Supplement expiration dates are not required by US law, but a company that prints one needs data to back it up. This guide explains what the rules say, what the wording means, and how to keep bottles in good shape.
This publication shares ownership with PeptaraLabs, Lab Ranked Agency, and Dental Link.
The short answer
Supplement expiration dates are optional in the United States. A company does not have to print one on a bottle. If it does, the date must be backed by data.
FDA says so in its labeling guidance. The question is whether expiration dating is required on dietary supplement labels. The answer is no, but a firm may include it if valid data support it.
So a missing date is not a violation. A printed date is a promise that the maker should be able to prove.
Sources: U.S. Food and Drug Administration, Dietary Supplement Labeling Guide, Chapter I, question on expiration dating (fda.gov).
What the manufacturing rules say
The current good manufacturing practice rule for supplements is 21 CFR Part 111. It does not tell makers to print a date. It does touch on shelf life and product protection in two places.
Section 111.465 covers reserve samples. A maker must keep a sample from each lot. The sample must be held for one year past the shelf life date, if shelf life dating is used. Otherwise it is held for two years after the last batch is distributed.
Section 111.470 covers distribution. A maker must distribute supplements under conditions that protect them against contamination and deterioration.
Note the words "if shelf life dating is used." The rule assumes some makers date their products and some do not.
Sources: 21 CFR 111.465 and 21 CFR 111.470 (ecfr.gov), as in force on this date; the manufacturing rule dates from 2007.
Best by, use by and expiration
Labels use several phrases. You may see "best by," "use by," "best before," or "exp." There is no single FDA definition for each phrase on supplement bottles.
In practice, makers use a date to say how long a product is expected to hold its stated amount. ConsumerLab describes a best-by date as the point at which potency is expected to fall below the labeled amount.
That is about quality, not a sudden safety cliff. A bottle does not turn bad at midnight on the printed day. But the further past the date, the less sure anyone can be about what is in the capsule.
A date of manufacture is different. It only shows when a lot was made. It does not tell you how long the product stays stable.
Sources: ConsumerLab, best-by date versus date of manufacture on supplement labels (consumerlab.com).
How makers support a date
A date should come from stability testing. The maker stores samples under set conditions and tests them over time to see if the labeled amounts hold.
On January 20, 2011, the Council for Responsible Nutrition and NSF announced a testing guideline for supplement expiration dates. An industry group built it with oversight from FDA and the NIH Office of Dietary Supplements. Before then, no testing method was widely recognized by industry for this job.
The guideline is voluntary. It shows what a careful stability program looks like. A bottle with a date and a documented program is a stronger signal than a bottle with a date and nothing behind it.
Sources: Nutritional Outlook, CRN and NSF announce testing guideline for dietary supplement expiration dates (nutritionaloutlook.com), January 2011.
How to store bottles
A printed date applies to an unopened container kept as the label says. Storage changes the outcome.
Heat and moisture can shorten shelf life a great deal. That points to simple habits. Keep bottles in a cool, dry place. A bathroom shelf or a spot over the stove is a poor choice. Close the cap tightly after each use. Leave any desiccant packet in the bottle.
Follow the storage line on the label. Some products, such as certain probiotics, ask for cool or cold storage. If the label gives conditions, those are the conditions the date assumes.
Sources: ConsumerLab, best-by date versus date of manufacture on supplement labels (consumerlab.com); 21 CFR 111.470 (ecfr.gov).
What to do with an old bottle
Start with the label. Look for a date, a lot number and storage directions. If there is no date, check the lot number or the maker's contact line and ask. A responsible company can say when a lot was made.
Look at the product itself. Changes in smell, color, or texture are signs to stop and replace it. Tablets that crumble or powders that clump point to moisture.
Buying smaller bottles that you finish well before the date is the easiest fix. For questions about a specific product, ask a pharmacist or the maker. This article does not give health advice.
Sources: U.S. Food and Drug Administration, Dietary Supplement Labeling Guide, Chapter I (fda.gov); ConsumerLab (consumerlab.com).
Sources
- U.S. Food and Drug Administration, Dietary Supplement Labeling Guide, Chapter I (fda.gov)
- 21 CFR 111.465 and 111.470, eCFR (ecfr.gov)
- ConsumerLab, best-by date versus date of manufacture (consumerlab.com)
- Nutritional Outlook, CRN and NSF testing guideline announcement, January 2011 (nutritionaloutlook.com)