Supplement shelf life: what buyers should ask
There is no single shelf life for all supplements. FDA’s CGMP guidance says the rule does not require an expiration date, but a date used on a label should have supporting data. Ask for evidence covering your formulation, packaging and storage conditions.
Ask what supports the proposed date
FDA distinguishes the absence of a mandatory expiration date from the need for data supporting a date that is used. Ask the manufacturer which measurements and acceptance criteria support the proposed period. Do not assume one product’s study covers a different formula or package.
Agree storage and change controls
Our buyer checklist asks who owns the stability evidence, which conditions the label assumes and what triggers reassessment after a supplier, formula or packaging change. Ask whether the protocol covers the characteristics that matter to the product rather than only its appearance.
Ask about reserve samples
21 CFR 111.83 requires reserve samples to be held one year past the shelf-life date when dating is used, or otherwise two years from distribution of the last batch associated with the sample. Sample retention and evidence for a shelf-life claim answer different questions.
Next steps
Sources
Sources checked . Company descriptions are their own statements; they are not certification verification.
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