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NHPs: Save Our Supplements

We launched a Save Our Supplements campaign in response to the latest changes coming out of Ottawa and the detrimental effects it will have on the natural health product (NHP) industry. Health Canada’s latest cost recovery proposal and new labelling requirements will force many NHPs off your shelves and the ones left will drastically rise in price.
We want to emphasize the importance of appropriate regulation and legislation aligned with the lower-risk profile of NHPs, allowing innovation and competitiveness to flourish within Canada and enabling informed health decisions for Canadians.

Health Canada is strangling natural health products in red tape. The recent changes coming from Ottawa are based on a broken system and will have devastating effects on the natural health product industry in Canada. There will be fewer products on the shelf for Canadians to choose from and force prices to rise for the remaining NHPs in Canada. This is bound to push Canadians to online, international marketplaces.

What’s Broken?

In 2014, the Self-Care Framework was proposed, separating lower-risk products (over-the-counter medication, cosmetics and NHPs) from pharmaceutical drugs. Yet almost ten years later, this framework remains incomplete. Despite this, Health Canada continues to push through regulatory changes, like new labelling requirements and the proposed new cost recovery program in a piecemeal approach while dealing with massive backlogs in product applications. These changes disregard the original framework and do nothing to combat foreign, unmonitored, and unregulated products which are easily accessible through international online marketplaces.

The natural health product industry has not been meaningfully consulted on any of the changes currently taking place. As it stands, these changes place an increased burden on the regulated domestic industry, driving increased costs and lower product availability for Canadians while failing to address the risks posed by unregulated products.

The Major Regulatory Changes Hitting our Industry:

New labelling requirements (aka Plain Language Labelling)

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

 

New user fees for regulatory activities (aka Cost Recovery)

Health Canada recently announced the fee program for NHPs. The timing of implementing this program at the same time as new labelling requirements will financially decimate many companies in our industry, making it extremely challenging for them to stay viable. These regulatory changes are unfair, unrealistic, and so costly they will force many small to medium-sized businesses to shut down Canadian operations. If it goes through as planned those businesses that stay open will struggle to stay afloat, prices will increase, product availability will suffer, and many brands will leave the Canadian market altogether. We will have less access to NHPs and pay much more for what’s available.

Protecting Canadians from Unsafe Drugs Act (aka Vanessa's Law)

Protecting Canadians from Unsafe Drugs Act (aka Vanessa’s Law) received royal assent on June 22, 2023 as part of bill C47. 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.

What does this mean for our industry?

The regulatory changes are unfair, unrealistic, and so costly they will force many small to medium-sized businesses to shut down Canadian operations. If it goes through as planned those businesses that stay open will struggle to stay afloat, prices will increase, product availability will suffer, and many brands will leave the Canadian market altogether.

Earlier this year, we conducted an economic impact study with Deloitte to understand how the labelling changes will impact our industry.

Here’s what we found:

Our economic impact study was based on the labelling changes set to go into effect in 2025. We expect the above numbers to increase drastically when considering the impacts of cost recovery.

What are we asking for?

We are urging the Minister of Health to work with industry to embrace modern labelling and adjust Health Canada’s proposed cost recovery rates to accurately reflect the size and scope of the industry.

New regulatory changes should only be implemented once backlogs are cleared, operations run efficiently, and there are policies and procedures in place to ensure that stable operations continue.

How You Can Help

  1. Click here to send a letter to your member of Parliament – a big impact that takes less than a minute.
  2. Download our Action Kit  and use our tools to spread the word to your friends, colleagues and family that the natural health products they use every single day are at great risk.
  3. Book a meeting with your MP: Check out our guide to meeting with your local government representatives.
  4. Our voice is stronger together. Connect with us on social and be part of the conversation by using #saveoursupplements in your posts.

Additional Resources

New Labelling Regulations

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

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.

Vanessa's Law

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.

Self-Care Framework

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.

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