Health Canada issues revised guidance and updated Homeopathic monograph for homeopathic medicines for cough, cold, flu for children under 12.
In late 2014, a CBC Marketplace investigation reported on the growing popularity of the use of homeopathics for immune support. The investigative team interviewed parents who were under the care of complimentary health care practitioners and reported that some practitioners were informing parents that homeopathic medicines could be used as effective alternatives to vaccines.
Then in early 2015, CBC Marketplace successfully submitted an application for a children’s homeopathic product in compliance with the NNHPD homeopathic monograph. Approval was given by Health Canada for the claim “Homeopathic medicine for the temporary relief from fever, pain and inflammation”. CBC Marketplace broadcasted the approved claim and highlighted a lack of supporting scientific evidence despite an approval from Health Canada.
On July 31, 2015, Health Canada published a statement for consumers with information on homeopathic remedies.
The statement began with a brief summary of the practise & beliefs of homeopathy. Details of the regulatory approval process were summarized and information on how to differentiate between homeopathics and products with full scientific substantiation was outlined. Further to this, Health Canada discussed the pitfalls of providing homeopathic remedies to children as an alternative to vaccines.
In light of the risks associated the use of homeopathics in children, Health Canada has revised their policies, homeopathic guidance document and homeopathic monograph regarding the approval of certain homeopathic medicines. The policy revisions have been outlined as follows:
In summary, Health Canada has confirmed that homeopathic medicines are not to be taken by children in place of vaccines and should not be used to provide relief from coughs, colds, or flu due to the increased risk of developing of serious childhood illnesses. Additional requirements with respect to labelling and substantiation for homeopathic products containing nosodes and for the relief of cough, cold and flu symptoms are now mandated.
dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can be reached at 1-866-647-3279 or info@dicentra.com. We can assist you with your homeopathic submissions for homeopathic monograph and non-monographed submissions with Health Canada and advise on any changes in the regulatory landscape.
References
Health Canada Information on Homeopathic Products. July 31, 2015. Available online: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/info_homeo-eng.php. Accessed: August 6, 2015.
CBC Marketplace. Drugstore remedies: Licence to Deceive. Episode – Season 42. Original broadcast March 13, 2015. Available online: http://www.cbc.ca/marketplace/episodes/2014-2015/drugstore-remedies-licence-to-deceive. Accessed: August 6, 2015.
CBC marketplace. Vaccine alternatives offered by homeopaths ‘irresponsible’. November 28, 2014. Available online: http://www.cbc.ca/news/health/vaccine-alternatives-offered-by-homeopaths-irresponsible-1.2852408. Accessed August 8, 2015.
Revised Guidance Document (Homepathic Medicines). July 31, 2015. Available online: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/new-neuf-eng.php. Accessed August 12, 2015