Shelf Life
ProductionAlso known as: Expiration date, Product shelf life, Best by date
The period during which a supplement maintains its labeled potency and safety under stated storage conditions.
What It Means
Shelf life is the duration from manufacture to the point where a product no longer meets its quality specifications (potency, purity, physical characteristics). For dietary supplements, shelf life determines the expiration date or 'best by' date on the label. Shelf life is established through stability testing: accelerated studies provide preliminary estimates, while real-time studies under normal storage conditions (25C/60% RH) provide definitive data. Factors affecting shelf life include ingredient stability, dosage form, packaging barrier properties, and storage conditions. Products sold past their expiration date may be subject to FDA enforcement.
What It Is Not
Shelf life is NOT a guarantee of safety or efficacy — it is a manufacturer's estimate based on stability data. A product one day past its expiration is not necessarily harmful, but its labeled potency may no longer be accurate. Shelf life claims on labels must be supported by stability data (though 21 CFR Part 111 does not explicitly require stability testing, it does require that label claims be truthful).
Evidence and References
- standardICH Q1A(R2) Stability Testing
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