Pediatric homeopathic medicines for cold and flu face labeling changes
On July 31, 2015, the former Health Minister Rona Ambrose announced changes for certain homeopathic products that fall under the Natural Health Product Regulations. As of July 2016, Health Canada will no longer approve specific health claims on homeopathic cough, cold and flu products for children 12 and under—unless these claims are supported by scientific evidence, such as clinical trials.
The CHPA believes that this change is fundamental when it comes to the kinds of evidence deemed acceptable to support health claims within the Natural Health Products (NHP) regulatory framework. This may have further implications for other subcategories of NHPs, perhaps all products claims of which are based on traditional use.
Health Canada states that the department “is introducing these changes to ensure that Canadians who chose to use homeopathic products have the information they need to improve their safe use, especially parents trying to make the best choices for their children.” How this will contribute to an informed choice is not at all clear.
The CHPA is challenging this policy decision. The entire NHP regulatory framework is focused on providing Canadians with access to information and products to enable consumers to make well-informed decisions when considering their healthcare needs.
Altering the accepted standards of evidence without any discussion with Canadians about what information they wish to see, does not lead to informed choice. We believe that if Health Canada’s policy is implemented, there will be almost no nonprescription pediatric cough, cold and flu medicines left on the market for children under six and no homeopathic cough and cold medicines for children under 12.
Instead of using homeopathic products formulated for children, parents will be left with the undesirable options of leaving the child untreated, estimating a child’s dose based on a product designed for an adult or increasing visits to healthcare providers to seek advice for otherwise self-limiting conditions.
Canada’s Natural Health Product Regulations were developed and implemented through an exhaustive national consultative process, following 53 recommendations of the House of Commons Standing Committee on Health adopted by the Minister of Health in 1998.
Homeopathic medicines are defined and regulated as a subcategory of NHPs. Health Canada has actually regulated homeopathic medicines much longer, since 1990, acknowledging their safety and permitting indications for use (claims) for multi-ingredient children’s homeopathic cough, cold and flu medicines since 1997.
In the interest of providing consumers with the information they need, the CHPA has asked Health Canada to pause and retrace the steps leading up to the July 31, 2015 decision so that all stakeholders can fully understand Health Canada’s concerns and explore other labeling and communications options that will result in a more informed choice and continued safe use of homeopathic medicines.
Philip Waddington, a naturopathic doctor, is the executive director of the Canadian Homeopathic Pharmaceutical Association (CHPA).
PHILIP WADDINGTON, ND
