Blue Horizon International, LLC(CBER 26-728085)

Issuing Office:

Center for Biologics Evaluation and Research (CBER)

United States

WARNING LETTER

May 26, 2026

CBER 26-728085

Dear Dr. Mehling:

The United States Food and Drug Administration (FDA) reviewed your company’s website at https://bluehorizonstemcells.com (last visited May 2026), through which your company markets “Stem Cell Therapy” derived from umbilical cord blood and “Exosome Therapy”1 derived from Wharton’s Jelly Mesenchymal Stem Cells (“WJ-MSC[s]”) for allogeneic use (hereafter, “your products”). This letter is to advise you that your misbranding of your products while held for sale after shipment in interstate commerce violates section 301(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 331(k).

Unapproved New Drug and Unlicensed Biological Product Violations

Based on information and records reviewed by FDA, including your website, https://bluehorizonstemcells.com, (last visited May 2026), your products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body. For example,

• After identifying your products, and under the heading “What Can We Treat,” your homepage lists various diseases and conditions, including:
  o Digestive System Diseases, including Hepatic steatosis and Chronic pancreatitis
  o Respiratory Diseases, including Allergic rhinitis, Rhinitis, and Sinusitis
  o Rheumatic Diseases, including Lupus
  o Endocrine Diseases, including Hashimoto’s thyroiditis and Hypothyroidism
  o Musculoskeletal Diseases, including Myositis, and Sports-related injury complications
  o Cardiovascular Diseases, including Coronary artery disease

• Your home page states, “Our stem cell treatments use ethically sourced cells from umbilical cord blood and adipose tissue to treat chronic conditions, injuries, and degenerative diseases.” This statement is followed by a link to your stem cell treatment webpage and a list of uses for stem cells: “Tissue regeneration[;] Immune modulation[;] Anti-inflammatory effects[; and] Pain reduction”.

• Under the heading “Revolutionary Stem Cell Therapy,” your stem cell treatment webpage states, “Explore the power of stem cells in treating various medical conditions[,]” followed by, among other conditions and diseases:
  o Neurological Marvels
   …Spinal Cord Regeneration
   Stroke Recovery
   Multiple Sclerosis Relief
  o Cardiovascular Miracles
   …Myocardial Rejuvenation
   …Cardiomyopathy Triumph
   Reversing Atherosclerosis
  o Musculoskeletal Wonders
   …Osteoarthritis Solutions
   Rheumatoid Arthritis Breakthrough
  o Lung Restoration
   … Defying COPD
  o Liver Regeneration
   Reviving Liver Function
   Cirrhosis Reversal
  o Bowel Revolution
   Conquering Crohn’s Disease
  o Metabolic Transformation
   Diabetes Remissions

• Under the heading “Our Results” on your exosome webpage, “These exosomes demonstrate strong regenerative and anti-inflammatory properties…”

• Under the heading “Our Exosomes” on your homepage: “These next generation therapies enhance tissue regeneration, reduce inflammation, and support natural healing processes through the body.”

• Under the heading “What Are Exosomes” on your exosome webpage, “Functionally, exosomes are pivotal in regulating immune responses, promoting tissue repair, and facilitating cellular regeneration.”

Therefore, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).

Your umbilical cord blood derived stem cell product is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d) and is subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264. HCT/Ps that do not meet all the criteria in 21 CFR 1271.10(a) are not regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271. Unless an exception in 21 CFR 1271.15 applies, such products are regulated as drugs, devices, and/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, Blue Horizon International does not qualify for any exception in 21 CFR 1271.15, and your umbilical cord blood derived stem cell product fails to meet all criteria in 21 CFR 1271.10(a).

Your umbilical cord blood derived stem cell product fails to meet the criterion that the HCT/Ps be “intended for homologous use only.” Homologous use means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P is intended to perform “the same basic function or functions in the recipient as in the donor” (21 CFR 1271.3(c) and 1271.10(a)(2)). Your umbilical cord blood derived stem cell product is not intended solely to perform the same basic function or functions of the HCT/P in the recipient as in the donor (e.g., forming and replenishing the lymphohematopoietic system). Rather, your umbilical cord blood derived stem cell product is intended for use in the treatment of several diseases and conditions, including multiple sclerosis, rheumatoid arthritis, cardiovascular and musculoskeletal conditions, which is not a basic function of umbilical cord blood in the donor.

Moreover, your umbilical cord blood derived stem cell product fails to meet the criterion in 21 CFR 1271.10(a)(4) because it is manufactured from allogeneic umbilical cord blood, is dependent on the metabolic activity of living cells for their primary function, and is not for autologous use, allogeneic use in a first-degree or second-degree blood relative, or reproductive use.

Therefore, this HCT/P is not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.2 See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your umbilical cord derived product is regulated as a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.

To lawfully market a drug that is also a biological product, a valid biologics license must be in effect. 42 U.S.C. § 262(a). Such licenses are issued only after a demonstration that the product is safe, pure, and potent. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations. 21 U.S.C. § 355(i); 42 U.S.C. § 262(a)(3); 21 CFR Part 312. Neither of your products are the subject of an approved biologics license application (BLA) nor is there an IND in effect for either of them.

Both your products, the umbilical cord blood derived stem cell product and the WJ-MSC/UC exosome product, are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1). A drug is misbranded under section 502(f)(1) if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. 21 CFR 201.5. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. § 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products are intended for use in the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your products fail to bear adequate directions for its intended uses and, therefore, is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1). Misbranding your products while they are held for sale after shipment of the drug or one or more of its components in interstate commerce is prohibited under section 301(k) of the FD&C Act, 21 U.S.C. § 331(k).

Conclusion

This letter is not intended to be an all-inclusive list of deficiencies that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure full compliance with all applicable requirements in the FD&C Act, PHS Act, and all applicable regulations.

This letter notifies you of our concerns and provides you with an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.

Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your products are in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.

Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.

Sincerely,
/S/

Vincent Amatrudo
Director (Acting)
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

_______________________

1 We direct your attention to FDA’s Public Safety Notification on Exosome Products, available at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products. FDA issued this public safety notification following multiple reports of serious adverse events experienced by patients who were treated with exosome products.

2 Because your products fail to meet at least one criterion in 21 CFR 1271.10(a), this letter does not evaluate all other criteria in 21 CFR 1271.10(a).