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Problems in the natural health products aisle

The struggle to implement quasi-scientific regulations on an industry that’s based on unscientific folklore


 

Problems in the natural health products aisleThe Canadian Health Food Association today launched a campaign aimed at bringing political attention to the regulatory mess their industry confronts. It’s an issue that few Canadians know anything about, but one that should be of interest to the millions who buy natural health products—from mild teas, to ordinary vitamins, to potent exotic substances.

The numbers tell much of the story about what’s got the association worried. According to the CHFA, 13,000 licences for natural health products have been issued by the federal National Health Product Directorate since the government moved to regulate this booming category of quasi-drugs six years ago.

But the directorate, run by Health Canada, has refused about as many applications, or the companies trying to get the products licenced have withdrawn their applications in the face of the directorate’s demands for more information. This pattern bodes ill for the government’s goal of having all natural health products on the market—an estimated 40,000 of them—properly licenced by next April.

As of today, the CHFA is urging its member companies to contact their MPs, the Prime Minister, or Health Minister Leona Aglukak. They fear that many of the products they now sell will not be licenced by next spring’s deadline, and therefore “availability of new NHPs will be significantly reduced.”

I’ve written twice about Ottawa’s trouble-plagued efforts to regulate the natural products sector, in 2005 and 2007. Both times I talked to advocates and critics of the regulatory system. I concluded that, at root, the problems flow from the contradictions inherent in trying to bring quasi-scientific regulation to an industry that’s based on unscientific folklore.

The 2004 federal regulations allow products to be licenced based, not on clinical research, but on traditional claims. That’s right: products can obtain a federal licence number—what surely looks to consumers like a government seal-of-approval on the label—on the basis of old beliefs. Clinical evidence is considered where it exists; but for most natural health products the foundation for federal approval is research into traditional uses in non-Western healing.

Critics like the Centre for Science in the Public Interest have justifiably taken aim at Health Canada for licencing products based on dubious traditional uses, such as “heart-health claims for garlic and menopause-relief claims for black cohosh when scientific evidence indicates both substances are no more effective than placebos.”

It has never made sense to me that Health Canada is validating traditional-use claims. Health Canada should be in the business of applying science to regulation. And it’s impossible to reconcile the two ways of looking at a product meant to make a person healthier.

(I do think it is enormously valuable that the Natural Health Products Direcorate has taken decisive action in cases where a natural product poses a clear health risk, as when it banned combinations of derivatives of the herb ephedra, known as ephedrine, with stimulants like caffeine, after research showed risks ranging from heart-rate irregularities to seizures.)

I wonder if the Canadian Health Food Association has thought this through. It’s campaign aims to get MPs, the PM and the health minister thinking hard about their industry’s regulatory woes. But maybe the politicians won’t come to the conclusion that licencing should be somehow expedited. Maybe they’ll conclude that the regulatory approach was flawed at the outset and should be overhauled, even tightened.

Whatever happens next, it obviously isn’t acceptable for a backlogged, confusing, possibly unenforceable, arguably indefensible, regulatory regime to go lurching along indefinitely. It’s not fair to the industry making these products or helpful to consumers.


 
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Problems in the natural health products aisle

  1. It's a difficult issue. I'm skeptical about natural health products, and approve of the new regulations – they prevent the sale of things that are either dangerous, or that would encourage people to abandon important health medications that actually work (for example, going off your heart or blood pressure medication for something that does absolutely nothing). But on the other hand, it doesn't seem quite fair to subject them to the same levels of testing as conventional pharmaceuticals: there are effective traditional remedies, and the cost of extensive testing is enough to throw anyone small-scale out of the business.

    My view is that if there's too much of a backlog, they should require proof that the item isn't dangerous (and the proof can be simple common sense in some cases – garlic isn't harmful), and beyond that just require a label in readable-size print saying "Health Canada cannot certify that this product is effective" if someone doesn't have scientific evidence that their product works. Then, if people want to try it out they can without having unreasonably high expectations.

    • I agree! There should be strict regulation that would prevent harmful products to be on the market but you do have to allow for individuals to make their own decisions. They shouldn't be allowed to make wild claims but at the same time what's the harm in taking vitamins, if they don't do anything it's still your choice to take them or not, the consumer has to take responsibility for what they buy it's not only the governments responsibility

  2. "Health Canada is reasonably confident this product will neither kill you nor make you sick, but there is NO REASON to believe anything else on the label of this product. Giving this to children or taking it while pregnant strikes every scientist at Health Canada as somewhere between 'not-recommended' and 'why-would-you-be-so-stupid.'"

    Anything beyond that is probably a fool's game.

  3. Can we let the individual make some decisions. If a product makes false claims they can be taken to task through existing legislation and asked to prove their claims.

    How much government do we want?

    • I think the article is trying to explain that the existing regulation is inadequate, and at least requires some review perhaps even overhaul to better protect the public.

      And if you don't like the government there's a whole nation with a paranoid style you might enjoy just south of the 49th parallel.

  4. So snake oil gets approved being a long standing product of traditional ahem claims? However a company that has a new natural blended product that has been tested and cleared of ill effects will kept off shelves because it has no market history? No wonder athletes claim that don't know why they failed drug tests. It's plausible if not smart.

  5. "Hello, Health Canada? I have a product that lowers blood sugar. Can i put that on the label?"

    "Um, sure, if you have proof."

    "Proof? You're part of the pharma conspiracy, aren't you?! Help, my freedom of choice is being oppressed!"

    Solution? Let them sell whatever they want, but make them prove any health claims they make. If they can't prove the claims, sue them senseless, and alert the class action lawyers.

  6. “Can we let the individual make some decisions. If a product makes false claims they can be taken to task through existing legislation and asked to prove their claims.

    How much government do we want?”

    1. Individuals best make decisions when they’re not dead. That’s one of the reasons we regulate products. Unfortunately, in the real world, companies do make and sell products that kill their customers, whether it makes sense to you or not. The free market doesn’t prevent cigarettes, lead face powder, ephedra pills, and Ford Pintos.

    2. It is not possible for individuals to make rational decisions about the efficacy of health products or treatments, hence the existence of double-blinded clinical trials with placebos. Let’s say you feel yourself coming down with something and you take moth wings or some other naturopathic nuttery, and your symptoms start to improve. Now, what exactly was it that caused your symptoms to improve? Did they do so on their own (spontaneous remission) as with most colds; was it the effect of the moth wings; or did mom’s chicken soup and lots of rest do it? With only a few data points to rely on, a single individual cannot draw any meaningful conclusions on which to base such decisions.

  7. Many drugs go throught clinical tests… are approved and finaly end up being more dangerous than dandelion tea. I think safety is the main concern for most people so if a product has been used for tousands of years with no reported problems then we should go ahead an approve it. No one can garantee that a drug or herb will get the result we are seeking. Unfortunately the whole thing is getting blown out of proportion. If Health Canada bans dandelions I will have to pick them out of my back yard…

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