Integrity is a regulatory posture, not a slogan.
BORN distinguishes what is validated from what is observed, and operates within every regulatory boundary. Here is exactly where the facility and the product stand.
Facility: registered 361 HCT/P lab
Operates under Section 361 of the Public Health Service Act, following 21 CFR 1271 standards for recovery, storage, screening, processing, and labeling.
Product: outside HCT/P classification
Per 21 C.F.R. § 1271.3(d)(3), Cell Factors are not HCT/Ps — neither a 351 nor a 361 product — confirmed by former FDA, DOJ, and OIG advisors.
Disease Awareness Communications
Disease-state education and product-specific materials are kept separate, so communications do not constitute labeling or advertising under the FDCA.
Drug-testing status
Not prohibited under WADA, IOC, the NFLPA CBA, or Drug Free Sport International. Patients have passed testing at the NFL, NBA, MLB, NCAA, and U.S. government levels.