| Determining the appropriate regulatory pathway is not always straightforward, especially when introducing a product from Canada into the U.S., or vice versa. For example, some foods contain components that when isolated could be a dietary supplement/Natural Health Product (NHP), and under certain circumstances, even a drug ingredient. |
|
By the end of this blog post, you should have a good understanding of who regulates supplements in the US and Canada, and how they differ from food and drug regulations. Continue reading if you are looking for information on how to sell supplements in Canada or the US. Understanding the category definitions as laid out by the respective regulation is one way to discern between frameworks; see table below.
| Regulatory Category |
Definition |
| Food Examples: Orange juice, poultry, bread, candy, live microbials |
Any article manufactured, sold or represented for use as a food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever. Source |
| Dietary Supplement (US) Examples: Vitamin D, echinacea, live microbials/probiotics, multi-vitamin gummy |
A product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. Source |
| Natural Health Product (Canada) Examples: Multi-vitamin gummy, calcium, omega-3 oil |
A substance or combination of substances which is manufactured, sold or represented for use in:
- The diagnosis, treatment, mitigation or prevention of disease, disorder or abnormal physical state or its symptoms in humans;
- Restoring or correcting organic functions in humans; or
- Modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
Source |
| Drug Examples: Ibuprofen, vaccines, antibiotics |
A drug includes any substance or mixture of substances manufactured, sold or represented for use in:
- the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals;
- restoring, correcting or modifying organic functions in human beings or animals; or
- disinfection in premises in which food is manufactured, prepared or kept.
Source |
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Prebiotics and probiotics aren't going anywhere. In fact, this emerging market has become so popular in recent years that there are now two major events dedicated solely to prebiotics/probiotics. Here we take a look at one of the most challenging aspects of the research and development (R&D) process for companies looking to bring prebiotics/probiotics to market.
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Clinical research has become a fundamental step in the development of a dietary supplement. Nutraceutical companies are investing more in clinical research than ever before to support health and marketing claims and gain a competitive advantage in a saturated marketplace.
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