Probiotics — No NDI Notification
Mistaking a New Strain for an Old One
Situation
A Korean probiotics manufacturer launched a new product in the U.S. The primary ingredients were three Lactobacillus strains, and the team assumed 'Lactobacillus has been used forever' and launched without an NDI notification.
Problem
Some Lactobacillus species are indeed Old Dietary Ingredients, but one of the strains in this product wasn't academically classified until 2001 and had no history of use in the U.S. supplement market before October 15, 1994. FDA determined the strain was an NDI, and a product launched without the required NDI Notification is considered adulterated regardless of the reason.
Timeline
- 6 months post-launch — FDA market surveillance checks the strain's NDI status
- After the check — confirms no NDI Notification was filed, product ruled adulterated
- Afterward — market recall demanded, NDI Notification filed retroactively, roughly 5 months to relaunch
Losses
Market recall costDiscarded inventoryNDI notification preparation costLost market opportunity during the relaunch delayDamage to brand credibility
📌 Even a strain with a familiar-sounding name needs its Old/NDI status confirmed at the specific strain level.