When it comes to vitamins, minerals, and dietary supplements, not all products are created equal, especially when you compare the regulatory landscapes between Canada and the United States.
NutriChem is a proudly Canadian, family owned and operated company, and we want to help you understand why where your supplements are made matters, and how Canadian products offer superior assurance in terms of quality, safety, and efficacy.
Differences in Supplement Regulations: Health Canada vs. the FDA
Canada:
In Canada, dietary supplements fall under the Natural Health Products Regulations (NHPR), overseen by Health Canada. Before any product reaches the shelves, it must be evaluated for safety, efficacy, and quality. There is a rigorous application process through Health Canada where companies must submit research regarding:
- efficacy of the product
- medicinal ingredients
- non-medicinal ingredients
- recommended use
- potential adverse effects
Only once this application is approved will a Natural Product Number (NPN) be assigned — a license that signifies the product meets strict regulatory requirements is a product allowed to be sold on the shelves or online in Canada.
USA:
In contrast, the U.S. Food and Drug Administration (FDA) regulates supplements as a category of food, not drugs. This means there is no pre-market approval process. Manufacturers are responsible for ensuring safety, but there is no requirement to prove efficacy before marketing. This means that the dosage and ingredients in the products being sold are not monitored.
The FDA does require that manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” notify the Food and Drug Administration (FDA) about these ingredients. A new dietary ingredient is one that was not marketed in the United States in a dietary supplement before October 15, 1994. However… There is no authoritative list of dietary ingredients that were marketed in dietary supplements before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if an ingredient is a “new dietary ingredient”.
For example, in Canada, the upper limit of Vitamin D that is able to be sold in a supplement form is 2500 IU per dose, with higher dose Vitamin D accessible by prescription only. Whereas in the U.S.A you can purchase Vitamin D capsules that have a potency of 10,000 IU or 15,000IU off the shelf, without a prescription, as the supplement companies are not regulated. Why is this concerning? Chronic ingestion of high doses of Vitamin D can be toxic and have harmful effects, this is why any capsules of Vitamin D over 10,000 IU in Canada must be prescribed by a healthcare provider as a prescription medication.
In summary: In Canada, the product must be proven safe and effective before you take it. In the U.S., the burden of proof often falls after a problem arises.
Health Claims: Evidence vs. Marketing
One thing I notice very frequently in my practice as a Naturopathic doctor is patients coming to me with a new “wonder supplement” that claims to be able to fix all of their problems. Every time I look at that product it is almost always manufactured outside of Canada, and the product page makes robust claims that are not well supported by sufficient evidence.
Here are some key differences in what manufacturers are allowed to put on the label of a product in Canada vs. the U.S.A.
Canada:
Health claims on supplements must be backed by scientific evidence. When applying for a natural product number (NPN), companies must actually submit evidence (studies) regarding the efficacy of their product or ingredients to Health Canada. Health Canada will then review the evidence and provide an outline regarding what is permitted to be written on the product label based on data. Health Canada restricts misleading or exaggerated language such as “cure” or “treats”. Even simple phrases like “supports immune health” must be substantiated with data.
USA:
American regulations are looser regarding health claims on supplements. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, companies can make broad, often vague, “structure-function” claims like “boosts vitality” or “promotes digestive comfort” without providing clinical evidence. These claims must include a disclaimer, but most consumers don’t notice it.
Here is an example of the exact same product but one is sold in the U.S.A and one is sold in Canada. Note how the expected benefits of the product are different. In Canada there is no approval for the claim that this product will support healthy insulin function, but instead it states that it may support immune function and healthy glucose metabolism.
In Summary: Canadian labels are less hype, more science. In the U.S., marketing often trumps evidence.
Quality Assurance and Testing
Canada:
Canadian manufacturers must follow Good Manufacturing Practices (GMPs) set by Health Canada, which include stringent controls on sourcing, production, contamination, and labeling. Random inspections and product testing are common. If a natural health product does not meet manufacturing standards, contains incorrect ingredient amounts compared to the label, or includes undeclared or unsafe ingredients, Health Canada can take action by stopping its sale, recalling the product, and suspending its license.
As a consumer in Canada, you can view the list of mislabeled or recalled natural health products in Canada here.
USA:
While GMPs are also required by the FDA, enforcement is sporadic, and many smaller manufacturers fly under the radar. Several studies have found discrepancies between what’s on the label and what’s in the bottle for U.S. products, including undeclared ingredients or improper dosages.
An example of this discrepancy in ingredients and challenges with U.S based natural health products is the contamination of sleep aids with hidden active drug ingredients. In 2019, the The FDA released a public notice regarding a “natural” sleeping aid called “U-Dream” which was found to contain a prescription sleeping aid most commonly known as Zopiclone. This is a serious concern as prescription sleeping aids such as zopiclone may cause impairment of driving and other activities the following morning, as well as other serious adverse effects.
Considering the vast number of supplements being manufactured and sold in the U.S., the FDA’s current online list for informing consumers is extremely limited, highlighting a clear lack of resources and investment in this area to adequately protect the public. You can view the full list here.
The bottom line: Canadian products are held to higher quality standards that are consistently enforced. However, there are still products that come into Canada that may be contaminated with unknown substances.
Monitoring and Post-Market Surveillance
Canada
Health Canada maintains a public database and actively monitors adverse event reports, with the authority to recall or pull unsafe products from the market quickly. Health Canada continues to monitor the safety and quality of natural health products by responding to complaints, testing products at our laboratories and conducting compliance monitoring projects.
USA:
Although the FDA can act against harmful products, it largely relies on consumer complaints. The reactive nature of the system means harmful products may linger on the market longer than they should.
The bottom line: Canada is more proactive; the U.S. is more reactive.
What This Means for You
- Trust the NPN: If you’re buying a supplement in Canada, look for the Natural Product Number (NPN). It’s your assurance of quality.
- Buy Local: Supporting Canadian-made products boosts your economy and protects your health.
- Be Cautious with Imports: Even though American supplements are widely available online, they don’t offer the same quality assurance. Imported products are often mislabeled or inconsistently formulated.
Final Thoughts: Choose Safe. Choose Smart. Choose Canadian.
As a Canadian company, we take pride in offering products that meet, and often exceed, Health Canada’s rigorous standards. With a supplement market flooded by bold claims and inconsistent quality, Canadian consumers deserve transparency, safety, and science-backed solutions.
Don’t leave your health to chance. When you choose Canadian-made supplements, you’re choosing quality you can count on.
References
U.S. Food and Drug Administration. (n.d.). Dietary supplements. https://www.fda.gov/food/dietary-supplements
Health Canada. (n.d.). Monitoring the safety of health products on the Canadian market. https://www.canada.ca/en/health-canada/services/inspecting-monitoring-drug-health-products/monitoring-health-products-canadian-market.html#a1
