Federal Executive Branch
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State Dept.: U.S. Sanctions Armed Group Leaders in Eastern Democratic Republic of the Congo
WASHINGTON, June 3 -- The U.S. State Department issued the following statement on June 2, 2026, by Principal Deputy Spokesperson Tommy Pigott:
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United States Sanctions Armed Group Leaders in Eastern Democratic Republic of the Congo
Today, the United States is taking further action to address threats to stability and prosperity in eastern Democratic Republic of the Congo (DRC) by sanctioning senior commanders of two armed groups the United States previously designated, the Democratic Forces for the Liberation of Rwanda (FDLR), and the Rwanda-backed March 23 Movement (M23).
We are designating
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WASHINGTON, June 3 -- The U.S. State Department issued the following statement on June 2, 2026, by Principal Deputy Spokesperson Tommy Pigott:
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United States Sanctions Armed Group Leaders in Eastern Democratic Republic of the Congo
Today, the United States is taking further action to address threats to stability and prosperity in eastern Democratic Republic of the Congo (DRC) by sanctioning senior commanders of two armed groups the United States previously designated, the Democratic Forces for the Liberation of Rwanda (FDLR), and the Rwanda-backed March 23 Movement (M23).
We are designatingGustave Kubwayo, commander of an FDLR intelligence and special operations unit. The FDLR has carried out ethnic violence against civilians, used child soldiers, committed sexual violence, and launched cross-border attacks that continue to threaten Rwanda's security. We are also designating John Imani Nzenze, chief of intelligence for the Rwanda-backed M23, an armed group that has committed killings, serious human rights abuses, and attacks on civilians in eastern DRC.
The Trump Administration is firmly committed to ensuring all parties uphold their commitments under the historic Washington Accords for Peace and Prosperity and Doha Framework and will continue using all available tools to advance lasting stability in the region.
Today's action is being taken pursuant to the authorities under Executive Order (E.O.) 13413, as amended. For more information on today's action, please see the Department of the Treasury's press release (https://home.treasury.gov/news/press-releases/sb0518).
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Original text here: https://www.state.gov/releases/office-of-the-spokesperson/2026/06/united-states-sanctions-armed-group-leaders-in-eastern-democratic-republic-of-the-congo/
State Dept. Issues Readout of Deputy Secretary Landau Meeting With Guyana Foreign Minister Todd
WASHINGTON, June 3 -- The U.S. State Department issued the following readout by Principal Deputy Spokesperson Tommy Pigott on Deputy Secretary Christopher Landau's meeting with Guyanese Foreign Minister Hugh Todd:
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Deputy Secretary Christopher Landau met with Guyanese Foreign Minister Hugh Todd to reaffirm the strong and expanding partnership between the United States and Guyana.
The Deputy Secretary underscored the importance of expanding U.S. private sector engagement in Guyana and increasing commercial ties and investment.
Both leaders discussed shared economic priorities, including
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WASHINGTON, June 3 -- The U.S. State Department issued the following readout by Principal Deputy Spokesperson Tommy Pigott on Deputy Secretary Christopher Landau's meeting with Guyanese Foreign Minister Hugh Todd:
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Deputy Secretary Christopher Landau met with Guyanese Foreign Minister Hugh Todd to reaffirm the strong and expanding partnership between the United States and Guyana.
The Deputy Secretary underscored the importance of expanding U.S. private sector engagement in Guyana and increasing commercial ties and investment.
Both leaders discussed shared economic priorities, includingexpanding opportunities for U.S. companies to contribute to Guyana's development through sustainable investment and commercial partnerships.
The Deputy Secretary reaffirmed the United States' commitment to Guyana's sovereignty and territorial integrity.
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Original text here: https://www.state.gov/releases/office-of-the-spokesperson/2026/06/deputy-secretary-landaus-meeting-with-foreign-minister-todd-of-guyana/
FDA Center for Drug Evaluation & Research Issues Warning Letter to HealthPartners Neuroscience Center Research & Innovation
WASHINGTON, June 3 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to HealthPartners Neuroscience Center Research and Innovation from its Center for Drug Evaluation and Research:
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Recipient: Leah R. Hanson, Ph.D., Senior Director, Neuroscience Research, HealthPartners Neuroscience Center Research and Innovation, 295 Phalen Boulevard, Saint Paul, MN 55130-2455, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
FDA Ref. No.: 26-HFD-45-05-02
Dear Dr. Hanson:
This
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WASHINGTON, June 3 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to HealthPartners Neuroscience Center Research and Innovation from its Center for Drug Evaluation and Research:
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Recipient: Leah R. Hanson, Ph.D., Senior Director, Neuroscience Research, HealthPartners Neuroscience Center Research and Innovation, 295 Phalen Boulevard, Saint Paul, MN 55130-2455, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
FDA Ref. No.: 26-HFD-45-05-02
Dear Dr. Hanson:
ThisWarning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at HealthPartners Neuroscience Center Research and Innovation (HPNC) between March 17 and 21, 2025. The investigators representing FDA reviewed the role of HPNC as the testing facility for the following nonclinical laboratory studies of the investigational drug (b)(4), performed for sponsor-investigator (b)(4) (formerly performed for (b)(4)).
* Protocol (b)(4): "(b)(4)"
* Protocol (b)(4): "(b)(4)"
This inspection was conducted as a part of FDA's Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure the quality and integrity of study data, in accordance with Title 21 of the Code of Federal Regulations, part 58 (21 CFR 58), Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies.
At the conclusion of the inspection, the FDA investigators presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your April 11, 2025, written response to the Form FDA 483, and your subsequent correspondence dated June 13, 2025.
From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written responses dated April 11 and June 13, 2025, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in 21 CFR 58 governing the conduct of nonclinical laboratory studies. We wish to emphasize the following:
1. Failure of the testing facility management to assure that tests for mixtures of articles with carriers were conducted by appropriate analytical methods to determine the uniformity of the mixture and the concentration of the test or control article in the mixture, as applicable [21 CFR 58.31(d) and 21 CFR 58.113(a)(1)].
The testing facility management for each nonclinical laboratory study must ensure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. For each test or control article that is mixed with a carrier, tests by appropriate analytical methods must be conducted to determine the uniformity of the mixture and to determine, periodically, the concentration of the test or control article in the mixture. The testing facility management failed to adhere to these requirements.
Specifically, the protocol and final study report for Study (b)(4) stated that the test article, (b)(4), was dissolved in sterile water to a final dose concentration of 1%, 10%, or 20% (b)(4) (0.5 mg, 5 mg, and 10 mg, respectively), and for Study (b)(4), to a final dose concentration of 1%, 10%, or 20% (b)(4) (2 mg, 20 mg, and 40 mg, respectively). However, after reconstituting the test article with sterile water to the desired final dose concentration, the testing facility failed to test, by appropriate analytical methods, the resulting mixtures to determine their uniformity and concentration before dosing all animals in studies (b)(4) and (b)(4).
In your April 11, 2025, written response to the Form FDA 483, and in your subsequent correspondence dated June 13, 2025, you acknowledged that the characteristics of the test article were not analyzed. As corrective and preventive actions, you stated that the following actions were taken: (1) you created a new SOP titled "Receipt, Identification, Storage, Handling, Mixing, and Method of Sampling Chemicals," which includes procedures for test article characterization; (2) you provided the certificate of analysis for the (b)(4) lot used in study (b)(4); (3) you performed mass spectrometry testing on April 19, 2025, on stored frozen dosing aliquots representative of formulated test articles administered to animals in both studies; and (4) you amended the final study reports for both studies to include the results of this subsequent testing, noting that the selected test article samples were within the concentration specified in the protocol.
While we acknowledge the corrective and preventive actions that your testing facility has taken, your response is inadequate because you did not include sufficient details about your corrective action plan. For example, while you provided the results of the testing performed on the stored aliquots that were representative of the test articles administered to animals, this testing occurred after animal dosing and the studies had been completed. We also note that while you provided the testing results for the concentration of these samples, you did not provide the testing results regarding the uniformity of the samples.
In addition, while we acknowledge that you created an SOP that includes test article characterization, your written response does not include details about how you will implement these procedures to ensure that testing to determine the concentration and uniformity of test articles is performed in accordance with FDA regulations. For example, your response does not provide sufficient details regarding any completed or planned training of study personnel on this new SOP, or any training on FDA regulations governing the conduct of nonclinical laboratory studies. Without this information, we are unable to determine whether your testing facility will be able to prevent similar violations in the future.
Your testing facility management failed to ensure that tests by an appropriate analytical method were conducted to determine the uniformity and concentration of the mixtures of articles with carriers at the beginning and throughout the study period, to verify the protocol-specified dose concentrations. Because of this failure, FDA is concerned about the uniformity of the mixtures and about the concentration of the test articles in the mixtures used in the nonclinical laboratory studies conducted at your testing facility.
2. Failure of the Quality Assurance unit (QAU) to review the final study report to assure that the reported results accurately reflect the raw data of the nonclinical laboratory study [21 CFR 58.35(b)(6)].
The QAU must review the final study report to ensure that the reported results accurately reflect the raw data of the nonclinical laboratory study. The QAU at your testing facility did not adhere to these requirements. Specifically, for Protocol (b)(4), the following observations were not accurately documented in the final study report:
a. The deaths of two male rats (Rats #41 and #42 in the 10% (b)(4) dosing group) during the conduct of the study were not reflected in the final study report.
b. A Day 13 clinical observation of abnormal nose was observed in Female Rat #53 in the 10% (b)(4) dosing group, and a Day 13 clinical observation of abnormal porphyrin was observed in Female Rat #51 in the 1% (b)(4) dosing group. However, the final study report inaccurately documents that abnormal nose was observed on Day 13 in the 1% (b)(4) dosing group, and that abnormal porphyrin was observed on Day 13 in the 10% (b)(4) dosing group.
c. Female Rat #84 in the 20% (b)(4) dosing group died on Day 3 of dosing. However, the final study report inaccurately documents that Rat #84 died on Day 1 of dosing.
In your April 11, 2025, written response to the Form FDA 483, you acknowledged the observation and stated that you amended the final study reports to make the necessary corrections. You stated that to address the root cause of the violation, you developed a new SOP titled "QAU Review of Final Report" and a checklist to be used in the QAU review of final study reports.
While we acknowledge the corrective and preventive actions that your testing facility has taken, your response is inadequate because you did not include sufficient details about your corrective action plan, including how procedures will be implemented at your site to ensure compliance with FDA regulations. For example, your corrective action plan does not include QAU training on the new SOP or the new checklist, or QAU training on FDA regulations governing the conduct of nonclinical laboratory studies, including the QAU's role and responsibilities. Additionally, your corrective action plan does not include a description of any planned audits to check for compliance with new QAU procedures. Without these details, we are unable to determine whether your corrective actions are adequate to prevent similar violations in the future.
Because your testing facility's QAU failed to ensure that the reported results in the final study report accurately reflect the raw data of the nonclinical laboratory studies, FDA has concerns about the integrity of the data generated and reported from the nonclinical studies conducted at your testing facility.
3. Failure of the testing facility management to assure the availability of equipment as scheduled and that the equipment used in the generation, measurement, or assessment of data shall be of appropriate design and adequate capacity to function according to the study protocol [21 CFR 58.31(e) and 21 CFR 58.61].
Testing facility management must ensure that equipment is available as scheduled. Additionally, equipment used in the generation, measurement, or assessment of data in a nonclinical laboratory study must be of appropriate design and adequate capacity to function according to the study protocol. The testing facility management failed to adhere to these requirements.
Specifically, during the conduct of nonclinical laboratory studies (b)(4) and (b)(4), the testing facility management failed to ensure that equipment of appropriate design and adequate capacity was available to analyze the blood of rat and rabbit species for the protocol-required hematology and serum chemistry laboratory parameters. As a result, the testing facility failed to generate the following Day 15 data:
* Hematology test results for male and female rats for Protocol (b)(4)
* Serum chemistry test results for male rats for Protocol (b)(4)
* Hematology test results for male and female rabbits for Protocol (b)(4)
Additionally, the testing facility management did not cross-validate the equipment used to analyze blood samples, to demonstrate their ability to accurately analyze rat blood in Protocol (b)(4) or rabbit blood in Protocol (b)(4).
We acknowledge that the finding described above was not included on the Form FDA 483 you received, and that the observation on the Form FDA 483 was limited to the unreported hematology laboratory results for Day 15 female rats in the final study report for Protocol (b)(4). Therefore, your written responses to the Form FDA 483 do not directly address the extent of this finding as discussed in this letter.
In your April 11, 2025, written response to the Form FDA 483, regarding the unreported hematology results, you stated that you amended the final study reports to make the necessary corrections. The amended final study reports gave details of the equipment that your testing facility used for hematology laboratory parameters testing in the study animals, and they explained that the hematology results obtained using the equipment were below or above the range of the machine, and therefore no results were displayed on the equipment.
While we acknowledge the corrective actions that your testing facility has taken regarding the unreported hematology results, your response is inadequate because we are unable to determine whether your testing facility will be able to ensure the availability of equipment of appropriate design and adequate capacity to evaluate protocol-required laboratory parameters in the animal species included in future nonclinical studies conducted at your testing facility. Because the testing facility management failed to ensure that appropriate equipment was available to conduct protocol-required laboratory assessments, FDA has concerns about the integrity of the data generated and reported from the nonclinical studies conducted at your testing facility.
4. Failure of the testing facility to establish standard operating procedures in writing, setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of the studies [21 CFR 58.81(a) and 58.81(b)].
A testing facility must establish and follow written SOPs for nonclinical laboratory studies, to ensure the quality and integrity of the data generated in the studies. Your testing facility did not adhere to these requirements. For example, your testing facility failed to establish SOPs for:
a. Receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles
b. Test system observations
c. Laboratory tests
d. Handling of animals found to be moribund or dead during a study
e. Collection and identification of specimens
In your April 11, 2025, written response to the Form FDA 483, and in your subsequent correspondence dated June 13, 2025, you acknowledged the observation and stated that you created an SOP titled "SOP Creation, Review, and Approval." Additionally, you created SOPs for the five procedures that were identified as lacking, along with additional SOPs that were not previously established. You also revised existing SOPs to include versioning and dates. We acknowledge your corrective and preventive actions. However, we emphasize that as a testing facility conducting nonclinical laboratory studies under 21 CFR 58, it is your responsibility to establish SOPs before conducting nonclinical laboratory studies. You are also responsible for following your written SOPs to ensure consistency in study conduct and to ensure the quality and integrity of data generated during your studies.
As evidenced by FDA's inspection findings, the deficiencies found in the oversight and conduct of the testing facility management and QAU at your testing facility demonstrate a failure to comply with FDA's GLP regulations governing the conduct of nonclinical laboratory studies. As a result, FDA is concerned about the validity and integrity of the nonclinical data generated by your testing facility.
We emphasize that as a testing facility conducting nonclinical laboratory studies under 21 CFR 58, you are responsible for ensuring that nonclinical laboratory studies submitted to FDA are conducted and reported in accordance with FDA regulations to ensure the quality and integrity of study data. Your failure to conduct and report nonclinical studies in accordance with FDA regulations raises concerns about the validity and integrity of the data collected at your site.
This letter is not intended to be an all-inclusive list of deficiencies with the nonclinical laboratory studies of investigational drugs conducted at your testing facility. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.
This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action without further notice to you. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.
Your written response, and any questions or concerns about this letter or the inspection, should be sent via email to the FDA at CDER-OSI-Communications@fda.hhs.gov.
Sincerely,
David C. Burrow, Pharm.D., J.D., Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/healthpartners-neuroscience-center-research-and-innovation-725333-05192026
FDA Center for Biologics Evaluation & Research Issues Warning Letter to Blue Horizon International
WASHINGTON, June 3 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Blue Horizon International LLC from its Center for Biologics Evaluation and Research:
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Recipient: Dr. Brian Mehling, Chief Medical Officer and Founder, Blue Horizon International, LLC, 214 State Street Suite 101, Hackensack, NJ 07601, United States, bmehling@bluehorizoninternational.com
Issuing Office: Center for Biologics Evaluation and Research (CBER), United States
WARNING LETTER
CBER 26-728085
Dear Dr. Mehling:
The United States Food and Drug
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WASHINGTON, June 3 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Blue Horizon International LLC from its Center for Biologics Evaluation and Research:
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Recipient: Dr. Brian Mehling, Chief Medical Officer and Founder, Blue Horizon International, LLC, 214 State Street Suite 101, Hackensack, NJ 07601, United States, bmehling@bluehorizoninternational.com
Issuing Office: Center for Biologics Evaluation and Research (CBER), United States
WARNING LETTER
CBER 26-728085
Dear Dr. Mehling:
The United States Food and DrugAdministration (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. Sec. 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. Sec. 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. Sec. 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. Sec. 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. Sec. 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. Sec. 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. Sec. 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. Sec. 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. Sec. 355(i); 42 U.S.C. Sec. 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. Sec. 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. Sec. 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. Sec. 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. Sec. 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
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Footnote:
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).
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blue-horizon-international-llc-728085-05262026
EM Highlights Potential Used Nuclear Fuel Collaborations at U.S.-Japan Meeting
WASHINGTON, June 3 -- The Department of Energy Office of Environmental Management issued the following news release:
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EM Highlights Potential Used Nuclear Fuel Collaborations at U.S.-Japan Meeting
SANTA FE, N.M. -- The U.S. Department of Energy's (DOE) Office of Environmental Management (EM) participated in the 13th U.S.-Japan Technical Meeting of the Civil Nuclear Energy Research and Development Working Group, where officials discussed continued cooperation on used nuclear fuel management and advanced fuel cycle technologies.
Hosted by Los Alamos National Laboratory, the meeting brought
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WASHINGTON, June 3 -- The Department of Energy Office of Environmental Management issued the following news release:
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EM Highlights Potential Used Nuclear Fuel Collaborations at U.S.-Japan Meeting
SANTA FE, N.M. -- The U.S. Department of Energy's (DOE) Office of Environmental Management (EM) participated in the 13th U.S.-Japan Technical Meeting of the Civil Nuclear Energy Research and Development Working Group, where officials discussed continued cooperation on used nuclear fuel management and advanced fuel cycle technologies.
Hosted by Los Alamos National Laboratory, the meeting broughttogether representatives from DOE and several Japanese government organizations, including the Ministry of Education, Culture, Sports, Science and Technology; Ministry of Economy, Trade and Industry; and the Japan Atomic Energy Agency.
The U.S.-Japan partnership reflects a strong foundation for future innovation and continued discussions on advanced conditioning of used nuclear fuel. The working group was created to enhance coordination of joint civil nuclear research and development efforts between the two countries.
During the recent meeting, EM presented its evolving vision for a future recycling and conditioning capability focused on unlocking the full value within used nuclear fuel. A presentation highlighted opportunities for continued collaboration on the management and advanced conditioning of damaged used nuclear fuel, and highlighted how the U.S.' extensive history and expertise in managing complex and challenging fuel forms provides a strong technical foundation for future recycling and conditioning capabilities.
EM representatives emphasized that the longstanding history of collaboration between the U.S. and Japan in nuclear energy is deep and robust, underpinned by a shared vision for the safe and secure management of used nuclear fuel and continued international cooperation in advancing future capabilities.
In addition to the technical sessions, the Japanese delegation toured several DOE facilities in Los Alamos, including the Low-Enriched Fuel Fabrication Facility, Los Alamos Neutron Science Center, Fuels Research Laboratory and other research facilities supporting nuclear energy missions.
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Original text here: https://www.energy.gov/em/articles/em-highlights-potential-used-nuclear-fuel-collaborations-us-japan-meeting
DOE Office of Environmental Management: Dual Historic Naval Reactors Prototype Demolitions Highlight Idaho Expertise
WASHINGTON, June 3 -- The Department of Energy Office of Environmental Management issued the following news release:
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Dual Historic Naval Reactors Prototype Demolitions Highlight Idaho Expertise
Demolition crew members sit inside the below-grade basin of the Submarine 5th Generation General Electric prototype, where they performed deactivation activities to prepare the prototype for demolition.
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IDAHO FALLS, Idaho -- Idaho Cleanup Project (ICP) crews are hard at work advancing decommissioning and demolition (D&D) on two Navy Nuclear Propulsion Program prototypes: the Submarine 5th Generation
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WASHINGTON, June 3 -- The Department of Energy Office of Environmental Management issued the following news release:
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Dual Historic Naval Reactors Prototype Demolitions Highlight Idaho Expertise
Demolition crew members sit inside the below-grade basin of the Submarine 5th Generation General Electric prototype, where they performed deactivation activities to prepare the prototype for demolition.
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IDAHO FALLS, Idaho -- Idaho Cleanup Project (ICP) crews are hard at work advancing decommissioning and demolition (D&D) on two Navy Nuclear Propulsion Program prototypes: the Submarine 5th GenerationGeneral Electric (S5G) and the Aircraft Carrier 1st Generation Westinghouse (A1W) prototypes.
Since 2024, the U.S. Department of Energy's Office of Environmental Management has focused on characterization, isolation and deactivation of the S5G prototype at the Naval Reactors Facility (NRF). This includes removal of hazardous materials like asbestos, lead and polychlorinated biphenyls.
Recently, crews removed large components from the S5G prototype basin and hull, and added 5,000 cubic yards of a cement mixture to the basin. The prototype sits below grade in the large basin.
An action memorandum calls for removal of the prototype and for the basin to be filled with concrete. These actions will allow the Office of Naval Reactors to repurpose the facility for future use. The work also reduces the environmental footprint at the Idaho National Laboratory Site.
Meanwhile, ICP and contractor Idaho Environmental Coalition (IEC) are progressing on above-ground demolition of the A1W prototype. To date, crews have completed the teardown of the A1W offices, laboratory and other buildings and support areas. Crews are performing deactivation work on the building's interior areas such as the primary component maintenance area, A1W's reactor compartments and both reactor vessels.
In coming months, IEC expects to topple the A1W crane house, which is a mobile facility previously used for refueling and maintenance of the prototype. Crews also will demolish the crane that sits atop the building.
"Our team is very talented and has demonstrated incredible efficiency in performing D&D at both the A1W and S5G prototypes," IEC D&D and Capital Projects Senior Director Mike Swartz said. "Their expertise and their ability to find solutions to complex problems allow us to complete work ahead of schedule."
NRF served as a training ground for prospective nuclear operators. Nearly 40,000 sailors and other Navy personnel were trained at the A1W, S5G and Submarine 1st Generation Westinghouse (S1W) prototypes.
Crews completed D&D of the S1W in 2025. IEC expects to complete demolition of the A1W and S5G over the next six years.
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Original text here: https://www.energy.gov/em/articles/dual-historic-naval-reactors-prototype-demolitions-highlight-idaho-expertise
BLS: Unemployment Rates Higher in 19 States Over the Year Ended April 2026
WASHINGTON, June 3 (TNSLrpt) -- The U.S. Department of Labor Bureau of Labor Statistics issued the following document on June 2, 2026, from Economics Daily:
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Unemployment rates higher in 19 states over the year ended April 2026
From April 2025 to April 2026, 19 states had unemployment rate increases from a year earlier, 6 states had decreases, and 25 states and the District of Columbia had little change. The national unemployment rate, 4.3 percent, was unchanged over the month and was little changed from April 2025.
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Chart: Change in unemployment rates for states, April 2025 to April
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WASHINGTON, June 3 (TNSLrpt) -- The U.S. Department of Labor Bureau of Labor Statistics issued the following document on June 2, 2026, from Economics Daily:
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Unemployment rates higher in 19 states over the year ended April 2026
From April 2025 to April 2026, 19 states had unemployment rate increases from a year earlier, 6 states had decreases, and 25 states and the District of Columbia had little change. The national unemployment rate, 4.3 percent, was unchanged over the month and was little changed from April 2025.
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Chart: Change in unemployment rates for states, April 2025 to April2026, seasonally adjusted
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The largest over-the-year unemployment rate increases were in Connecticut (+1.2 percentage points) and Florida (+1.1 points). Six states had over-the-year rate decreases, the largest of which was in Ohio (-0.9 percentage point). Twenty-five states and the District of Columbia had jobless rates that were not notably different from those of a year earlier, though some had changes that were at least as large numerically as the significant changes.
These data are from the Local Area Unemployment Statistics (https://www.bls.gov/lau/) program and are seasonally adjusted. Data for the most recent month are preliminary. To learn more, see "State Employment and Unemployment -- April 2026 (https://www.bls.gov/news.release/archives/laus_05222026.htm)." We also have charts and maps of state employment and unemployment data (https://www.bls.gov/charts/state-employment-and-unemployment/).
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SUGGESTED CITATION
Bureau of Labor Statistics, U.S. Department of Labor, The Economics Daily, Unemployment rates higher in 19 states over the year ended April 2026 at https://www.bls.gov/opub/ted/2026/unemployment-rates-higher-in-19-states-over-the-year-ended-april-2026.htm (visited June 03, 2026).
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View original text plus charts and tables here: https://www.bls.gov/opub/ted/2026/unemployment-rates-higher-in-19-states-over-the-year-ended-april-2026.htm
