Aromatherapy is defined by the NHPD as the branch of botanical medicine which uses essential oils and other volatile/aromatic plant extracts for therapeutic or medicinal effect1. While essential oils and other volatile aromatic plant extracts can be taken orally through ingestion of capsules, aromatherapy is generally considered for those products that follow an inhaled or topical (massage, bath) route of administration.
For products attributing their benefits to aromatherapy, the term “aromatherapy” is required to qualify all claims. General claims that are considered suitable include “Used in Aromatherapy” or “Aromatherapy product”. If sufficient and appropriate evidence is provided in the application, more specific claims can be utilized though they must be preceded by the qualifier “Used in aromatherapy for…” (ex. “Used in Aromatherapy as a decongestant”).
To support the efficacy of an aromatherapy claim, two independent references demonstrating the use of the ingredient in the aromatherapy paradigm are required. Both references should be administration-specific and at least one reference should support the extraction information. Aromatherapy textbooks for professionals are the ideal references, though clinical trials and pharmacopoeias approved by other regulatory agencies (for safety) are also considered acceptable. Currently the NHPD is revising the draft document on “Pathway for licensing natural health products” which includes aromatherapy products. dicentra will be sure to update you when the document is finalized.
Completing a licence application for a product utilizing aromatherapy? At dicentra, we have a team of scientific experts that can help in substantiating specific claims that would be considered acceptable by the NHPD, both in aromatherapy and other streams of medicine. We can be reached at 1-866-647-3279 or email@example.com.
1. Pathway for Drug licensing natural health products making modern health claims Version 1.0: Aromatherapy:- Essential Oil. April 2012. Available: http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult_modern-eng.php. Accessed: December 3rd, 2012.