Project Summery

This project is trying to answer this question: are manufacturers of natural health products (“NHPs”) marketing/advertising their products in ways that do not align with their Health Canada licenses as permitted under the Food and Drugs Act, 1985 (“FDA”)? To narrow our focus, we are using the schedule A / section 3 of the FDA that lists the diseases for which both prescription and non-prescription drugs, as well as NHPs, cosmetics, and food, can not be marketed for as this poses the greatest risk to the consumer.

We believe that due to the very large number of products currently licensed by the NNHPD (over 100 000) that it is impossible for Health Canada to enforce these restrictions, and the illegal marketing of these products for the schedule A diseases could be done with impunity. This will be one of the first studies of its kind in Canada and we hope to bring to light the problems in the marketing of NHPs to consumers.

We will be starting with a pilot study focusing on cancer claims to confirm our design and then expanding it to all of the diseases on schedule A.

We already submitted violations of these regulations surrounding the marketing of homeopathic nosodes for the prevention of influenza in 2015, which resulted in changes to the marketing of those products by distributors. We will be submitting our findings from this new study to the Marketed Health Products Directorate so they can seek corrective action.

For an in-depth analysis of the problems at Health Canada, see the CBC The Fifth Estate documentary, Vitamins and Suppliments: Magic Pills

Background

As a result of the Stop Nosodes project, it became clear that there is a disconnect between the Health Canada interpretation of the labeling standard for most natural health products (NHPs), and the interpretation by NHP product distributors and sellers. The Food and Drug Act (FDA), which regulates the sale and advertising of NHPs, prohibits the following:

3. (1) No person shall advertise any food,
drug, cosmetic or device to the general public
as a treatment, preventative or cure for any of
the diseases, disorders or abnormal physical
states referred to in Schedule A.

AND

9. (1) No person shall label, package, treat,
process, sell or advertise any drug in a manner
that is false, misleading or deceptive or is likely
to create an erroneous impression regarding its
character, value, quantity, composition, merit
or safety.

It is our understanding that it is the responsibility of the Marketed Health Products Directorate to enforce these laws and the associated regulations. However, there may be a gap in enforcement that has been allowing homeopaths, naturopaths and health food stores, as well as manufacturers and distributors, to make unsupportable scientific claims about their products (i.e. claims that are not allowed under that product’s license or for which there is no evidence).

If unsupportable claims are being made and the rules are not being enforced by the appropriate authorities, Canadian consumers are at risk of choosing NHPs that don’t work over other medicine that does. This can result in a worsening of their condition and confer a greater cost on the public health care system or their own personal finances. We believe the average Canadian is being misled about the general efficacy of NHPs  and, as such, the rise in popularity of these products will put more people at risk for eschewing mainstream healthcare.

We wish to bring any inappropriate claims to the attention of the public and the authorities and, if a gap in enforcement exists, we would like to work with Health Canada to close it.

Project Goals

This project has started with an expected completion date of April 2017. The goals of this research project are to:

  1. Identify the scope of the misrepresentation of natural health products by retailers of these products in Canada.
  2. Increase the capacity of the concerned consumer to report inappropriate marketing of NHPs.
  3. Start to build relationships with key stakeholders in the Marketed Health Products Directorate and the Non-prescription and Natural Health Products Directorate.

Volunteers Required

We continue to seek volunteers for the project. To apply for a position, please contact volunteer.coordinator@badsciencewatch.ca

Project Members

Michael Kruse, (Project Leader)

Michael is an advanced-care paramedic in York Region, just north of Toronto, Ontario. A theatrical lighting designer as well, he re-trained in 2005 as an EMT-Paramedic Specialist at the University of Iowa and as an advanced care paramedic at Durham College. Michael is currently enrolled at the University of Toronto working towards an undergraduate degree in physiology and the history and philosophy of science. Michael has been active in the science advocacy community for 7 years and is committed to a compassionate defence of science for the betterment of all Canadians.

 Christopher Jang, PH.D., (Science Adviser)

Chris is a postdoctoral research fellow studying the biochemistry behind human circadian rhythms at the University of Pennsylvania in Philadelphia. He was born and raised in Vancouver, and completed his bachelor’s in biochemistry at Queen’s University in Kingston, Ontario. He then went back to British Columbia to complete his Ph.D. in biochemistry and molecular biology at the University of British Columbia, where his doctoral work was devoted to characterizing mechanisms that viruses use to take over host cells. Chris has also taught undergraduate biochemistry at both the University of British Columbia and the University of Pennsylvania, and in his spare time, works with the Canadian Science Policy Centre.

Chris Hebbern

Chris holds a PhD in Plant Sciences from the University of Copenhagen. Now based in Ottawa, he has completed an NSERC Visiting Fellowship in environmental epidemiology at Health Canada, studying temperature-related mortality and the health effects of climate change. He is currently a researcher in the field of air pollution and health interactions.

John Monroe
Ashley Payette

Ashley is a lawyer currently practicing as an in-house counsel for a professional regulator in Toronto, Ontario. After her undergraduate studies in biology at Queen’s University she pursued law abroad obtaining her LL.B from the University of Buckingham in the U.K. Despite leaving the world of science professionally, Ashley has maintained a keen interest in debunking bad science and advocating for science based medicine in her personal life. The mandate of Bad Science Watch is perfectly in line with her desire to see evidence based legislation designed to effectively protect the public.

Jonathan Paynter

With a background in social work and counselling psychology, Jonathan has worked as a Registered Social Worker for a number of years in a variety of positions. Currently he does assessments for Criminal and Family Courts in Eastern Ontario, as well as counselling and family mediation. Jonathan has a strong interest in science and community involvement, which led him to volunteer for Bad Science Watch.

Kristen Simkus

Kristen works for the federal government as an epidemiologist in Ottawa and has a passion for evidence-based policy and sound science advocacy. She holds a Bachelor’s of Science with Specialization in Immunology and Infection from the University of Alberta and a Masters of Public Health from the University of Manchester. Kristen has been working in public health for over eight years, with experience in provincial and federal government and the private sector. Her areas of expertise include infectious disease, immunization, epidemiology, and public health surveillance.

Quinlan Wylie

Quinlan is an undergraduate co-op student currently in her last year at McMaster University. She recently completed her thesis in adipocyte metabolism. She is now working a co-op term in private industry for a consulting agency which performs market research in the pharmaceutical and medical device fields. Quinlan has always been passionate about science advocacy. She looks forward to bringing her experience in academic and market research to further public awareness of natural and homeopathic products, and to help promote new standards for their regulation.