Health Canada regulates natural health products through the Natural Health Products Regulations (the "Regulations"), which came into force on January 1, 2004, and the Natural Health Products Directorate ("the Board"). Pursuant to the Regulations, producers of such products must submit a product licence application ("PLA") to the Board and have it approved before the product can be sold. The PLA includes, among other things, information about the safety and efficacy of the natural health product at issue.

The Board refused to approve a PLA for Therapeutix's "Maori Miracle" Joint Health Companion, a product containing avian sternal cartilage powder, also known as Kolla2, citing insufficient evidence. The Board's first refusal was reconsidered twice and was twice upheld. The Board based its final refusal on a consideration of the scientific evidence submitted by the applicant and distinguished that evidence from the use of Kolla2 on the grounds of different manufacturing process and dose, different or unspecified type of collagen, and insufficient details on primary data. The Board stated that previous marketing experience alone is insufficient to obtain approval for natural health products.

The Federal Court decision relates to the second reconsideration. Justice O'Keefe held that "the Board came to a reasonable finding that" the evidence before it was "deficient." Justice O'Keefe held that the Board repeatedly found that it had insufficient evidence before it on the safety and efficacy of Kolla2 at the recommended conditions of use in the applicant's product. The studies relied on pertained to different types of collagen than that used in Kolla2.

North American Nutriceutical Inc v Canada (Attorney General), August 30, 2012.

Federal Court decision — 2012 FC 1044.