Introduction

The College of Naturopaths of Ontario (the College) is responsible for reviewing the prescribed substances that naturopathic doctors may administer by injection or inhalation and the designated drugs that they may prescribe, dispense, compound, or sell. These substances and drugs are listed on the Tables that are included in the General Regulation (Ontario Regulation 168/15) made under the Naturopathy Act, 2007. This responsibility includes ensuring that the drugs and substances accessible by Naturopathic Doctors are safe and effective within naturopathic practice.

To meet this responsibility, the College will receive proposals from system partners, registrants and interested third parties seeking the addition or amendment to the tables set out in the General Regulation. The College receives these proposals, undertakes a comprehensive review, and will make recommendations to the Minister of Health for amendments if they are deemed necessary and appropriate.

To amend one or more of the Tables, the Council of the College must propose an amending regulation which, after review by the Minister of Health, must be approved by the Lieutenant Governor in Council.

Background

In 2019, the College had submitted proposed changes to the Tables of the General Regulation. At the time, changes were proposed to progesterone. While several changes were completed, progesterone was not among them.

The College received a proposal from the Ontario Association of Naturopathic Doctors (OAND) to amend the General Regulation to add Oral Micronized Progesterone (OMP) to Tables 3, 4, 5 and 6 of the Regulation. Key aspects of the submission included:

• Indications for use – Menopausal Hormone Therapy (MHT) – Oral micronized progesterone is approved as part of MHT for menopausal women with an intact uterus, primarily to reduce the risk of endometrial hyperplasia when estrogen therapy is used. This protective role helps reduce the risk of endometrial cancer associated with unopposed estrogen.
• Indications for use – Menopausal Symptoms – Progesterone is used to help manage menopausal symptoms, including vasomotor symptoms, as part of a combined hormone therapy regimen.

Process

Upon receipt of the proposal, the College engaged Dr. Jamie Kellar, BScHK, PharmD, PhD, Associate Dean, Academic, Associate Professor, Teaching Stream, with the Leslie Dan Faculty of Pharmacy at the University of Toronto to conduct an independent expert review of the submission. In the past, the College would have used the Drug Information Resource Centre (DIRC) to conduct such a review; however, DIRC has ceased operations and is no longer available to conduct reviews.

The College also asked that Dr. Kellar obtain an independent review of her report prior to submitting the report to the College. Dr. Kellar retained the services of Tiana Tilli, BScHK, PharmD, RPh, ACPR, Lecturer and Clinical Pharmacist at the Faculty of Pharmaceutical Sciences, University of British Columbia. Both Dr. Kellar and Dr. Tilli were remunerated for their work as independent reviewers. Neither has had any prior relationship with the College, the OAND nor with drug manufacturers related to Oral Micronized Progesterone.

In preparing the report, Dr. Kellar was asked to consider the initial DIRC report, which was obtained during the earlier drug review in 2019, and identify what, if any, factors had changed given the initial review was conducted in 2018. A copy of the report is attached. The key highlights are:

• Indications for use – The only approved label indication for oral micronized progesterone in Canada is for the prophylaxis of endometrial hyperplasia. Other proposed indications such as vasomotor symptoms or infertility are considered off label indications.
• Using OMP in combination with topical estrogen is viable and beneficial to a patient and that oral estrogen is not required when prescribing OMP.
• Physician co-management is reserved for high-risk medications of which OMP is not one; however, referral or physician co-management is recommended to certain listed patient populations.
• Ontario NDs who have completed the Canadian Therapeutic Prescribing Course and Examination, i.e., have met the Standard of Practice for Therapeutic Prescribing can effectively and safely prescribe and use OMP.
• Combining transdermal estrogen with oral micronized progesterone is evidence-based, effective, and safe for most healthy women needing hormone therapy.
• OMP is considered the gold standard for progesterone therapy in hormone replacement treatment plans and has a favourable safety profile for most individuals when used as prescribed.

A copy of Dr. Kellar’s full report is being released by the College and forms a part of this consultation.

After receiving Dr. Kellar’s report, the College’s Working Group on drugs and laboratory tests reviewed the report and indicated its support of the OAND’s proposal.

On May 28, 2025, the Council of the College received a briefing on the OAND submission, Dr. Kellar’s Report, the Working Group feedback and was asked to consider the matter. Specifically, the Council was asked to consider adding Oral Micronized Progesterone to Table 3 with a limitation that it would only be permitted for use in accordance with the indications on the label.  The Council agreed with the rationale set out and thus is moving forward with the proposal to add OMP only to Table 3 in the General Regulation.

Between June 30 and September 8, 2025, the College initiated a public consultation on the proposed addition to Table 3 of the General Regulation, Ontario Regulation 168/15 by adding the following:

Drug	Limitations, routes of administration, dosages
Progesterone (oral micronized)	For use only in accordance with label indications approved by Health Canada.

Consultation Feedback

During the public consultation period, the College received feedback of support for the addition of OMP to Table 3 of the General Regulation from:

• The Association of Ontario Midwives
• The Ontario Association of Naturopathic Doctors
• The Ontario Pharmacists Association
• The Nurse Practitioners Association of Ontario
• The Canadian College of Naturopathic Doctors
• 47 Naturopathic Students
• 22 Members of the Public
• 58 Naturopathic Doctors
• 2 Pharmacists
• 3 Nurse Practitioners
• 2 Medical Doctors

During the initial consultation, the College did not receive any public consultation feedback opposing the addition of OMP to Table 3 of the General Regulation.

Several respondents to the public consultation, although in support of the addition of Oral Micronized Progesterone to Table 3 of the General Regulation, recommended the removal of the limitation “For use only in accordance with label indications approved by Health Canada.”  The removal of this limitation would allow for NDs to prescribe OMP for purposes that are not currently approved by Health Canada.  The term “off-label” refers to the use of a medication in a manner that is different from what Health Canada has approved to be marketed in Canada. For example, when research shows that the benefits of using the medication in new ways outweighs the risks, prescribers may wish to provide this option to their patients. Off-label use includes prescribing a medication for a new health condition or to a different age group. 

The purpose of the initial limitation approved for consultation was to ensure a narrow and controlled addition of the drug while maintaining alignment with evidence considered in previous Ministry reviews.  This limitation was included as the Independent Expert Review stated: “The only approved label indication for oral micronized progesterone in Canada is for the prophylaxis of endometrial hyperplasia. Other proposed indications such as vasomotor symptoms or infertility are considered off label indications.”  The consultation feedback did note that the Independent Expert Review confirmed that OMP has a favourable safety profile and is not considered a high-risk medication and that off-label prescribing is common in OMP therapy and is commonly utilized by other prescribers in Ontario. 

In considering the public consultation feedback, the Council received a presentation on off-label use by its external reviewer, Dr. Jamie Kellar, BScHK, PharmD, PhD. In her submission, Dr. Kellar detailed what off-label prescribing was and why it was relevant to practices involved prescribing, the importance of available evidence for using a drug off-label, the ethical and safety considerations including informed consent and vigilant patient monitoring when using drugs off-label. Dr. Kellar noted that off-label use is common and clinically safe when:

• There is a clear, evidence-informed rationale for off-label use,
• Care is taken in the selection of a patient who meets the profile of patients for off-label use based on the evidence,
• Vigilant monitoring and follow up is taken and the drug is stopped the moment contraindications may arise,
• There is documentation of the risk-benefit analysis for use in a particular patient, and
• Informed consent was given by the patient for the off-label use.

A copy of Dr. Kellar’s slides used in this presentation are provided for reference.

The Council was in support of the rationale set out in the consultation feedback and the information provided by its external reviewer regarding the potential removal of the original limitation included with adding OMP to Table 3 in the General Regulation.

Summary of Drugs to be Added

In summary, the Council of the College of Naturopaths of Ontario is proposing an amendment to Table 3 of the General Regulation, Ontario Regulation 168/15 by adding the following:

Table 3
Drugs that may be Prescribed

Drug	Limitations, routes of administration, dosages
Progesterone (oral micronized)	No limitations, etc., specified.

Purpose of the Consultation

The purpose of this consultation is to seek feedback from registrants, system partners, and interested parties on the proposed addition of Oral Micronized Progesterone to Table 3 of the General Regulation with no limitations to be included.

Supporting Documentation

In line with this consultation’s intent, the following supporting documents are being released as a part of this consultation:

Name	Description
Independent Expert Review – Oral Micronized Progesterone	This document is the Independent Expert Review referred to in the information above and sets out the full analysis of the use of oral micronized progesterone by the profession.
Table 3	This document highlights the proposed amendment to Table 3 of the General Regulation made under the Naturopathy Act, 2007 with the addition set out in green lettering.
Independent Expert Presentation – Off Label OMP Prescribing	This document is the presentation provided to Council from the Independent Expert Reviewer setting out information on the off-label prescribing of OMP.

Feedback

Feedback can be provided in the following ways:

Via Email:	general@collegeofnaturopaths.on.ca
Via Fax:	416-583-6011
Via Regular Mail:	College of Naturopaths of Ontario 10 King Street East, Suite 1001 Toronto, ON M5C 3C3

All feedback is carefully considered, even that which is not reflected in the College’s final recommendations or documents.

Timeframe

This is a formal consultation being undertaken on the part of the Council of the College of Naturopaths of Ontario. The consultation opened on or about January 2, 2026, and will close at 5:00 pm on March 4, 2026.