.

Melaleuca alternifolia, commonly known as the tea tree, is a small tree or shrub native to Australia. It is well-known for its essential oil, which is derived from the leaves of the plant and is called tea tree oil.

Tea tree oil products are widely available in various forms, including essential oils, creams, shampoos, and soaps, and are used for a range of wellness and cosmetic purposes.




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