Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) is consulting on proposed revisions to its existing Workout Supplements monograph. Rather than introducing an entirely new framework, the consultation focuses on expanding eligible ingredient sources, revising creatine dosage requirements, clarifying sodium restrictions, and updating ingredient-specific safety and labelling provisions.
Among the most significant proposals are the addition of alternative creatine sources, new carbohydrate ingredients, selected botanical and mineral-derived complementary ingredients, and provisions permitting limited quantities of sodium in eligible workout supplements.
These changes could provide manufacturers with greater formulation flexibility while introducing new considerations for Product Licence Applications (PLAs), ingredient specifications, dosage calculations, and product labels.
Stakeholders have until January 15, 2027, to submit feedback. The revisions remain proposals and are not yet finalized.
Health Canada’s Compendium of Monographs establishes standardized conditions for licensing eligible Natural Health Products (NHPs).
The Workout Supplements monograph provides a regulatory framework for certain products intended to support physical performance, muscle development, and other exercise-related functions.
The existing monograph already covers proteins, amino acids, carbohydrates, ergogenic agents, caffeine, vitamins, minerals, and complementary ingredients. It also specifies permitted health claims, ingredient doses, combinations, directions for use, and risk information.
The latest consultation proposes targeted amendments to this framework, reflecting additional ingredient sources, revised dosage calculations, and updated safety considerations.
For manufacturers, the important question is not simply which ingredients appear in the document, but which provisions Health Canada is proposing to add, remove, or modify—and how those changes could affect product licensing.
The following table summarizes the principal substantive changes identified in the consultation draft’s tracked revisions.
Summary of Proposed Changes
| Regulatory Area | Previous Monograph | Proposed Revision |
| Carbohydrate sources | Existing Group 3 already permitted various carbohydrates, including glucose, fructose, maltodextrin, and starches. | Adds specific sources, including isomaltulose, trehalose, highly branched cyclic dextrin, highly branched modified starch, and additional glucose/fructose sources. |
| Creatine | Creatine provisions centred on creatine monohydrate, with dosage requirements expressed in creatine monohydrate amounts. | Adds creatine hydrochloride, creatine pyruvate, and dicreatine malate; revises dosage requirements to express total creatine content. |
| Creatine dosage | Loading and maintenance ranges included 15–20 g, 3–5 g, and other quantities of creatine monohydrate. | Recalculates the corresponding amounts as creatine, including 13.25–17.62 g for one loading option and 2.63–4.45 g for certain other dosing options. |
| Complementary ingredients | Group 6 already included ingredients such as agmatine, choline, deanol, taurine, and various botanicals. | Adds selected ingredients, including black ginger, Rosa roxburghii, Lithothamnion corallioides, and Phymatolithon calcareum, with associated conditions. |
| Sodium | A general restriction excluded sodium and ingredients substantially composed of sodium as medicinal ingredients. | Proposes permitting sodium from specified sources below 230 mg/day for eligible workout supplements, with restrictions for other uses or higher amounts. |
| Caffeine | Maximum of 200 mg per single dose already applied. | Adds supporting scientific rationale for the existing limit; does not increase the permitted single dose. |
| Sweetening agents | Existing ingredient classification rules applied. | Adds explanatory wording clarifying that gram-level quantities of certain sweeteners do not automatically make them medicinal ingredients. |
| Safety and labelling | Existing ingredient-specific directions and warnings applied. | Updates requirements to reflect expanded creatine sources and newly added complementary ingredients, including specific warnings and duration-of-use provisions. |
These proposals affect different parts of the licensing process, from selecting raw materials to calculating medicinal ingredient quantities and determining required label statements.
1. Additional Carbohydrate Ingredients and Sources
Carbohydrates were already included in the previous Workout Supplements monograph. The proposed change is an expansion of the specific ingredients and sources recognized within Group 3.
The draft adds several carbohydrate options, including:
The proposed wording also clarifies that when high-fructose corn syrup is used as a source material, both glucose and fructose must be declared as medicinal ingredients in the formulation.
Industry impact: These additions could expand the range of carbohydrate sources available for compendial workout supplement formulations. Manufacturers should review the identity and declaration of each carbohydrate ingredient, particularly when a source material contributes more than one medicinal constituent.
2. Expansion of Creatine Sources and Revised Dosage Calculations
One of the most consequential proposed changes concerns creatine.
The previous monograph centred on creatine monohydrate. The consultation draft expands the permitted source ingredients to include creatine hydrochloride, creatine pyruvate, and dicreatine malate.
Health Canada also proposes changing the dosage framework from quantities of creatine monohydrate to quantities of creatine itself.
For example, the draft changes a loading-phase range of 15–20 g of creatine monohydrate to 13.25–17.62 g of creatine. Other loading and maintenance values are similarly recalculated.
A new footnote clarifies that the recommended dose refers to the total creatine supplied by all creatine-containing medicinal ingredients in the product. The individual source ingredient quantities may also be declared.
This distinction matters because different creatine compounds contain different proportions of creatine by weight.
Industry impact: The proposed revisions could create opportunities for products using alternative creatine sources, but manufacturers would need to calculate doses based on total creatine rather than simply the weight of each source ingredient.
Existing creatine monohydrate formulations should also be assessed carefully when applying the revised dose expressions, although the change in numerical values should not automatically be interpreted as a reduction in the equivalent amount of creatine permitted.
3. New Complementary Ingredients
The consultation also proposes additions to Group 6, which already covers complementary ingredients used in workout supplement formulations.
Among the newly proposed ingredients are:
These ingredients would be subject to specified source, preparation, and dosage conditions.
For example, the draft proposes a maximum of 1.5 g of dried rhizome per day for black ginger under the listed preparation conditions.
For the two newly listed marine algae, the draft specifies standardized powdered preparations with minimum calcium content requirements and maximum daily quantities. It also introduces a footnote limiting iodine content to 800 mcg per day, consistent with the applicable multivitamin/mineral monograph provisions.
Industry impact: The additions could support a wider range of botanical and mineral-derived formulations under the Workout Supplements monograph.
However, manufacturers must distinguish ingredient eligibility from permission to make specific health claims. Each formulation would still need to meet the applicable monograph conditions, and the addition of an ingredient does not independently establish new performance claims.
4. Revised Approach to Sodium
The proposed treatment of sodium is another important substantive change.
The previous monograph generally excluded sodium and ingredients in which sodium was a substantial component from use as medicinal ingredients, citing concerns about chronic supplemental sodium intake and hypertension.
The consultation draft proposes a more specific approach.
Sodium chloride is proposed as acceptable for workout supplement products at a daily dose below 230 mg, while products marketed for other purposes or providing 230 mg/day or more of sodium chloride would require a Class III application under the proposed restriction.
The draft also adds sodium to the complementary ingredient table, including sodium chloride and sodium citrate sources, with a proposed sodium dose below 230 mg/day.
As drafted, these provisions are unclear. The restriction refers to 230 mg per day of sodium chloride, while the complementary-ingredient table specifies less than 230 mg per day of sodium. Those quantities are not equivalent. Health Canada should clarify which amount the limit applies to before manufacturers rely on the proposed allowance.
Industry impact: The proposal could offer additional formulation flexibility for certain workout supplements containing sodium, including products intended for use around physical activity.
Manufacturers should verify the applicable quantity basis, ingredient source, and product purpose before assuming a formulation meets the proposed conditions. The consultation also provides an opportunity to seek clarification on how the sodium and sodium chloride provisions should operate together.
5. Updated Safety, Directions for Use, and Ingredient Specifications
The proposed changes extend beyond ingredient eligibility.
Health Canada is also revising associated directions for use, risk information, and specifications to account for the expanded ingredient provisions.
For creatine, references to creatine monohydrate are replaced in several places with broader references to creatine. This aligns the relevant instructions with the proposed addition of alternative creatine sources.
For black ginger, the draft introduces a recommendation to consult a health care practitioner for use beyond eight weeks when a product provides more than 500 mg of dried rhizome per day.
The draft also expands certain existing warnings to include Panax notoginseng, including warnings relating to diabetes and hypersensitivity.
The new marine algae provisions introduce specific considerations concerning calcium standardization and iodine exposure.
Finally, the document adds clarification that sweetening agents such as D-allulose and erythritol do not automatically require medicinal ingredient classification solely because they are present at gram-level quantities, when their function is non-medicinal.
Industry impact: Manufacturers considering newly permitted ingredients will need to assess the complete regulatory requirements rather than ingredient eligibility alone. Dosage instructions, warning statements, ingredient specifications, and the medicinal or non-medicinal role of each component may affect the final product licence application.
6. Clarification of the Existing Caffeine Limit
The consultation draft also revises the supporting explanation for caffeine’s maximum single dose.
The 200 mg maximum per single dose is not a new requirement.
Instead, Health Canada proposes adding explanatory text referencing scientific evidence and international safety assessments, including the European Food Safety Authority’s evaluation of single caffeine doses.
Industry impact: This change primarily clarifies the regulatory rationale behind an existing restriction. Manufacturers should not interpret the consultation as proposing a higher caffeine allowance or a newly introduced 200 mg limit.
The proposed revisions could have practical implications for manufacturers, ingredient suppliers, and NHP product licence holders.
Greater formulation flexibility: Additional carbohydrate sources, alternative creatine compounds, and selected complementary ingredients could provide more options for product development within the existing monograph framework.
More precise dosage calculations: The revised creatine provisions would require manufacturers to assess total creatine content across all contributing source ingredients, rather than relying exclusively on creatine monohydrate quantities.
New opportunities and limitations for sodium-containing products: The proposed allowance for limited sodium quantities could be useful for certain formulations, but the applicable thresholds and Class III restrictions will need careful review.
Additional quality and safety obligations: Newly listed botanical and marine-derived ingredients introduce specific preparation, dosage, standardization, and warning requirements that could affect supplier qualification and product labelling.
Implications for product licensing: Companies developing new formulations may be able to use additional compendial options if the revisions are finalized. Existing product licence holders should evaluate whether any future formulation or label changes require the appropriate notification or amendment.
The proposed revisions do not automatically authorize new formulations or modify existing NPNs. Until finalized, the current applicable requirements remain in effect.
Health Canada is accepting stakeholder feedback on the proposed Workout Supplements monograph revisions until January 15, 2027.
Comments can be submitted to:
nnhpd.consultation-dpsnso@hc-sc.gc.ca
Manufacturers and ingredient suppliers may wish to focus their submissions on the practical implications of the proposed changes, including the eligibility of alternative creatine sources, dosage calculations, newly listed carbohydrate and botanical ingredients, sodium restrictions, and associated quality or labelling requirements.
Submissions supported by scientific evidence, ingredient specifications, and formulation experience may help Health Canada assess the proposed conditions before the monograph is finalized.
Health Canada’s proposed Workout Supplements monograph revisions are more targeted than a broad overhaul of sports nutrition regulation.
The most meaningful changes involve expanding specific ingredient options, revising creatine dosage expressions, introducing a limited sodium allowance, and aligning safety and quality provisions with the newly proposed ingredients.
For manufacturers, the consultation offers an opportunity to evaluate potential new formulations and identify regulatory questions before the changes take effect.
With feedback due January 15, 2027, companies operating in the Canadian workout supplement market should review the tracked changes and assess their implications for current and planned products.
Changes to Health Canada’s NHP monographs can create new product development opportunities while introducing technical questions concerning ingredient eligibility, formulation, dosage, labelling, and product licensing.
With more than 20 years of regulatory consulting experience, dicentra supports Natural Health Product manufacturers, ingredient suppliers, and brand owners in navigating Canadian regulatory requirements.
Our services include:
Whether you’re developing a new workout supplement, evaluating alternative creatine sources, or assessing the regulatory implications of the proposed changes, dicentra can help determine an appropriate path forward.
Contact dicentra to discuss your product development, NPN registration, or Canadian market-entry strategy.