The federal government is planning some pretty major changes to the way it regulates non-prescription drugs, natural health products and cosmetics. The move is designed to simplify the rules and help assure consumers the products on store shelves "are safe and do what they claim to do," according to Health Canada's consultation document outlining the proposed new framework.
It appears the biggest impact would be felt by Canada's multi-billion-dollar natural health products industry, which includes vitamins, minerals, supplements and homeopathic solutions. Under the new rules, companies that want to put health claims on their labels would need to provide scientific evidence and Health Canada will determine whether there is sufficient proof to warrant the claim. It's a substantial change from the current system, under which Health Canada grants licences to all approved natural health products licenses and allows them to make a variety of health claims, which serve as important marketing tools.
According to Canada's natural health products industry, the proposed changes will make natural health product makers meet the same regulations as prescription drugs and that the rules will force many products Canadians rely on to disappear from the market. Shortly after the proposal was released in September, the Canadian Health Food Association launched a social media campaign and petition calling on the government to "save our supplements."
The rhetoric is alarming and misleading. Health Canada isn't taking anyone's supplements away – it's trying to prevent companies from making unsubstantiated health claims as a way of selling products. Something that happens far too often under today's system.
Why are the changes necessary?
Under the current framework, companies selling non-prescription drugs, natural health products and cosmetics each have to follow different sets of rules for safety, making health claims and how to bring a product to market. This sounds good in theory, but it has resulted in a system that treats products making similar claims on their labels very differently. There are also some serious gaps in the government's ability to remove potentially dangerous products from store shelves or order a company to change its labels.
Let's use cold and flu products as an example. The maker of a non-prescription treatment for the symptoms of a cold or flu has to submit evidence from rigorous clinical trials to Health Canada and provide ample safety data before its product is allowed for sale. Manufacturers also pay some fairly hefty fees to Health Canada to have their products assessed. Once the product is approved, the government has the power to remove the product from store shelves or make the company change its label if safety problems emerge.
The situation for natural health products is much different. The maker of a cold and flu treatment has to submit evidence for approval, but the scope and quality is not the same as what's required for non-prescription drugs. A company can get approved by submitting textbook references or small, methodologically flawed studies. In some cases, a product can be approved if manufacturers can simply show it's been in use for a few generations. If Health Canada learns a natural health product contains a dangerous ingredient or poses another health risk, it can't order a recall. It has to ask the company to stop selling the product.
What is Health Canada proposing?
Instead of regulating products by category, Health Canada wants to regulate them by the potential risk they pose: higher risk, moderate risk and lower risk. Higher-risk products could include drugs switching from prescription status to non-prescription and would require a full government review of science-based evidence before a product can be sold or health claims are approved. Moderate-risk products could include oral painkillers, such as ibuprofen or acetaminophen, allergy treatments and cough and cold products. They would also need a full Health Canada review and would need to be backed by science-based evidence to be sold and make claims. Lower-risk products could include vitamins, toothpaste and homeopathic products. They would not be reviewed by Health Canada and could not make any claims about diagnosis, treatment, prevention or mitigation of a health condition.
The consultation period on the proposed changes ended on Oct. 24 and the next step is for the government to publish new regulations that spell out exactly how the new framework would operate.
Proponents of natural health products say these changes mean vitamins and minerals would have to meet the same standards as drugs in order to be approved and that it would drive countless products from the market. Some online commenters even claim that Big Pharma is the driving force behind these changes, as that industry would benefit from putting the natural health products industry out of business.
On its website, the Canadian Health Food Association (CHFA) claims the new framework will reduce oversight of products and restrict information available to consumers as well as increase the costs of vitamins, minerals and other natural products. In an interview, association president Helen Long said the current regulatory framework is working fine and warned these changes could threaten the availability of natural health products.
"I think both members [of the association] and the public are concerned that they will be able to continue to access the products they know and they trust," she said.
The association's website also states that there's "legitimate concern" that fewer products will be available because of Health Canada's heavy-handed approach. It further states that the industry has concerns about the fact the proposal document mentions fees for companies that want to make health claims, as that would pose a financial burden to natural health product makers.
The reality check
Despite the alarming messages, Health Canada is not restricting access to natural health products. It is, however, proposing to move away from a system that allows makers of vitamins, minerals and homeopathic products to make bold health claims about curing, preventing or treating illnesses with little to no scientific evidence.
According to an example on the CHFA website, a bottle of tumeric (sic) that can currently state on its label "used in herbal medicine to aid digestion" may only be able to state "provides antioxidants for the maintenance of good health" in the future. This, apparently, will deprive consumers of vital information and as a result, they may not purchase that product. Or manufacturers may decide it's not worth it to sell here. If Health Canada imposes fees on companies that want their products licensed and health claims approved, that could cause some companies to reconsider doing business here.
Canada's natural health products industry is valued at $3-billion, according to the CHFA. If companies decide user fees are too much to bear, or that not being able to make specific health claims is unacceptable, it's their choice to leave the market.
But to paint the changes as an attempt by the government to unfairly and unnecessarily restrict access to natural health products is inaccurate, misleading and unfair.
Tim Caulfield, Canada Research Chair in health law and policy at the University of Alberta, said Health Canada's new framework is a long overdue step in the right direction.
"What they want to do is ensure the information getting out there is accurate and supported by evidence," he said. "How can anyone be against what they're proposing?"
Canada's natural health products industry says the current regulatory system should remain as is. That would allow manufacturers to enjoy the status quo. But it won't address the fact many of the products being sold to Canadians use misleading marketing messages and health claims that have little to no basis in science.