Quality & complianceOfficial

FDA warns Calibrate IV Hydration over unapproved umbilical cord and exosome products sold online

🇺🇸 FDA CBER · Tue 27 Oct 2026

CBER says the company's stem cell and exosome IV offerings are unapproved new drugs and unlicensed biological products, and that the umbilical cord product is not a homologous-use HCT/P.

The US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) issued a warning letter on 13 October 2026 (ref. CBER 26-729846) to Calibrate IV Hydration. The letter was addressed to its medical director, Neville Campbell, MD, and published on 27 October.

FDA reviewed the company's website, which sells umbilical cord-derived and exosome products for allogeneic use. The agency concluded that these products are unapproved new drugs under section 505(a) of the FD&C Act and unlicensed biological products under section 351(a)(1) of the PHS Act. It also said that introducing them into interstate commerce, or causing this, is prohibited under section 301(d) of the FD&C Act.

The agency relied on website claims for a Stem Cell IV treatment, an Exosome IV treatment and combination packages. It cited statements about supporting neurological, immune, hormonal and lung function, joint, muscle and bone health, inflammation management and skin regeneration. FDA said these show the products are intended to diagnose, cure, mitigate, treat or prevent disease, or to affect the structure or function of the body, which makes them drugs and biological products.

For the umbilical cord-derived product, FDA said it is also a human cell, tissue, or cellular or tissue-based product (HCT/P). It found the product fails the homologous-use criterion in 21 CFR 1271.10(a), because it is marketed for joint pain, arthritis pain, inflammation, damaged tissue and hip pain, which are not basic functions of umbilical cord in the donor. FDA therefore said the product is not regulated solely under section 361 of the PHS Act and 21 CFR part 1271, and that no exception in 21 CFR 1271.15 applies. The published text breaks off before the rest of the letter, including any required corrective actions.

What it means for your team

  • Wellness and IV clinics selling cord-derived or exosome products should expect FDA to treat website benefit claims as evidence of intended use.
  • Claims framed as 'supporting' health or 'natural processes' were still cited as indicating drug intent, so softer wording gave no protection in this letter.
  • HCT/P sponsors should check homologous-use and 21 CFR 1271.15 exception status; non-homologous marketing triggers premarket review requirements.
  • Compliance teams should audit product pages and linked marketing material, as FDA cited specific URLs.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

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