Natural Health Regulations: The Yawning Crevice Between “Consumer” and “Protection”

 
Back in March, I embarked on an experiment to test Canada’s consumer protection mechanisms as they relate to natural health products. As you may recall, I made three simultaneous complaints about a product called Provize to Health Canada, Ad Standards Canada, and the Competition Bureau. Provize is a natural health product that claims to prevent prostate cancer, yet provides only unpublished test tube data as evidence.

My assessment was that this fell afoul of the rules of all three regulatory bodies, and I was curious to see how each would respond. All three complaints were made on March 28th, and pro forma acknowledgments came in that day (Ad Standards), March 30th (Competition Bureau), and April 13th (Health Canada).

I wasn’t expecting anything further from the Competition Bureau, as prior research had told me that their investigations are done on behalf of all Canadians, and therefore they don’t provide feedback to the complainants themselves. But the back and forth with Ad Standards and Health Canada has been extremely instructive, and points to just how incomplete our consumer protections are. Here’s what happened:

April

Ad Standards was the first to provide a substantive response on April 6th, as follows:

Since this appears to involve unauthorized claims related to prostate cancer (a disease referred to in Schedule A of the Food and Drugs Act), the adjudication of your complaint does not fall within ASC’s scope of responsibility. However, with your permission, we will forward your complaint to Health Canada who is responsible for dealing with this type of complaint as per established procedures.

I spoke to them shortly after receiving this letter, and I did understand their position. They’re generalists, and not really qualified to assess medical evidence. Since there’s a regulatory body that is qualified, such a referral makes sense. Of course, I had already submitted the complaint to Health Canada, so I told them that a referral wasn’t necessary at that time.

May

It was more than a month later when I received Health Canada’s response on May 12th. Can you guess what they said? I’ll be you can:

Complaints involving consumer-directed advertising of exemption number issued natural health products for human use are processed by Advertising Standards Canada (ASC).

Please refer to the informational link below for further details found on the Health Canada Web site for your information and reference: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/declar_nhp-psn-eng.php

As such, you are requested to complete and return the Consent to Release of Information form attached, and return it to my attention so that our office can refer this complaint to ASC for adequate processing.

The link they reference does indeed indicate that Health Canada has subordinated complaint adjudication to Ad Standards Canada for products that have received Exemption Numbers, as Provize has. Too bad Ad Standards Canada doesn’t seem to be aware of this, and are referring me back to Health Canada.

Minister of Health Leona Aglukkaq

For fun (and in a fit of admitted immaturity), I did take each agency up on their offer to refer my file to the other, in an attempt to create some sort of elegant regulatory ouroboros. But knowing that would just bring more delay, and realizing that ultimately Health Canada would have to own this, I decided also to call them to see if I could clear this up more expediently.

On May 19th I spoke to Penny at Health Canada, the woman who had sent the above email, and who turned out to just be a liaison that hadn’t made the decision and couldn’t really justify it. Frustrated, I was probably less polite than I should have been, but eventually pulled back, apologized, and asked her to have someone who could answer my questions call me. She followed up with a note introducing me to Ingrid Popesku, Senior Compliance Officer with Western Operations Centre of the Health Products and Food Inspectorate, who would be handling the file.

June

Turns out that Ingrid didn’t get the message from Penny that my complaint shouldn’t really be sent to Ad Standards, because when she finally called me back five weeks later, on June 27th, it was after referring it out and receiving word back from Ad Standards that they had already passed on the file. She told me that Ad Standards had sent it to a different directorate within Health Canada – the Marketed Health Products Directorate. Of course, I already knew that, because the MHPD had sent me a letter on June 8th acknowledging receipt of the complaint from Ad Standards and indicating — finally — that indeed the cancer claims were a problem:

Health Canada has reviewed the Nature’s Method Web site and noted claims to both
prevent and treat prostate cancer. These claims have not been assessed or authorized by Health Canada. Additionally, cancer is listed on Schedule A to the Food and Drugs Act. Schedule A is a list of serious diseases for which prevention, treatment or cure claims may not be advertised to the general public. Because Nature’s Way is located in British Columbia, your complaint is being handled by the Western Operation Centre of the Health Products and Food Branch Inspectorate. The Inspectorate is the branch of Health Canada responsible for compliance and enforcement action for this type of contravention of the health product advertising legislation.

OK, so 3 months in, all roads lead to Rome, right? The complaint I made to Ad Standards had been forwarded to Health Canada’s MHPD, which was forwarding it to the Western Operations Centre of the Food Branch Inspectorate. Conveniently, this was the same group that already had my complaint to Health Canada. No problem? Well, maybe.

Before all of this could be harmonized, Ingrid had to contact a go-between in Ottawa (in the Compliance & Encorcement Directorate) to get in touch with the MHPD and get the file transferred to her. She was literally not allowed to contact them directly, and thus could not tell me when they might talk or what they might do once they did.

So more bureaucratic ping pong. Perfect time to go on vacation.

July

This space left intentionally blank

August

Two months had now passed since I last heard from Ingrid, so I decided to put in a call this week. Seems she did get things worked out with the MHPD and had actually made contact with Nature’s Method on July 15th asking them to come into compliance.

“That’s great,” I said. “So what happened then?”

Well, nothing really. Nature’s Method didn’t respond. And the deadline she’d given them had already passed, but no further followup had occurred.

Ingrid promised to resume enforcement activities, and I’ll give her the benefit of the doubt and assume she would have done so eventually whether I’d called to prod her or not.

Meanwhile, as of today, Nature’s Method still advertises Provize for prostate cancer protection with impunity:

 

8 Responses to “Natural Health Regulations: The Yawning Crevice Between “Consumer” and “Protection””

  1. Jason says:

    I simply shudder when I read that the regulatory and bureaucratic maze that has been assembled with the best of intentions is peppered with inefficiencies. (still trying to locate that sarcasm font ) Though I suppose the mantra ‘we can always do better’ is an appropriate take away message, the main message I find is slightly different. Be informed, remain skeptical and investigate …. take it upon oneself to ask questions and formulate a conclusion instead of relying upon others, even those with the best of intention.

    It is my personal belief that the dissemination of information like that presented in the article ( a rather interesting activity in pressing 1 for english, 2 for french, indeed a brave soul for the time devoted ) can and must be a more effective example of a regulatory mechanism than any federal program entrusted with the protection of all consumers from the multitude of products available. No doubt, these agencies and programs are here to stay. I thank the active and engaged author(s) of such article(s) in informing the public but do remain skeptical that no matter the volume of articles written there will never be a time when such an article will not be available for authorship. I dare say if someone where to produce an ‘efficient government pill’ they would not only be amazingly rich but perhaps the most hated individual on the planet. As bad and obvious as government inefficiencies may be, I shudder equally as hard when contemplating what it might be like even if half those disappeared.

  2. Thomas Doubts says:

    Great work, Erik! Your diligence is admirable. Too bad no one has published a primer on “Navigating Bureaucracy”. From your article, I propose you author that little number.

  3. Dave Francis says:

    I spoke with a customer service rep for the product today. For some reason, the number listed on the site is actually for another product. I almost had to remind the person on the phone what Provize is before they were able to tell me that the number is in fact for that product as well.

    After asking some questions about where I could review published data on the efficacy of the product (and constantly being referred back to the one thing on the website), I was referred to a Dr. (last name escapes me at the moment). The customer service rep asked that I write an email detailing my questions and he would forward it to the Dr. today, which he did about an hour ago.

    Nothing yet from the doctor, but the extension of his email is hedron.ca who apparently specializes in herbal and nutraceudical research.

    Should be interesting.

  4. Dave Francis says:

    Made up testimonials?

    The website lists identical testimonials from the same people, for 2 different products. I don’t know whether they’ve simply renamed their product to Provize, but their site has people saying the exact same things about a product called Prostaid.

    “As you may remember I stopped by your farm a few months ago and bought some of your willow herb product, Provize. You may remember me too as the fellow who had prostate hyperplasia and a leakage problem, for more than 15 years. After just 2 months on Provize my symptoms cleared and the leakage problem ceased. I can’t thank you enough for this freedom. I wish you the best of luck with your product and if people don’t know which prostate remedy to buy, please show them this letter”

    Jeff M. – Ferndale, Washington, USA

    “As you may remember I stopped by your farm a few months ago and bought some of your willow herb product, Prostaid. You may remember me too as the fellow who had prostate hyperplasia and a leakage problem, for more than 15 years. After just 2 months on Prostaid my symptoms cleared and the leakage problem ceased. I can’t thank you enough for this freedom. I wish you the best of luck with your product and if people don’t know which prostate remedy to buy, please show them this letter”

    Jeff M. Ferndale, USA

    Seems odd to me. You can compare the rest of the testimonials at the links below.

    http://www.naturesmethod.com/Products/Prostaid_Testimonials.php

    http://www.naturesmethod.com/Products/Provize_Testimonials.php

    I don’t know whether they have simply renamed their product, that is certa

    • Erik Davis says:

      I think they’ve changed the name of the product a few times — it was also called Pro-5x. If you click Order Prostaid, it takes you to an Order Provize page.

      • Dave Francis says:

        Sorry, yes. I was going to include that possibility and kind of did before that sentence was cut off (internet has been unreliable lately). I still think it is a little misleading to include identical testimonials for products with different names – even if they are the same product. They should make it explicitly clear if they’re going to just update their testimonials as the product changes names.

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  • Erik Davis

    Erik is a technology professional based in Toronto, focused on the intersection of the internet and the traditional media and telecommunications sectors. A reluctant blogger, he was inspired by the great work Skeptic North has done to combat misinformation and shoddy science reporting in the Canadian media, and in the public at large. Erik has a particular interest in critical reasoning, and in understanding why there’s so little of it in the public discourse. You can follow Erik's occasional 140 character musings @erikjdavis