Federal Executive Branch
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White House: President Trump and VP Vance Deliver Manufacturing Renaissance to Michigan
WASHINGTON, Sept. 2 -- The White House issued the following news on Aug. 31, 2026:
* * *
President Trump and VP Vance Deliver Manufacturing Renaissance to Michigan
Vice President JD Vance is in Michigan today to mark the Trump Administration's unprecedented crackdown on fraud and the comeback of American manufacturing under the leadership of President Donald J. Trump. Since taking office, the Trump Administration has onshored production, restored factory jobs, and put vehicles back on Michigan assembly lines -- while delivering tax relief that leaves more money in workers' pockets and driving ... Show Full Article WASHINGTON, Sept. 2 -- The White House issued the following news on Aug. 31, 2026: * * * President Trump and VP Vance Deliver Manufacturing Renaissance to Michigan Vice President JD Vance is in Michigan today to mark the Trump Administration's unprecedented crackdown on fraud and the comeback of American manufacturing under the leadership of President Donald J. Trump. Since taking office, the Trump Administration has onshored production, restored factory jobs, and put vehicles back on Michigan assembly lines -- while delivering tax relief that leaves more money in workers' pockets and drivinga sharp decline in crime across the state.
Record Investments. Record Sales. American Jobs.
Michigan is locking in tens of billions in new capital and thousands of high-paying jobs as companies respond to the Trump Administration's America First agenda.
* General Motors is investing $6 billion in U.S. manufacturing -- including a major expansion at its Orion Township plant -- and is onshoring more production to meet demand for American-built vehicles. GM is also adding an overtime shift at Flint as pickup demand surges.
* Ford Motor Company is investing $3 billion in its BlueOval Battery Park in Marshall, creating 1,700 new jobs. Ford added a third shift at the Dearborn Truck Plant as the F-series continues to dominate global pickup sales.
* Stellantis is investing $388 million in a state-of-the-art "megahub" in Van Buren Township, $140 million to expand its Detroit plant, and $100 million to add production at Warren.
* Detroit Diesel is recalling laid-off workers and adding a third shift.
* 2025 marked the strongest year for new vehicle sales since 2019. Ford posted its best annual U.S. sales in six years. General Motors delivered soaring overall volume and its strongest SUV performance in decades. Jeep sales rose for the first time since 2018.
A Broader Manufacturing Boom Across Michigan
Michigan is winning in advanced manufacturing, energy, aerospace, food production, and the infrastructure of the AI economy.
* OpenAI, Oracle, and Related Digital are building a hyperscale data center campus in Saline Township -- investing more than $7 billion, with thousands of construction jobs and hundreds of permanent positions.
* Pratt Industries pledged $5 billion to reindustrialize America, with thousands of jobs headed to Michigan workers.
* Corning is investing $1.5 billion in Saginaw County, adding more than 400 new advanced manufacturing jobs.
* Chobani is investing $567 million to expand its La Colombe plant in Norton Shores, creating hundreds of new jobs and sharply increasing purchases of Michigan milk.
* GE Aerospace is investing $60 million to boost aircraft engine and avionics production at its Michigan facilities.
* Saginaw Control & Engineering is investing $50 million to expand in Thomas Township.
* Adrian Steel is investing $43.4 million to significantly grow its operations.
* American Rheinmetall is investing $31.7 million in its Michigan facilities.
Historic Tax Relief for Michigan Workers and Families
President Trump's Working Families Tax Cuts put money back in Michiganders' pockets.
* No Tax on Social Security: About 1.7 million Michigan seniors benefit from the new senior deduction.
* No Tax on Overtime and No Tax on Tips: Roughly a quarter of Michigan employees regularly work overtime and can benefit -- so workers keep more of what they earn.
* Made-in-America Auto Loan Interest: Families who buy a vehicle assembled in the U.S. can deduct the interest -- a tax cut that doubles as industrial policy.
* Bigger Refunds: Michigan taxpayers saw average refunds of $3,508.
* Rural Health Investments: Michigan secured about $173 million in first-year Rural Health Transformation Program funding.
* Protecting Jobs and Wages: The Working Families Tax Cuts safeguarded 170,000 Texas jobs, $30 billion in state GDP, and $15 billion in workers' wages.
Michiganders are Safer
The Trump Administration is making Michigan safe again -- and the numbers tell the success.
* So far in 2026, violent offenses are down compared to the same period last year -- with homicide down 19%, rape down 18%, and robbery down 17%.
* In 2025, violent crime and motor vehicle thefts all fell compared to the previous year.
* In 2025, Detroit recorded the fewest homicides since 1964 and the first time the city fell below 200 killings in six decades.
* * *
Original text here: https://www.whitehouse.gov/releases/2026/08/president-trump-and-vp-vance-deliver-manufacturing-renaissance-to-michigan/
* * *
President Trump and VP Vance Deliver Manufacturing Renaissance to Michigan
Vice President JD Vance is in Michigan today to mark the Trump Administration's unprecedented crackdown on fraud and the comeback of American manufacturing under the leadership of President Donald J. Trump. Since taking office, the Trump Administration has onshored production, restored factory jobs, and put vehicles back on Michigan assembly lines -- while delivering tax relief that leaves more money in workers' pockets and driving ... Show Full Article WASHINGTON, Sept. 2 -- The White House issued the following news on Aug. 31, 2026: * * * President Trump and VP Vance Deliver Manufacturing Renaissance to Michigan Vice President JD Vance is in Michigan today to mark the Trump Administration's unprecedented crackdown on fraud and the comeback of American manufacturing under the leadership of President Donald J. Trump. Since taking office, the Trump Administration has onshored production, restored factory jobs, and put vehicles back on Michigan assembly lines -- while delivering tax relief that leaves more money in workers' pockets and drivinga sharp decline in crime across the state.
Record Investments. Record Sales. American Jobs.
Michigan is locking in tens of billions in new capital and thousands of high-paying jobs as companies respond to the Trump Administration's America First agenda.
* General Motors is investing $6 billion in U.S. manufacturing -- including a major expansion at its Orion Township plant -- and is onshoring more production to meet demand for American-built vehicles. GM is also adding an overtime shift at Flint as pickup demand surges.
* Ford Motor Company is investing $3 billion in its BlueOval Battery Park in Marshall, creating 1,700 new jobs. Ford added a third shift at the Dearborn Truck Plant as the F-series continues to dominate global pickup sales.
* Stellantis is investing $388 million in a state-of-the-art "megahub" in Van Buren Township, $140 million to expand its Detroit plant, and $100 million to add production at Warren.
* Detroit Diesel is recalling laid-off workers and adding a third shift.
* 2025 marked the strongest year for new vehicle sales since 2019. Ford posted its best annual U.S. sales in six years. General Motors delivered soaring overall volume and its strongest SUV performance in decades. Jeep sales rose for the first time since 2018.
A Broader Manufacturing Boom Across Michigan
Michigan is winning in advanced manufacturing, energy, aerospace, food production, and the infrastructure of the AI economy.
* OpenAI, Oracle, and Related Digital are building a hyperscale data center campus in Saline Township -- investing more than $7 billion, with thousands of construction jobs and hundreds of permanent positions.
* Pratt Industries pledged $5 billion to reindustrialize America, with thousands of jobs headed to Michigan workers.
* Corning is investing $1.5 billion in Saginaw County, adding more than 400 new advanced manufacturing jobs.
* Chobani is investing $567 million to expand its La Colombe plant in Norton Shores, creating hundreds of new jobs and sharply increasing purchases of Michigan milk.
* GE Aerospace is investing $60 million to boost aircraft engine and avionics production at its Michigan facilities.
* Saginaw Control & Engineering is investing $50 million to expand in Thomas Township.
* Adrian Steel is investing $43.4 million to significantly grow its operations.
* American Rheinmetall is investing $31.7 million in its Michigan facilities.
Historic Tax Relief for Michigan Workers and Families
President Trump's Working Families Tax Cuts put money back in Michiganders' pockets.
* No Tax on Social Security: About 1.7 million Michigan seniors benefit from the new senior deduction.
* No Tax on Overtime and No Tax on Tips: Roughly a quarter of Michigan employees regularly work overtime and can benefit -- so workers keep more of what they earn.
* Made-in-America Auto Loan Interest: Families who buy a vehicle assembled in the U.S. can deduct the interest -- a tax cut that doubles as industrial policy.
* Bigger Refunds: Michigan taxpayers saw average refunds of $3,508.
* Rural Health Investments: Michigan secured about $173 million in first-year Rural Health Transformation Program funding.
* Protecting Jobs and Wages: The Working Families Tax Cuts safeguarded 170,000 Texas jobs, $30 billion in state GDP, and $15 billion in workers' wages.
Michiganders are Safer
The Trump Administration is making Michigan safe again -- and the numbers tell the success.
* So far in 2026, violent offenses are down compared to the same period last year -- with homicide down 19%, rape down 18%, and robbery down 17%.
* In 2025, violent crime and motor vehicle thefts all fell compared to the previous year.
* In 2025, Detroit recorded the fewest homicides since 1964 and the first time the city fell below 200 killings in six decades.
* * *
Original text here: https://www.whitehouse.gov/releases/2026/08/president-trump-and-vp-vance-deliver-manufacturing-renaissance-to-michigan/
Secretary of State Rubio Issues Statement on Slovakia National Day
WASHINGTON, Sept. 2 -- The U.S. State Department issued the following statement on Sept. 1, 2026, by Secretary Marco Rubio on Slovakia National Day:
* * *
On behalf of the United States of America, I congratulate the people of Slovakia as you mark Constitution Day.
The United States and Slovakia share a strong partnership built on mutual respect, shared responsibility, and the principle that sovereign nations are strongest when they are free to make their own choices and defend their own interests.
Over the past year, we have deepened this partnership through our cooperation on Slovakia's military ... Show Full Article WASHINGTON, Sept. 2 -- The U.S. State Department issued the following statement on Sept. 1, 2026, by Secretary Marco Rubio on Slovakia National Day: * * * On behalf of the United States of America, I congratulate the people of Slovakia as you mark Constitution Day. The United States and Slovakia share a strong partnership built on mutual respect, shared responsibility, and the principle that sovereign nations are strongest when they are free to make their own choices and defend their own interests. Over the past year, we have deepened this partnership through our cooperation on Slovakia's militarymodernization efforts and in the field of civil nuclear energy. These efforts make both our nations stronger and contribute to a more secure and prosperous transatlantic community.
My visit to Bratislava earlier this year reaffirmed the importance the United States places in our relationship with Slovakia. We look forward to building on that momentum by expanding trade and investment, advancing our shared energy and security interests, and pursuing practical cooperation that benefits both the American and Slovak people.
* * *
Original text here: https://www.state.gov/releases/office-of-the-spokesperson/2026/09/slovakia-national-day-2/
* * *
On behalf of the United States of America, I congratulate the people of Slovakia as you mark Constitution Day.
The United States and Slovakia share a strong partnership built on mutual respect, shared responsibility, and the principle that sovereign nations are strongest when they are free to make their own choices and defend their own interests.
Over the past year, we have deepened this partnership through our cooperation on Slovakia's military ... Show Full Article WASHINGTON, Sept. 2 -- The U.S. State Department issued the following statement on Sept. 1, 2026, by Secretary Marco Rubio on Slovakia National Day: * * * On behalf of the United States of America, I congratulate the people of Slovakia as you mark Constitution Day. The United States and Slovakia share a strong partnership built on mutual respect, shared responsibility, and the principle that sovereign nations are strongest when they are free to make their own choices and defend their own interests. Over the past year, we have deepened this partnership through our cooperation on Slovakia's militarymodernization efforts and in the field of civil nuclear energy. These efforts make both our nations stronger and contribute to a more secure and prosperous transatlantic community.
My visit to Bratislava earlier this year reaffirmed the importance the United States places in our relationship with Slovakia. We look forward to building on that momentum by expanding trade and investment, advancing our shared energy and security interests, and pursuing practical cooperation that benefits both the American and Slovak people.
* * *
Original text here: https://www.state.gov/releases/office-of-the-spokesperson/2026/09/slovakia-national-day-2/
FDA Center for Drug Evaluation & Research Issues Warning Letter to Tex Peptides
WASHINGTON, Sept. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to TXP Innovations LLC dba Tex Peptides from its Center for Drug Evaluation and Research:
* * *
Recipient: Felicia Romero, CEO, TXP Innovations LLC dba Tex Peptides, 539 West Commerce Street, Dallas, TX 75208-1953, United States, support@texpeptide.com, texpeptides@gmail.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Reference Number: 735067
To Felicia Romero:
This warning letter advises you of significant ... Show Full Article WASHINGTON, Sept. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to TXP Innovations LLC dba Tex Peptides from its Center for Drug Evaluation and Research: * * * Recipient: Felicia Romero, CEO, TXP Innovations LLC dba Tex Peptides, 539 West Commerce Street, Dallas, TX 75208-1953, United States, support@texpeptide.com, texpeptides@gmail.com Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER Reference Number: 735067 To Felicia Romero: This warning letter advises you of significantviolations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body's key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.
FDA Review
Violations were identified and documented during a review of your website texpeptide.com in July 2026. Based on our review, "Semaglutide (GLP-1 SEM)," "Tirzepatide (GLP-2 TRZ)," "Retatrutide (GLP-3 RT)," "SS-31 (Elamipretide)," "Tesamorelin," "PT-141 (Bremelanotide)," and "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.
Unapproved New Drug Violations
Based on a review of your website,"Semaglutide (GLP-1 SEM)," "Tirzepatide (GLP-2 TRZ)," "Retatrutide (GLP-3 RT)," "SS-31 (Elamipretide)," "Tesamorelin," "PT-141 (Bremelanotide)," and "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" are drugs under 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./1 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
GLP-1 SEM (Semaglutide)
On the webpage https://texpeptide.com/product/glp-1-sem/:
* "By binding to GLP-1 receptors, it enhances insulin secretion, suppresses glucagon release, and slows gastric emptying, ultimately helping to regulate blood glucose levels. This makes GLP-1 SEM a key area of interest in the management of type 2 diabetes, obesity, and metabolic disorders."
* "In addition to its glucose-lowering effects, GLP-1 SEM has been shown to support weight loss by reducing appetite and promoting a feeling of fullness, making it a valuable therapeutic candidate in obesity management. Research also suggests potential benefits for cardiovascular health, liver function, and neuroprotection, expanding its relevance beyond diabetes care."
GLP-2 TRZ (Tirzepatide)
On the webpage https://texpeptide.com/product/glp-2-trz/:
* "GLP-2 TRZ enhances insulin secretion, reduces glucagon levels, and promotes appetite regulation, offering a powerful approach to improving blood sugar control and weight management."
* "Beyond its primary effects on glucose metabolism and weight loss, GLP-2 TRZ is being investigated for its potential in cardiovascular health, lipid regulation, and reducing systemic inflammation. Its role in insulin sensitivity, appetite suppression, and long-term metabolic improvements makes it a promising therapeutic option in endocrinology and obesity research."
GLP-3 RT (Retatrutide)
On the webpage https://texpeptide.com/product/glp-3-rt/:
* "GLP-3 RT offers a unique and comprehensive approach to regulating glucose metabolism, energy balance, and weight management."
* "Early research suggests that GLP-3 RT may provide superior outcomes compared to GLP-1 or dual agonists alone, including greater weight reduction, improved insulin sensitivity, enhanced lipid metabolism, and better long-term metabolic stability. Additionally, studies are investigating its potential in cardiovascular protection, liver health (NAFLD/NASH), and neuroendocrine regulation."
SS-31 (Elamipretide)
On the webpage https://texpeptide.com/product/ss-31/:
* "SS-31 helps stabilize mitochondrial membranes, reduce oxidative stress, and improve electron transport chain efficiency, ultimately enhancing cellular energy production (ATP)."
* "This peptide has been widely studied for its antioxidant and cytoprotective properties, making it a promising therapeutic candidate for conditions linked to mitochondrial dysfunction."
Tesamorelin
On the webpage https://texpeptide.com/product/tesamorelin/:
* "Tesamorelin is a synthetic peptide analog of Growth Hormone-Releasing Hormone (GHRH), a naturally occurring hormone that stimulates the pituitary gland to release growth hormone (GH). By mimicking the natural activity of GHRH, Tesamorelin effectively increases the production and secretion of growth hormone, which in turn elevates levels of insulin-like growth factor-1 (IGF-1) in the body."
PT-141 (Bremelanotide)
On the webpage https://texpeptide.com/product/pt-141/:
* "PT-141, also known as bremelanotide . . . is specifically researched for its ability to increase arousal and desire. PT-141 targets the central nervous system directly to improve libido and pleasure. It's an effective and powerful enhancer for both mood and your senses."
Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)
Your firm offers "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the six above-mentioned products. The sale of these products together demonstrates that you intend your "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" to be used in combination for injection. Therefore, your "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" is a drug.
Semaglutide (GLP-1 SEM)," "Tirzepatide (GLP-2 TRZ)," "Retatrutide (GLP-3 RT)," "SS-31 (Elamipretide)," "Tesamorelin," "PT-141 (Bremelanotide)," and "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" 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 (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug 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 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. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Conclusion
As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number "735067" in the subject line of the email.
If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
Please note FDA posts warning letters on www.fda.gov.
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, U.S. Food and Drug Administration
* * *
Footnote:
1/ Despite statements on your product labeling marketing your products "research use only", "for research and laboratory use only", and "not for human or veterinary use," evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water as a solvent for reconstituting your products, thus, providing the means to prepare an injectable drug for human administration.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026
* * *
Recipient: Felicia Romero, CEO, TXP Innovations LLC dba Tex Peptides, 539 West Commerce Street, Dallas, TX 75208-1953, United States, support@texpeptide.com, texpeptides@gmail.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Reference Number: 735067
To Felicia Romero:
This warning letter advises you of significant ... Show Full Article WASHINGTON, Sept. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to TXP Innovations LLC dba Tex Peptides from its Center for Drug Evaluation and Research: * * * Recipient: Felicia Romero, CEO, TXP Innovations LLC dba Tex Peptides, 539 West Commerce Street, Dallas, TX 75208-1953, United States, support@texpeptide.com, texpeptides@gmail.com Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER Reference Number: 735067 To Felicia Romero: This warning letter advises you of significantviolations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body's key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.
FDA Review
Violations were identified and documented during a review of your website texpeptide.com in July 2026. Based on our review, "Semaglutide (GLP-1 SEM)," "Tirzepatide (GLP-2 TRZ)," "Retatrutide (GLP-3 RT)," "SS-31 (Elamipretide)," "Tesamorelin," "PT-141 (Bremelanotide)," and "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.
Unapproved New Drug Violations
Based on a review of your website,"Semaglutide (GLP-1 SEM)," "Tirzepatide (GLP-2 TRZ)," "Retatrutide (GLP-3 RT)," "SS-31 (Elamipretide)," "Tesamorelin," "PT-141 (Bremelanotide)," and "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" are drugs under 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./1 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
GLP-1 SEM (Semaglutide)
On the webpage https://texpeptide.com/product/glp-1-sem/:
* "By binding to GLP-1 receptors, it enhances insulin secretion, suppresses glucagon release, and slows gastric emptying, ultimately helping to regulate blood glucose levels. This makes GLP-1 SEM a key area of interest in the management of type 2 diabetes, obesity, and metabolic disorders."
* "In addition to its glucose-lowering effects, GLP-1 SEM has been shown to support weight loss by reducing appetite and promoting a feeling of fullness, making it a valuable therapeutic candidate in obesity management. Research also suggests potential benefits for cardiovascular health, liver function, and neuroprotection, expanding its relevance beyond diabetes care."
GLP-2 TRZ (Tirzepatide)
On the webpage https://texpeptide.com/product/glp-2-trz/:
* "GLP-2 TRZ enhances insulin secretion, reduces glucagon levels, and promotes appetite regulation, offering a powerful approach to improving blood sugar control and weight management."
* "Beyond its primary effects on glucose metabolism and weight loss, GLP-2 TRZ is being investigated for its potential in cardiovascular health, lipid regulation, and reducing systemic inflammation. Its role in insulin sensitivity, appetite suppression, and long-term metabolic improvements makes it a promising therapeutic option in endocrinology and obesity research."
GLP-3 RT (Retatrutide)
On the webpage https://texpeptide.com/product/glp-3-rt/:
* "GLP-3 RT offers a unique and comprehensive approach to regulating glucose metabolism, energy balance, and weight management."
* "Early research suggests that GLP-3 RT may provide superior outcomes compared to GLP-1 or dual agonists alone, including greater weight reduction, improved insulin sensitivity, enhanced lipid metabolism, and better long-term metabolic stability. Additionally, studies are investigating its potential in cardiovascular protection, liver health (NAFLD/NASH), and neuroendocrine regulation."
SS-31 (Elamipretide)
On the webpage https://texpeptide.com/product/ss-31/:
* "SS-31 helps stabilize mitochondrial membranes, reduce oxidative stress, and improve electron transport chain efficiency, ultimately enhancing cellular energy production (ATP)."
* "This peptide has been widely studied for its antioxidant and cytoprotective properties, making it a promising therapeutic candidate for conditions linked to mitochondrial dysfunction."
Tesamorelin
On the webpage https://texpeptide.com/product/tesamorelin/:
* "Tesamorelin is a synthetic peptide analog of Growth Hormone-Releasing Hormone (GHRH), a naturally occurring hormone that stimulates the pituitary gland to release growth hormone (GH). By mimicking the natural activity of GHRH, Tesamorelin effectively increases the production and secretion of growth hormone, which in turn elevates levels of insulin-like growth factor-1 (IGF-1) in the body."
PT-141 (Bremelanotide)
On the webpage https://texpeptide.com/product/pt-141/:
* "PT-141, also known as bremelanotide . . . is specifically researched for its ability to increase arousal and desire. PT-141 targets the central nervous system directly to improve libido and pleasure. It's an effective and powerful enhancer for both mood and your senses."
Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)
Your firm offers "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the six above-mentioned products. The sale of these products together demonstrates that you intend your "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" to be used in combination for injection. Therefore, your "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" is a drug.
Semaglutide (GLP-1 SEM)," "Tirzepatide (GLP-2 TRZ)," "Retatrutide (GLP-3 RT)," "SS-31 (Elamipretide)," "Tesamorelin," "PT-141 (Bremelanotide)," and "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" 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 (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug 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 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. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Conclusion
As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number "735067" in the subject line of the email.
If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
Please note FDA posts warning letters on www.fda.gov.
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, U.S. Food and Drug Administration
* * *
Footnote:
1/ Despite statements on your product labeling marketing your products "research use only", "for research and laboratory use only", and "not for human or veterinary use," evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water as a solvent for reconstituting your products, thus, providing the means to prepare an injectable drug for human administration.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026
FDA Center for Drug Evaluation & Research Issues Warning Letter to Peptide Partners
WASHINGTON, Sept. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Peptide Partners LLC from its Center for Drug Evaluation and Research:
* * *
Recipient: Zachary David Hoff, Peptide Partners LLC, 8350 Bee Ridge, #379, Sarasota, FL 34241-9607, United States, support@peptide.partners, (b)(6), (b)(7)(C)
Issuing Office: Center for Drug Evaluation and Research (CDER) United States
Pirsek Technologies, 6776 Timberland Lane, Sarasota, FL 34241-9760
WARNING LETTER
Reference Number: 735063
To Zachary David Hoff:
This warning ... Show Full Article WASHINGTON, Sept. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Peptide Partners LLC from its Center for Drug Evaluation and Research: * * * Recipient: Zachary David Hoff, Peptide Partners LLC, 8350 Bee Ridge, #379, Sarasota, FL 34241-9607, United States, support@peptide.partners, (b)(6), (b)(7)(C) Issuing Office: Center for Drug Evaluation and Research (CDER) United States Pirsek Technologies, 6776 Timberland Lane, Sarasota, FL 34241-9760 WARNING LETTER Reference Number: 735063 To Zachary David Hoff: This warningletter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body's key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.
FDA Review
Violations were identified and documented during a review of your website https://peptide.partners/ in July 2026. Based on our review,"GLP-1 S (Semaglutide)," "GLP-2 T (Tirzepatide)," "GLP-3 Reta (Retatrutide)," "SS-31 (Elamipretide)," "Tesa Peptide (Tesamorelin)," "PT-141 (Bremelanotide)," and "Reconstitution Solution (BAC)" are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.
Unapproved New Drug Violations
Based on a review of your website, "GLP-1 S (Semaglutide)," "GLP-2 T (Tirzepatide)," "GLP-3 Reta (Retatrutide)," "SS-31 (Elamipretide)," "Tesa Peptide (Tesamorelin)," "PT-141 (Bremelanotide)," and "Reconstitution Solution (BAC)" are drugs under 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.
1 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
GLP-1 S (Semaglutide)
On the webpage https://peptide.partners/product/glp-1-semaglutide/:
* "This laboratory study . . . suggests that semaglutide could have potential benefits for bone health by promoting the generation of new bone tissue."
* "[T]his lab experiment . . . [suggests] that semaglutide might help improve metabolism by making muscle cells better at producing energy, even if it doesn't directly fix the insulin resistance problem."
* "[T]his laboratory study . . . suggests that semaglutide could have a protective effect on brain cells, which might be relevant for neurodegenerative diseases like Alzheimer's."
GLP-2 T (Tirzepatide)
On the webpage https://peptide.partners/product/glp-2-tirzepatide/:
* "This research explains how tirzepatide . . . mainly activates the GIP receptor strongly but only partly activates the GLP-1 receptor . . . [which] may help explain why tirzepatide is effective in lowering blood sugar and reducing weight."
* "This study shows that tirzepatide . . . help[s] improve blood sugar and lipid levels without increasing fat mass, offering a better understanding of how tirzepatide works to improve metabolic health in diabetes and obesity."
* "This study shows that tirzepatide . . . has direct protective effects on the kidneys, which could be beneficial for patients with diabetic kidney disease."
GLP-3 Reta (Retatrutide)
On the webpage https://peptide.partners/product/glp-3-retatrutide-12mg-vials/:
* "Retatrutide . . . can activate three different hormone receptors in the body that control appetite and metabolism . . . allow[ing] it to effectively 'talk' to all three at once, leading to its powerful effects on weight loss and blood sugar control."
* "Retatrutide, a new drug for diabetes and obesity, helps lower bad fats in the blood . . . part of Retatrutide's effectiveness in improving cholesterol levels comes from its direct action on the liver."
* "Scientists have discovered how the weight-loss drug Retatrutide can also help treat a type of breast cancer that is more common in obese patients . . . made the cancer cells more sensitive to chemotherapy . . . uncover[ing] a new way that obesity affects cancer and suggests that drugs like Retatrutide could be used to improve cancer treatment in obese patients."
SS-31 (Elamipretide)
On the webpage https://peptide.partners/product/ss-31/:
* "This lab study looked at how the peptide SS-31 could protect eye cells from damage . . . when the cells were treated with SS-31 beforehand, they were better able to survive and had less damage . . . suggest[ing] that SS-31 could be a potential treatment to protect the retina."
* "SS-31 helps the cells to clean out waste and damaged parts . . . suggesting it could be a promising agent for treating liver inflammation."
Tesa Peptide (Tesamorelin)
On the webpage https://peptide.partners/product/tesamorelin/:
* "[R]esearchers investigated how Tesamorelin affects the liver in people with HIV-associated fatty liver disease . . . and found that the drug changed the activity of genes involved in inflammation, tissue repair, and cell division . . . provid[ing] important insights into the molecular mechanisms by which Tesamorelin improves liver health in this patient population."
PT-141 (Bremelanotide)
On the webpage https://peptide.partners/product/pt-141/:
* "PT-141 works by binding to and activating specific protein receptors on cell surfaces called melanocortin receptors . . . important for understanding how the drug might work in the body to affect sexual function and other processes controlled by these receptors."
* "This study discovered that bremelanotide can kill brain cancer cells (glioblastoma) grown in laboratory culture dishes without harming normal cells."
Reconstitution Solution (BAC)
Your firm offers "Reconstitution Solution (BAC)" for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the six above-mentioned products. The sale of these products together demonstrates that you intend for your "Reconstitution Solution (BAC)" to be used in combination for injection. Therefore, your "Reconstitution Solution (BAC)" is a drug.
"GLP-1 S (Semaglutide)," "GLP-2 T (Tirzepatide)," "GLP-3 Reta (Retatrutide)," "SS-31 (Elamipretide)," "Tesa Peptide (Tesamorelin)," "PT-141 (Bremelanotide)," and "Reconstitution Solution (BAC)" 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 (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug 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 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. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Conclusion
As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number "735063" in the subject line of the email.
If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
Please note FDA posts warning letters on www.fda.gov.
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, U.S. Food and Drug Administration
* * *
Footnote:
1/ Despite statements on your product labeling marketing your products "for research use only" and "not for human or veterinary use," evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water as a solvent for reconstituting your products, thus, providing the means to prepare an injectable drug for human administration.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026
* * *
Recipient: Zachary David Hoff, Peptide Partners LLC, 8350 Bee Ridge, #379, Sarasota, FL 34241-9607, United States, support@peptide.partners, (b)(6), (b)(7)(C)
Issuing Office: Center for Drug Evaluation and Research (CDER) United States
Pirsek Technologies, 6776 Timberland Lane, Sarasota, FL 34241-9760
WARNING LETTER
Reference Number: 735063
To Zachary David Hoff:
This warning ... Show Full Article WASHINGTON, Sept. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Peptide Partners LLC from its Center for Drug Evaluation and Research: * * * Recipient: Zachary David Hoff, Peptide Partners LLC, 8350 Bee Ridge, #379, Sarasota, FL 34241-9607, United States, support@peptide.partners, (b)(6), (b)(7)(C) Issuing Office: Center for Drug Evaluation and Research (CDER) United States Pirsek Technologies, 6776 Timberland Lane, Sarasota, FL 34241-9760 WARNING LETTER Reference Number: 735063 To Zachary David Hoff: This warningletter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body's key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.
FDA Review
Violations were identified and documented during a review of your website https://peptide.partners/ in July 2026. Based on our review,"GLP-1 S (Semaglutide)," "GLP-2 T (Tirzepatide)," "GLP-3 Reta (Retatrutide)," "SS-31 (Elamipretide)," "Tesa Peptide (Tesamorelin)," "PT-141 (Bremelanotide)," and "Reconstitution Solution (BAC)" are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.
Unapproved New Drug Violations
Based on a review of your website, "GLP-1 S (Semaglutide)," "GLP-2 T (Tirzepatide)," "GLP-3 Reta (Retatrutide)," "SS-31 (Elamipretide)," "Tesa Peptide (Tesamorelin)," "PT-141 (Bremelanotide)," and "Reconstitution Solution (BAC)" are drugs under 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.
1 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
GLP-1 S (Semaglutide)
On the webpage https://peptide.partners/product/glp-1-semaglutide/:
* "This laboratory study . . . suggests that semaglutide could have potential benefits for bone health by promoting the generation of new bone tissue."
* "[T]his lab experiment . . . [suggests] that semaglutide might help improve metabolism by making muscle cells better at producing energy, even if it doesn't directly fix the insulin resistance problem."
* "[T]his laboratory study . . . suggests that semaglutide could have a protective effect on brain cells, which might be relevant for neurodegenerative diseases like Alzheimer's."
GLP-2 T (Tirzepatide)
On the webpage https://peptide.partners/product/glp-2-tirzepatide/:
* "This research explains how tirzepatide . . . mainly activates the GIP receptor strongly but only partly activates the GLP-1 receptor . . . [which] may help explain why tirzepatide is effective in lowering blood sugar and reducing weight."
* "This study shows that tirzepatide . . . help[s] improve blood sugar and lipid levels without increasing fat mass, offering a better understanding of how tirzepatide works to improve metabolic health in diabetes and obesity."
* "This study shows that tirzepatide . . . has direct protective effects on the kidneys, which could be beneficial for patients with diabetic kidney disease."
GLP-3 Reta (Retatrutide)
On the webpage https://peptide.partners/product/glp-3-retatrutide-12mg-vials/:
* "Retatrutide . . . can activate three different hormone receptors in the body that control appetite and metabolism . . . allow[ing] it to effectively 'talk' to all three at once, leading to its powerful effects on weight loss and blood sugar control."
* "Retatrutide, a new drug for diabetes and obesity, helps lower bad fats in the blood . . . part of Retatrutide's effectiveness in improving cholesterol levels comes from its direct action on the liver."
* "Scientists have discovered how the weight-loss drug Retatrutide can also help treat a type of breast cancer that is more common in obese patients . . . made the cancer cells more sensitive to chemotherapy . . . uncover[ing] a new way that obesity affects cancer and suggests that drugs like Retatrutide could be used to improve cancer treatment in obese patients."
SS-31 (Elamipretide)
On the webpage https://peptide.partners/product/ss-31/:
* "This lab study looked at how the peptide SS-31 could protect eye cells from damage . . . when the cells were treated with SS-31 beforehand, they were better able to survive and had less damage . . . suggest[ing] that SS-31 could be a potential treatment to protect the retina."
* "SS-31 helps the cells to clean out waste and damaged parts . . . suggesting it could be a promising agent for treating liver inflammation."
Tesa Peptide (Tesamorelin)
On the webpage https://peptide.partners/product/tesamorelin/:
* "[R]esearchers investigated how Tesamorelin affects the liver in people with HIV-associated fatty liver disease . . . and found that the drug changed the activity of genes involved in inflammation, tissue repair, and cell division . . . provid[ing] important insights into the molecular mechanisms by which Tesamorelin improves liver health in this patient population."
PT-141 (Bremelanotide)
On the webpage https://peptide.partners/product/pt-141/:
* "PT-141 works by binding to and activating specific protein receptors on cell surfaces called melanocortin receptors . . . important for understanding how the drug might work in the body to affect sexual function and other processes controlled by these receptors."
* "This study discovered that bremelanotide can kill brain cancer cells (glioblastoma) grown in laboratory culture dishes without harming normal cells."
Reconstitution Solution (BAC)
Your firm offers "Reconstitution Solution (BAC)" for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the six above-mentioned products. The sale of these products together demonstrates that you intend for your "Reconstitution Solution (BAC)" to be used in combination for injection. Therefore, your "Reconstitution Solution (BAC)" is a drug.
"GLP-1 S (Semaglutide)," "GLP-2 T (Tirzepatide)," "GLP-3 Reta (Retatrutide)," "SS-31 (Elamipretide)," "Tesa Peptide (Tesamorelin)," "PT-141 (Bremelanotide)," and "Reconstitution Solution (BAC)" 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 (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug 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 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. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Conclusion
As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number "735063" in the subject line of the email.
If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
Please note FDA posts warning letters on www.fda.gov.
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, U.S. Food and Drug Administration
* * *
Footnote:
1/ Despite statements on your product labeling marketing your products "for research use only" and "not for human or veterinary use," evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water as a solvent for reconstituting your products, thus, providing the means to prepare an injectable drug for human administration.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026
FDA Center for Drug Evaluation & Research Issues Warning Letter to NuScience Peptides
WASHINGTON, Sept. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to NuScience Peptides LLC from its Center for Drug Evaluation and Research:
* * *
Recipient: Joseph and Ratsamy DeRosa, Managers, NuScience Peptides LLC, 20311 Chartwell Center Dr., Suite 212, Cornelius, NC 28031, United States, info@nusciencepeptides.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Reference Number: 733652
To Joseph and Ratsamy DeRosa:
This warning letter advises you of significant violations ... Show Full Article WASHINGTON, Sept. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to NuScience Peptides LLC from its Center for Drug Evaluation and Research: * * * Recipient: Joseph and Ratsamy DeRosa, Managers, NuScience Peptides LLC, 20311 Chartwell Center Dr., Suite 212, Cornelius, NC 28031, United States, info@nusciencepeptides.com Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER Reference Number: 733652 To Joseph and Ratsamy DeRosa: This warning letter advises you of significant violationsobserved during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body's key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.
FDA Review
Violations were identified and documented during a review of your website nusciencepeptides.com in July 2026. Based on our review, "GLP-2 Tirz Peptide," "GLP-1 Sema Research Peptide," "GLP-3 RT (Retatrutide) Research Peptide," "Survodutide," "Mazdutide," "PT-141 Peptide (Bremelanotide)," "Tesamorelin Research Peptide," "Tesamorelin Ipamorelin Blend," and "Bacteriostatic water for Peptides (BAC Water)" are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.
Unapproved New Drug Violations
Based on a review of your website, "GLP-2 Tirz Peptide," "GLP-1 Sema Research Peptide," "GLP-3 RT (Retatrutide) Research Peptide," "Survodutide," "Mazdutide," "PT-141 Peptide (Bremelanotide)," "Tesamorelin Research Peptide," "Tesamorelin Ipamorelin Blend," and "Bacteriostatic water for Peptides (BAC Water)" are drugs under 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.//1 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
GLP-2 Tirz Peptide
On the webpage https://nusciencepeptides.com/product/glp-2-tz-2/:
* "GLP-2 Tirz, a research peptide of significant interest, is known for its dual agonist activity on glucagon-like peptide-2 (GLP-2) and glucose-dependent insulinotropic polypeptide (GIP) receptors. This peptide has been extensively studied in rodent models, particularly rats, to explore its metabolic effects and potential therapeutic applications in various conditions. Researchers use these models to gain valuable insights into the complex mechanisms of metabolic regulation and the integrated actions of incretin hormones."
GLP-1 Sema Research Peptide
On the webpage https://pubchem.ncbi.nlm.nih.gov/compound/56843331#datasheet=LCSS (hyperlinked from https://nusciencepeptides.com/product/glp-1-sm/):
* "**Mechanism of cardiovascular benefit and weight loss** In hypercholesterolemia, semaglutide is believed to reduce the progression of atherosclerosis via decreased gut permeability and decreased inflammation. Weight loss is believed to occur via the reduction of appetite and food cravings after semaglutide administration."
GLP-3 RT (Retatrutide) Research Peptide
On the webpage https://nusciencepeptides.com/product/glp-3-rt/:
* "GLP-3 RT (Retatrutide) is a novel investigational peptide being explored for its potential research applications in metabolic disorders, particularly obesity and type 2 diabetes. Also known as LY3437943, it functions as a triple receptor agonist -- a glp3 peptide that targets the GLP-1, GIP, and glucagon receptor pathways simultaneously"
Survodutide
On the webpage https://nusciencepeptides.com/product/survodutide/:
* "Survodutide (BI 456906) is a dual agonist targeting both the glucagon receptor (GCGR) and the glucagon-like peptide-1 receptor (GLP-1R), developed for laboratory research into obesity and type 2 diabetes metabolic pathways. Preclinical studies in rodent models have demonstrated its efficacy in promoting weight loss and improving glycemic control."
* "In conclusion, survodutide's dual GCGR/GLP-1R agonism offers a multifaceted approach to treating metabolic disorders. Its efficacy in preclinical models supports further investigation and development as a subject of investigation for obesity and metabolic disorder research."
Mazdutide
On the webpage https://nusciencepeptides.com/product/mazdutide/:
* "Mazdutide (IBI362), a dual agonist targeting both GLP-1 and glucagon receptors, has shown promising results in clinical trials for weight management and metabolic disorders. This mazdutide peptide has been extensively studied in humans, but preclinical research, particularly in rat models, remains limited."
* "Furthermore, mazdutide has been associated with reductions in liver fat content and improvements in insulin sensitivity in clinical trials, highlighting its potential for treating non-alcoholic fatty liver disease and type 2 diabetes."
PT-141 Peptide (Bremelanotide)
On the webpage https://nusciencepeptides.com/product/pt-141-bremelanotide/:
* "PT-141, also known as bremelanotide, is a synthetic PT-141 peptide classified as a non-selective agonist of melanocortin receptors, with primary activity at MC3R and MC4R. This research peptide has been widely examined in preclinical models to better understand melanocortin-mediated signaling pathways involved in sexual behavior and neuroendocrine regulation."
* "Additional studies examining melanocortin receptor agonists support the role of PT-141 in modulating sexual behaviors across sexes through central nervous system pathways. The involvement of the melanocortin system highlights the relevance of PT-141 peptide in experimental research exploring neural control of sexual function."
Tesamorelin Research Peptide and Tesamorelin Ipamorelin Blend
On the webpage https://nusciencepeptides.com/product/tesamorelin/:
* "Beyond metabolic effects, tesamorelin has demonstrated the ability to reduce muscle fat and increase muscle area in clinical studies . . . [s]uch findings are particularly relevant for exploring interventions in muscle-wasting conditions."
* "Furthermore, research indicates that tesamorelin may enhance cognitive function, including improvements in executive function and verbal memory."
On the webpage https://nusciencepeptides.com/product/tesamorelin-ipamorelin/:
* "Tesamorelin, a growth hormone-releasing hormone (GHRH) analog, has been shown to significantly reduce visceral adipose tissue and improve liver health by decreasing liver fat and preventing fibrosis progression."
* "[R]esearch has indicated that ipamorelin can counteract glucocorticoid-induced reductions in bone formation, suggesting its potential in mitigating bone density loss associated with glucocorticoid therapy."
Bacteriostatic water for Peptides (BAC Water)
Your firm offers "Bacteriostatic water for Peptides (BAC Water)" for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the above-mentioned products. The sale of these products together demonstrates that you intend for your "Bacteriostatic water for Peptides (BAC Water)" to be used in combination for injection. Therefore, your "Bacteriostatic water for Peptides (BAC Water)" is a drug.
"GLP-2 Tirz Peptide," "GLP-1 Sema Research Peptide," "GLP-3 RT (Retatrutide) Research Peptide," "Survodutide," "Mazdutide," "PT-141 Peptide (Bremelanotide)," "Tesamorelin Research Peptide," "Tesamorelin Ipamorelin Blend," and "Bacteriostatic water for Peptides (BAC Water)" 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 (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug 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 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. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Conclusion
As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number "733652" in the subject line of the email.
If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
Please note FDA posts warning letters on www.fda.gov.
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, U.S. Food and Drug Administration
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Footnote:
1/ Despite statements on your product labeling marketing your products "for laboratory, research, and analytical use" and "not intended for human or veterinary use," evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water alongside a "peptide calculator," a resource that provides the means to prepare an injectable drug for human administration.
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026
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Recipient: Joseph and Ratsamy DeRosa, Managers, NuScience Peptides LLC, 20311 Chartwell Center Dr., Suite 212, Cornelius, NC 28031, United States, info@nusciencepeptides.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Reference Number: 733652
To Joseph and Ratsamy DeRosa:
This warning letter advises you of significant violations ... Show Full Article WASHINGTON, Sept. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to NuScience Peptides LLC from its Center for Drug Evaluation and Research: * * * Recipient: Joseph and Ratsamy DeRosa, Managers, NuScience Peptides LLC, 20311 Chartwell Center Dr., Suite 212, Cornelius, NC 28031, United States, info@nusciencepeptides.com Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER Reference Number: 733652 To Joseph and Ratsamy DeRosa: This warning letter advises you of significant violationsobserved during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body's key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.
FDA Review
Violations were identified and documented during a review of your website nusciencepeptides.com in July 2026. Based on our review, "GLP-2 Tirz Peptide," "GLP-1 Sema Research Peptide," "GLP-3 RT (Retatrutide) Research Peptide," "Survodutide," "Mazdutide," "PT-141 Peptide (Bremelanotide)," "Tesamorelin Research Peptide," "Tesamorelin Ipamorelin Blend," and "Bacteriostatic water for Peptides (BAC Water)" are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.
Unapproved New Drug Violations
Based on a review of your website, "GLP-2 Tirz Peptide," "GLP-1 Sema Research Peptide," "GLP-3 RT (Retatrutide) Research Peptide," "Survodutide," "Mazdutide," "PT-141 Peptide (Bremelanotide)," "Tesamorelin Research Peptide," "Tesamorelin Ipamorelin Blend," and "Bacteriostatic water for Peptides (BAC Water)" are drugs under 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.//1 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
GLP-2 Tirz Peptide
On the webpage https://nusciencepeptides.com/product/glp-2-tz-2/:
* "GLP-2 Tirz, a research peptide of significant interest, is known for its dual agonist activity on glucagon-like peptide-2 (GLP-2) and glucose-dependent insulinotropic polypeptide (GIP) receptors. This peptide has been extensively studied in rodent models, particularly rats, to explore its metabolic effects and potential therapeutic applications in various conditions. Researchers use these models to gain valuable insights into the complex mechanisms of metabolic regulation and the integrated actions of incretin hormones."
GLP-1 Sema Research Peptide
On the webpage https://pubchem.ncbi.nlm.nih.gov/compound/56843331#datasheet=LCSS (hyperlinked from https://nusciencepeptides.com/product/glp-1-sm/):
* "**Mechanism of cardiovascular benefit and weight loss** In hypercholesterolemia, semaglutide is believed to reduce the progression of atherosclerosis via decreased gut permeability and decreased inflammation. Weight loss is believed to occur via the reduction of appetite and food cravings after semaglutide administration."
GLP-3 RT (Retatrutide) Research Peptide
On the webpage https://nusciencepeptides.com/product/glp-3-rt/:
* "GLP-3 RT (Retatrutide) is a novel investigational peptide being explored for its potential research applications in metabolic disorders, particularly obesity and type 2 diabetes. Also known as LY3437943, it functions as a triple receptor agonist -- a glp3 peptide that targets the GLP-1, GIP, and glucagon receptor pathways simultaneously"
Survodutide
On the webpage https://nusciencepeptides.com/product/survodutide/:
* "Survodutide (BI 456906) is a dual agonist targeting both the glucagon receptor (GCGR) and the glucagon-like peptide-1 receptor (GLP-1R), developed for laboratory research into obesity and type 2 diabetes metabolic pathways. Preclinical studies in rodent models have demonstrated its efficacy in promoting weight loss and improving glycemic control."
* "In conclusion, survodutide's dual GCGR/GLP-1R agonism offers a multifaceted approach to treating metabolic disorders. Its efficacy in preclinical models supports further investigation and development as a subject of investigation for obesity and metabolic disorder research."
Mazdutide
On the webpage https://nusciencepeptides.com/product/mazdutide/:
* "Mazdutide (IBI362), a dual agonist targeting both GLP-1 and glucagon receptors, has shown promising results in clinical trials for weight management and metabolic disorders. This mazdutide peptide has been extensively studied in humans, but preclinical research, particularly in rat models, remains limited."
* "Furthermore, mazdutide has been associated with reductions in liver fat content and improvements in insulin sensitivity in clinical trials, highlighting its potential for treating non-alcoholic fatty liver disease and type 2 diabetes."
PT-141 Peptide (Bremelanotide)
On the webpage https://nusciencepeptides.com/product/pt-141-bremelanotide/:
* "PT-141, also known as bremelanotide, is a synthetic PT-141 peptide classified as a non-selective agonist of melanocortin receptors, with primary activity at MC3R and MC4R. This research peptide has been widely examined in preclinical models to better understand melanocortin-mediated signaling pathways involved in sexual behavior and neuroendocrine regulation."
* "Additional studies examining melanocortin receptor agonists support the role of PT-141 in modulating sexual behaviors across sexes through central nervous system pathways. The involvement of the melanocortin system highlights the relevance of PT-141 peptide in experimental research exploring neural control of sexual function."
Tesamorelin Research Peptide and Tesamorelin Ipamorelin Blend
On the webpage https://nusciencepeptides.com/product/tesamorelin/:
* "Beyond metabolic effects, tesamorelin has demonstrated the ability to reduce muscle fat and increase muscle area in clinical studies . . . [s]uch findings are particularly relevant for exploring interventions in muscle-wasting conditions."
* "Furthermore, research indicates that tesamorelin may enhance cognitive function, including improvements in executive function and verbal memory."
On the webpage https://nusciencepeptides.com/product/tesamorelin-ipamorelin/:
* "Tesamorelin, a growth hormone-releasing hormone (GHRH) analog, has been shown to significantly reduce visceral adipose tissue and improve liver health by decreasing liver fat and preventing fibrosis progression."
* "[R]esearch has indicated that ipamorelin can counteract glucocorticoid-induced reductions in bone formation, suggesting its potential in mitigating bone density loss associated with glucocorticoid therapy."
Bacteriostatic water for Peptides (BAC Water)
Your firm offers "Bacteriostatic water for Peptides (BAC Water)" for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the above-mentioned products. The sale of these products together demonstrates that you intend for your "Bacteriostatic water for Peptides (BAC Water)" to be used in combination for injection. Therefore, your "Bacteriostatic water for Peptides (BAC Water)" is a drug.
"GLP-2 Tirz Peptide," "GLP-1 Sema Research Peptide," "GLP-3 RT (Retatrutide) Research Peptide," "Survodutide," "Mazdutide," "PT-141 Peptide (Bremelanotide)," "Tesamorelin Research Peptide," "Tesamorelin Ipamorelin Blend," and "Bacteriostatic water for Peptides (BAC Water)" 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 (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug 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 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. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Conclusion
As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number "733652" in the subject line of the email.
If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
Please note FDA posts warning letters on www.fda.gov.
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, U.S. Food and Drug Administration
* * *
Footnote:
1/ Despite statements on your product labeling marketing your products "for laboratory, research, and analytical use" and "not intended for human or veterinary use," evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water alongside a "peptide calculator," a resource that provides the means to prepare an injectable drug for human administration.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026
Economics Daily: On Average, 71 Percent of Wage and Salary Workers Had Access to Take Paid Leave in 2024-25
WASHINGTON, Sept. 2 -- The U.S. Department of Labor Bureau of Labor Statistics issued the following document from Economics Daily:
* * *
On average, 71 percent of wage and salary workers had access to take paid leave in 2024-25
On average, 71.0 percent of wage and salary workers 15 years and older had access to paid leave at their main jobs in 2024-25, 77.7 percent had access to unpaid leave, and 94.2 percent had access to either paid or unpaid leave. The average percentage of wage and salary workers with access to paid leave increased from 66.0 percent in 2017-18.
In 2024-25, wage and salary ... Show Full Article WASHINGTON, Sept. 2 -- The U.S. Department of Labor Bureau of Labor Statistics issued the following document from Economics Daily: * * * On average, 71 percent of wage and salary workers had access to take paid leave in 2024-25 On average, 71.0 percent of wage and salary workers 15 years and older had access to paid leave at their main jobs in 2024-25, 77.7 percent had access to unpaid leave, and 94.2 percent had access to either paid or unpaid leave. The average percentage of wage and salary workers with access to paid leave increased from 66.0 percent in 2017-18. In 2024-25, wage and salaryworkers in management, business, and financial operations occupations were the most likely to have access to paid leave (89.5 percent). Workers in service occupations (44.9 percent) and construction and extraction occupations (50.0 percent) were the least likely to have access to paid leave. The gains in access to paid leave between 2017-18 and 2024-25 were widespread across occupations including construction and extraction, transportation and material moving, and management, business, and financial operations. Occupations showing decreases were not significantly different from prior years.
These data are from a supplementary set of questions asked as part of the 2024 and 2025 American Time Use Surveys (ATUS) collected directly from wage and salary workers, excluding self-employed. The data thus represent only workers' knowledge on these topics; workers sometimes do not know whether they can use leave until they have a need to do so. To learn more, see "Access to and Use of Leave -- 2024-2025 Data from the American Time Use Survey."
SUGGESTED CITATION
Bureau of Labor Statistics, U.S. Department of Labor, The Economics Daily, On average, 71 percent of wage and salary workers had access to take paid leave in 2024-25 at https://www.bls.gov/opub/ted/2026/on-average-71-percent-of-wage-and-salary-workers-had-access-to-take-paid-leave-in-2024-25.htm (visited September 02, 2026).
OF INTEREST
* BLS Videos: Occupational Employment Projections 2025-35
* Debunking common misconceptions about the Job Openings and Labor Turnover Survey: BLS research disproves overcounting and other myths in JOLTS data
* The cost of doing business: input shares and trends in input-related price indexes
* Examining the mortality of young baby boomers by age 58: evidence from the NLSY79
* Skills savvy: a skills-based look at occupational data
* * *
View original text plus charts and tables here: https://www.bls.gov/opub/ted/2026/on-average-71-percent-of-wage-and-salary-workers-had-access-to-take-paid-leave-in-2024-25.htm
* * *
On average, 71 percent of wage and salary workers had access to take paid leave in 2024-25
On average, 71.0 percent of wage and salary workers 15 years and older had access to paid leave at their main jobs in 2024-25, 77.7 percent had access to unpaid leave, and 94.2 percent had access to either paid or unpaid leave. The average percentage of wage and salary workers with access to paid leave increased from 66.0 percent in 2017-18.
In 2024-25, wage and salary ... Show Full Article WASHINGTON, Sept. 2 -- The U.S. Department of Labor Bureau of Labor Statistics issued the following document from Economics Daily: * * * On average, 71 percent of wage and salary workers had access to take paid leave in 2024-25 On average, 71.0 percent of wage and salary workers 15 years and older had access to paid leave at their main jobs in 2024-25, 77.7 percent had access to unpaid leave, and 94.2 percent had access to either paid or unpaid leave. The average percentage of wage and salary workers with access to paid leave increased from 66.0 percent in 2017-18. In 2024-25, wage and salaryworkers in management, business, and financial operations occupations were the most likely to have access to paid leave (89.5 percent). Workers in service occupations (44.9 percent) and construction and extraction occupations (50.0 percent) were the least likely to have access to paid leave. The gains in access to paid leave between 2017-18 and 2024-25 were widespread across occupations including construction and extraction, transportation and material moving, and management, business, and financial operations. Occupations showing decreases were not significantly different from prior years.
These data are from a supplementary set of questions asked as part of the 2024 and 2025 American Time Use Surveys (ATUS) collected directly from wage and salary workers, excluding self-employed. The data thus represent only workers' knowledge on these topics; workers sometimes do not know whether they can use leave until they have a need to do so. To learn more, see "Access to and Use of Leave -- 2024-2025 Data from the American Time Use Survey."
SUGGESTED CITATION
Bureau of Labor Statistics, U.S. Department of Labor, The Economics Daily, On average, 71 percent of wage and salary workers had access to take paid leave in 2024-25 at https://www.bls.gov/opub/ted/2026/on-average-71-percent-of-wage-and-salary-workers-had-access-to-take-paid-leave-in-2024-25.htm (visited September 02, 2026).
OF INTEREST
* BLS Videos: Occupational Employment Projections 2025-35
* Debunking common misconceptions about the Job Openings and Labor Turnover Survey: BLS research disproves overcounting and other myths in JOLTS data
* The cost of doing business: input shares and trends in input-related price indexes
* Examining the mortality of young baby boomers by age 58: evidence from the NLSY79
* Skills savvy: a skills-based look at occupational data
* * *
View original text plus charts and tables here: https://www.bls.gov/opub/ted/2026/on-average-71-percent-of-wage-and-salary-workers-had-access-to-take-paid-leave-in-2024-25.htm
Brookhaven Lab to Lead $14M AI Project for Nation's Electric Grid
UPTON, New York, Sept. 2 -- The U.S. Department of Energy Brookhaven National Laboratory issued the following news release:
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Brookhaven Lab to Lead $14M AI Project for Nation's Electric Grid
Funded through the Genesis Mission Phase II Request for Application, Brookhaven Lab will lead a three-year effort to develop a next-generation grid foundation model
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The U.S. Department of Energy's (DOE) Brookhaven National Laboratory has been selected by DOE to lead a $14.2 million project through the Genesis Mission Phase II Request for Application (RFA). The award to Brookhaven and its collaborators ... Show Full Article UPTON, New York, Sept. 2 -- The U.S. Department of Energy Brookhaven National Laboratory issued the following news release: * * * Brookhaven Lab to Lead $14M AI Project for Nation's Electric Grid Funded through the Genesis Mission Phase II Request for Application, Brookhaven Lab will lead a three-year effort to develop a next-generation grid foundation model - The U.S. Department of Energy's (DOE) Brookhaven National Laboratory has been selected by DOE to lead a $14.2 million project through the Genesis Mission Phase II Request for Application (RFA). The award to Brookhaven and its collaboratorswill support three years of research to develop a next-generation grid foundation model (GridFM), an artificial intelligence (AI) system that can rapidly simulate scenarios for adding new loads to the electric grid. With the goal of building a model that can simulate 1 billion scenarios in 24 hours, the project aims to significantly accelerate grid expansion planning with optimal accuracy, affordability, and efficiency in operations.
The funding was announced today at Brookhaven Lab by DOE Assistant Secretary for the Office of Electricity (OE) Catherine Jereza. OE is administering the funding for this Genesis Mission project, called "Foundation Models for the Electric Grid: From Proof of Concept to Real-world Impacts." $3.9 million of the total project funds will be allocated to Brookhaven, with the rest being shared by collaborating institutions.
"This project represents a bold step forward to supercharge scientific discovery using artificial intelligence to modernize America's electric grid," Assistant Secretary Jereza said. "By providing utilities enhanced AI tools, they can plan and operate the grid faster, more reliably, and more cost-effectively to help meet the demands of a growing economy while delivering affordable, reliable power for homes and businesses while unleashing American energy dominance."
"This award reflects DOE's confidence in Brookhaven Lab to bring together science, artificial intelligence, and strong partnerships to address challenges of national importance," said Brookhaven Lab Director John Hill. "As electricity demand continues to grow, we need new approaches to strengthen, expand, and efficiently operate the nation's electric grid. We're proud to lead this effort and to work with an outstanding team to turn innovation into real-world impact for America's energy future."
The GridFM Genesis Mission Phase II project led by Brookhaven Lab includes collaborators from the National Laboratory of the Rockies, the Massachusetts Institute of Technology, the University of Illinois at Urbana Champaign, Stony Brook University, Cornell University, the University of Texas Arlington, GE Vernova Research, IBM Research, NVIDIA, Accenture Federal Services, Amazon Web Services, Alvarez and Marsal, Microsoft, the New York Power Authority, Alabama Power, the Long Island Power Authority, National Grid, Con Edison, New York Independent System Operators, the New York State Energy Research and Development Authority, Great River Energy, the National Rural Electric Cooperative Association, LF Energy, the Advanced Energy Center, the Horizon Institute for Public Service, and the GridFM Corporation.
The GridFM initiative, on a larger scale, is a community project spanning industry, academia, and government, with contributions from more than 150 organizations. The initiative is strengthened by collaboration between utilities -- which provide operational data and system experience -- and researchers and technology providers, who provide AI expertise and computing resources. Open-source development of GridFM is administered and managed in partnership with the Linux Foundation Energy.
"AI is often seen as a growing burden on the electric grid, but through the Genesis Mission we have an opportunity to turn that challenge into an advantage," said Hendrik Hamann, chief AI scientist for Innovation, Science, and Security at Brookhaven Lab, joint appointee at Stony Brook University, and principal investigator for the project. "By bringing together the right partners and scaling AI and grid foundation models for the electric grid, we can accelerate planning, improve operations and efficiency, and help build a more affordable, resilient energy system."
The Genesis Mission is a historic national initiative led by DOE, which is building the world's most powerful integrated science discovery platform. By uniting government, industry, academia, and philanthropy, it is accelerating breakthroughs in energy, scientific discovery, and national security through a new platform that combines AI, supercomputing, quantum systems, and advanced scientific instruments.
Brookhaven is advancing the goals of the Genesis Mission by improving AI for science and society across the Lab's research initiatives. In July, DOE awarded Brookhaven seven Phase I Genesis Mission projects supporting AI research for microelectronics, nuclear and high energy physics, computational science, and atmospheric science. The Lab is also contributing to 29 additional Phase I projects led by other National Laboratories, research universities, and private industry. Now, as the leader of a Phase II RFA project, Brookhaven Lab is expanding its contributions to this historic mission and helping to further ensure the nation's energy security.
"Assistant Secretary Katie Jereza's visit and the announcement of Genesis Phase II underscore that Long Island is at the forefront of America's scientific and energy innovation," said U.S. Rep. Nick LaLota. "BNL's work strengthens our energy security, fuels technological breakthroughs, and helps ensure the United States remains the world's leader in scientific research. In Congress, I'll continue fighting for targeted investments that advance our national security, strengthen our economy, and deliver long-term value for taxpayers. I'm excited to see Genesis Phase II build on Brookhaven's remarkable legacy of innovation."
* * *
Brookhaven National Laboratory is supported by the Office of Science of the U.S. Department of Energy. The Office of Science is the single largest supporter of basic research in the physical sciences in the United States and is working to address some of the most pressing challenges of our time. For more information, visit science.energy.gov.
* * *
Original text here: https://www.bnl.gov/newsroom/news.php?a=123136
* * *
Brookhaven Lab to Lead $14M AI Project for Nation's Electric Grid
Funded through the Genesis Mission Phase II Request for Application, Brookhaven Lab will lead a three-year effort to develop a next-generation grid foundation model
-
The U.S. Department of Energy's (DOE) Brookhaven National Laboratory has been selected by DOE to lead a $14.2 million project through the Genesis Mission Phase II Request for Application (RFA). The award to Brookhaven and its collaborators ... Show Full Article UPTON, New York, Sept. 2 -- The U.S. Department of Energy Brookhaven National Laboratory issued the following news release: * * * Brookhaven Lab to Lead $14M AI Project for Nation's Electric Grid Funded through the Genesis Mission Phase II Request for Application, Brookhaven Lab will lead a three-year effort to develop a next-generation grid foundation model - The U.S. Department of Energy's (DOE) Brookhaven National Laboratory has been selected by DOE to lead a $14.2 million project through the Genesis Mission Phase II Request for Application (RFA). The award to Brookhaven and its collaboratorswill support three years of research to develop a next-generation grid foundation model (GridFM), an artificial intelligence (AI) system that can rapidly simulate scenarios for adding new loads to the electric grid. With the goal of building a model that can simulate 1 billion scenarios in 24 hours, the project aims to significantly accelerate grid expansion planning with optimal accuracy, affordability, and efficiency in operations.
The funding was announced today at Brookhaven Lab by DOE Assistant Secretary for the Office of Electricity (OE) Catherine Jereza. OE is administering the funding for this Genesis Mission project, called "Foundation Models for the Electric Grid: From Proof of Concept to Real-world Impacts." $3.9 million of the total project funds will be allocated to Brookhaven, with the rest being shared by collaborating institutions.
"This project represents a bold step forward to supercharge scientific discovery using artificial intelligence to modernize America's electric grid," Assistant Secretary Jereza said. "By providing utilities enhanced AI tools, they can plan and operate the grid faster, more reliably, and more cost-effectively to help meet the demands of a growing economy while delivering affordable, reliable power for homes and businesses while unleashing American energy dominance."
"This award reflects DOE's confidence in Brookhaven Lab to bring together science, artificial intelligence, and strong partnerships to address challenges of national importance," said Brookhaven Lab Director John Hill. "As electricity demand continues to grow, we need new approaches to strengthen, expand, and efficiently operate the nation's electric grid. We're proud to lead this effort and to work with an outstanding team to turn innovation into real-world impact for America's energy future."
The GridFM Genesis Mission Phase II project led by Brookhaven Lab includes collaborators from the National Laboratory of the Rockies, the Massachusetts Institute of Technology, the University of Illinois at Urbana Champaign, Stony Brook University, Cornell University, the University of Texas Arlington, GE Vernova Research, IBM Research, NVIDIA, Accenture Federal Services, Amazon Web Services, Alvarez and Marsal, Microsoft, the New York Power Authority, Alabama Power, the Long Island Power Authority, National Grid, Con Edison, New York Independent System Operators, the New York State Energy Research and Development Authority, Great River Energy, the National Rural Electric Cooperative Association, LF Energy, the Advanced Energy Center, the Horizon Institute for Public Service, and the GridFM Corporation.
The GridFM initiative, on a larger scale, is a community project spanning industry, academia, and government, with contributions from more than 150 organizations. The initiative is strengthened by collaboration between utilities -- which provide operational data and system experience -- and researchers and technology providers, who provide AI expertise and computing resources. Open-source development of GridFM is administered and managed in partnership with the Linux Foundation Energy.
"AI is often seen as a growing burden on the electric grid, but through the Genesis Mission we have an opportunity to turn that challenge into an advantage," said Hendrik Hamann, chief AI scientist for Innovation, Science, and Security at Brookhaven Lab, joint appointee at Stony Brook University, and principal investigator for the project. "By bringing together the right partners and scaling AI and grid foundation models for the electric grid, we can accelerate planning, improve operations and efficiency, and help build a more affordable, resilient energy system."
The Genesis Mission is a historic national initiative led by DOE, which is building the world's most powerful integrated science discovery platform. By uniting government, industry, academia, and philanthropy, it is accelerating breakthroughs in energy, scientific discovery, and national security through a new platform that combines AI, supercomputing, quantum systems, and advanced scientific instruments.
Brookhaven is advancing the goals of the Genesis Mission by improving AI for science and society across the Lab's research initiatives. In July, DOE awarded Brookhaven seven Phase I Genesis Mission projects supporting AI research for microelectronics, nuclear and high energy physics, computational science, and atmospheric science. The Lab is also contributing to 29 additional Phase I projects led by other National Laboratories, research universities, and private industry. Now, as the leader of a Phase II RFA project, Brookhaven Lab is expanding its contributions to this historic mission and helping to further ensure the nation's energy security.
"Assistant Secretary Katie Jereza's visit and the announcement of Genesis Phase II underscore that Long Island is at the forefront of America's scientific and energy innovation," said U.S. Rep. Nick LaLota. "BNL's work strengthens our energy security, fuels technological breakthroughs, and helps ensure the United States remains the world's leader in scientific research. In Congress, I'll continue fighting for targeted investments that advance our national security, strengthen our economy, and deliver long-term value for taxpayers. I'm excited to see Genesis Phase II build on Brookhaven's remarkable legacy of innovation."
* * *
Brookhaven National Laboratory is supported by the Office of Science of the U.S. Department of Energy. The Office of Science is the single largest supporter of basic research in the physical sciences in the United States and is working to address some of the most pressing challenges of our time. For more information, visit science.energy.gov.
* * *
Original text here: https://www.bnl.gov/newsroom/news.php?a=123136