Federal Executive Branch
Here's a look at documents from the U.S. Executive Branch
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Uruguay to Improve Secondary Education With IDB Support
WASHINGTON, Nov. 7 -- The Inter-American Development Bank issued the following news release:
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Uruguay to Improve Secondary Education with IDB Support
The Inter-American Development Bank (IDB) is lending $60 million to help Uruguay enhance access and quality in its secondary education system. This operation is the third under a Conditional Credit Line for Investment Projects approved in 2016 to finance a broader program of educational support for secondary students.
The new loan aims to lower drop-out rates and the share of students who repeat grades. The program, focusing on students in
... Show Full Article
WASHINGTON, Nov. 7 -- The Inter-American Development Bank issued the following news release:
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Uruguay to Improve Secondary Education with IDB Support
The Inter-American Development Bank (IDB) is lending $60 million to help Uruguay enhance access and quality in its secondary education system. This operation is the third under a Conditional Credit Line for Investment Projects approved in 2016 to finance a broader program of educational support for secondary students.
The new loan aims to lower drop-out rates and the share of students who repeat grades. The program, focusing on students inthe most vulnerable situations, will also expand an educational model that extends school hours to provide more learning opportunities and reinforce student-school ties.
The program will counteract high absenteeism rates, which are more acute in vulnerable contexts. It will implement a tutoring plan for first-time scholarship students to support their transition and overcome learning gaps, focusing on the knowledge they need to continue progressing through their education. In pursuing this objective, the program will also strengthen information systems and attendance records by deploying better technological tools.
The program will directly benefit students in vulnerable situations with 60,000 scholarships and social and educational orientation activities. It will grant an additional 35,000 students the opportunity to attend extended school day centers.
The IDB loan has a 22.5-year repayment term, an 8-year grace period, and an interest rate based on the Secured Overnight Financing Rate (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: www.iadb.org/en.
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Original text here: https://www.iadb.org/en/news/uruguay-improve-secondary-education-idb-support
USCIS Received 35,000 Applications for Homeland Defenders, Most for Any Job in Agency History
WASHINGTON, Nov. 7 -- The U.S. Department of Homeland Security U.S. Citizenship and Immigration Services issued the following news release on Nov. 6, 2025:
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USCIS Received 35,000 Applications for Homeland Defenders, Most for Any Job in Agency History
USCIS has made hundreds of job offers and is recruiting even more Homeland Defenders
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U.S. Citizenship and Immigration Services today announced that since starting its hiring campaign for Homeland Defenders on Sept. 30, the agency has received an overwhelming 35,000-plus applications--the most for any position in agency history. The agency
... Show Full Article
WASHINGTON, Nov. 7 -- The U.S. Department of Homeland Security U.S. Citizenship and Immigration Services issued the following news release on Nov. 6, 2025:
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USCIS Received 35,000 Applications for Homeland Defenders, Most for Any Job in Agency History
USCIS has made hundreds of job offers and is recruiting even more Homeland Defenders
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U.S. Citizenship and Immigration Services today announced that since starting its hiring campaign for Homeland Defenders on Sept. 30, the agency has received an overwhelming 35,000-plus applications--the most for any position in agency history. The agencysays its aggressive social media campaign is attracting Americans to join USCIS and restore integrity to the nation's immigration system after four years of Biden's border chaos.
USCIS is cutting bureaucratic red tape to hire fiercely dedicated, America-first patriots to serve on the frontlines and hold the line against terrorists, criminal aliens, and bad actors intent on infiltrating our nation. This includes interviewing aliens, reviewing applications, and identifying criminal or ineligible aliens.
"The Homeland Defender Campaign has already been a tremendous success and has resonated with the American people. I'm pleased to announce that in addition to seeing a historic number of applications, we are starting to bring on applicants at a rapid pace," said USCIS Director Joseph Edlow. "USCIS is not wasting time, we are committed to implementing President Trump's priorities. These candidates are not just applying for a job--they are applying to guard our values and defend our homeland. I look forward to onboarding many more Homeland Defenders in the coming weeks."
USCIS has made hundreds of job offers and looks forward to onboarding the first Homeland Defenders soon. Among those receiving offers are former law enforcement personnel and veterans who have experience serving and protecting their communities and our homeland.
USCIS Homeland Defenders may be eligible for signing bonuses up to $50,000, student loan repayment, flexible duty locations, and remote work options for select openings, with expedited hiring for entry-level positions that do not require a college degree. These opportunities aim to attract talented individuals quickly while providing competitive benefits.
USCIS has cut red tape and can make on-the-spot job offers at upcoming job fairs. Go to uscis.gov/join for information on positions and upcoming job fairs. Find USCIS job openings at uscis.usajobs.gov.
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Original text here: https://www.uscis.gov/newsroom/news-releases/uscis-received-35000-applications-for-homeland-defenders-most-for-any-job-in-agency-history
TVA Accelerates American Energy Dominance in FY25 With Nuclear and Grid Expansion
WASHINGTON, Nov. 7 -- The Tennessee Valley Authority issued the following news release:
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TVA Accelerates American Energy Dominance in FY25 with Nuclear and Grid Expansion
Release Summary
* TVA leads the U.S. in advanced nuclear development with major milestones that include the first Gen IV nuclear power purchase agreement and support for a commercial fusion plant.
* TVA added new generation capacity, maintained strong performance across its gas, hydro, and coal fleets, and is planning to build over 6,200 megawatts with over 3,500 megawatts of new power already under construction, enough
... Show Full Article
WASHINGTON, Nov. 7 -- The Tennessee Valley Authority issued the following news release:
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TVA Accelerates American Energy Dominance in FY25 with Nuclear and Grid Expansion
Release Summary
* TVA leads the U.S. in advanced nuclear development with major milestones that include the first Gen IV nuclear power purchase agreement and support for a commercial fusion plant.
* TVA added new generation capacity, maintained strong performance across its gas, hydro, and coal fleets, and is planning to build over 6,200 megawatts with over 3,500 megawatts of new power already under construction, enoughfor 2 million homes.
* TVA helped attract over $6.6 billion in investment and expects to create over 9,000 new jobs, supported energy efficiency upgrades for over 200,000 residents, and joined Hurricane Helene environmental restoration efforts, all while working to reduce costs through its Enterprise Transformation Program.
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KNOXVILLE, Tenn. -- The Tennessee Valley Authority is accelerating America's energy dominance through investments in advanced nuclear, grid modernization, and strategic partnerships to position the Tennessee Valley, and the nation, to lead the global energy race. At its November meeting, the TVA Board of Directors received updates on the agency's progress, recognized the strong performance and dedication of employees, and reaffirmed its commitment to delivering affordable, reliable, and innovative American energy solutions to meet rising demand, fuel economic growth, and power next-generation infrastructure of the AI era.
"American energy dominance is measured in more than megawatts; it's measured in the strength and ingenuity of our people," said Don Moul, TVA President and CEO. "In FY25, that strength helped us transform TVA to keep the power grid strong, grow the economy, and help our communities thrive. Together with our partners, we're modernizing the power grid, expanding American energy, and powering the technologies that will create jobs and define the next century."
Year of Fast Progress, Strong Leadership
In FY25, TVA rapidly advanced its role as a national leader in energy innovation, a hub for next-generation nuclear technology, and a key driver of regional economic growth. During the Board meeting, Moul shared the year's successes that reflect the agency's momentum:
* New Nuclear Innovation: TVA is the only utility with a construction permit application accepted by the Nuclear Regulatory Commission for the BWRX-300 SMR technology, demonstrating the agency's national leadership in small modular reactor development. In addition, TVA is the first U.S. utility to sign a power purchase agreement for electricity from an advanced Gen IV nuclear reactor - Kairos Power's Hermes 2. TVA also signed a collaboration agreement with ENTRA1 to explore the development of up to 6 gigawatts of new nuclear power generation to advance the nation's energy security and maintain America's nuclear leadership.
* Fusion Energy Development: With support from Tennessee Governor Bill Lee, TVA and Type One Energy signed a letter of intent to bring the nation's first commercial stellarator fusion power plant to the Tennessee Valley. TVA's highly skilled workforce will help manufacture components for the prototype fusion machine at TVA's Bull Run site.
* Meeting Power Demand: TVA's gas, hydro, and coal generation fleet delivered strong reliability performance this year, with 389 billion cubic feet of natural gas and 14 million tons of coal supplied. This fuel mix generated enough electricity to power an estimated 7.2 million homes, underscoring the fleet's critical role in meeting energy demands. To continue to meet record-breaking power demand, like in January, TVA completed 530 megawatts of new generation at its New Johnsonville natural gas plant and has more than 3,500 megawatts currently under construction -- enough to power over two million homes. TVA plans to build more than 6,200 megawatts of new generation to support industrial growth, economic development and energy security. TVA is working closely with communities to identify optimal locations for new energy assets.
* Economic Development: TVA, with its partners, helped attract over $6.6 billion in projected capital investment to the region that is expected to create more than 9,000 jobs while expecting to retain about 43,250 jobs - earning Site Selection Magazine's recognition for 20-years in a row. Companies include: Barrett firearms, GE Aerospace, Hitachi Energy, Mahle, Oklo and U.S. Space Command. Over the past five years, TVA has helped create over $44 billion in projected capital investment, which is expected to bring more than 81,000 new jobs and retain more than 230,000 jobs.
* Energy Efficiency & Demand Response: In partnership with local power companies and communities, TVA programs enabled energy upgrades to more than 200,000 residents and 98 schools across the Valley. Since October 2023, TVA's energy efficiency programs have delivered almost $750 million in lifetime energy savings for participants.
* Disaster Response & Environmental Stewardship: Following the impact of Hurricane Helene, TVA joined a year-long cleanup effort in partnership with FEMA, TEMA, and TDEC to restore Douglas Lake. This initiative reinforced TVA's commitment to community resilience and earned the Outstanding Watershed Management Project Award from the Clean Water Professionals of Kentucky and Tennessee.
* Enterprise Transformation Program (ETP): TVA met its FY25 cost optimization reduction targets and has plans to meet the targets set for FY26. ETP is designed to enable TVA to deliver at least $500 million of sustainable reductions to planned cost increases in FY26 and beyond to support future fleet investments needed to meet growing demand. TVA's ETP is focused on improving financial health, enhancing asset performance, automating processes, optimizing third-party spend through the supply chain, and making the workforce more efficient.
"At TVA, we're not just building energy infrastructure, we're laying the foundation for America's energy future," said Moul. "We're proving that when we lead with purpose, and partner with vision, there's no limit to what we can achieve."
Board Actions
In other business, the Board:
* Approved FY26 CEO total compensation, which continues to balance recognition of leading TVA's complex operations with the agency's public service mission and remains well below the national median compensation of similar organizations.
* The Board approved the payout for TVA's short-term at-risk compensation for Winning Performance/EAIP, recognizing the continued performance of the team in meeting demanding goals under challenging conditions.
* The Board approved the Long-Term Incentive (LTI) Plan payout percentage based on FY25 scorecard performance.
To learn more about TVA's innovation strategy and partnerships, visit tva.com.
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About TVA
The Tennessee Valley Authority is the nation's largest public power supplier, delivering energy to more than 10 million people across seven southeastern states. TVA has one of the most diverse energy systems - including nuclear, hydro, coal, gas, solar and advanced technologies. TVA is making significant investments in its power system toward new generation and transmission.
TVA is a corporate agency of the United States, receiving no taxpayer funding, deriving virtually all of its revenues from sales of electricity. TVA maintains some of the lowest energy costs and highest reliability in the nation. TVA's residential rates are lower than those paid by 80% of customers of the top 100 U.S. utilities, and its industrial rates are lower than those paid by over 90% of customers of the top 100 U.S. utilities. In addition, TVA provides flood control, navigation, and land management for the Tennessee River system, and assists local power companies and state and local governments with economic development and job creation. Learn more at tva.com.
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Original text here: https://www.tva.com/news-media/releases/tva-accelerates-american-energy-dominance-in-fy25-with-nuclear-and-grid-expansion
FDA Issues Warning Letter to Meamo
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Meamo from the Center for Drug Evaluation and Research:
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Recipient: Meamo, South Korea
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Meamo:
This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.meamoshop.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs
... Show Full Article
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Meamo from the Center for Drug Evaluation and Research:
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Recipient: Meamo, South Korea
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Meamo:
This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.meamoshop.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugsin violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. Sec.Sec. 331(a), 331(d), 353(b), and 355(a)]. As discussed below, FDA has observed that www.meamoshop.com introduces into interstate commerce unapproved and misbranded injectable botulinum toxin drug products.
There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.meamoshop.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.
Unapproved New Drugs:
Certain products offered for sale by www.meamoshop.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. Sec. 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. Sec. 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. Sec. 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. Sec. 331(d)] and 505(a) of the FD&C Act.
An example of an unapproved botulinum toxin drug product you offer for sale on www.meamoshop.com is botulinum toxin type A marketed as "X4 Wondertox 100U Set" and "Wondertox". Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim "Treatment of benign essential blepharspasm in adult patients."
While there are FDA-approved versions of botulinum toxin drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "X4 Wondertox 100U Set" and "Wondertox" offered by www.meamoshop.com. Currently there are several botulinum toxin products FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. Examples of FDA-approved botulinum toxin products with a summary of their indications are: BOTOX(R) (onabotulinumtoxinA), indicated for the treatment of overactive bladder, neurogenic detrusor overactivity, chronic migraine, spasticity, cervical dystonia, severe primary axillary hyperhidrosis, strabismus, and blepharospasm and prophylaxis of headaches in adults with chronic migraines; DAXXIFY(R) (daxibotulinumtoxinA-lanm), indicated for the temporary improvement in the appearance of glabellar lines and the treatment of cervical dystonia; and MYOBLOC(R) (rimabotulinumtoxinB), indicated for the treatment of cervical dystonia and chronic sialorrhea.
Furthermore, FDA-approved botulinum toxin drug products bear a boxed warning, commonly referred to as a "black box warning," which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of distant spread of toxin effect to produce symptoms consistent with botulinum toxin effects. In addition, swallowing and breathing difficulties can be life threatening and there have been reports of death.
Misbranded Drugs:
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. Sec. 352(f)(1)] if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. Sec. 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.
Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.meamoshop.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. Sec. 331(a)].
FDA is sending this warning letter to www.meamoshop.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.
If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.
Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
Sincerely,
/s/ Sangeeta Vaswani Chatterjee, Pharm.D., Acting Director, Office of Drug Security, Integrity, and Response, Office of Compliance, Center for Drug Evaluation and Research
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/meamo-11032025
FDA Issues Warning Letter to Cosmenic
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Cosmenic from the Center for Drug Evaluation and Research:
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Recipient: Cosmenic, Panama
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Cosmenic:
This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.cosmenic.net and has observed that your website introduces into interstate commerce misbranded and unapproved new
... Show Full Article
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Cosmenic from the Center for Drug Evaluation and Research:
* * *
Recipient: Cosmenic, Panama
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Cosmenic:
This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.cosmenic.net and has observed that your website introduces into interstate commerce misbranded and unapproved newdrugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. Sec.Sec. 331(a), 331(d), 353(b), and 355(a)]. As discussed below, FDA has observed that www.cosmenic.net introduces into interstate commerce unapproved and misbranded injectable botulinum toxin drug products.
There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.cosmenic.net cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.
Unapproved New Drugs:
Certain products offered for sale by www.cosmenic.net are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. Sec. 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. Sec. 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. Sec. 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. Sec. 331(d)] and 505(a) of the FD&C Act.
An example of an unapproved botulinum toxin drug product you offer for sale on www.cosmenic.net is botulinum toxin type A marketed as "NABOTA(R) (JEUVEAU(R)) 100u". Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim "Botulinum toxin type A (Nabota) is indicated for the prevention of headaches in adults with chronic migraine."
While there are FDA-approved versions of botulinum toxin drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "NABOTA(R) (JEUVEAU(R)) 100u" offered by www.cosmenic.net. Your marketing implies that your product is the same as the FDA-approved product, JEUVEAU(R), when it is not. Currently there are several botulinum toxin products FDA-approved for the U.S. market, and these products are only available pursuant to a prescription from a licensed practitioner. In addition to JEUVEAU (prabotulinumtoxinA-xvfs), indicated for the temporary improvement in the appearance of glabellar lines, other examples of FDA-approved botulinum toxin products with a summary of their indications are: BOTOX(R) (onabotulinumtoxinA), indicated for the treatment of overactive bladder, neurogenic detrusor overactivity, chronic migraine, spasticity, cervical dystonia, severe primary axillary hyperhidrosis, strabismus, and blepharospasm and prophylaxis of headaches in adults with chronic migraines; DAXXIFY(R) (daxibotulinumtoxinA-lanm), indicated for the temporary improvement in the appearance of glabellar lines and the treatment of cervical dystonia; and MYOBLOC(R) (rimabotulinumtoxinB), indicated for the treatment of cervical dystonia and chronic sialorrhea.
Furthermore, FDA-approved botulinum toxin drug products bear a boxed warning, commonly referred to as a "black box warning," which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of distant spread of toxin effect to produce symptoms consistent with botulinum toxin effects. In addition, swallowing and breathing difficulties can be life threatening and there have been reports of death.
Misbranded Drugs:
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. Sec. 352(f)(1)] if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. Sec. 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.
Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.cosmenic.net is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. Sec. 331(a)].
FDA is sending this warning letter to www.cosmenic.net because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.
If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.
Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
Sincerely,
/S/ Sangeeta Vaswani Chatterjee, Pharm.D., Acting Director, Office of Drug Security, Integrity, and Response, Office of Compliance, Center for Drug Evaluation and Research
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cosmenic-718621-11032025
FDA Issues Warning Letter to AceCosm
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to AceCosm from the Center for Drug Evaluation and Research:
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Recipient: AceCosm, Hong Kong SAR China
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
AceCosm:
This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.acecosm.com and has observed that your website introduces into interstate commerce misbranded and unapproved
... Show Full Article
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to AceCosm from the Center for Drug Evaluation and Research:
* * *
Recipient: AceCosm, Hong Kong SAR China
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
AceCosm:
This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.acecosm.com and has observed that your website introduces into interstate commerce misbranded and unapprovednew drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. Sec.Sec. 331(a), 331(d), 353(b), and 355(a)]. As discussed below, FDA has observed that www.acecosm.com introduces into interstate commerce unapproved and misbranded injectable botulinum toxin drug products.
There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.acecosm.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.
Unapproved New Drugs:
Certain products offered for sale by www.acecosm.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. Sec. 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. Sec. 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. Sec. 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. Sec. 331(d)] and 505(a) of the FD&C Act.
An example of an unapproved botulinum toxin drug product you offer for sale on www.acecosm.com is botulinum toxin type A marketed as "[SET] NABOTA 200U + SALINE 20ML" and "Nabota 200U Botulinum Toxin Type A". Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims "Prevention of chronic migraine in adults," "Treatment of urinary incontinence due to neurogenic detrusor overactivity, resulting from conditions such as spinal cord injury or multiple sclerosis," and "Management of focal armpit hyperhidrosis."
While there are FDA-approved versions of botulinum toxin drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "[SET] NABOTA 200U + SALINE 20ML" and "Nabota 200U Botulinum Toxin Type A" offered by www.acecosm.com. Currently there are several botulinum toxin products FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. Examples of FDA-approved botulinum toxin products with a summary of their indications are: BOTOX(R) (onabotulinumtoxinA), indicated for the treatment of overactive bladder, neurogenic detrusor overactivity, chronic migraine, spasticity, cervical dystonia, severe primary axillary hyperhidrosis, strabismus, and blepharospasm and prophylaxis of headaches in adults with chronic migraines; DAXXIFY(R) (daxibotulinumtoxinA-lanm), indicated for the temporary improvement in the appearance of glabellar lines and the treatment of cervical dystonia; and MYOBLOC(R) (rimabotulinumtoxinB), indicated for the treatment of cervical dystonia and chronic sialorrhea.
Furthermore, FDA-approved botulinum toxin drug products bear a boxed warning, commonly referred to as a "black box warning," which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of distant spread of toxin effect to produce symptoms consistent with botulinum toxin effects. In addition, swallowing and breathing difficulties can be life threatening and there have been reports of death.
Misbranded Drugs:
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. Sec. 352(f)(1)] if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. Sec. 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.
Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.acecosm.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. Sec. 331(a)].
FDA is sending this warning letter to www.acecosm.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.
If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.
Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
Sincerely,
/S/ Sangeeta Vaswani Chatterjee, Pharm.D., Acting Director, Office of Drug Security, Integrity, and Response, Office of Compliance, Center for Drug Evaluation and Research
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/acecosm-718610-11032025
Blue Oven Bakery Issues a Voluntary Recall Due to Undeclared Milk Allergens in Their English Muffin
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following recall notice:
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Blue Oven Bakery, Inc. Issues a Voluntary Recall Due to Undeclared Milk Allergens in Their English Muffin
Summary
Company Announcement Date: October 31, 2025
FDA Publish Date: November 06, 2025
Product Type: Food & Beverages
Reason for Announcement: Undeclared milk
Company Name: Blue Oven Bakery, Inc.
Brand Name: Blue Oven Bakery, Inc.
Product Description: English muffin
Government Agency Partner Announcement
Cincinnati, Ohio (October 31, 2025)
... Show Full Article
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following recall notice:
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Blue Oven Bakery, Inc. Issues a Voluntary Recall Due to Undeclared Milk Allergens in Their English Muffin
Summary
Company Announcement Date: October 31, 2025
FDA Publish Date: November 06, 2025
Product Type: Food & Beverages
Reason for Announcement: Undeclared milk
Company Name: Blue Oven Bakery, Inc.
Brand Name: Blue Oven Bakery, Inc.
Product Description: English muffin
Government Agency Partner Announcement
Cincinnati, Ohio (October 31, 2025)Blue Oven Bakery, Inc. is issuing a voluntary recall on their english muffin for misbranding due to the milk allergen not being declared on the label. The english muffin was sold fresh as a baked product in a 13.04 oz sealed plastic bag.
These products have been produced since 04/24/25 with the last production date of 10/24/2025, and were sold at the following locations:
* Harvest Market- 308 Main St. Milford, OH 45150
* Country Fresh Market- 8315 Beechmont Ave. #15 Cincinnati, OH 45255
* Kremers Market- 755 Buttermilk Pike Crescent Springs, KY 41017
* Back Ally Mercantile- 221 Walnut St. #102 Lawrenceburg, IN 47025
* European Cafe- 9450 Montgomery Rd. Cincinnati, OH 45242
No reports of illnesses involving this product have been reported. Individuals exhibiting signs or symptoms of a foodborne illness, or an allergic reaction should contact a physician immediately. If you would like to return these products for a full refund, please do so at 1719 Elm Street Cincinnati, OH 45202 on 11/4/25 or 11/5/25.
If you have any questions, please contact Blue Oven Bakery at 513.706.0901 or blueovencustomerservice@gmail.com.
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Original text here: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blue-oven-bakery-inc-issues-voluntary-recall-due-undeclared-milk-allergens-their-english-muffin
