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Health Canada Proposes New Natural Health Product Regulations (October 2016)

Health Canada is proposing that the regulatory standards of natural health products be held to the same level as over-the-counter drugs (otc drugs). The agency is addressing three classes of health products, referred to as “self-care” products, which will be regulated similarly under the newly proposed guidance:

  • Cosmetics: Products such as creams, makeup, deodorants, and shampoo used to clean, improve, or beautify the face or body
  • Natural health products: Products including mineral supplements, probiotics, and traditional homeopathic medicines
  • Non-prescription drugs: Over-the-counter drugs used to treat some minor conditions such as allergies or a common cold

Current System vs. Proposed System

Health Canada recognizes that the existing system for regulating self-care products can be improved, and is proposing a new system to better inform consumers of products available for purchase and create a more consistent approach to product safety.

  1. Different regulations for different types of products: Self-care products are currently subject to different regulatory approaches depending on their product class. These categories are typically based on ingredients and claims rather than risk levels. This may cause both insufficient and inconsistent reviews of products.
  2. Inconsistencies in the amount of evidence required to support the same claim: The safety and efficacy of non-prescription drugs are backed with scientific evidence, while natural health care products making the same claims may not be. Consumers will consequently purchase one product over the other without being able to differentiate the two and make an informed decision.
  3. Limitations for Health Canada to effectively enforce rules and penalties: Health Canada is limited in its ability to enforce penalties based on the category self-care products fall in to. Currently, violations are more costly for non-prescription drugs than natural health products making similar claims because the two product classes aren’t subject to the same regulatory and scientific standards.
  4. Different user fee applications based on product type: Companies do not have to pay fees bringing natural health products to market, whereas companies marketing over-the-counter medications do. However both still benefit from Health Canada’s regulations.

As a result of these inconsistencies, Health Canada is proposing strengthened regulations for self-care products. The proposal consists of three main components:

  • Similar treatment for products with similar risk
  • Scientific evidence to support all health claims
  • Compliance and safety monitoring using a risk-based approach



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