Nutrasource Blog

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

Tags: Pharmaceuticals, Regulatory, Dietary Supplements/Natural Health Products

The first steps when developing any health and wellness product is to know first, what it is and second, how its regulated and in each target market as categorization may differ between regions. Many factors are taken under consideration when determining product classification as summarized in the figure below.

Tags: Product Marketing, Regulatory, Concept to Claim, Dietary Supplements/Natural Health Products

You've developed a new product and are keen to market it as a dietary supplement in the U.S. You're confident it fulfills the FDA's definition, but its "star" ingredient is newer to the market and, to your knowledge, hasn't been used in foods to date. This means that if you marketed it as is, the product would be considered adulterated.

What options do you have to go to market, and what is the most effective way to do so without raising regulatory red flags and risking your brand reputation?

Tags: Regulatory, Foods & Beverages, Dietary Supplements/Natural Health Products

Starting with the end in mind

Budget, timelines, and pressure to be innovative are just a few of the barriers that many companies face when looking to gain market access. The trick is knowing what you want to say about your product, what you can say, and having a clear understanding of the marketplace you’re looking to penetrate. From there, a strategic solution can be developed to assist in achieving your goals.

Tags: Product Marketing, Claims, Concept to Claim, Dietary Supplements/Natural Health Products

Sesame has recently been added to the list of major food allergens, here's what you need to know for product labelling.

Tags: Product Marketing, Regulatory, Foods & Beverages, Dietary Supplements/Natural Health Products

Developing dietary supplements with strong claims not only allows brands to stand out from the pack but also provides a competitive advantage.

Tags: Claims, Regulatory, Concept to Claim, Dietary Supplements/Natural Health Products

The current pandemic situation highlights a weakness in our traditional approach to clinical trials.  You are probably experiencing some form of lock-down (“stay at home order” by your local or national government).  Our innate sense of optimism says this crisis will blow over fast, but there are also dark clouds suggesting weeks may turn to months and true return to normality will take longer than we dare to think.

Tags: Clinical Trials, Concept to Claim, Foods & Beverages, Dietary Supplements/Natural Health Products

Medical Foods is a unique regulatory category wedged between supplements and drugs, a category where nutrients can be marketed with a claim for the management of a disease. A claim that has led some to call this category “supplements on steroids”.

Tags: Regulatory, Concept to Claim, Foods & Beverages, Dietary Supplements/Natural Health Products

Whether you are launching a new product or looking to substantiate a novel claim, strong science is crucial to the success of your health product. In Canada, many ingredients have been “pre-cleared” for specific claims at particular doses. Monographs give guidance and provide substantiation for these ingredients, so you don’t have to.

Tags: Clinical Trials, Dietary Supplements/Natural Health Products

The global health product industry is constantly innovating—leveraging current science and consumer trends to launch products that pique the interest of health-conscious consumers. Probiotics are among the most popular health supplements worldwide, with global sales surpassing $44 billion USD in 2019 (Euromonitor, 2019).

Tags: Probiotics, Dietary Supplements/Natural Health Products