Regulatory Guidance

 Nosodes and Homeopathic Labelling

On July 31, 2015, the Honourable Rona Ambrose, Minister of Health (Canada) released the following statement:

OTTAWA - Today, I am taking additional steps to protect and ensure the safety of Canadian children, by introducing changes for certain homeopathic products that fall under the Natural Health Product Regulations (NHPR). Many Canadians choose to purchase natural health products, including homeopathic products, to maintain and improve their health. The Government of Canada is committed to ensuring that they continue to have access to a wide variety of these products, however, current package labelling for some homeopathic products may not be adequate for Canadians to make informed choices. The changes apply to the labelling of some homeopathic products, specifically nosode products as well as homeopathic cough, cold and flu products for children 12 and under.

I am introducing these changes to ensure that Canadian parents who choose to use homeopathic products have the information they need to make informed health choices for themselves and their children.

Today, all nosode product license holders are being made aware of this change. They are requested to include a new statement on nosode labels: “This product is neither a vaccine nor an alternative to vaccination. This product has not been proven to prevent infection. Health Canada does not recommend its use in children and advises that your child receive all routine vaccinations.” Nosode licence holders have been asked to comply with the new labelling changes by January 2016.

Furthermore, Health Canada will no longer approve specific health claims on homeopathic products for cough, cold, and flu for children 12 and under, unless those claims are supported by scientific evidence.

Companies have been asked to comply with this new labelling change by July 2016.

To date, the Department has authorised the sale of 121 nosode products and 139 homeopathic products for cough, cold and flu for children under 12. All those products are included in the scope of the labelling changes as described in the updated monographs, which are available online. The Department has also added information on its website about nosodes and other homeopathic products and how they are regulated.

Following the implementation dates for the new labelling changes, Health Canada Officials will verify that products on the market include the labelling changes and steps will be taken should they not.

As I have mentioned many times before, I continue to encourage vaccination, as it is safe and provides important benefits for our children's health throughout their lives.

Related Advice

The College of Naturopaths of Ontario’s Vaccination Policy reflects the Health Canada position on nosodes when it states “under Health Canada rules, nosodes cannot be positioned as an alternative to a vaccine although a member can recommend nosodes as part of a broader treatment plan.”  As such the recent announcement by Health Canada should not change what Members communicate to their patients when recommending nosodes in accordance with the above policy.

The Health Canada position on labeling of homeopathic products is that it “will no longer approve health claims on homeopathic products for symptomatic relief of cough, cold, and flu for children 12 and under, unless they are supported by scientific evidence”.  This position is also in alignment with the College’s Standard of Practice for Advertising. The standard states that a Member ensures that information contained in an advertisement must be accurate, true and verifiable and any reference to a cure of symptoms or disease is not allowed.

Members take their role of "doctor as teacher" seriously. As such, when patients come with questions about these changes on the labels of homeopathic remedies they have purchased from a retail store ensure that you are aware of the above policy and standard when providing information knowing it must be accurate and verifiable.

Dr. Mary-Ellen McKenna, ND (Inactive)
Regulatory Education Specialist
October 14, 2015