Calibrate IV Hydration

On October 13, 2026, FDA's Center for Biologics Evaluation and Research (CBER) issued a warning letter to Neville Campbell, MD, Medical Director of Calibrate IV Hydration, citing the company's sale of umbilical cord-derived and exosome products for allogeneic use as unapproved new drugs in violation of section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), and as unlicensed biological products in violation of section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). The products are sold via the company's website and include a Stem Cell IV treatment, an Exosome IV treatment, and Stem Cell and Exosome Combination Packages. None of the products are the subject of an approved biologics license application (BLA). FDA determined that the products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products under section 351(i) of the PHS Act, 42 U.S.C. § 262(i), based on website claims that the products support neurological function, maintain immune response, promote tissue repair, manage inflammation, balance hormonal function, and address signs of aging. These claims establish that the products are intended to diagnose, cure, mitigate, treat, or prevent disease or to affect the structure or function of the body. The umbilical cord-derived product is also classified as a human cell, tissue, or cellular or tissue-based product (HCT/P) under 21 CFR 1271.3(d) and is subject to 21 CFR Part 1271 under section 361 of the PHS Act, 42 U.S.C. § 264. FDA found that the product fails to meet the homologous use criterion of 21 CFR 1271.10(a)(2) because it is marketed for treatment of joint pain, arthritis pain, inflammation, damaged tissue, and hip pain, none of which constitutes a basic function of umbilical cord in the donor. No exception under 21 CFR 1271.15 applies. Because the product does not meet all criteria in 21 CFR 1271.10(a), it is not regulated solely under section 361 of the PHS Act and instead is subject to full drug and biological product regulation, including premarket review requirements. FDA warned that failure to adequately respond within 15 working days may result in enforcement action including seizure or injunction, without further notice.