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A supplement expiry date marks the end of the period in which the product keeps its quality and strength. In short, stability data sets it. The lot number links each bottle to the batch it came from. In Canada, natural health product labels must show both. In the US, the rules require a lot number in manufacturing records, while an expiration date is optional but needs data behind it.
Key takeaways
- In Canada, a natural health product label must show its lot number and expiry date, expressed at minimum as a year and month.
- Under Canada’s rules, the expiry date is the earlier of the end of the stability period and the date the manufacturer recommends.
- In the US, FDA says a supplement expiry date is optional on labels, but valid data must back any date you print.
- US rules require a batch, lot or control number for each lot of packaged and labelled dietary supplement.
The two small codes on the bottom of a bottle carry a lot of weight, because each one answers a different question. When a customer complains, the lot number tells you which batch, which raw materials and which test results to pull. Meanwhile, the supplement expiry date is a promise backed by data. This guide explains what each code means and what the rules require. Then it shows how to plan your label so both codes print cleanly.
What a lot number does
Canada’s Natural Health Products Regulations define a lot number as any combination of letters, figures or both. So it lets you trace a product in manufacture and identify it in distribution. In practice, the code points to a batch record. Then that record shows the ingredients in the lot, the test results and where the finished units went.
Also, the rules expect you to use it. Section 50 requires every manufacturer, packager, labeller, importer and distributor to keep a recall system. Plus, it must permit the rapid and complete recall of every lot. If a recall starts, section 62 gives you three days to send Health Canada the details. Those details also include the number of each lot recalled.
In the US, the dietary supplement CGMP rule in 21 CFR Part 111 requires a batch, lot or control number. In fact, each lot of packaged and labelled product needs one. The rule also says you must be able to determine the complete manufacturing history of a packaged product through distribution. Complaint records must include the lot number where available.
How a supplement expiry date is set
In Canada, the supplement expiry date is the earlier of two dates. Each must show at least a year and month.
- The end of the stability period the manufacturer or importer determines under section 52.
- The date after which the manufacturer recommends that people stop using the product.
Section 52 asks the manufacturer and the importer to determine how long the product keeps its purity and physical characteristics. Medicinal ingredients must also keep their quantity per dose and their potency over that period. Storage conditions also matter: either the recommended conditions on the label, or room temperature if there are none. So a supplement expiry date is only as good as the stability data behind it.
In the US, FDA’s Dietary Supplement Labeling Guide says expiration dating isn’t required. A firm may include it if valid data support it and it isn’t false or misleading. Still, most retailers and online shoppers expect a supplement expiry date, so most brands print one.
Supplement expiry date and lot rules at a glance
| Question | Canada (natural health products) | US (dietary supplements) |
|---|---|---|
| Lot number on the label? | Yes, on the outer label | You must assign and record a lot code |
| Expiry date on the label? | Yes | Optional |
| Basis for the date | Stability period or the maker’s recommendation, whichever is earlier | Valid data showing it isn’t misleading |
| Minimum date format | Year and month | Not set in the labelling guide |
| Recall link | Recall system for every lot; report within 3 days | Records must trace each lot through distribution |
If you sell in both countries, the Canadian rules are the stricter baseline for the label. Print both codes on every unit, and you meet the needs of both markets.
Reading a lot code: a simple example
Because no single format is mandatory, each manufacturer builds its own. A common pattern combines a year, a production date and a sequence. For example, a code like 26-1104-02 might mean the second batch made on 4 November 2026. The meaning lives in the manufacturer’s records, not on the label.
For you, the code must be unique to the lot. Next, your manufacturer should pull the batch record from it quickly. Then ask how long that takes. At Welsdom, each private label batch comes with batch documentation for traceability and a certificate of analysis. Our guide to what testing you need for supplement products in Canada explains what sits behind that certificate.
7 checks before your label goes to print
- Leave a blank panel. The lot number and supplement expiry date change with every run. So print them at packing time, not in the artwork.
- Pick the spot. Bottle bottoms, label edges and pouch seals all work, if the code stays readable.
- Test the ink. Make sure the printed code doesn’t smudge on coated labels or rub off in shipping.
- Match the format. In Canada, show at least the year and month for the expiry date.
- Label the codes. Words such as “Lot” and “Exp” help customers and retailers read them.
- Check the storage line. The expiry date depends on storage, so the label’s storage directions must match the stability study.
- Plan the outer box. If you use a carton, Canada expects the codes on the outer label too.
When the supplement expiry date needs a second look
Some changes can shorten shelf life and move your supplement expiry date. Health Canada’s GMP guidance expects shelf life to be re-evaluated after significant changes, including changes to the packaging. A new bottle, desiccant, supplier or storage claim can all justify fresh stability work. Our post on stability testing for skincare and supplements explains the options.
Finally, keep returned products separate. Under the Canadian rules, a quality assurance person must approve a returned product before it goes back on sale. A clear lot number makes that check far easier.
Related guides
- What testing is required for supplement products in Canada: the tests that sit behind each lot’s release, so you know what to ask.
- FDA CGMP basics for supplement brand owners: the US manufacturing rules in plain language.
- Stability testing for skincare and supplements: how a lab builds the data behind an expiry date.
Frequently Asked Questions
Is a supplement expiry date required in Canada?
Yes, for natural health products. The label must show an expiry date and a lot number. The date is the earlier of the end of the stability period and the maker’s recommended date. It shows at least a year and month.
Do US supplements need an expiration date?
No. FDA says expiration dating is not required on dietary supplement labels. However, if a brand includes a date, valid data must show it isn’t false or misleading.
What is a lot number on a supplement?
It is a code of letters, numbers or both that links a unit to the batch it came from. It lets the manufacturer pull the batch record, test results and distribution records for that lot.
Can I sell supplements after the expiry date?
No. The expiry date marks the end of the period in which the product should still meet its specifications. Remove expired stock from sale.
Who sets the expiry date on a private label supplement?
The date comes from stability data. In Canada, the rules place the duty on the manufacturer and the importer. Your contract manufacturer usually runs or arranges the stability work, so agree on who owns that data.
When you’re ready to launch a supplement with traceable batches from day one, get a quote on our private label supplements page.