Last month, Health Canada announced proposed changes to how it regulates natural health products – everything from herbal supplements to minerals to homeopathic medicines. The new rules will prohibit natural health companies from making health claims on product labels, unless there is sufficient scientific evidence to back up those claims.
Critics have called the current regulatory standards “a joke” and say the system favours manufacturers’ profits over consumers’ rights to safe and effective treatments.
Others disagree. The Canadian Health Food Association (CHFA) says the proposed rules, if adopted, would cause many herbs and supplements to “disappear forever.” The CHFA represents companies that sell, manufacture or distribute organic foods, supplements and herbal and homeopathic products. Shawn O’Reilly, executive director of the Canadian Association of Naturopathic Doctors, is also concerned about the new regulations. “The proposed changes will limit the amount of information provided to consumers and limit the options they have,” she argues.
Health Canada, meanwhile, says consumers “will continue to have access to a wide range of” natural health products and that the changes are meant to help consumers identify which products have been proven effective, and which have not.
Michael Kruse, executive director of Bad Science Watch, a non-profit consumer advocacy organization, argues the CHFA is claiming to be concerned about the consumer, but they represent the manufacturers. And it’s not true that Health Canada’s changes will restrict access to these products, he says. Under the proposed regulations, he explains, “if you want to sell your pomelo leaf herb, you can still sell it, you just can’t claim it actually treats anything.”
Of course, if removing those health claims makes consumers less likely to buy products, that’s an issue for Canada’s $3.9 billion natural health product industry. In a 2011 Ipsos Reid survey, 73% of the Canadians polled said they’d used a natural health product, and 32% said they took natural health products daily.
Health Canada has invited Canadians to provide feedback on the proposal before October 24.
Currently, natural products are permitted to make health claims based on homeopathic textbooks, anecdotal information or the historical use to treat a condition. They’re not required to show their products have demonstrated effectiveness in controlled, scientific studies, as prescription and over-the-counter pharmaceutical drugs are.
The current regime has come under scrutiny in recent years. Last year, for example, CBC Marketplace was able to get a fake natural product licensed as an effective treatment by Health Canada. Submitting only a 1902 homeopathic reference book, the bogus children’s medication was approved to claim “effective relief from fever, pain and inflammation” on the label.
Ubaka Ogbogu, a professor of law and pharmacy at the University of Alberta, says more rigorous standards are long overdue, as there are serious dangers to taking natural health products that make unproven claims. “There’s the danger people will forgo actual treatments in favour of things that don’t work, and there’s the danger that natural health products can interact with other drugs a person may be taking,” he says. For example, the herb St. John’s Wort can interact with a variety of drugs, including blood thinners and some painkillers. (The herb can exaggerate or reduce the effects of certain pharmaceuticals). There’s also “the financial danger.” If Canadians buy an ineffective product they’ve been misled to think works, they’re wasting their money.
It’s important to keep in mind that we’re using “natural” as Health Canada does, to describe products “often made from plants,” but sometimes made from “animals, microorganisms and marine sources.” Many question the label, noting that pharmaceuticals are also often derived from plants and “natural” products can be highly processed and concentrated in forms that don’t exist in nature.
Many herbal supplements, vitamins and homeopathic products won’t be permitted to make health claims
According to the proposal, natural health products would be defined as “low-risk” so long as they don’t make claims about the “diagnosis, treatment, prevention, cure or mitigation of a disease or serious health condition.” These products would not be reviewed by Health Canada but they may be required to provide evidence for other claims they make, such as “source of Omega 3.” (It’s not clear when such claims would have to be backed up and when they wouldn’t.) Health Canada is considering putting a disclaimer on these products to explain that they haven’t been vetted for effectiveness. These products would no longer have a natural product number or homeopathic medicine number, which have until now indicated that the products have been licensed and reviewed by the federal agency.
However, natural products that make health claims would be classified as moderate or high risk and would be vetted for effectiveness and licensed by Health Canada. These products would be required to submit scientific evidence that they work – traditional medicine textbooks or anecdotal information would no longer suffice. Health Canada hasn’t made clear, however, what level of scientific evidence would be required, such as whether large, randomized trials would be necessary or not.
According to Ogbogu, it’s a good step that natural health products that aren’t scientifically backed won’t have a Health Canada stamp of approval. Currently, he says, the fact that herbal and homeopathic products have a Health Canada licence number on their label creates a “fake legitimacy.” In a study published last month, Ogbogu and his colleagues surveyed about 400 pharmacists in Alberta and found that 68% recommended natural health products to patients. Pharmacists were more likely to recommend natural products with a Health Canada number.
Critics worry, however, that companies would still be able to make unfounded health claims. Health Canada’s examples of what it considers to be non-health claims – or claims that won’t require scientific proof – include “generally supports health maintenance” and “helps metabolize fat.” Such claims could lead people to think these products improve health, critics point out.
We asked Health Canada about the concern that these “non-health claims” could indeed be interpreted as health claims. Media relations advisor Anna Maddison responded in an email that such claims would “still have to be truthful and accurate. Companies would need to have information to support these claims.” We subsequently asked if supporting information would be required to be scientific or if alternative medicine philosophies would suffice. Health Canada did not respond to this question as of press time.
Scott Gavura, a pharmacist in Ontario, is also concerned. In a blog post on the proposed changes, he writes, “Putting warning labels on approved products to tell consumers that they really don’t actually work is a clumsy and possibly dangerous approach to regulation.”
In their submission to Health Canada, Bad Science Watch argues such claims shouldn’t be allowed in the low-risk category. “A maintenance claim is a prevention claim. It’s claiming to prevent bad health,” says Kruse.
Joe Schwarcz, director of McGill University’s Office for Science and Society argues, meanwhile, that products that have no beneficial effect shouldn’t be sold, period. “Homeopathy should be banned. It’s scientifically implausible,” he argues. “Health Canada may think it’s benign nonsense, and so they don’t see a need to regulate it, but people believing in non-existent therapies can lead them down the garden path and avoid the things that really work.”
Trials costly for herbal and homeopathic companies
On the other side of the debate, Michelle Book, director of communications for the CHFA, argues that alternative medicine information deserves to be publicized. She believes that consumers should be able to know that a product has been used for a specific condition for hundreds of years, for example. “Our current pre-market approval system respects traditional values from many different cultures,” she says.
For natural health products that want to make health claims, the scientific evidence requirement is unfair, she argues, pointing out that clinical studies are “vastly expensive.” The annual revenue for a natural health product, on average, was reported at $0.2 million in Canada in 2011. A single human randomized, controlled trial can cost millions.
Ogbogu argues, however, when a natural compound has a high potential of working, companies “have no problem” spending money to isolate, patent and test the active ingredient. “You can patent extraction processes, and if you are the first one to extract some natural compound, you can patent that too,” adds Schwarcz. That said, Schwarcz recognizes that most small natural health companies aren’t positioned to fund high-quality trials.
At any rate, “marketability” shouldn’t be a factor in how a health agency regulates drugs, Ogbogu argues. “We regulate to make sure the products are safe and efficacious,” he says.
Ideally, this would be the case, agrees Schwarcz. But, he says, “there’s tax money involved, there’s thousands of thousands of jobs that are involved and the supposed freedom of choice for people. The government has to take all of those things into account.”
Will the proposed changes ensure that natural health products are safe?
Health Canada’s proposed changes may shed some more light on a product’s effectiveness, but will the regulations improve safety standards? Yes and no.
Currently, says Kruse, few standards exist to ensure that what’s listed on the bottle of a natural health product is what’s contained therein. “There’s no requirement for mandatory [chemical or DNA] testing…for example, each time there’s a change in a product run or after a certain amount of time,” says Kruse. “If you compare it to standards for the pharmaceutical industry, the safety standards for natural products are far lower.”
While Health Canada’s proposal is vague, it doesn’t seem that pre-market safety measures will significantly change. “Health Canada would continue to take appropriate steps to help ensure the safety of products before and after they go onto the market in Canada,” Maddison wrote in an email.
A 2013 study led by Steven Newmaster, a biology professor at the University of Guelph, found more than half of 44 herbal products studied contained plant species not listed on the label, some of which can have damaging effects. A third of the products studied contained other ingredients not listed, including fillers like rice and wheat, which could cause allergic reactions.
Schwarcz and Kruse argue that while Health Canada doesn’t have the resources to inspect all natural health product companies, they should conduct random inspections and tests to ensure accurate labelling.
Of course, even those ingredients that are listed may be dangerous. In a review of 50 systematic reviews of herbal medicines, 15 reported moderately severe adverse effects, while four concluded the herbal medicine was unsafe. The adverse effects included acute psychosis, liver damage, respiratory arrest and many more, though the review didn’t quantify how rare or common these effects were.
Health Canada does, however, seem interested in strengthening its powers to respond to safety issues that arise. One of the consultation questions asks whether recalls of natural health products should be required and financial penalties applied “to help address safety issues.”
Kruse points out that this could mean applying “Vanessa’s Law,” or a version of it, to herbal and homeopathic products and vitamins. In 2014, the legislation gave Health Canada more powers to require mandatory recalls and/or product label changes when a safety issue arose after a drug had been put on the market. The law increased the penalty for not complying from $5,000 per day to $5 million per day. But, the law does not currently apply to the natural health product industry, which argued in parliament at the time that they should be exempt.
While he welcomes many of the changes, Schwarcz argues that what Health Canada says it does “on paper” is different than what it is able to implement in practice. Health Canada didn’t take action in response to Newmaster’s study, for example – though New York State did. “The Natural Health Products division is totally overwhelmed by the thousands and thousands of applications,” says Schwarcz. “There’s not enough clamping down.”
[poll id=”195″]
The comments section is closed.
I have come to find out that herbal medicine its the best solution to all STDs and STIs and other health related threatening issues/diseases, cause i was once tested positive for herpes and i have lived with it for about 5 years tried all form of medication all to know avail, until i get a recommendation from someone online about herbal medicine fro Dr Ofua , indeed i actually do a little/more research about the Herbalist and found out he has the possible cure to my ailment, i gave it a try by contacting him on WhatsApp messenger (2347059497969) or email (thegreatherbalhealinghome gmail com) he had the herbal medicine he sent to me and gave me dietary instructions to follows up while using the herbal medicine, he suggest that i used the medicine for a period of 21 days that after then i should go for a check up at the hospital to know the status of my herpes, which i actually did, after few weeks as recommended by him, I go for check up and behold i was now tested Negative, ever since then i have vowed to let everyone knows that herbal medicine is the solution to any diseases/infections, despite these Big pharma company trying to makes us not to use herbal medicine framing all sort of bad reviews just to diminished herbal medication for their selfish interest and big wallets purpose, my advice to you all is that try herbal medicine today and be glad that you have tried it and i assured you that if you do you will have cause to share a testimony online just am doing now, visit Websites: ( dr-ofua-ofure-herbal-healing-home.business.site) to know more about the great herbalist that help me and am sure he too will help you.
What I find interesting that half of meds and other derive from what our ancestors passed down! Plants and natural herbs The Big Pharma and other Giants perfected it Rather then go thru all that baloney! Just send sample of your product for approval! If not toxic let the consumer judge for self! Trust me? If something dont work garbage! Im wondering where Big Pharma falls into this
Long overdue changes, as I believe the current behaviour of most these companies is fraudulent.
Providing the ingredients are labelled accurately with no hidden excipients ; I see no problem in stating that a herb has been used traditionally for a condition. To dismiss human experience in herb use over centuries in favour of modern science is an Orwellian step to rewrite history and destroy many small herb businesses that cant afford peer reviewed studies.
Safe and effective medications are highly subjective tools of therapy; its effects vary with time, race, sex and environment as it relates to the vast natural variability of the enzymatic and cellular substrates of these medications. It is impossible to use medical tools that might have been used thousands of years ago (traditional) or therapies used by certain “ethnic” groups and generalize to global use. Clinical studies are developed to resolve this issue. Herbal products should be evidence-based or at least their effects should be statistically analyzed if they really work. Same arguments need to be applied to all nutraceuticals and health products
Been talking about this since 1994 when HPB, the name Health Canada had at the time, decided to do exactly what it is repurposing now! Of course there will be many nay-sayers who claim that consumers will be deprived of their “choice” in favour for the pharmaceutical industry’s benefits since most products would be taken off the shelf. This is where health authorities need to find their balance. They need to find knowledgeable unbiased educated party similar to the Commission E monograph in Germany. This group would base regulations on studies, with giving some regards to ones that are not as rigorous as what we want as clinicians but balance those with some benefits vs risks assessments in order to make best educated advice to claims. If this were done properly, at the end of the day, consumers would also benefit as their choice would still be there but with less bias and randomness. Right now most claims are costing consumers much money with little health benefits, maybe at the end of the day , it will cost consumers some money with some health benefits. Is it worth the process? Sure…
How many adverse side effects are there from so called tested drugs
gov never did any good sticking thier nose in to any thing its all about control and more money
Though these changes to the regulation would no doubt put the damper on some false claims for ineffective or even dangerous products; it would do far more harm by preventing people from benefiting from the hundreds of products that have demonstrated their effectiveness over decades and even hundreds of years by their being used by the general public even though no officially approved trials have been registered.
Regulations! Health Canada has been on a “merry go round” of indecision for over 30 years as per alternatives to drugs…. This has cost the consumer – yes the consumer – thousands of dollars as they have to absorb the cost when Manufactures have to complying to these never ending changes! As well think of the millions of our tax dollars spent by Health Canada while they flounder about. This is a make work project! As per the quality of these products – The only way to regulate the quality is to randomly test them and publish the results.Health Canada can not afford this? – Well why not? They have spent millions on changing the regulations for over the past 30 years!! as well stop the importation of foods and herbs from China. How will we be exposed to the heavy metals in our foods and herbs from China? We regulate our own foods more than we regulate imports form China. As per effectiveness – the current system is a good one – clinical trials and traditional use-evidence is required… no absolute claims are allowed. Make our natural supplements drugs? Just recently we learned that a very high % of women taking the birth control pills suffer from depression – if the drug regulations are better why did we not know this before? Depression is a serious illness. Why where the makers of birth control pills not asked to test for this side effect? Why? Contrary to what people think a real clinical study takes over 20 years – using a very large number of humans as guinea pigs! So women have been used in a clinical trial – now we know that birth control pills may cause depression in almost 25% of those who take them…! Drugs are not safe. Calling a Nutraceutical a drug will not ensure safety. How many people have died or become critically ill using natural supplements? Well – just do a little research and you will find that a very large number of people are adversely effected by drugs and also die from the use of these drugs – every day! I am not sure what has triggered this change- CBC? well we all know that they have had a issue with natural products fr many years and that they constantly engaged in unethical reporting. When they have an agenda it is clear form the coverage it is not balanced. When did they ever do a program and interview consumers who have had great results using natural health products? Why not? The last program they did they used an American lab (yes an American Lab not a Canadian Lab) to test some natural products and then they went on air to “expose all these Canadian Manufactures” and guess what the tests were wrong!! I hope those manufactures took legal action. As well we need to keep in mind that Pharmaceutical companies do not like nutraceutical products (Natural Health Products) – it takes away from their bottom line – people are using nutraceuticals as an option to drugs in increasing numbers – if Natural Products do not work why are they using them? As well Canada is on the brink of signing 2 large trade deals – one with Europe – could this be the issue? These countries do not like our current system! German Pharmaceutical companies that “rule the roost ” in Europe do not like our system! In Europe Vitamin C is allowed at 60mg per day in Canada and the USA we are allowed up to 2000mg – so you see if this is the issue we are on the road to loosing our alternatives to drugs. Removing the claims we now have on Nutraceuticals will remove an educational tool we have developed for consumers. We are all busy people – do we have time to do research as to what herbs may help improve sleep or what nutrients may help to improve vision or maintain vision as we age as per the clinical studies done to date? We need to ask – WHY THIS CHANGE? WE NEED TO GET THE ANSWER TO THIS QUESTION? Why change the existing regulations – what has prompted this turn about – they were so right 5 years ago?
Why is melatonin ( a known hormone) allowed to be sold over the counter? When I tried to educate myself on the risks and benefits of melatonin, I found the Health Canada information sheet was very superficial and lacked the scientific data to actually assess the risks and benefits of this known physiologically active compound. The reference it provided regarding risks did not actually address the question of risks, It just suggested that studies are needed to assess risks. I hope that HC changes its approach to accurately inform and protect the public.
If a compound has a physiological effect, then there will also be a risk of an adverse effect. It does not matter if the compound is natural or synthetic. Both should have proper evidence to evaluate if they actually work and what the risk of harm is so that people can make an informed decision to use that compound.
Synthetic compounds (Drugs) require studies to show that they work and that they do not have dangerous side effects. Similar standards should apply to natural compounds as well.
I think regulation of naturopathic (N) and homeopathic (H) medecines should be done, yes, but by N/H experts. Conventional medicine cannot speak to N/H, so unless Health Canada has N/H experts on staff, it has no qualification to test or regulate any N/H medicines, nor any right to limit or withhold N/H medecines from anyone. I don’t think any so-called “disproved” or “unproved” medicines should be banned, but just not included on the list of medicines that can be claimed by health coverage.
Most of the herbal products are sold with unproven and unscientific claims, and it is time modern scientific techniques are deployed to sift actual benefits from quackery……
I’m laughing that the people selling natural products are complaining that the products might no longer be sold. Look, if you believe your product works, you should be all for this. Use it as a way to edge out your competition. Prove your claims. The only reason to be against this is if deep down you know your product can’t meet the new requirements.
The problem with science getting involved with natural medicine is that unless they can patent any drug or natural medicine they are not interested in research In other words if they can suck every last nickel out of the public while they are ill they are interested it’s all about money If they found a drug or natural medicine that really shows promise they would sweep their promising research under the rug and opt for some thing more financial rewarding We live in a very sad world
This is a great summary of the issues that Health Canada faces it it tries – once again – to get the balance right on this issue.
And, yes, this IS a balancing act. As a science-based organisation, Health Canada should not be blurring the lines between evidence-based products and those that are based on nothing more than tradition or discredited concepts like homeopathy. The proposed approach to licensing and approving only science-based products is therefor a huge step in the right direction. That said, there are valid reasons for not outright banning the products in the latter category, unless they pose a risk to the user’s health. One is that there are many Canadians with strong cultural attachments to alternative medical models, including traditional Chinese medicine, Ayurveda and First Nations medicine, who will seek out these products. Capturing them in a framework that at least regulates quality standards and labelling is preferable to creating a void that will be filled with black market products sold through a wide variety of outlets. Similarly, the Internet is filled with options that are accessible to Canadians seeking health products, but effectively beyond Health Canada’s regulatory reach. A regulatory framework that provides safer alternatives to these unregulated products will reduce the overall risk to Canadians who choose to seek out alternatives to science-based products.
If alternative medicine, specifically homeopathy, claims to improve health and function as a drug, they should meet the same rigorous standards that drug manufacturers face.