Health Canada's New Draft Quality Guide for Natural Health Products: What NHP Brands Need to Know

On July 20, 2026, Health Canada opened a consultation on a draft revised Quality of natural health products guide, replacing the current 2015 version if finalized. The consultation is open until September 20, 2026, with Health Canada aiming to publish the final updated guide later this year, followed by an appropriate transition and implementation period.

The draft is guidance rather than a new regulation. However, it provides a much more detailed interpretation of how companies can establish, demonstrate and maintain the quality of NHPs.

For brands and manufacturers, the message is important: quality is increasingly being treated as a lifecycle responsibility, not simply something to demonstrate when obtaining a product licence.

What is changing?

The existing Quality Guide was published in 2015. Health Canada says the proposed revision is intended to reflect current science and make the guidance clearer and easier to use. It covers quality considerations across areas including characterization, performance, identity, quantity, potency, purity and stability.

The draft takes a broader lifecycle approach to quality, covering activities from raw material characterization and product development through manufacturing, finished product release, stability and post-licensing changes.

This is particularly relevant as NHP companies increasingly work with complex formulations, contract manufacturers, third-party laboratories and multiple suppliers.

Finished Product Specifications become an even more important quality tool

One of the key areas addressed in the draft is Finished Product Specifications (FPS).

An FPS establishes the criteria a finished product must meet, including appropriate tests, analytical procedures and acceptance limits. Health Canada continues to expect licence holders to establish and maintain FPS for their products.

This is particularly timely because Health Canada changed its FPS submission process in June 2026. As of June 15, companies no longer need to routinely submit FPS with Class II and III product licence applications and amendments. However, they remain responsible for maintaining those specifications and providing them to Health Canada when requested.

In practice, this makes having accurate, current and scientifically justified specifications even more important.

Companies should be asking:

• Are our specifications aligned with the current formulation?

• Are our analytical methods appropriate and adequately supported?

• Are our acceptance criteria scientifically justified?

• Are changes to ingredients, suppliers or manufacturing processes reflected?

• Can we quickly produce the relevant documentation if Health Canada requests it?

Greater attention to testing and analytical methods

The draft also provides more detailed guidance around analytical methods, including considerations for method validation, verification, equivalency and transfer.

For companies using contract manufacturers or third-party laboratories, this reinforces the importance of understanding not just what was tested, but whether the testing method is appropriate for the specific ingredient, product and matrix.

This can become particularly important as brands expand their product portfolios or introduce new dosage forms.

Newer NHP formats bring new quality considerations

The draft also reflects how the NHP market has evolved since the current guide was published.

It provides more specific guidance for dosage forms including:

• Gummies

• Oral pouches

• Sprays

• Transdermal products

• Modified-release formulations

• Suspensions

For companies developing newer product formats, this means quality testing may need to be considered specifically in the context of the product's formulation and performance rather than relying on a one-size-fits-all approach.

Stability, packaging and impurities also matter

The proposed guide provides expanded guidance around stability, including considerations related to packaging, storage conditions, transportation and in-use periods.

Packaging is therefore not simply a commercial or design decision. It can form part of the overall quality assessment of an NHP.

The draft also provides updated considerations around impurities and contaminants, reflecting developments in scientific understanding and current quality risks.

For brands, this reinforces the importance of keeping quality documentation connected across formulation, manufacturing, packaging and testing rather than treating each as a separate activity.

What should NHP brands do now?

The draft is still under consultation, so companies do not need to overhaul their quality systems immediately.

However, this is a good time to conduct a gap assessment against the areas where Health Canada is providing more detailed guidance.

1. Review your Finished Product Specifications

Make sure specifications are current, scientifically justified and aligned with your actual product, manufacturing process and testing methods.

2. Review your analytical methods

Check that testing methods are appropriately validated or verified and that supporting documentation is available, particularly when testing is performed by third-party laboratories.

3. Review newer dosage forms

If your portfolio includes gummies, sprays, oral pouches or other newer formats, assess whether your existing testing and quality controls adequately address the characteristics of those products.

4. Review stability and packaging

Consider whether your stability programs appropriately account for packaging configurations, storage conditions and the expected lifecycle of the product.

5. Strengthen your quality documentation

Quality information can span formulations, specifications, supplier documentation, laboratory results, manufacturing records and change controls.

As portfolios grow, keeping this information accurate and accessible becomes increasingly important.

What this means for the future of NHP compliance

The draft Quality Guide comes shortly after Health Canada's updated Good Manufacturing Practices (GMP) Guide for NHPs, which was published in September 2025 and became effective in March 2026. The updated GMP guide provides clearer guidance around quality systems, manufacturing, testing, records, stability and other GMP requirements.

Together, these developments point towards a more integrated approach to NHP quality in Canada.

The direction is clear:

Quality is becoming a lifecycle responsibility, not a one-time licensing exercise.

For NHP brands and manufacturers, preparing now is less about predicting exactly what the final guidance will say and more about building stronger systems for managing product quality, documentation and regulatory change.

Companies that can maintain clear, accessible and up-to-date quality information will be better positioned to respond as requirements evolve—and to scale their products with greater confidence.

The consultation on the draft Quality of natural health products guide is open until September 20, 2026. Companies affected by the proposed changes can review the draft and submit feedback directly to Health Canada.

Official Health Canada sources

• Health Canada: Consultation on the Draft Revised Quality of Natural Health Products Guide

• Health Canada: Draft Quality of Natural Health Products Guide

• Health Canada: Expectations for Finished Product Specifications, June 2026

• Health Canada: Good Manufacturing Practices Guide for Natural Health Products

• Health Canada: Current Quality of Natural Health Products Guide