All fluoride containing toothpastes are regulated by the U. S. Food and Drug Administration (USFDA). We put an expiration date on our products that coincides with our product stability testing results and depending on the product, it varies from 18 to 24 months after manufacturing date. After this time has elapsed, the fluoride and aesthetic aspects (i.e. flavor, consistency) may diminish. Therefore, even though the toothpaste is not harmful, we do not recommend using it.