Ara Testing Labs has been receiving questions recently about regulatory expectations and when stability studies are needed. This article shares insight that will help you understand both topics on a deeper level.

Much of the confusion comes from how expiration dates, “best‑by” dates, and manufacture dates are interpreted.

The Importance of the Expiration or “Best By” Date

The key point is simple and often overlooked:

If a dietary supplement carries an expiration or best‑by date, the manufacturer must have scientific stability data that demonstrates the product meets all label claims through that date.

This requirement is tied to the FDA’s dietary supplement cGMP rule in 21 CFR Part 111, which requires products to meet their identity, purity, strength, and composition specifications throughout their shelf life.

Instead, many brands choose to use a Manufacture Date (MFG). A manufacture date is a factual statement showing when the product was produced, and it does not require long‑term stability data. FDA does not prohibit the use of MFG dates. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers are responsible for ensuring products are not adulterated or misbranded, but DSHEA does not require expiration dating on supplements.