On June 22, 2023, Bill C-47 received Royal Assent, introducing amendments to the Food and Drugs Act (FDA) concerning Natural Health Products (NHPs). These amendments extend the enforcement power of Health Canada by implementing provisions meant to “safeguard public health”. The key provisions, which take immediate effect, include:

1. Recall Authority
   Health Canada now has the ability to order a recall of NHPs that present a serious or imminent risk of injury to human health.
2. Labelling and Packaging Modifications
   Health Canada now has the authority to require a label change or package modification if they deem an NHP product presents a serious risk of injury to human health.
3. Increased Fines and Penalties
   Health Canada can now impose higher fines and penalties to deter non-compliance with NHP regulations.
4. Information Disclosure
   Health Canada can now order individuals or entities to provide information to determine if they deem an NHP product presents a serious risk of injury to human health.
5. Confidential Business Information
   This provision grants Health Canada the authority to disclose confidential business information if they deem that an NHP may present a serious health or injury risk, or for the protection and promotion of human health.
6. Incorporation by Reference
   This provision grants Health Canada the ability to incorporate external documents, standards, or guidelines by reference, streamlining the regulatory process and aligning with recognized best practices.
7. Prohibition of False or Misleading Statements
   False or misleading statements, or providing inaccurate information to the Minister is now expressly prohibited.

What Does Bill C-47 Mean for Industry?

Bill C-47 amends the definition of therapeutic products in the Food and Drugs Act (FDA) to remove the existing exemption for Natural Health Products from Vanessa’s Law within the NHPR. This means that existing provisions of the FDA, as described above, now apply equally to natural health products. However, the extent to which Health Canada will enforce these provisions is based on the safety risk of the product and that “these authorities would generally only be used when a serious health and/or safety risk is identified”. Of particular note, the amendments include fines of up to $5,000,000.00 CAD as a penalty for failing to comply with the provisions.

How to Prepare for Bill C-47

If you manufacture, distribute, sell, import, package, and/or label NHPs in Canada, we recommend you review the therapeutic product provisions and the NHPR to ensure your products are in compliance. dicentra can help facilitate this process with our full life-cycle product support services for Natural Health Products.

Additional Questions?

Contact dicentra today to learn about Bill C-47 and how it can impact your business.