Unapproved Natural Health Products Banned from Ontario Pharmacies

In a stunning move, the Ontario College of Pharmacists has prohibited Ontario pharmacies from selling health products that are not approved for safety and efficacy by Health Canada. This directive, which takes effect immediately, banishes some of the most questionable “alternative” health products from pharmacy shelves. This message was sent to all pharmacies and pharmacists on January 20, 2010:

ADVISORY NOTICE

To All Pharmacists and Pharmacies

OCP Position re: Sale of Non-Approved Marketed Health Products

Dear Colleague:

At its meeting on December 10, 2009 the Council of the Ontario College of Pharmacists approved the adoption of the following national position statement approved by the Board of the National Association of Pharmacy Regulatory Authorities (NAPRA) at its November meeting:

“Pharmacists should not sell a marketed health product without a Drug Identification Number (DIN), Natural Health Product Number (NPN) or Drug Identification Number for Homeopathic Medicine (DIN-HM).”

Accordingly, pharmacists are advised not to purchase or accept for sale any marketed health products, including natural health products, that do not possess a DIN, NPN, or DIN-HM.

A copy of the position statement can be found on the NAPRA website www.napra.ca.

Your cooperation is much appreciated.

Yours truly,
Original signed by:
Deanna L. Williams, R.Ph., B.Sc.Phm., C.Dir., CAE
Registrar

This is a bold, decisive decision by a pharmacy regulator, and a tremendous victory for advocates of science-based pharmacy. As I’ve pointed out, the Canadian framework for regulating supplements, vitamins, and alternative health products (the Natural Health Products Regulations) were enacted in 2004, but the implementation has been slow. With the regulations, Health Canada mandated basic manufacturing quality standards, but significantly relaxed the standard for efficacy claims (compared to drugs). Manufacturers are permitted to make efficacy claims based on “traditional uses” and other sources that are essentially anecdotal in nature. The NHP regulations apply to nutritional supplements, probiotics, traditional Chinese medicine, vitamins, herbal products, and homeopathy.

Over 10,000 natural health products have been approved for sale by Health Canada, but thousands of products are unapproved, and openly sold on pharmacy shelves. Why? Health Canada permits the sale of unapproved products, as long as an application for review has been filed. But this left pharmacists in a difficult position when dealing with unapproved products: Had an application for review been filed? There was no easy way to determine this. Did an unapproved product meet basic manufacturing & quality standards? There was no regulator assurance. But with this order, the Ontario College of Pharmacists has eliminated the issue: If it isn’t approved, it cannot be sold in an Ontario pharmacy.

I was particularly pleased to see this statement  from the National Association of Pharmacy Regulatory Authorities:

Pharmacists are obliged to hold the health and safety of the public or patient as their first and foremost consideration. As such, they must follow very specific standards of practice to fulfill this role. When presented with a product that does not bear a number issued by Health Canada, it leaves the pharmacist and their patient with no confirmation that the product was properly assessed for its safety, efficacy and quality nor granted approval for sale.

and

Even though an argument can be made that an NHP or homeopathic product without a product license is not necessarily unsafe, the reverse is also true. There is no guarantee that the required criteria for product safety were met. Pharmacists should not be placed in situations where they may be in a position to sell products that have not received approval for sale in Canada.

Fantastic. Professionalism and patient safety first.

Is a particular product licensed by Health Canada? You can look it up here, in Health Canada’s Licensed Natural Health Products Database. Or you can look on the package. If the product does not have a DIN (drug identification number) NPN (natural health product number) or DIN-HM (homeopathic remedy number), then the product is not approved. It may not be sold in an Ontario pharmacy.

Does this take all the pseudoscience out of Ontario pharmacies? No. The fact that “approved” homeopathic remedies are permitted for sale in pharmacies is an embarrassment to the profession of pharmacy (and a lesson that British pharmacies are learning the hard way). Checking through the database, there are some dubious “cleanse” and “detox” products that have actually been approved for sale and given NPNs. (Happily, no oil of oregano products appear to have been approved, so they should be disappearing from pharmacy shelves). But at a minimum, licensure signals to pharmacists and consumers that what is on the label should actually be what’s in the bottle.

Will this directive restrict patient access to natural health products? No. Over 10,000 products have been approved for sale in Canada. This is enough to fill a warehouse-sized pharmacy. If consumers really want unlicensed products, they can buy them elsewhere. Pharmacies in Ontario are raising the quality standard for consumers – only approved products may be sold.

While there are still a lot of unproven and questionable products that remain on pharmacy shelves, today we’ll celebrate this massive WIN in Ontario. Kudos to the Ontario College of Pharmacists for this move to enhance pharmacy practice and patient safety.

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25 thoughts on “Unapproved Natural Health Products Banned from Ontario Pharmacies

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  3. Hmm… While it’s awesome that they are finally protecting people better, I wonder how much people will conflate “safe” with “effective”. Perhaps there should be different numbers, one for safety and one indicating the evidence level behind it or something like that (easy enough to update as studies come out). ?

  4. Pro:
    – prevents people from buying an unapproved NHP because they feel that it’s “safe” since it’s purchased from a pharmacy which can reduce NHP related adverse reactions
    – takes a load off govt’s regulatory dept so that they can pursue other high risk and unapproved therapeutic products in the market.

    Con:
    – may cause people to buy the unapproved NHPs from elsewhere outside of the pharmacy without advising their pharmacist. This could become an important problem for patient safety, since pharmacists will now become unaware that a client is taking such NHP which may have drug interactions with their Rx drugs.

    overall though, I am quite pleased by this bold move.

    • This is the biggest farce! There are more “approved” products for sale on pharmacy shelves that cause collateral damage and side effects quite often worse than the problem being addressed! Just watch a few commercials on TV for such drugs and listen to the litany of side effects, cautions and disclaimers ending with “stop taking this drug and consult your physician or health care practitioner”. Yet doctors still mindlessly write scripts for such drugs and pharmacies still happily fill them and collect their fees. BIG PHARMA a.k.a. ‘the organ grinder’is running the show. The doctors and pharmacists and the mighty college are the ‘monkeys’!

      • Well, it didn’t take long for the “Pharma Shill” gambit to be trotted out. As Orac points out,

        The “pharma shill” gambit, like other varieties of ad hominem or well-poisoning rhetoric, conveniently frees alties from having to argue for their favorite remedies on the science and clinical studies supporting them (which in most cases tend to be badly designed or nonexistent).

        If I was calling the shots for a pharmaceutical company, I’d want to get in on Big Placebo’s action with natural health products – no research and development, no requirement for time-consuming, expensive clinical trials, no proof of efficacy required, a lowered bar for safety monitoring, cheap registration with Health Canada, and in the case of homeopathy, no active ingredients at all!

      • Pharma shill gambit indeed is an intellectual cop-out by people who don’t want or can’t debate medical issues.

        In medicine and pharmacy, it’s all about the benefit vs risk ratio. If a certain medication has many side-effects but saves lives, physicians know to use them only when necessary and monitor for those side effects. When drugs have minor side effects are but have huge benefits, like statins or insulin, then the upside is huge so physicians will appropriately prescribe them frequently.

        Direct patient drug advertising is not legal in Canada, the commercials we see here are from US, but the list of side effects
        in those are required by law, even if they have not been proven to be caused by the drug. And its all done in order for patients to have a knowledge of risks with the drugs. If they cleared those side effects with their physician, then drug is appropriate. And what r u talkin about with drug company fees and how can I get in on those! lol!

  5. The fact that there’s a NPN and a DIN-HM makes me wonder just how effective this system is, and also what the point is of having such a system…

    Does approved for sale mean that its been tested for efficacy and/or safety?

    Is this a step in the right direction? Or is it just lending an air of authority to those products that have been granted this license?

  6. The best way to see if the supplement is made out of chemicals or natural ingredients is to see if you can understand the ingredients on the label except the preservatives and other minor ingredients.

    • You could be inferring a false dichotomy – it’s not clear from your comment. A chemical is a collection of atoms. Chemicals can be naturally sourced or synthetically sourced. Any chemical, natural or synthetic, can help or harm – it’s all in the dose.

  7. Wow guys, way to close the barn door after the horse has already escaped…

    Pharmacies can’t sell products that aren’t approved by the government; this is a good thing.

    The government now approves everything that isn’t clearly hazardous to health, with absolutely zero requirement for evidence of efficacy, up to and including homeopathic products, which have been conclusively demonstrated in multiple peer-review, controlled, double-blind studies to be absolutely useless; this is a *bad* thing.

  8. Obviously everyone who has made a comment has never completed a product licence application for a natural health product — so please refrain from comments about which you know nothing about.

    Point of note — garlic can be purchased without an NPN at your local food store, but add a claim like “promotes good health” and now garlic is a natural health product which must be registered. Now please explain why a company would go through expensive clinical trials to support the claim that garlic “promotes good health” when the data is already available?

    • The NHP regulations, to be clear, do not require clinical trials to be conducted in order to attach a claim. A variety of less rigorous data can be used, right down to the level of anecdotal evidence – including references to ‘traditional use’. The level of evidence required is directly tied to the type of claim.

      What exactly does “promotes good health” mean?

  9. I would like someone actually in the know to enlighten us on how much of this unapproved stuff is actually BIG PHARMA. Many seem think this is a David and Goliath story but I always had the impression that BIG PHARMA is also producing this non-approved stuff. If that is the case, then this is not a story about BIG PHARMA squeezing out some kind of competition, is it.

    • The NHP industry is mainly small companies (under 50 employees) with 40% reporting earnings between $1 million and $10 million, according to the Fraser Institute report. [PDF] There is zero evidence that this decision has anything to with pharmaceutical companies. This is the pharmacy profession making a decision to stop selling unlicensed natural health products in pharmacies – regardless of who makes them.

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  14. What you may not know is that there is absolutely no record of someone dying from a natural health product in Canada, at least from confederation. You should also be aware that Health Canada is licencing products like Red Bull while denying applications like parsley.

    Certainly there is no money in a healthy population and for those who have for decades enjoyed better health withour side-effects through high quality natural health supplements that Health Canada is now eliminating, this is a sad day.

  15. an approved product is one that is on a list.

    as they say : ” Natural health product – means a substance set out in Schedule 1 (see Appendix I) or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in… ”

    if a really simple ingredient is not on this list ( per exemple clover of some kind) you will not receive a NPN unless you request an exemption ( should take a couple of years.. i heard there was 50,000 product not yet on the list )

    i have tried to find THE list in appendix 1but despite the fact it was available a couple of years ago, it now “has been moved” and it pratically very difficult to find. see http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/man_comp-fab_prep_tc-tm-eng.php.
    we can only access the database wich is extracting information on 1 component.

    this whole thing reminds me of the agriculture problem ( Monsanto and so forth ) if it is not on the list it aint good

  16. Um…you are happy oil of oregano is no longer available. I’m really curious as to what your issue is with this natural product? Makes me wonder if you are somehow making money off this scam because with what has happened you can be sure Big Pharma is making a killing…while we the people, who are told we live in a democratic, free country – are being stripped of our right to choose. I wouldn’t trust Health Canada to protect me if they were the last people on earth.

  17. Pharmaceuticals kill more people than all street drugs combined. It is a corrupt profit based system. The writer of article should be ashamed. Natural health products are safer, and in my experience much more effective. What is the issue with oil of oregano? Oh, is it that it gets in the way of the profit margin because it actually HELPS people avoid prescriptions? I am flat out disgusted by the blatant arrogance of those who support big pharma and debunk remedies that have worked safely and more effectively for centuries. Monsanto and the food industry help to make us sick and big pharma swoops in to treat the symptoms. They make a great team. Thankfully people are becoming wiser and moving away from pharmacies and into natural health stores for remedies that don’t come with more side effects than benefits.

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