I hope you all caught Scott’s excellent post over at Science Based Medicine last week, comparing the regulatory regimes for natural health products in Canada and the US. This article will pick up one of his points — the weak enforcement of fraudulent health claims — and summarize some investigations I’ve conducted over the last few months.
Scott neatly captures the biggest problem with our Natural Health Products Regulations — that the issuance of a registration number is Health Canada’s declaration that a product is effective, yet the standard of evidence they require is so low as to render those efficacy claims meaningless. This is particularly acute with homeopathic products, where indistinguishable sugar pills with no evidence of efficacy are being given unique registration numbers and indications of use.
This last bit has always struck me as the weakest link in the regulatory framework’s armour, because any health claims made by homeopathic remedies are, by definition, fraudulent. Health Canada issuing a registration number makes them complicit in that fraud, and thus any enforcement regime they administer is unlikely to provide redress.
Exploring Other Avenues
But this is Canada, allegedly a nanny state, so I figured that there must be some other agency looking after the interests of consumers. And indeed there is — the Competition Bureau, which administers the Competition Act, a federal statute that covers health fraud, among other consumer protections. From the Bureau website:
Paragraph 74.01(1)(a) of the Act is a civil provision. It prohibits the making, or the permitting of the making, of a representation to the public, in any form whatever, that is false or misleading in a material respect. [Source]
. . .
Paragraph 74.01(1)(b) of the Competition Act is a civil provision. It prohibits the making, or the permitting of the making, of a representation to the public, in any form whatever, about the performance, efficacy or length of life of a product, which is not based on an adequate and proper test. [Source]
. . .
The test should indicate that the result claimed is not a mere chance or one-time effect.
Non-repetition of test — it is axiomatic that the reliability of the data resulting from a test is conditional upon the achievement of similar results from a repetition of the test.
User-tests — When consumers are asked to use and evaluate a product, various “test effects” can influence their behaviour….Unless such weaknesses are controlled, user tests would not be adequate and proper. At minimum, control groups are necessary in such situations.
Unrepresentative samples may produce biased test results. If, for example, subjects selected for the test were already known users of the product (and therefore potentially biased in its favour), the use of such results, unless expressly qualified in the representation, would likely contravene this provision. [Source]
All of the provisions above take into account the general impression conveyed by a representation, in addition to its literal meaning. This includes sins of omission, misleading use of texts, misleading visuals, etc. This seems to suggest that fine print like the Quack Miranda may not provide full immunity.
Redress Under the Act
A Complaint Form is available online. According to the Bureau InfoLine, the process is confidential, and the complainant’s info is not made public. However, when action is taken, it’s taken on behalf of all Canadians, not just the complainant, who receives no feedback throughout the process. And the process itself takes a while…often over a year.
If the Competition Bureau agrees that the complaint is justified, the first step is to contact the company and demand compliance. Non-compliance can result in fines or criminal charges. Compliance usually includes the requirement to notify customers of the past transgression.
Bureau Programs Combatting Health Fraud
According to the Bureau, nealry 9 million Canadians search for health-related information online, with almost a quarter of them searching for information on alternative remedies. Additionally, only 38% spoke with their health care professional about the information they found online. Accordingly, the Bureau has several programs already designed to stamp out deceptive healthcare claims.
For example, Project False Hope is an “education and enforcement” program started in March, 2008 targeted at misleading claims about cancer treatments. There’s a brochure co-authored with the Canadian Cancer Society, an online quiz, and a fake cancer treatment site, all designed as educational tools. The Bureau also conducts proactive online surveillance of false claims, and when they spot them, demand changes to the claims. By the end of 2008, they boasted over 100 compliance requests, over 92% of which were adhered to. In Feb, 2009, they announced a consent agreement with Bioenergy Wellness out of Edmonton, makers of Papimi, Magnapulse, and Far Infrared Sauna treatment devices, to stop making unsubstantiated claims, post a corrective notice on their site, and offer full refunds to customers. The next “win” is 15 months later, with a guilty plea by a man selling counterfeit cancer meds — he’s facing up to 20 years and $1.25M in fines. Still, it’s not a lot to show for 2.5 years of work, and the Bureau is frustratingly parsimonious with information — their InfoLine would provide no more detail than is on their site, which is not much.
The Bureau also announced last November a joint initiative with the RCMP and Health Canada to combat fraudulent claims about H1N1 prevention. No followup information on this program is provided on the website, though a few articles have mentioned that Novalis Integra Center for Healing and Transformation, an Ottawa-based homeopathy center, received a demand from the Bureau to remove it claims relating to “free swine flu natural immunization.”
The Bureau also has a brochure called Miracle Cure for Diabetes which states: “There is no pill, herb or “all natural” health product that will miraculously cure diabetes” and provides tips for spotting scams. Then it unhelpfully explains how Health Canada requires all health products to provide evidence of safety and efficacy, as indicated by its Drug ID number, Natural Product Number, or Homeopathic Medicine Number….clearly showing the disconnect between the agencies.
None of these programs address homeopathic products directly, and a search on the Competition Bureau’s website gets only two hits, both in passing – the diabetes brochure above, and a white paper on generic drugs that mentions that manufacturing facilities for homeopathic remedies are exempt from the Health Canada’s establishment licensing regime. When I asked the Bureau InfoLine about the conflict between their mandate and Canada Health’s regime, they suggested I submit a detailed information request online, as the requests are responded to directly by a a competition law officer.
And That I Did
1) Does either the Competition Act or Consumer Packaging and Labelling Act apply to false or misleading testimonials made, sanctioned, or approved by, a federal department?
2) If so, does the Competition Bureau have sufficient jurisdiction to investigate and remediate such testimonals?
3) Is a Competition Bureau Complaint the most effective way of getting this issue investigated and remediated, or are there other approaches (within or outside the remit of the Bureau) that may be more effective?
About 10 days later, I got a call from a competition law officer named Melanie Larouche. The call was mostly level setting and clarification of my request, and she asked for a week to confer with some other officers before giving me a final answer.
True to her word, I got a call about a week later from another officer named Lise Landry, as Melanie was on vacation. She confirmed that the Act does not exclude investigation of government departments; however: in practice, the Bureau would most likely refer such a complaint to the department with the expertise (Health Canada) rather than investigate it themselves. She didn’t explicitly discourage me from submitting a complaint — I suspect she was duty bound not to — but her estimation was that it would not be the best path toward redress.
Where do we go from here?
In the end, I did not make a Competition Bureau complaint, though I still may. While my investigations convinced me that the Bureau is unlikely to be of much use in this endeavour, I’ve considered that the competition law officer’s advice may have a political dimension, i.e. if they never see a complaint, they don’t have to address what might be a contentious inter-departmental issue. Still, the opacity of the process and the limited number of announced “wins” in this area have left me searching for more fruitful avenues of redress. I’ll report back when I find one.