Quick answer
A supplement's shelf life is how long it keeps its labeled amounts and quality when stored as directed. FDA does not require supplements to carry an expiration date, but says any date a maker prints, including a best if used by date, should be backed by data, ideally from stability testing (72 FR 34752).1
Key facts
- When a maker uses shelf life dating, FDA's rule ties record keeping to it: reserve samples are kept for 1 year past the shelf life date, or 2 years after distribution if no date is used.2
- FDA held back from requiring expiration dates partly because validated methods to measure the strength of some ingredients, especially botanicals, were still developing.1
- In a 12 month study of probiotic supplements, storage temperature was the main driver of survival, and the largest losses tended to come at room temperature.3
- Makers must hold supplements under conditions of temperature, humidity and light that keep their identity, purity, strength and composition from being affected.4
How shelf life is set
FDA has recommended a written stability testing program, with the results used to set storage conditions and dates. Comments on its 2007 rule described data from a maker's experience with a product, or from accelerated testing of similar products in the same container.1
FDA did not require expiration dating in that rule, citing uncertainty about whether methods exist to back dates for many ingredients, botanicals in particular. It did say that any date printed on a label should be backed by data.1
What shortens shelf life
- Heat: probiotic counts held up best in the refrigerator or freezer, and some products missed their declared counts by the end of shelf life whatever the storage.3
- Moisture: vitamin C losses in supplements tracked their moisture content in one study, and 30 days at 40 °C cost tablets up to about 25% of their vitamin C.5
- Light: FDA's rule names light, with temperature and humidity, among the conditions to control when holding supplements.4
- The ingredient itself: in coenzyme Q10 products, the ubiquinone form broke down or converted during storage, even at room temperature within the labeled shelf life.6
Packaging is part of the system. FDA requires reserve samples to be kept in the same container and closure the product is sold in, since that is what protects it from contamination and deterioration.2
After the date
Past its date, a product is outside the period its maker's data are meant to cover. Strength can drift down near the end of shelf life, as the probiotic study found for declared counts.1,3
A shelf life assumes the storage on the label. FDA's rule has makers keep their own reserve samples under the conditions the label recommends, or ordinary storage conditions if it gives none.7
Questions people ask
Is a supplement still good after its shelf life?
It may look the same, but the date marks the end of the period the maker's data are meant to cover. Vitamin C and probiotic counts are examples of contents known to fall over time.1,3,5
How long do vitamins keep their potency?
It depends on the ingredient, the form and the storage. FDA leaves the length to each maker and has recommended stability testing to set it.1
Should probiotics be refrigerated?
Follow the label. In one study of multi-strain products, cold storage kept counts highest, and a few products fell short of their declared counts by the end of shelf life however they were stored.3
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Sources
- Food and Drug Administration. Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Final Rule. Federal Register 72 FR 34752, June 25, 2007. Opened 2026-10-07.
- 21 CFR 111.83. What are the requirements for reserve samples? Opened 2026-10-07.
- Brousilova T, Vlkova E, Neuzil-Bunesova V, Musilova S, Kadlec-Modrackova N. Storage temperature as a determinant of probiotic long-term stability in commercial dietary supplements. Front Nutr. 2026;13:1933900. Opened 2026-10-07.
- 21 CFR 111.455. What requirements apply to holding components, dietary supplements, packaging, and labels? Opened 2026-10-07.
- Giménez R, Cabrera C, Olalla M, Ruiz MD, López MC. Ascorbic acid in diet supplements: loss in the manufacturing process and storage. Int J Food Sci Nutr. 2002;53(6):509-518. Opened 2026-10-07.
- Temova Rakuša Ž, Kristl A, Roškar R. Stability of reduced and oxidized coenzyme Q10 in finished products. Antioxidants (Basel). 2021;10(3):360. Opened 2026-10-07.
- 21 CFR Part 111. Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Electronic Code of Federal Regulations, up to date as of October 6, 2026. Opened 2026-10-07.
This page is information, not medical advice. Talk to your doctor or pharmacist about your own situation.