Natural Health Products (NHPs) are naturally occurring substances that maintain, promote, or restore good health.1 To receive Health Canada approval, an NHP must carry at least one health claim and that health claim must have a health context. For example, “Source of antioxidants for the maintenance of good health.” In addition to the recommended use or purpose statement(s), there are several parameters that form part of an NHP’s Product Licence or Terms of Market Authorization (TMA), including product classification, product representation, composition / ingredients, directions for use, dura ..read more

    UNDERSTANDING MASTER FILES  Master Files (MFs) are reference documents that contain proprietary and/or publicly-available data on aspects of drug or Natural Health Product (NHP) safety, efficacy, and/or quality that are submitted to regulatory authorities in support of various application types, including Clinical Trial Applications (CTAs), Investigational New Drugs (INDs), Abbreviated New Drug Applications or Submissions (ANDAs / ANDS), New Drug Applications or Submissions (NDAs / NDS), and Product Licence Applications (PLAs). MASTER FILES SUBMISSION MFs are submitted by i ..read more

Today’s consumers are doing more research about the products they purchase than ever before ..read more

As a result of the pandemic, respiratory and seasonal illnesses, and other emerging threats, consumers are more interested, invested, and involved in their wellbeing than ever before. When it comes to health products, consumers are motivated by those that are clean or naturally-sourced, convenient, scientifically substantiated, and tailored to meet their personal needs. Thus, driving industry trends towards transparency, sustainability, personalization, and virtual approaches.   ..read more

If you're already selling your supplement on Amazon in the U.S. or elsewhere around the globe, Canada is a natural next step to achieve growth and gain market share. But if you're looking to enter the Canadian market for the first time via Amazon.ca, be warned - it's not as simple as setting up an account and listing your products ..read more

  Companies looking to obtain authorization to market a new pharmaceutical must either file a New Drug Submission (NDS) to Health Canada or a New Drug Application (NDA) to the United States Food and Drug Administration (U.S. FDA), depending on their market-of-interest. The regulatory dossier must include data around the following: Pre-clinical (in vitro and in vivo) studies Clinical (human) studies Details on the manufacturing, packaging, and labelling of the drug substance and drug product Therapeutic claims and side-effects In summary, what this means is that the regulatory dossier mu ..read more

In today’s regulatory climate of full accountability and transparency, it is critical to have strong science to back-up any claim made on a health product, be it a dietary supplement sold in the United States (U.S.) or a Natural Health Product (NHP) marketed in Canada. This will be a key component of your dietary supplement and NHP marketing strategy. We know advertising health products is critical to your marketplace success and we want to help you make sure it is done the right way. Firstly, it is important to note that while dietary supplements are equivalent to the NHP categories, there ar ..read more

Background On July 6th, 2022, Health Canada published new labelling requirements under the Natural Health Products Regulations (NHPR). These changes are driven by a need to help consumers make informed choices and manage preventable harms through consistent, clear, and easy to understand product labels. The amendments also ensure alignment with rules that have already been established for comparable non-prescription drugs. Below is a summary of the key requirements ..read more

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 C ..read more

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 ..read more