Earned, not assumed.
Precision microbiome care starts with knowing exactly what's in the formulation — identity, purity, potency, stability. Nothing enters a patient without passing every gate.
The standard every ingredient must meet
A pipeline of gates. Each gate must clear before the ingredient touches a formulation.
GRAS Status Verification
Every ingredient must hold Generally Recognized as Safe status — self-affirmed with expert panel determination, or FDA GRAS notification with accepted filing. No exceptions.
Identity Verification
We confirm the ingredient is what it claims to be before it enters any protocol.
Purity & Contaminant Screening
Heavy metals, pesticides, mycotoxins, allergen cross-contamination, and microbial contaminants. Certificate of Analysis required from an accredited third-party lab.
Potency Verification
Active-compound concentrations verified at time of manufacture AND at expiration. If it doesn't hold potency through shelf life, it doesn't ship.
Stability Testing
Accelerated and real-time stability data under controlled temperature, humidity, and light conditions. The ingredient must perform the same in month one and month twelve.
Manufacturing standards
Our suppliers meet the same bar we hold ourselves to.
cGMP Compliance
All manufacturing partners operate under current Good Manufacturing Practice regulations (21 CFR Part 111 for dietary supplements). Facility audits on file.
Lot Traceability
Every ingredient lot is traceable from raw material through manufacturing, packaging, and delivery to the patient. Full chain of custody, every batch.
Allergen Controls
Top-14 allergen screening and facility cross-contamination controls.
Cold Chain Integrity
Temperature-sensitive ingredients ship under monitored cold chain. Data loggers confirm the chain held on arrival.
For ingredient suppliers
If your ingredient meets these standards, our Ingredient Partnership Program is open.