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Federal Executive Branch
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Presidential Message on Victory Day for World War I
WASHINGTON, Nov. 12 -- President Trump issued the following statement on Nov. 11, 2025:* * *
Presidential Message on Victory Day for World War I
On this day 107 years ago, the immortal causes of liberty, sovereignty, and human dignity were secured in glory at the conclusion of World War I--one of the most extraordinary displays of U.S. military might in the history of our country. Today, we remember the sacrifice of every hero of freedom who shed his blood for the survival of our civilization, and we renew our pledge to always defend the needs, values, and interests of the American people first.
Following ... Show Full Article WASHINGTON, Nov. 12 -- President Trump issued the following statement on Nov. 11, 2025: * * * Presidential Message on Victory Day for World War I On this day 107 years ago, the immortal causes of liberty, sovereignty, and human dignity were secured in glory at the conclusion of World War I--one of the most extraordinary displays of U.S. military might in the history of our country. Today, we remember the sacrifice of every hero of freedom who shed his blood for the survival of our civilization, and we renew our pledge to always defend the needs, values, and interests of the American people first. Followingthe first shots of World War I in the summer of 1914, the European continent descended into fiery chaos, dragging the western world into grueling and treacherous warfare. After a series of deadly German submarine attacks against the United States, in 1917, America righteously entered the war to protect its citizens, defend its interests, and secure the cause of peace--triggering a decisive turning point in the conflict and signaling the unrivaled strength of the U.S. Armed Forces to the entire world. Bolstered by the unmatched prowess of American industry, millions of young men courageously departed their homes and families to halt the Central Powers' vicious reign of conquest and oppression.
On November 11, 1918, an armistice between the Allies and Germany forced tyranny to its knees, marking the triumphant end of one of the deadliest conflicts in human history. Over the course of the war, American Soldiers, Sailors, and Marines gave everything they had for the future of freedom. Tragically, more than 320,000 suffered casualties, but their sacrifices were not in vain. Without the heroic bravery of our American soldiers, the war would not have been won, and our world today would look drastically different.
From the Battle of Verdun to the Meuse-Argonne Offensive, from the Somme to Belleau Wood to Flanders Fields, the Great War marked a critical turning point for U.S. military strength, initiating the dawn of American air power, advancing battlefield medicine, and revolutionizing the nature of warfare and weaponry both on land and at sea. Today, my Administration is proudly upholding this hard-won legacy of Peace Through Strength. Since I took office, I have negotiated a series of historic peace agreements--including a deal to end the devastating war in Gaza--helping nations around the world move beyond longstanding conflicts of the past toward a shared future of peace, prosperity, and success.
More than one century following the end of World War I, we honor the valiant American Service members whose victory sent a resounding message to the entire world: No tyranny can topple the strength of the American military, no nation can compete with the power of American industry, and no adversary can withstand the unwavering vigor of the American spirit. As we approach 250 glorious years of American independence and continue the work of saving our country, we look to their grit, valor, and patriotism--and in their honor, we vow to never stop fighting for the sacred causes that sustain our Republic, our way of life, and our birthright of freedom.
* * *
Original text here: https://www.whitehouse.gov/briefings-statements/2025/11/presidential-message-on-victory-day-for-world-war-i/
FDA Issues Warning Letter to Taizhou Kangping Medical Science & Technology
WASHINGTON, Nov. 12 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Taizhou Kangping Medical Science and Technology Co. Ltd. from the Center for Drug Evaluation and Research:* * *
Recipient: Mr. Yuegen Wang, General Manager, Taizhou Kangping Medical Science and Technology Co., Ltd., Building 3, No 27 Tai'an Road, Hailing Industrial Park, Hailing Qu Taizhou Shi Jiangsu Sheng, 225300, China
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-01
Dear Mr. Wang:
The United States ... Show Full Article WASHINGTON, Nov. 12 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Taizhou Kangping Medical Science and Technology Co. Ltd. from the Center for Drug Evaluation and Research: * * * Recipient: Mr. Yuegen Wang, General Manager, Taizhou Kangping Medical Science and Technology Co., Ltd., Building 3, No 27 Tai'an Road, Hailing Industrial Park, Hailing Qu Taizhou Shi Jiangsu Sheng, 225300, China Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-01 Dear Mr. Wang: The United StatesFood and Drug Administration (FDA) inspected your drug manufacturing facility, Taizhou Kangping Medical Science and Technology Co., Ltd., FEI 3013321339, at Building 3, No 27 Tai'an Road, Hailing Industrial Park, Taizhou City, Jiangsu, China 225300, from March 10 to March 14, 2025.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your April 4, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate because you failed to take corrective actions to bring your operations into compliance with CGMP.
During our inspection, our investigator observed specific violations including, but not limited to, the following:
1. Failure to establish procedures designed to prevent micro-contamination in products purporting to be sterile (21 CFR 211.113(b)).
Your (b)(4) are labeled as "Sterile unless (b)(4)." However, your (b)(4) are not sterilized, which you confirmed in your response on May 10, 2025: "... (b)(4)... is Nonsterile product ...." Sterile (b)(4) may be used by healthcare practitioners as a (b)(4). Sterile (b)(4), if labeled as sterile, must have controls in place to ensure sterility. The inspection documented that you do not perform sterility testing of the drug product, and that the Specification and Analysis Method on (b)(4) tests the Finished Product Quality Standards to Microbial Limits USP <61> method, with acceptance criteria of (b)(4) cfu/gram of total aerobic bacteria and (b)(4) cfu/gram of mold, yeast.
Drugs purported to be sterile must comply with applicable 21 CFR 211 CGMP requirements (including sterility assurance).
On July 16, 2025, FDA held a teleconference with you and your U.S. agent. We acknowledge your decision to initiate a recall of all your (b)(4) within expiry currently in distribution to the U.S. market.
2. Failure to establish appropriate product specifications and scientifically sound testing procedures (21 CFR 211.160(b)).
A. Your high-performance liquid chromatography (HPLC) analyses for (b)(4) Assay Content lacked an appropriate determination of system suitability, as outlined in USP <621>, before sample injections. Your quality approved test method, Quality Specification and Operating Procedures for Testing (b)(4), is not scientifically sound in that your Quality Control (QC) analysts are instructed to generate a chromatographic standard curve "(b)(4)." This method of calculation from the standard curve has the practical effect of masking system drift and performance issues that affect the quantitative accuracy of batch-specific test results, because the frequency is conducted "(b)(4)."
In your response, you commit to revising the frequency of establishing a standard curve (linear solution test) from "(b)(4)" to "at the same time with each sample test." However, your response is inadequate because you have not committed to ensuring that standard curves (linear solution tests) performed "at the same time with each sample test" are extended to include gas chromatography (GC), which is used to determine (b)(4) Assay Content.
B. Your firm lacked sufficient controls over GC and HPLC data acquisition systems that are used to test assay label claims for drug products before release. Specifically, Excel worksheets used to perform chromatogram calculations were not retained, and access accounts to the GC and HPLC workstations were shared by job title and were not attributable to the individual analyst. The inspection documented the deletion of several recent Excel spreadsheets that were used to perform suitability and assay calculations. Your QC Supervisor/Manager confirmed that the Excel spreadsheets that were relied upon to generate the finished product quality standards, had not been validated, controlled, retained, or quality verified for data integrity before they were used for product release. Further, this individual was the only analyst who performed testing, yet maintained administrative privileges within the system. When further questioned on this practice, the QC Supervisor/Manager identified that the administrative role was the only primary access point to the Gas Chromatography data acquisition software for OTC (b)(4) product release and stability testing.
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA's guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP-compliant data integrity practices, at https://www.fda.gov/media/119267/download.
We acknowledge that you are using an independent third-party consultant to audit your operation and assist in meeting FDA requirements. In response to this letter, provide:
* A comprehensive investigation into the extent of the inaccuracies in data records and reporting, including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.
* A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity, and analyses of the risks posed by ongoing operations.
* A management strategy for your firm that includes the details of your global corrective action and preventive action plan (CAPA). The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm, including microbiological and analytical data, manufacturing records, and all data submitted to FDA.
Product Specifications
Upon further review of the records and information you provided, process controls for the (b)(4) appear to be inconsistent with the applicable conditions for an OTC (b)(4) formulated with (b)(4) as an active ingredient. For OTC (b)(4) drug products marketed under 505G of the FD&C Act, such as the (b)(4), the allowable concentration for the active ingredient (b)(4) is (b)(4)%-(b)(4)%. However, throughout the product lifecycle for the (b)(4), your operations seem to far exceed the allowable concentration of (b)(4) as indicated in your process validation. For example, your Specification and Analysis Method allows for the release of products with concentrations of (b)(4) up to (b)(4)%. In addition, your 2024 Annual Quality Review and 2023 Process Validation summary of Critical Quality Attributes reports also include concentrations of (b)(4) that are well above what is allowed with values detected at (b)(4)-(b)(4)%. Although your (b)(4) are labeled with (b)(4) at a concentration of (b)(4)%, as noted, your operations and process controls appear to deviate from the proposed conditions and requirements for an OTC (b)(4) product. For consistent regulatory compliance it is essential that OTC (b)(4) products like your (b)(4) conform to the applicable FDA requirements and OTC monograph conditions for the lawful distribution of this OTC drug product without an approved application.
Drug Production Ceased
Your written responses to date commit to cease the commercial distribution of OTC products in the U.S. market starting March 14, 2025. If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure that your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.
Drug Recall
On July 16, 2025, FDA held a teleconference with you and your U.S. agent, during which you committed to the recall of all your (b)(4) within expiry currently in distribution to the U.S. market.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on September 18, 2025.
Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.
Failure to address any violations may also result in the FDA's continuing to refuse admission of articles manufactured at Taizhou Kangping Medical Science and Technology Co., Ltd., located at Building 3, No 27 Tai'an Road, Hailing Industrial Park, Taizhou City, Jiangsu, China 225300, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated or misbranded may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B), and are misbranded under section 502 of the FD&C Act, respectively.
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3013321339 and ATTN: Kara S. Quinn.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
/S/ Tina Smith, Captain, U.S. Public Health Service, Director, Office of Unapproved Drugs & Labeling Compliance, Office of Compliance, Center for Drug Evaluation and Research
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/taizhou-kangping-medical-science-and-technology-co-ltd-711081-10092025
FDA Issues Warning Letter to Miers Laboratories
WASHINGTON, Nov. 12 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Miers Laboratories Ltd from the Center for Drug Evaluation and Research:* * *
Recipient: Mr. Andrew Criglington, Chief Executive Officer, Miers Laboratories, Ltd, 32 Waiu Street, Wainuiomata Lower Hutt, Wellington 5014, New Zealand, ac@mierslabs.co.nz
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-13
Dear Mr. Criglington:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing ... Show Full Article WASHINGTON, Nov. 12 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Miers Laboratories Ltd from the Center for Drug Evaluation and Research: * * * Recipient: Mr. Andrew Criglington, Chief Executive Officer, Miers Laboratories, Ltd, 32 Waiu Street, Wainuiomata Lower Hutt, Wellington 5014, New Zealand, ac@mierslabs.co.nz Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-13 Dear Mr. Criglington: The United States Food and Drug Administration (FDA) inspected your drug manufacturingfacility, Miers Laboratories, Ltd, FEI 3004087508, at 32 Waiu Street, Wainuiomata, Lower Hutt, Wellington, from May 19 to 21, 2025.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We have not yet received a response from your firm stating the actions you are taking to address the deficiencies identified during the inspection and cited on our Form FDA 483.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).
You manufacture homeopathic drug products, several of which are intended for use in (b)(4). You failed to perform adequate identity testing on incoming components used in the manufacture of your homeopathic drug products. You solely relied on your suppliers' certificates of analysis (COAs) without establishing the reliability of your component suppliers' test analyses at appropriate intervals.
(b)(4)
You failed to perform identity testing on a batch of (b)(4) containing up to (b)(4)% (b)(4). You used this material as a solvent for (b)(4) tablets with homeopathic active pharmaceutical ingredients to manufacture numerous drug product batches for the U.S. market. The United States Pharmacopeia identity test for (b)(4) includes a (b)(4) limit of (b)(4) ppm. Your use of (b)(4) with (b)(4) is unacceptable.
You manufacture multiple drugs that contain (b)(4). The use of (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See (b)(4)
Homeopathic active pharmaceutical ingredients
You failed to perform adequate testing on homeopathic active pharmaceutical ingredients. For example, you used a batch of (b)(4) that was more than 14 years past its expiration to manufacture numerous batches of finished drug products without determining whether the component continued to meet quality attributes.
Without appropriate testing of incoming components, you cannot verify that the identity, purity, strength, quality, and safety of components meet specifications, and cannot confirm their suitability for intended use.
This is a repeat violation from your 2019 inspection.
In response to this letter, provide:
* A comprehensive review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
* The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.
* A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your suppliers' COAs instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your suppliers' results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
* A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
* A summary of results obtained from testing reserve samples of finished products on the U.S. market for (b)(4) content. If such testing identifies drug products with unacceptable (b)(4) levels, take rapid corrective actions such as notifying customers and product recalls.
2. Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
During the inspection, our investigator observed that your quality unit (QU) did not provide adequate oversight for the manufacture of your homeopathic drug products. Your QU failed to ensure the following:
* Appropriate batch production and control records that include documentation of the accomplishment of each significant step in manufacturing of your drug products (21 CFR 211.188(b)). This is a repeat violation from your 2014 and 2019 inspections.
* Establishment of written procedures for managing quality unit functions including deviations, investigations, and corrective actions and preventive actions (21 CFR 211.22(d)). This is a repeat violation from you 2019 inspection.
* Establishment of an adequate quality control unit to approve or reject components and drug products (21 CFR 211.22(a)).
Your firm's quality systems are inadequate. See FDA's guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.
In response to this letter, provide the following:
* A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
o A determination of whether procedures used by your firm are robust and appropriate
o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
o A complete and final review of each batch and its related information before the QU disposition decision
o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
Repeat Violations at Facility
In a previous inspection, performed June 17 to 21, 2019, FDA cited similar CGMP observations. You acknowledged these observations and informed our investigators that you would correct all observations during the closeout meeting. Despite these commitments, when FDA reinspected your facility, the violations had not been corrected. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.
CGMP Consultant Recommended
Because you failed to correct repeat violations, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.
Your use of a consultant does not relieve your firm's obligation to comply with CGMP. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on October 27, 2025.
Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Miers Laboratories, Ltd., at 32 Waiu Street, Wainuiomata, Lower Hutt, Wellington, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3004087508 and ATTN: Emily Wu.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/miers-laboratories-ltd-715378-11032025
FDA Issues Warning Letter to IBSPOT.com
WASHINGTON, Nov. 12 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to IBSPOT.com Inc. from the Center for Drug Evaluation and Research:* * *
Recipient: Danielle White, President, IBSPOT.com Inc., 1414 Willow Avenue, Elkins Park, PA 19027, United States, support@ibspot.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
October 27, 2025
RE: 715657
Dear Danielle White:
This letter concerns your firm's distribution of "Taoscare Motion Sickness Patch" and "Navabelle Motion Sickness ... Show Full Article WASHINGTON, Nov. 12 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to IBSPOT.com Inc. from the Center for Drug Evaluation and Research: * * * Recipient: Danielle White, President, IBSPOT.com Inc., 1414 Willow Avenue, Elkins Park, PA 19027, United States, support@ibspot.com Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER October 27, 2025 RE: 715657 Dear Danielle White: This letter concerns your firm's distribution of "Taoscare Motion Sickness Patch" and "Navabelle Motion SicknessPatches" products that violate the Federal Food, Drug, and Cosmetic Act (the "FD&C Act"). As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Furthermore, these products are misbranded drugs under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). As explained further below, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and 355(a).
FDA purchased "Taoscare Motion Sickness Patch" and "Navabelle Motion Sickness Patches" products through your website, www.ibspot.com. These products were introduced or delivered for introduction into interstate commerce by IBSPOT.com./1 FDA confirmed through laboratory analyses that "Taoscare Motion Sickness Patch" and "Navabelle Motion Sickness Patches" purchased on www.ibspot.com contained the ingredients diphenhydramine, diphenhydramine N-oxide, and diclofenac, which are not listed on the product labels.
Unapproved New Drugs
"Taoscare Motion Sickness Patch" and "Navabelle Motion Sickness Patches" are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Examples from your product labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:
Taoscare Motion Sickness Patch
* Images of a plane, boat/ship, train, and bus
* "Motion Sickness Patch"
* "Fast Acting"
* "Anti-Nausea Fast"
* "Non-Drowsy"
* "72h LONG EFFECT"
* "The patch can be used behind the ears and on the navel at the same time if motion sickness is serious."
Navabelle Motion Sickness Patches
* Images of a plane, boat/ship, train, and car
* "MOTION SICKNESS PATCHES"
* "Anti-Nause Fast" [sic]
* "Non-Drwsy" [sic]
* "INDICATIONS:
Relieve the vomiting, nausea, dizziness, anorexia, and other sickness symptoms caused by taking cars, ships, planes, trains, and other means of transport."
* "Anti-Nausea Relief Patches"
"Taoscare Motion Sickness Patch" and "Navabelle Motion Sickness Patches" are "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs and the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Misbranded Drugs
In addition, "Taoscare Motion Sickness Patch" and "Navabelle Motion Sickness Patches" are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article's labeling or advertising "is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations." The respective labeling for "Taoscare Motion Sickness Patch" and "Navabelle Motion Sickness Patches" does not declare that the products contain the ingredients diphenhydramine, diphenhydramine N-oxide, or diclofenac. With the omission of these ingredients on the label, consumers may not be able to determine whether the products are appropriate for them to use due to, for example, potential drug allergies or interactions. The failure to disclose these ingredients in the products' labeling renders "Taoscare Motion Sickness Patch" and "Navabelle Motion Sickness Patches" misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).
The introduction or delivery for introduction into interstate commerce of these misbranded drugs is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive statement of violations 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 that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier "715657" in the subject line of the email.
Sincerely,
/S/ Tina Smith, M.S., Captain, U.S. Public Health Service, Director, Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration
* * *
Footnote:
1/ IBSPOT.com distributed each of the products to individual U.S. consumers. Each of the products discussed in the warning letter was "fulfilled" by IBSPOT; your product listings for each of these products stated, "Fulfilled by IBSPOT."
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ibspotcom-inc-715657-10272025
FDA Issues Warning Letter to Compass Group USA
WASHINGTON, Nov. 12 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Compass Group USA from the Human Foods Program:* * *
Recipient: Tim Lonc, President, Compass Group USA, 2400 Yorkmont Road, Charlotte, NC 28217, United States, Tim.lonc@compass-usa.com
Issuing Office: Human Foods Program, United States
WARNING LETTER
CMS #709592
Dear Mr. Lonc:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, Fresh & Ready Foods LLC, located at 1145 Arroyo Ave, Units A-C, San Fernando, ... Show Full Article WASHINGTON, Nov. 12 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Compass Group USA from the Human Foods Program: * * * Recipient: Tim Lonc, President, Compass Group USA, 2400 Yorkmont Road, Charlotte, NC 28217, United States, Tim.lonc@compass-usa.com Issuing Office: Human Foods Program, United States WARNING LETTER CMS #709592 Dear Mr. Lonc: The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, Fresh & Ready Foods LLC, located at 1145 Arroyo Ave, Units A-C, San Fernando,CA 91340, from March 31 to April 15, 2025. Your firm manufactures ready-to-eat (RTE) sandwiches, salads, wraps, snack items, and entrees. The inspection was initiated as part of a multistate foodborne outbreak investigation of Listeria monocytogenes (L. monocytogenes) linked to your RTE foods. According to the Centers for Disease Control and Prevention (CDC), as of July 24, 2025, ten (10) people from two (2) states (California and Nevada) have been infected with the outbreak strain of L. monocytogenes. On May 10, 2025, your firm recalled RTE foods, including sandwiches and snack items, with "Use By" dates from 4/22/2025 to 05/19/2025 because they had the potential to be contaminated with L. monocytogenes.
During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility.
Based on FDA's inspectional findings and analytical results for samples collected from your production environment, we have determined that your RTE sandwiches, salads, wraps, and snacks are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. Sec. 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. Sec. 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at www.fda.gov.
At the conclusion of the inspection, FDA issued an FDA Form 483 (FDA-483), Inspectional Observations, listing deviations found at your facility. We received your firm's emailed responses to the FDA-483 and sample results on May 1, 2025, May 5, 2025, May 7, 2025, and May 14, 2025, describing corrective actions taken and planned by your firm. After reviewing the inspectional findings and your responses, we are issuing this letter to advise you of FDA's continuing concerns and provide detailed information describing the findings at your facility. We discuss your responses below.
Multiyear Multistate Outbreak of Listeria monocytogenes Linked to RTE Foods
The FDA, along with CDC and state and local partners, investigated a multiyear, multistate outbreak of L. monocytogenes linked to RTE sandwiches and snack items manufactured by Fresh & Ready Foods, LLC. According to the CDC, as of July 24, 2025, ten (10) people from two (2) states (California and Nevada) have been infected with the outbreak strain of L. monocytogenes. Specimen collection dates range from December 3, 2023, to September 9, 2024. Among the ten (10) people with available information, all were hospitalized and there was one death attributed to listeriosis. Whole Genome Sequencing (WGS) performed on the clinical isolates from the cases in California and Nevada revealed that the clinical isolates match two (2) environmental swabs taken from your production area during the recent FDA inspection of your facility conducted from March 31 to April 15, 2025.
FDA and CDC have determined, based upon the epidemiologic, traceback evidence, and WGS analysis, that RTE foods produced by Fresh & Ready Foods LLC are the likely source of this outbreak. On May 10, 2025, your firm recalled RTE foods, including sandwiches and snack items, with "Use By" dates from 4/22/2025 to 05/19/2025 because they had the potential to be contaminated with L. monocytogenes.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not appropriately evaluate a known or reasonably foreseeable hazard to determine it required a preventive control in your RTE sandwiches, salads, wraps, snacks, and entrees products, as required by 21 CFR 117.130(a)(1). Specifically:
a. Your facility processes refrigerated RTE sandwiches, salads, wraps, snacks, and entrees products that are exposed to the environment prior to packaging, where they may be contaminated with environmental pathogens such as L. monocytogenes. You did not appropriately evaluate contamination with environmental pathogens, such as L. monocytogenes, to determine whether it is a hazard requiring a preventive control in your RTE products. Your facility's written hazard analysis considered biological pathogens such as L. monocytogenes at the RTE product preparation, assembly, and (b)(4) steps but you determined this hazard was not reasonably likely to occur and did not require a preventive control due to your Sanitation Standard Operational Procedures (SSOPs) and Good Manufacturing Procedures (GMPs). However, your RTE products are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation controls). Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR 117.135(c)(3)). Furthermore, as evidenced by the following analytical results, your SSOPs and GMPs are not adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of environmental pathogens such as L. monocytogenes, as required by 21 CFR 117.135(c)(3).
Listeria monocytogenes in your facility:
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without adequate controls, it can proliferate in food processing facilities and subsequently contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive, and to apply controls or take corrective actions, as necessary, to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening, illness called listeriosis, a foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
FDA's most recent inspection included the collection of environmental swabs on March 31, 2025, during the production of RTE sandwiches and wraps; (b)(4) of one (b)(4) swabs were confirmed positive for L. monocytogenes. The positive findings included the food-contact surfaces of a:
- Conveyor belt and roller where in-process RTE sandwiches were placed.
- Slicer 3-gauge plate/knife cover which is used to slice component ingredients for RTE sandwich and wrap products.
This was not the first time L. monocytogenes was found in environmental samples collected at your facility. In 2017, FDA detected L. monocytogenes in (b)(4) environmental swabs, which included a swab collected from a direct food-contact surface taken from a mixing bowl. You promised immediate corrective actions at that time.
Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples. Based on the results of the WGS analysis, the environmental samples collected at your facility during our 2025 and 2017 inspections represent (b)(4) strains of L. monocytogenes, including:
i. (b)(4) of these strains included isolates obtained from (b)(4) environmental swabs collected in 2025 which clustered with ten (10) clinical isolates belonging to the outbreak strain, and (b)(4) other food and environmental [historical/older] isolates, which indicates that this strain of L. monocytogenes is capable of causing illness.
ii. The second (b)(4) included isolates obtained from (b)(4) environmental swabs collected in 2025 that clustered with (b)(4) clinical isolate, not associated with the above referenced outbreak and (b)(4) other food and environmental isolates. This indicates that this strain of L. monocytogenes is also capable of causing illness.
iii. The third (b)(4) included isolates obtained from (b)(4) environmental swabs collected in 2017 that clustered with (b)(4) other environmental isolates.
We advised you of these WGS results, our inspectional findings, and the outbreak investigation during calls held on April 24, 2025, May 6, 2025, and May 9, 2025. On May 10, 2025, your firm voluntarily recalled all RTE FDA-regulated food products with "Use By" dates from 4/22/2025 to 05/19/2025 due to potential contamination with L. monocytogenes.
The reoccurring presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts have been inadequate to effectively control or prevent L. monocytogenes in your facility so as to prevent contamination of food. Appropriate control of L. monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the corresponding hygienic practices necessary to control this pathogen. Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen's movement and cross-contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive, and to apply controls or take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.
We acknowledge the corrective actions you have taken in response to these findings. In response to our April 11, 2025, notification about the L. monocytogenes detection in (b)(4) environmental swabs, your firm disposed of finished product manufactured on Line (b)(4) and Slicer (b)(4), and removed and isolated the equipment from the production environment. Additionally, on April 11, 2025, you conducted intensified cleaning of your equipment and production room and conducted verification swabbing which did not detect L. monocytogenes. Further, in response to the issued FDA-483, you indicate that you updated your food safety plan to identify the hazard of recontamination with environmental pathogens at the (b)(4) step, you ceased production on April 26, 2025, conducted a full facility cleaning and sanitation on April 26 through April 28, 2025, conducted environmental swabbing, and retained a third-party consultant on May 5, 2025 to review your facility's sanitation processes. Additionally, you assessed the cleanability of equipment and removed conveyor belts which were deemed difficult to clean between April 11 and May 3, 2025, and you expanded the use of cleaning and sanitation chemicals following training from your sanitation chemical provider.
However, you have not provided any additional information regarding your investigation on identifying the sources of L. monocytogenes to show that you have located and eradicated the harborage site(s), your updated food safety plan, your revised sanitation preventive control program, details regarding your revised environmental monitoring program to identify the target test microorganism, and the analytical methods you will be using. You also did not provide any of your associated cleaning and sanitation records to reflect your corrective actions, and you did not provide any training records that demonstrate your employees have been trained in proper sanitation.
Given the history of Listeria findings in your processing environment and most recent inspectional findings, we continue to be concerned about your ability to maintain a sanitary environment, implement an effective sanitation preventive control, and take adequate corrective actions. We would encourage you to perform a comprehensive root-cause analysis to identify potential sources and routes of contamination and implement adequate corrective actions based on your findings. Furthermore, we encourage you continue to identify potential harborage sites in your processing environment and implement the necessary methods and controls to ensure L. monocytogenes does not contaminate your environment or your RTE food products. You should implement and monitor your sanitation preventive control and verify it is working through a robust environmental monitoring program with associated aggressive corrective actions when Listeria is found in your facility environment. We remind you that environmental sampling is most effective at identifying pathogens when extensive sampling occurs several hours into production, because production activities may dislodge pathogens from harborage sites. You should continue to implement the necessary methods and controls to ensure foodborne pathogens do not contaminate your environment or your RTE food products. Your record keeping will be critical to demonstrate your implementation of these corrective actions consistently over time. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.
b. You did not appropriately evaluate physical hazards such as metal, to determine whether it is a hazard requiring a preventive control in your RTE products. Your hazard analysis for sandwiches, vegetarian wraps, vegetarian salads, vegetarian snacks, and nonmeat entrees considered the physical hazard of metal at the RTE products preparation and (b)(4) steps and determined it was not a hazard reasonably likely to occur because you have a pre-requisite GMP program. You perform visual inspections of metal surfaces and utensils and conduct periodic metal detector checks for lines with metal detectors during operations.
You did not have adequate controls in place, as evidenced by missing metal lacing segments observed on Lines (b)(4) conveyor belts on March 31, 2025. Further, product manufactured on Line (b)(4) did not pass through a metal detector. Missing metal lacing segments is a repeat observation from our previous inspection of your facility.
We acknowledge your May 1, 2025, response states you purchased additional metal detectors in September 2024 (prior to the recent inspection) and plan to place metal detectors at the end of every conveyor belt, beginning with conveyor belts with metal lacings. However, your response does not indicate whether you will identify the physical hazard of metal as requiring a preventive control and establish and implement a preventive control program to control this hazard. We will assess the adequacy of your corrective actions during our next inspection.
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or 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 that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address these violations may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
In addition to the violations described above, we offer the following comments:
* You did not appropriately evaluate the hazard of biological pathogens associated with your ingredients as a known or reasonably foreseeable hazard requiring a preventive control, although you have a vendor approval program for ingredients. Your facility produces ready-to-eat products containing ingredients with reasonably foreseeable biological hazards (specifically, chilled RTE produce) that do not undergo a validated (b)(4) step or other adequate lethality treatment within your facility to eliminate these identified hazards. Therefore, for those ingredients, you are required to establish and implement a supply chain program to comply with 21 CFR 117.405(a)(1). This requirement includes verifying that your suppliers maintain appropriate controls for these biological hazards and maintaining adequate documentation to demonstrate such supplier verification activities.
* Non-pathogenic Listeria species has been found in your environment for a number of years. In 2017, Listeria innocua (L. innocua), a non-pathogenic Listeria species, was confirmed in (b)(4) swabs. Further, in 2018 L. innocua was confirmed in (b)(4) environmental swabs and Listeria welshimeri (L. welshimeri), a non-pathogenic Listeria species, was confirmed in (b)(4) environmental swabs. And in 2011, L. innocua was confirmed in (b)(4) environmental swabs. The presence of Listeria species such as L. innocua and L. welshimeri suggests that conditions also are suitable for survival and/or growth of L. monocytogenes, which, as noted above, has been found in your facility.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Shannon J. Hall, Compliance Officer, Human Foods Program, Office of Compliance and Enforcement, Office of Compliance Intervention and Consultation - Division of Recalls and Emerging Issues, 5001 Campus Drive, College Park, MD 20740 or via email (preferred) at shannon.hall@fda.hhs.gov. If you have any questions, you may contact Compliance Officer Hall at shannon.hall@fda.hhs.gov. Please reference CMS #709592 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/ Priya Rathnam, Acting Office Director, Office of Compliance Intervention and Consultation, Office of Compliance and Enforcement, Human Foods Program
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/compass-group-usa-709592-09052025
Chile to Strengthen Sustainability in Construction Sector With IDB Support
WASHINGTON, Nov. 12 -- The Inter-American Development Bank issued the following news release:* * *
Chile to Strengthen Sustainability in Construction Sector with IDB Support
The Board of Executive Directors of the Inter-American Development Bank (IDB) has approved a $30 million loan to strengthen Chile's construction sector, promoting its growth, productivity, and sustainability through the implementation of industrialized methods based on the use of wood.
The "Sustainable Construction Support Program" is the fourth under the Conditional Credit Line for Investment Projects (CCLIP), aimed at ... Show Full Article WASHINGTON, Nov. 12 -- The Inter-American Development Bank issued the following news release: * * * Chile to Strengthen Sustainability in Construction Sector with IDB Support The Board of Executive Directors of the Inter-American Development Bank (IDB) has approved a $30 million loan to strengthen Chile's construction sector, promoting its growth, productivity, and sustainability through the implementation of industrialized methods based on the use of wood. The "Sustainable Construction Support Program" is the fourth under the Conditional Credit Line for Investment Projects (CCLIP), aimed atboosting productivity and sustainable development in Chile and originally approved in 2022. The program will be executed by the Production Development Corporation (CORFO).
The initiative is designed to benefit companies in the wood construction value chain, as well as training institutions, research centers, and financial entities across at least seven regions of the country: Valparaiso, O'Higgins, Maule, Nuble, Biobio, Araucania, Los Rios, and Los Lagos.
The program aims to improve the sector's efficiency and inclusiveness. It will focus on enhancing access to financing for companies in the wood construction value chain through public guarantees that support key investments, helping to mitigate information asymmetries and perceived risks within the financial sector. Special attention will be given to women-led businesses and those with diverse workforces.
The plan also seeks to improve operational efficiency by strengthening the sector's ecosystem through the provision of complementary public goods such as technical standards, digital tools, gender-focused training, and support for innovation, entrepreneurship, and technology adoption.
The loan, under the specific investment modality, has a repayment term of 23.5 years, a grace period of seven years, and an interest rate based on SOFR.
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About the IDB
The Inter-American Development Bank (IDB), a member of the IDB Group, is devoted to improving lives across Latin America and the Caribbean. Founded in 1959, the Bank works with the region's public sector to design and enable impactful, innovative solutions for sustainable and inclusive development. Leveraging financing, technical expertise, and knowledge, it promotes growth and well-being in 26 countries. Visit our website:
https://www.iadb.org/en.
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Original text here: https://www.iadb.org/en/news/chile-strengthen-sustainability-construction-sector-idb-support
Amazon Countries Launch $1 Billion Facility for Resilient Infrastructure and Cities Under IDB Group's Amazonia Forever Program
WASHINGTON, Nov. 12 -- The Inter-American Development Bank issued the following news release on Nov. 11, 2025:* * *
Amazon Countries Launch $1 Billion Facility for Resilient Infrastructure and Cities under IDB Group's Amazonia Forever Program
BELEM, Brazil -- Amazon countries - Bolivia, Brazil, Colombia, Ecuador, Guyana, Peru, and Suriname - today launched the Amazonia Forever Facility for Cities and Resilient Infrastructure, a regional alliance that seeks to mobilize more than $1 billion to accelerate investments in water security, clean energy, and resilient urban infrastructure, with a multisectoral ... Show Full Article WASHINGTON, Nov. 12 -- The Inter-American Development Bank issued the following news release on Nov. 11, 2025: * * * Amazon Countries Launch $1 Billion Facility for Resilient Infrastructure and Cities under IDB Group's Amazonia Forever Program BELEM, Brazil -- Amazon countries - Bolivia, Brazil, Colombia, Ecuador, Guyana, Peru, and Suriname - today launched the Amazonia Forever Facility for Cities and Resilient Infrastructure, a regional alliance that seeks to mobilize more than $1 billion to accelerate investments in water security, clean energy, and resilient urban infrastructure, with a multisectoraland territorial approach.
The initiative, led by the Amazonia Network of Ministers of Finance and Planning, was formalized through a joint declaration signed by member states. It is supported by the Inter-American Development Bank Group (IDB Group), within the framework of its flagship Amazonia Forever program, and is backed by multilateral climate funds, bilateral donors, and local leaders.
The new facility will leverage innovative financial mechanisms - including blended financing, performance-based concessionality schemes, mechanisms for mitigating exchange-rate risk, and credit-substitution guarantees - while providing technical assistance for infrastructure projects in urban and peri-urban areas.
Brazil's Planning and Budget Minister Simone Tebet formalized the launch at COP30 in her capacity as chair of the Amazonia Network of Ministers of Finance and Planning.
"This important tool will enable us to take action not only on forest and water resources, but also on urban challenges, since cities are home to the vast majority of the Amazonian population. In this way, we are strategically complementing efforts on these two fronts of the region's environmental challenges," she said.
"This facility is a practical example of what Amazonia Forever is all about; providing people with livelihoods and jobs in the region's cities is the best way to preserve the forest," said IDB Group President Ilan Goldfajn. "And building resilient infrastructure helps protect around 60 million people who call the Amazon home."
More than 70% of the population of the Amazon region, or Amazonia, lives in cities and peri-urban areas, which face gaps in water, sanitation, adequate solid-waste management, energy, mobility, and risk management for extreme events. Addressing these challenges is essential not only for improving people's quality of life, but also to protect forests, according to a recent IDB study prepared by more than 60 experts.
The Amazonia Forever Facility comes with new support from international partners to promote climate-resilient infrastructure, clean energy, connectivity, and sustainable urbanization in the Amazon region. Among them:
* Denmark, Norway, and Sweden committed to work toward signing a guarantee which will enable the IDB to increase its lending capacity for clean-energy projects within the Amazonia Forever and America en el Centro programs by $800 million.
* The IDB's Water Security and Climate Resilience Program in Amazonia, in partnership with the Green Climate Fund (GCF), will deploy $162 million in concessional financing, technical assistance, and pre-investment resources for resilient infrastructure projects in drinking water, sanitation, drainage, and solid-waste management, as well as improvements to early-warning systems and strengthened cross-border cooperation.
* The Clean Energy Access Accelerator in the Amazon, supported by the Climate Investment Funds (CIF), will provide $215 million in concessional resources and grants to expand universal access to clean energy and clean cooking solutions, and promote the adoption of emerging technologies.
* The Spanish Agency for International Development Cooperation (AECID) contributed 6 million euros to the IDB's Spanish Cooperation Fund for Water and Sanitation in Latin America and the Caribbean, with a focus on the Amazon.
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The IDB Group at COP30
The IDB Group is hosting more than 80 events at COP30 to showcase solutions for closing gaps in financing for resilient development through partnerships, innovation, and a focus on measurable impact in Latin America and the Caribbean. Journalists on site are invited to visit our venues, with no registration required: IDB Group Pavilion in the Blue Zone, IDB Group in the Green Zone, and the AMAZONIA SEMPRE Station at the Goeldi Museum. Follow our COP30 page for all news and event schedules.
At COP30, the IDB Group is acting as a bridge - connecting governments and investors, the public and private sectors, people and communities - to mobilize at least $6 billion in announcements to help close gaps in financing for resilient development and support national priorities.
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About Amazonia Forever
Amazonia Forever is the IDB Group's regional coordination program that aims to protect biodiversity and accelerate sustainable development through three lines of action: expanding innovative financing, boosting knowledge exchange, and facilitating regional coordination among the eight countries that the Amazon encompasses. During COP30, it will host the AMAZONIA SEMPRE Station at the Goeldi Museum from November 8 to 21. See the full program here: www.bit.ly/COP30AMAZONIASEMPRE.
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About the IDB Group
The Inter-American Development Bank Group (IDB Group) is the leading source of financing and knowledge for improving lives in Latin America and the Caribbean. It comprises the IDB, which works with the region's public sector and enables the private sector; IDB Invest, which directly supports private companies and projects; and IDB Lab, which spurs entrepreneurial innovation.
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Original text here: https://www.iadb.org/en/news/amazon-countries-launch-1-billion-facility-resilient-infrastructure-and-cities-under-idb-groups