Myths and facts on proposed self-care product regulation
Health Canada has consulted Canadians to seek their views on a new approach to the regulation of self-care products, including natural health products, cosmetics and over-the-counter drugs. As the discussion progresses, a need to clarify some aspects of the proposal has emerged.
Review the facts of Health Canada’s position on the regulation of self-care products.
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Myth: Health Canada wants to limit access to natural health products for Canadians.
Fact: Natural health products will continue to be readily available. Low-risk products, including many natural health products, will actually get to store shelves faster without compromising safety.
Differences from prescription drugs
Myth: Self-care products will be treated like prescription drugs.
Fact: The rules for self-care products will not be the same as those for prescription drugs.
Self-care products would have the appropriate level of oversight to ensure consumer safety. This oversight would be different from that for prescription drugs since self-care products are generally lower risk.
Ease of bringing products to market
Myth: Health Canada is planning to add more rules and red tape for companies.
Fact: Companies will face less red tape to bring many self-care products to market. The rules will be applied based on the type of risk associated with the product, such as:
- higher risk products could receive more review by Health Canada
- lower risk self-care products could receive less review and get to market faster
Myth: Health claims will be banned on self-care products.
Fact: Self-care products will be allowed to make claims if they’re supported by evidence as long as:
- all claims are truthful and accurate
- scientific evidence supports certain types of claims
- claims on packages help consumers make informed choices
Myth: Canadians are well-informed about the self-care products they use.
Fact: Polling shows that Canadians don’t feel informed when choosing and using self-care products. Public opinion research conducted in April 2016 showed that fewer than 2 in 5 Canadians feel knowledgeable about the effectiveness of self-care products.
Canadians feel like they have little knowledge of the safety and effectiveness of these products, and feel generally uninformed when making a purchase. The self-care proposal will support informed choice.
Myth: Natural health products are safe and don’t need many rules.
Fact: Most natural health products are low risk, but they are not without risk.
There is a wide range of natural health products, some of which can interact with other medications and/or cause serious adverse reactions. Health Canada will continue to have safety checks in place.
Myth: There is no scientific evidence to support any natural health products.
Fact: Many natural health products are supported by scientific evidence, while others rely on a history of traditional use or non-scientific information.
Myth: Health Canada’s new self-care proposal came out of the blue.
Fact: Health Canada has been looking to modernize the rules for self-care products for some time. Health Canada has been working to modernize its approach to health products, including launching the regulatory roadmap in 2012 and conducting a consultation on consumer health products in 2014. Through the current consultation, the Department wants to hear from Canadians to inform the way forward.
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