Health Canada launched a labelling initiative linked to the Self-Care framework, aimed at supporting consumers in making informed choices about self-care products. On July 6, 2022, Health Canada published these new labelling requirements under the Natural Health Products Regulations (NHPR). The amendments were also made to ensure alignment with rules that have already been established for non-prescription drugs. In addition to the regulations, Health Canada published a Guidance Document providing further interpretation of the new labelling requirements; however, this document is very technical and offers little flexibility.

The natural health products industry is facing a time where over-regulation and rapidly evolving regulatory changes are making it hard for the industry to keep growing. These restrictive and costly label changes will negatively impact profit margins, cause packaging sizes to double, and beyond current supply chain challenges, further limit product availability while hurting competition, innovation, and new product offerings.

Examples of what is changing under the new regulations include: 

• Implementation of the Product Fact Tables (PFT)
  • NHPs are currently required to list important information on the label, but the PFT brings a new standardized format of presenting information
• Revisions to existing formatting requirements
  • Intended to improve current legibility requirements by providing font size and type, and contrast restrictions
• New allergen labelling requirements 
  • Labelling of food allergens, gluten, sulphites, and aspartame
• Tamper evidence alignment under Canada-United States-Mexico Agreement (CUSMA)
  • Mandatory requirement for security seals for ingestible, inhalable or insertable, mouthwashes and eye care products
• Modernized contact information for manufacturers or importers
  • The change will replace the current requirement of a postal address with an e-mail address, telephone number, or website

Cost Recovery is the process of collecting user fees for services, including regulatory activities such as product evaluation, site licenses and annual renewal fees. Health Canada charges fees to recover part or all the costs incurred to deliver its programs. Some examples of cost recovered programs include drugs, medical devices, and cannabis.

With the establishment of the Natural Health Product Regulations in 2004, natural health products have not been subject to cost recovery. We understand cost recovery is a necessary part of doing business in Canada however, any cost recovery efforts should be phased over multiple years and be based on accurate data reflecting the current NHP sector which is mostly comprised of small/mid-sized companies and include measurable service standards. Currently, the foundation of our regulatory system is stretched to the brink with massive backlogs in product applications. In short, data used to establish this current program is dramatically flawed and the proposed fees will financially decimate the natural health product industry in Canada.

The Protecting Canadians from Unsafe Drugs Act was published in November 2014 (known commonly as Vanessa’s Law). It amends the Food and Drugs Act to include new rules that increase the regulation of therapeutic products and mandates the reporting of adverse reactions by healthcare institutions. In addition, these measures intend to modify Health Canada's ability to collect post-market safety information and take action when a serious health risk is identified.

As part of the Federal Budget 2023, Health Canada proposed to amend the Food and Drugs Act under Bill C-47 to extend the use of Vanessa’s Law to natural health products. Bill C-47 received Royal Assent on June 22, when Division 27 of Part 4 amended the Food and Drugs Act to extend measures regarding therapeutic products to natural health products.

This means the government has the power to require information, tests or studies, to require a label change/package modification, and to recall unsafe therapeutic products.

CHFA believes that protecting the health and safety of Canadians is a top priority, and that the regulations prior to June 22, 2023 that included seizures, stop sales, cancellations and suspensions of licenses were sufficient. Any amendment to the Food and Drugs Act to extend the use of Vanessa’s Law to NHP’s should have been properly studied, discussed and debated with industry and stakeholders.

The Natural Health Products Regulations came into force in 2004 and continues to evolve, providing Canadians access to safe, effective, high quality NHPs. These regulations makes Canada one of the strongest, most unique, and most reputable NHP markets in the world. In 2014, Health Canada introduced the Self-Care Framework. The purpose was to modernize and simplify regulations for specific lower-risk products, such as NHPs. The primary objective of the framework was to consider the potential risks associated with a product and ensure it receives the suitable level of regulatory supervision. Yet almost ten years later, this framework remains far from complete.