NHP packaging requirements in Canada catch a lot of brand owners late, usually after the closures are already ordered. Two rules do most of the work. First, most natural health products must sit in a security package that shows whether it was opened. Second, some products also need a child-resistant closure. Both rules live in the Natural Health Products Regulations, and both affect your bottle, cap and label before the first run. So it pays to settle them early.
Key Takeaways
- Section 95 of the NHP Regulations requires a security package for any NHP that people swallow, inhale, insert into the body or use in the eye, plus mouthwashes.
- Lozenges are the only named exemption from the security packaging rule.
- Your labels must point to the tamper-evident feature, unless that feature is self-evident and built into the immediate container.
- Child-resistant packaging applies through section 97, which pulls in specific Food and Drug Regulations triggers such as more than 250 mg of elemental iron per package.
- A closure counts as child-resistant only if it passes the defined test or meets CSA Z76.1, ISO 8317 or the US 16 CFR 1700.15 standard.
What the Regulations Say: NHP Packaging Requirements in Canada
Part 5 of the Natural Health Products Regulations covers labelling and packaging. Most brand owners know the labelling half well. However, two short sections on packaging matter just as much for a launch. Section 95 sets the security packaging rule. Section 97, in turn, borrows the child-resistant rules from the Food and Drug Regulations.
Here's what that means in practice: the NHP packaging requirements in Canada shape your component order, not just your artwork. For example, a dropper bottle, a cap with a breakaway ring and a printed carton all have to work together. If one part fails the rule, the whole package fails it.
These rules also sit alongside the label content rules. For that side of the job, see our guide to NHP label requirements for herbal products. In addition, the new Product Facts table may change how much panel space you have left for packaging statements.
Security Packaging: The Tamper-Evident Rule
Section 95(1) says no person shall sell or import a packaged NHP unless it is in a security package, if the product is one of three types. The list covers a mouthwash, a product to be inhaled, ingested or inserted into the body, and a product for ophthalmic use. Section 95(2) then exempts lozenges.
The regulations define a security package as one with a feature that gives consumers reasonable assurance it has not been opened before purchase. In other words, the rule targets evidence of opening. It does not demand a specific technology.
The practical implication: almost every tincture, glycerite, capsule, tablet or tea that a person swallows falls inside this rule. As a result, the tamper-evident feature becomes a fixed part of the spec for most herbal products. By contrast, a cream or salve that stays on the skin sits outside section 95.
Common tamper-evident options include a cap with a breakaway band, an induction seal under the cap, a shrink band over the closure, or a sealed outer carton. Each one changes your component cost and your fill-line setup. So the choice belongs in the same conversation as your bottle and dispensing format.
Label Statements for the Security Feature
The security feature needs to be visible to the buyer, and section 95(3) handles that through the label. A statement or illustration that draws attention to the feature must appear on the inner label. Also, if the feature is part of the outer package, the statement must appear on the outer label too.
There is one exception. Section 95(4) drops the label statement if the feature is self-evident and an integral part of the immediate container. A breakaway ring moulded into the cap may fit that description. An induction seal hidden under the cap usually does not, because the buyer can't see it until they open the bottle.
This is where most brands run into trouble. They approve artwork first and choose the seal later, so the label says nothing about the feature. Therefore, lock the tamper-evident method before final artwork, and add a line such as "Do not use if seal is broken or missing" when the feature isn't self-evident.
Child-Resistant NHP Packaging Requirements in Canada
Child-resistant rules work differently. The NHP Regulations do not write their own list. Instead, section 97 applies selected provisions of the Food and Drug Regulations to natural health products, including sections C.01.029 and C.01.031.
Section C.01.029 names the triggers. They include salicylic acid and its salts, salicylamide, acetylsalicylic acid, acetaminophen, and more than five per cent alkyl salicylates. They also include a package that contains more than the equivalent of 250 mg of elemental iron. For herbal brands, the iron trigger and the alkyl salicylate trigger are the ones to watch. For example, methyl salicylate, the main constituent of wintergreen oil, is an alkyl salicylate.
Products that hit a trigger must carry a "keep out of reach of children" statement. Above certain amounts, such as 250 mg of elemental iron per package, the label also needs a statement that the package holds enough to seriously harm a child.
Section C.01.031 then sets the packaging rule itself. If the label recommends the product solely for children, it must use a child-resistant package. Otherwise, at least one package size on sale must be child-resistant. Any size that ships in a regular package must state on the outer label that the product is available in a child-resistant package.
What Counts as a Child-Resistant Package
A cap doesn't become child-resistant because the supplier says so. Section C.01.001(2) of the Food and Drug Regulations sets two routes to qualify.
The first route is a test with panels of children and adults. At least 85 per cent of children must fail to open the package before a demonstration, and 80 per cent after it. Meanwhile, at least 90 per cent of adults must be able to open it, and to reclose it if the design is reclosable.
The second route is compliance with a named standard. The regulations list CAN/CSA-Z76.1 for reclosable packages, EN 28317, which mirrors ISO 8317, and the US standard at 16 CFR 1700.15. The short version: ask your closure supplier for a certificate of conformity to one of these standards for the exact cap and bottle neck you plan to use.
Exemptions Worth Knowing
Several exemptions carry over through section 97. The child-resistant rules do not apply to a product in effervescent or powder form, or in suppository form. Likewise, topical products are exempt, unless they are liquids with more than five per cent alkyl salicylates.
Non-reclosable packages holding no more than two adult standard dosage units are also exempt, as is toothpaste. In addition, the rules do not apply when a pharmacist or practitioner repackages a product at the time of sale.
Worth understanding before you proceed: these exemptions cover the child-resistant rules only. A powder you swallow still needs a security package under section 95. So the two rules have to be checked separately for each format.
Building NHP Packaging Requirements Into Your Launch
Treat packaging as a regulatory decision, not just a design one. Start with three questions for each SKU. Will people swallow it, inhale it, insert it or use it in the eye? Does the formula hit a section C.01.029 trigger? And will you sell more than one package size?
Next, collect documents from your component suppliers. You'll want a specification for the tamper-evident feature and, where needed, a child-resistant certificate for the exact closure and neck finish. Keep these with your product records, because an inspector may ask how you met the rule.
Finally, think about export early. If you plan to sell into the United States, US rules also require child-resistant packaging for dietary supplements with 250 mg or more of elemental iron per package. Choosing one closure that meets both markets saves a second component order.
Getting NHP packaging requirements in Canada right before the first run is cheaper than relabelling or recalling stock. If you're planning a private label line and want to talk through formats, closures and timelines, our manufacturing services page is a good place to start, or contact us for a quote.
Published: October 29, 2026