| 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 |
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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 |
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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 |
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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:
|
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Drug Examples: Ibuprofen, vaccines, antibiotics |
A drug includes any substance or mixture of substances manufactured, sold or represented for use in:
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Foods: Sometimes Mistaken for Natural Health Products
Of the categories listed above, foods, which include beverages, pose the lowest risk; they are meant for ad libitum consumption and presumed to be safe. The Canadian Food and Drugs Act, along with its associated Regulations, outline laws on food labelling, advertising and claims, food standards and compositional requirements, fortification, food additives, and more. Products in a food form such as juices, energy bars, or drinks, that have added vitamins, minerals, or amino acids can be mistaken for NHPs, but are in fact foods because of their intended use and representation.
Dietary Supplements (US) and Natural Health Products (Canada) Have Different Regulatory Requirements
The Food and Drug Administration, or FDA, is the regulating body who oversees the enforcement of dietary supplement regulations in the US. Whereas, in Canada, Health Canada is responsible for enforcing Natural Health Product Regulations. Dietary supplements in the U.S. are often interchangeable with NHPs in Canada, but there are notable differences in the regulatory requirements per country. Dietary supplements are restricted to products that are orally ingested (e.g., tablets, capsules, powder, liquid, etc.) and do not include conventional food or topical formats (i.e., gels, creams, or ointments). Not only can NHPs be taken orally, but they can also be administered via topical application, in granules, patches, sprays, and suppositories. Dietary supplements are regulated as a subset of food in the U.S. and while a pre-market notification may be required for new dietary ingredients, there is no pre-market approval process. That being said, dietary supplements are limited to structure-function claims (i.e., those that describe the role of a dietary ingredient intended to affect the normal structure or function of the human body). Because NHPs are regulated as a subset of drugs, they are subject to Health Canada approval prior to sale, but can also carry more aggressive claims on-pack.
Drugs vs Natural Health Products
The definitions of a drug and NHP overlap in that they both can be intended for “the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in humans.” While drug products clearly encompass prescription and non-prescription pharmaceuticals, the difference between a drug and an NHP can be as subtle as the dosage amount or form. For instance, a product that provides 2500 IUs of Vitamin D orally per day would be an NHP, but a quantity above 2500 IUs or an injectable form would automatically be deemed a drug.
Overall, many factors are taken under consideration when distinguishing between foods, dietary supplements, NHPs, and drugs. With a good understanding of the differences between drugs, Natural Health Products, and dietary supplements, we can now focus on strategy. As mentioned, regulatory requirements for dietary supplements differ from regulatory requirements for Natural Health Products. The team at SGS Nutrasource is well-versed in all of these areas and can help navigate the nuances of each regulatory category and structure to ensure compliance. Contact us today to help determine which is the appropriate regulatory pathway to take.
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Stephanie Hall, BSc, joined the NHP & Pharmaceutical Regulatory Sciences team at SGS Nutrasource in 2021 and brings a variety of experience in the Natural Health Products and Cannabis industries in Canada. Stephanie has helped numerous clients with submissions to the Natural and Non-Prescription Health Products Directorate. |
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