A controversial new proposal from Health Canada would add new regulatory scrutiny for natural health products and bring them in line with higher scientific standards used to regulate over-the-counter drugs.
The proposal, unveiled in late September, would cover the three buckets of health products and group them together as part of new regulations for “self-care products,” which is part of the regulator’s wider effort to refocus the approval of health claims based on scientific proof.
The new approach, according to Health Canada, will include three main proposals:
- Products of similar risk profiles would be treated in a similar manner, which could help to ensure rules for bringing products to market are more consistent and easier to understand.
- Companies would need to provide scientific proof to support health claims.
- A risk-based approach to compliance and safety monitoring will continue to allow Health Canada to take action to protect consumers.
What’s stirring the controversy is the second item, as currently, natural health product companies must submit documents to Health Canada to show that a product is safe and effective, but the level of proof required can vary and non-scientific information is accepted to demonstrate efficacy.
And because the level of proof required and provided by companies of OTC drugs “is usually of a higher standard, particularly for a claim,” Health Canada says it’s pushing to bring more natural health products under this higher standard.
“Health Canada's practice of accepting other non-scientific information to support claims for natural health products is based on an attempt to recognize that these products are not the same as conventional drugs, and often have a basis in philosophies that support the general health benefits of some ingredients through means other than scientific standards. Some products, like traditional Chinese medicines, are based on thousands of years of use. Homeopathic products (also a type of natural health product) are grounded in homeopathy, a system that is not supported by science,” the regulator says.
The Canadian Health Food Association, Canada’s largest trade association for natural health and organic products, has begun a “Save Our Supplements” advertising campaign against the new proposal, claiming it will “Cause many of the supplements that you use to disappear forever…Increase the cost of the products that are left…[and] reduce the amount of information available to you about the natural health products you rely on."
But as Health Canada explains, the shift might actually be positive for consumers because when an OTC drug and a homeopathic product make a similar claim (such as "relieves cough"), not just the claim on the OTC drug will be supported by scientific evidence.
“In our current system, this difference may not be clear to the consumer because there is no signal on the product label, so these products could appear to consumers as if they are equally effective,” Health Canada adds.
In addition, Health Canada is looking to bring in line the fines for self-care products and companies that break the law as currently natural health products and cosmetic companies can only see a maximum fine of $5,000, whereas OTC drug companies see fines in excess of $5 million.
The proposal would also group all three types of products under a new proposed risk classification system:
And in some instances, Health Canada notes that even if the product is not making a diagnosis, treatment, prevention, cure or mitigation claim, “there may be a need to ensure that the product is reviewed for safety only. A pathway would be created to enable this.”