Should herbal and homeopathic medicines be regulated like drugs?
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.
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.”