Natural Health Product Manufacturers

The Self-care Framework is a multi-step initiative set into motion by Health Canada in 2017 with an end goal of harmonizing our natural health product regulations with the pharmaceutical model. If achieved, this will result in the loss of countless natural health products and increase prices on products that remain.

Cost Recovery is being imposed on the natural health product industry. Businesses like yours will be charged significant annual fees to license and manufacture their products. This will result in the loss of many products and Canadian businesses who cannot afford these fees. The fees are to come into effect on December 1 2025.

Vanessa’s Law now applies to natural health products, resulting from definition changes in the annual budget bill (Bill C-47), passed on June 22 2023. Vanessa’s Law empowers Health Canada to order recalls, impose tougher penalties, and require companies to change labels or run expensive tests at their whim. It’s important to note that Vanessa’s Law was designed for pharmaceutical drugs and was never intended to apply to natural health products.

Under Vanessa’s Law, Health Canada now has the power to levy fines up to $5,000,000 per day that you are found to be in offence. Previously, the fine for noncompliance was $5000 per offence. A $5,000,000 penalty is appropriate for the pharmaceutical industry, but will only serve to destroy natural product companies and silence retaliation. As a natural health product manufacturer, you are individually responsible for these new fines under Vanessa’s Law. There is no corporate veil to protect you, your family, or your personal assets.

Still to come in the Self-care Framework, Health Canada intends to:

• Restrict natural product claims to minor conditions for which a person would not seek the advice of a practitioner licensed by a province 
• Impose the chemical drug standards of evidence onto natural products
• Stop allowing traditional use evidence to support treatment claims and license natural products

Natural health product manufacturers are one of the industry stakeholder groups that stand to be most affected and therefore lose the most when the Self-care Framework is fully implemented. Some of the expected effects include:

• If you make any health claim about a product outside of the Health-Canada approved label claims, even if you know it to be true, you and your employees could face a $5M/per day fine. With these new fines, you are personally liable, there is no corporate veil to protect you. You are also liable for the statements of any of your employees, including your sales and customer service staff.
• With the new fees and fines being imposed on natural health product manufacturers like you, we can expect that many companies will go out of business, especially our beloved small and medium-sized companies, and their products will disappear along with them. Multiple companies have already stated they will not survive cost recovery and will be forced to cease operations in Canada. Will you be one of them?
• The manufacturers that stay in business will be forced to increase their product prices to recover new licensing costs, and retailers will pass those increased costs along to customers. This means that many Canadians who currently purchase your products will no longer be able to afford to.
• The industry will also lose the right to rely on traditional-use evidence to license products. For example, it will no longer be acceptable to claim on a product label that “ginger is traditionally used to treat nausea”, all of this leading to more lost products and fewer options to stock your retailers’ shelves.
• Standards of evidence will be harmonized with the chemical drug regulations. Many products will not be licensed without double-blind, placebo-controlled, drug-style clinical trials. Can you afford to fund these studies for a product you can’t patent?
• The Self-Care Framework will also restrict natural health products to over-the-counter uses. In other words, natural health products will not be licensed for any condition that you’d typically seek the advice of a licensed practitioner for. And remember, neither you or the retailer can tell customers about off-label uses. How can you sell a product if you can’t tell the customer what it can be used for?

1. Repeal sections 500-504 of Bill C-47
2. Stop Cost Recovery on natural health product businesses
3. Stop the Self-care Framework
4. Regulate natural health products as foods, not drugs.
5. Enact the Charter of Health Freedom to ensure fair regulations of natural health products