Self-affirmed GRAS status
AKK PROBIO® holds self-affirmed Generally Recognized As Safe status under 21 CFR §170.30, covering both live and pasteurized forms for food use.
FDA New Dietary Ingredient Notification #1468
AKK PROBIO® completed FDA NDI Notification #1468 for the pasteurized heat-inactivated postbiotic form only. The live form does not have NDI status.
AFU and TFU are separate contexts
GRAS use level: up to 7.0 x 10^10 AFU per serving. NDI condition of use: 170 mg/day, equal to 3.4 x 10^10 TFU/day, for the pasteurized form only.
Clear U.S. regulatory terminology
The appropriate terminology is self-affirmed GRAS for food-use safety status and completed FDA NDI Notification #1468 for the pasteurized dietary ingredient form.
Regulatory position
U.S. status by form
Important distinctions
- NDI #1468 covers the pasteurized form only; the live form does not have NDI status.
- NDI notification is a dietary ingredient notification pathway, distinct from drug approval.
- AFU is used for the GRAS serving context; TFU is used for the pasteurized-form NDI context.
- Product-specific compliance should be reviewed by the customer's regulatory team.
Documentation
Request the regulatory dossier for technical review
Request NDI information, GRAS conclusion summaries, COA samples, specification sheets, safety summaries, evidence materials, and use-case notes through the B2B sample request flow.
Manufacturing Context
In-house production and quality control
AKK PROBIO® is supported by Thankcome's own manufacturing and quality systems, giving regulatory, QA, and formulation teams a single point of review for strain identity, production context, and documentation.
- Production, QA, and technical documentation can be requested through the B2B review flow.
- Materials should be evaluated by application, market, dosage, and selected form.
Document Review
Process materials for regulatory and QA teams
The production-process overview is presented as supporting context. Detailed regulatory and quality materials are shared through the request flow so each team receives documents matched to the intended use case.
- Available request items include NDI context, GRAS summaries, COA samples, specification sheets, safety summaries, and evidence materials.
- NDI 1468 applies to the pasteurized postbiotic form for dietary supplement use; the live form is not NDI-covered.
What is AKK PROBIO's U.S. regulatory status?
AKK PROBIO® holds self-affirmed GRAS status for both live and pasteurized forms. The pasteurized form has completed FDA New Dietary Ingredient Notification #1468 for dietary supplement use.
What is the difference between GRAS and NDI?
GRAS is a safety standard for food ingredients under 21 CFR §170.30. NDI notification is a pre-market notification pathway for dietary ingredients not marketed before October 15, 1994.
Can AKK PROBIO be used in live and pasteurized forms?
Both forms are covered by self-affirmed GRAS for food use. For dietary supplement use, FDA NDI Notification #1468 specifically covers the pasteurized postbiotic form.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Regulatory information on this page is provided for B2B ingredient sourcing and technical review.