NHP Allergen Labelling in Canada: The NHPR Rules Licence Holders Miss

On 6 August 2026, Health Canada posted a recall for New Roots Herbal Probiotic Intensity. The reason was not contamination, a failed test, or a safety signal from the ingredients. The reason was the label. One lot (Lot 68775, expiry 2027-07-07, NPN 80136157) carried a "No Dairy" claim while the capsules contained bovine colostrum, a dairy-derived ingredient. The claim was the exact inverse of the truth.

Eight days earlier, on 30 July 2026, a different natural health product was recalled for a different label failure. Pharmasave Regular Strength Dairy Digestive Supplement, a lactase enzyme product, reached shelves with the wrong Natural Product Number printed on the carton. Two label control failures in eight days, both on natural health products, both traced to artwork and claim control rather than the science in the bottle.

For natural health product (NHP) licence holders in Canada, that pattern is the story of 2026. This article walks through what the Natural Health Products Regulations require for allergen declaration and labelling, section by section, and shows where licence holders keep getting caught. Every rule cited here is read directly from the Natural Health Products Regulations, SOR/2003-196, current to 2026-06-17.

Executive summary

Labelling is a condition of sale. Section 86(1) prohibits the sale of any NHP that is not labelled and packaged in accordance with the Regulations.
If an NHP contains a food allergen, gluten or added sulphites, section 93.1(11) requires the statement "Allergens / Allergènes" in bold under the "Warnings / Mises en garde" heading, followed by the allergen source statement, also in bold.
Section 91.1 exempts allergens present only through cross-contamination from that declaration. Intentionally added ingredients are never exempt. This one distinction is where most errors begin.
The product number must appear on the principal display panel (s.93(b)) and be preceded by "NPN" (s.91(b)). A wrong NPN means the product on shelf is not the product Health Canada authorized.
A positive claim such as "No Dairy" must match the current bill of materials and the terms of the product licence. When it does not, the outcome is a recall.

What do Canada's NHP allergen labelling rules require?

In short: if a natural health product contains a food allergen, gluten or added sulphites, the Regulations require a bold "Allergens / Allergènes" statement under the Warnings heading, followed by the allergen source in bold. The obligation sits in section 93.1(11), and selling a non-compliant product breaches section 86(1).

Section 86(1) is the anchor. It states that no person shall sell a natural health product unless it is labelled and packaged in accordance with the Regulations. Labelling is not a marketing layer applied at the end. It is a legal condition of sale, and every downstream rule in Part 5 flows from it. When an inspector or a recall coordinator asks whether a product could lawfully be sold, section 86(1) is the test.

The allergen obligation itself is precise. Section 93.1(11) provides that if the product contains a food allergen, gluten or added sulphites, the statement "Allergens / Allergènes" must be shown in bold type under the "Warnings / Mises en garde" heading, followed by the food allergen source, gluten source and added sulphites statement, also in bold. The bold requirement is not a style preference. It is written into the rule, and a declaration in regular type is a deficiency.

How each allergen is named is governed by section 91.2. Milk, egg, mustard, sesame, soy, wheat and the rest must be shown using the specific names the Regulations set out, drawing on the same food allergen definitions used in the Food and Drug Regulations. A vague phrase like "contains dairy" does not satisfy the requirement if the prescribed source name is "milk". Gluten sources follow section 91.3, and added sulphites follow section 91.4. A parallel rule, section 93.1(12), requires a bold "Contains aspartame / Contient de l'aspartame" statement where aspartame is present.

The cross-contamination carve-out: NHPR section 91.1

Section 91.1 is the rule most often misread. It says the requirement to declare a food allergen source, gluten source or added sulphites does not apply when the allergen is present only as a result of cross-contamination. Intentionally added ingredients get no such exemption.

Read carefully, section 91.1 draws a bright line. Bovine colostrum in the New Roots product was an intentionally added source ingredient. It is the product. There is no version of section 91.1 that would exempt it, and there is certainly no basis for a positive "No Dairy" claim on top of it. The exemption exists only for allergens that arrive by cross-contamination, meaning unavoidable carry-over from shared equipment or a shared environment, not anything on the recipe.

The practical danger is the reverse error: treating a formulation ingredient as if it were cross-contact and leaving it off the label. Firms conflate the two constantly. The safeguard is a documented allergen decision tree that separates declared ingredients from genuine cross-contact, with a written rationale for every call. Note too that section 91.1 exempts the mandatory declaration only. It does not switch off good manufacturing practice controls, and it is not a licence to ignore a real cross-contact risk that a precautionary statement and validated cleaning should still address.

Where the NPN must appear, and why a wrong one is a licence failure

The product number must be shown on the principal display panel of the inner label, and on the outer label if there is one (s.93(b)), and it must be preceded by the designation "NPN" (s.91(b)). A wrong NPN is not a typo. It means the product on the shelf is not the product Health Canada licensed.

That is the failure behind the Pharmasave recall. The affected lot carried an incorrect NPN on the carton while the correct number appeared on the bottle. To a consumer the two numbers look interchangeable. To Health Canada they are not. The NPN is the unique link between the physical product and the specific product licence, its authorized medicinal ingredients, its permitted claims and its terms of market authorization. Break that link and you have a licence-integrity failure, not a printing error.

Section 55 requires labellers to keep records that let a product be reconstructed and reconciled. Those labeller records are exactly what an investigator asks for when the wrong artwork reaches a line. A disciplined artwork approval workflow, per-component reconciliation at line clearance, and QAP sign-off before printing are the controls that stop a wrong NPN before it ships. Our guide to ten ways to prevent labelling errors sets out the workflow in more detail.

How allergens fit into the Product Facts table

Allergen declarations live inside the Product Facts / Info-produit table required by section 93.1. The table has a fixed set of headings in a fixed order, and the "Allergens / Allergènes" statement sits under "Warnings / Mises en garde".

Section 93.1(1)(f) requires the outer label (or the inner label where there is no outer label) to carry a bilingual "Product Facts / Info-produit" table, or two single-language tables. Subsections (4) to (6) fix the seven permitted headings and their order: Medicinal ingredients, Uses, Warnings, Directions, Other information, Non-medicinal ingredients and Questions. Risk information goes under Warnings (subsection 10), and the bold allergen statement follows in the same block under subsection (11). The heading structure is not optional and cannot be reordered.

Section 93.2 governs the typography: the title and headings must be bold, separated from other content by solid black lines, with the title larger than the headings and the headings larger than the body text, all in a single font. Section 93.3 provides the escape route when the label surface is too small: condensed characters down to a 5 point minimum for non-medicinal ingredient information and 5.5 points for everything else, and only then a leaflet, package insert or website for the overflow. Allergen information is never the content you push to a website, because it belongs with the warnings the consumer must see at the point of sale.

The Product Facts table itself is the largest NHP labelling change in a generation, and it carries a hard transition deadline of 21 June 2028. If your portfolio still uses legacy panel labelling, allergen placement is only one part of a much larger relabelling project. We cover the full conversion in our companion article on the NHP Product Facts table and the 2028 transition.

Case study: a "No Dairy" claim on a colostrum product

The New Roots recall is a claim-substantiation failure, not a science failure. Bovine colostrum is a legitimate, intentionally added ingredient. The problem was a positive absence claim, "No Dairy", printed on a product whose source material is a dairy derivative. Two controls should have caught it, and neither did.

First, claim substantiation. Every claim on a label should be mapped to the current bill of materials and the terms of the product licence before artwork is approved. A "No Dairy" claim mapped against a formula that lists colostrum fails on sight. Second, allergen declaration. Because colostrum is added, section 93.1(11) required a bold milk source statement under Warnings. Instead the label asserted the opposite. Section 92 is also relevant: it prohibits label references that are not specifically required by law, and it reinforces that claims must be disciplined, not decorative.

The fix is a change-controlled artwork workflow in which no claim survives that is not tied to a current, signed formula, and in which the QAP owns the final sign-off. The same discipline prevented very similar failures in other sectors: an edible cannabis product recalled for undeclared milk shows the identical claim-versus-formula gap playing out under a different set of regulations.

NHPR labelling provisions at a glance

The table below maps the provisions that govern allergen declaration and label integrity for natural health products. Each is drawn from SOR/2003-196, Part 5.

Provision	What it requires
s.86(1)	No NHP may be sold unless labelled and packaged in accordance with the Regulations.
s.90	The lot number must be preceded by "Lot number", "Lot No.", "Lot" or "(L)".
s.91(b)	The product number must be preceded by "NPN" (or "DIN-HM" for homeopathic medicines).
s.91.1	The allergen, gluten and sulphites declaration does not apply where the substance is present only through cross-contamination.
s.91.2	Each food allergen source must be named using the specific prescribed name (for example "milk", "soy", "sesame").
s.93(b)	The product number must appear on the principal display panel of the inner label and, if present, the outer label.
s.93.1(11)	"Allergens / Allergènes" in bold under Warnings, followed by the source statement, also in bold.
s.93.2	Table typography: bold title and headings, solid black separators, relative type sizes, single font.
s.93.3	Insufficient surface: condensed type of 5 pt and 5.5 pt minimums, then leaflet, insert or website for overflow.
s.55	Labellers must keep records that allow a product and its labelling to be reconciled.
s.62 and s.25	Recall reporting under the GMP provisions (s.62) and the product licence provisions (s.25).

NHP allergen and label control checklist

Build a full allergen inventory covering every medicinal and non-medicinal ingredient, every derivative, and every source material, not just the obvious ones.
Classify each allergen as intentionally added or cross-contact, using a documented decision tree, and remember that only genuine cross-contact is exempt under section 91.1.
Confirm that any food allergen, gluten or added sulphites present as an ingredient is declared in bold under Warnings, using the section 91.2 source name.
Map every label claim, including absence claims like "No Dairy" or "gluten free", to the current bill of materials and the terms of the product licence.
Verify the NPN on both the inner and outer labels, preceded by "NPN" and matching the licensed product.
Confirm the Product Facts table headings, order and typography meet sections 93.1 and 93.2, and keep allergen information on the physical label.
Run a documented line clearance and per-component reconciliation before printing and before each labelling run.
Route every artwork version through QAP sign-off, and keep labeller records under section 55 that let you reconstruct any run.
Trigger a label review on any ingredient substitution, supplier change or formula amendment, and treat it as a change control, not a reprint.
Keep a recall procedure current and test it, so that reporting under sections 62 and 25 is fast if a label defect does escape.

Common mistakes that lead to recalls

Treating a source ingredient as cross-contact. Colostrum, whey, casein, lecithin and similar derivatives are ingredients and must be declared. Section 91.1 does not reach them.
Absence claims that outrun the formula. A "No Dairy" or "vegan" claim survives on the artwork after a reformulation added an animal-derived ingredient.
Allergen statements set in regular type. Section 93.1(11) requires bold, and a non-bold statement is a documented deficiency.
An NPN that does not match the licensed product, or that is missing the "NPN" designation required by section 91(b).
No change control on artwork, so a supplier or formula change never triggers a label review and the two drift apart.

Frequently asked questions

Do natural health products have to declare allergens in Canada?

Yes. Under section 93.1(11) of the Natural Health Products Regulations, if an NHP contains a food allergen, gluten or added sulphites, the statement "Allergens / Allergènes" must appear in bold under the "Warnings / Mises en garde" heading, followed by the food allergen source statement, also in bold.

Does cross-contamination have to be declared on an NHP label?

No. Section 91.1 states the allergen, gluten and sulphites declaration does not apply where the substance is present only as a result of cross-contamination. Intentionally added ingredients are not exempt and must be declared.

Can a supplement say "dairy free" if it contains colostrum?

No. Bovine colostrum is a dairy-derived ingredient. A "dairy free" or "No Dairy" claim on a colostrum-containing product is false, requires the product to declare milk as an allergen, and is the exact failure behind the New Roots Herbal recall of 6 August 2026.

Where does the NPN have to appear on the label?

Section 93(b) requires the product number on the principal display panel of the inner label and, if there is an outer label, on its principal display panel. Section 91(b) requires it to be preceded by the designation "NPN".

What is a Type II recall?

A Type II recall involves a product that may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote. An undeclared allergen on an NHP is commonly classified in this range, but the classification is made case by case by Health Canada.

Who is responsible for the label, the manufacturer or the licence holder?

The product licence holder is accountable for the compliance of the marketed product, including its label and claims, even when manufacturing, packaging or labelling is outsourced. Contracts and quality agreements should make artwork approval and reconciliation responsibilities explicit, but accountability rests with the holder.

How MFLRC can help

MF License & Regulatory Consultants works with natural health product licence holders across Canada to close exactly the gaps behind these recalls. Our natural health product services and quality assurance and quality control support include label and artwork control gap assessments, claim substantiation reviews that map every claim to the bill of materials and the licence terms, NHP allergen risk assessments with a documented cross-contact decision tree, SOP development for artwork approval and line clearance, QAP services, mock recall programmes and site licence and GMP compliance support.

Two NHP label recalls in eight days. If your artwork approval workflow cannot prove that every claim on the label matches the current bill of materials and the terms of your product licence, you have the same gap. We can help you find and fix it before it becomes a recall.

Book a consultation

Conclusion

The two recalls of late July and early August 2026 were not caused by weak science or unsafe ingredients. They were caused by labels that did not match the products behind them. The Natural Health Products Regulations set out, in plain terms, what an allergen declaration must say, where the NPN must sit, and how the Product Facts table must be built. The organizations that treat labelling as a controlled, evidence-backed process, not a final cosmetic step, are the ones that stay off the recall list. For the wider framework, see our overview of NHP licensing, GMP and labelling obligations.